{"id":8322,"date":"2026-01-23T20:29:07","date_gmt":"2026-01-23T12:29:07","guid":{"rendered":"https:\/\/ozellemed.com\/?p=8322"},"modified":"2026-01-31T00:45:00","modified_gmt":"2026-01-30T16:45:00","slug":"fda-510k-and-ce-mark-ivdr-for-cbc-analyzers-two-distinct-regulatory-systems-how-to-navigate-both","status":"publish","type":"post","link":"https:\/\/ozellemed.com\/en\/fda-510k-and-ce-mark-ivdr-for-cbc-analyzers-two-distinct-regulatory-systems-how-to-navigate-both\/","title":{"rendered":"FDA 510(k) and CE Mark (IVDR) for CBC Analyzers: Two Distinct Regulatory Systems\u2014How to Navigate Both"},"content":{"rendered":"\n<p>Regulatory approval is essential but structurally different across the US and EU for <a href=\"https:\/\/ozellemed.com\/en\/auto-hematology-analyzer\/\">CBC analyzer suppliers<\/a>. The FDA&#8217;s 510(k) pathway and EU&#8217;s IVDR CE marking system employ distinct procedural architectures, evidence requirements, and governance models\u2014not simply varying speeds for the same goal.<\/p>\n\n\n\n<p>FDA 510(k) achieves clearance via predicate-device equivalence in 4\u201312 months (if strong predicates exist). CE marking under IVDR requires Notified Body conformity assessment across five risk-stratified modules (Class A\u2013D) with 12\u201318 month timelines, but emphasizes systematic clinical evidence review over predicate comparison. Each system has distinct advantages depending on available predicates, manufacturing location, and clinical data.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-the-three-regulatory-pathways-at-a-glance\">The Three Regulatory Pathways at a Glance<\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/09\/gqh3yfteurm-1024x576.jpg\" alt=\"\" class=\"wp-image-7537\" srcset=\"https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/09\/gqh3yfteurm-1024x576.jpg 1024w, https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/09\/gqh3yfteurm-300x169.jpg 300w, https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/09\/gqh3yfteurm-768x432.jpg 768w, https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/09\/gqh3yfteurm-18x10.jpg 18w, https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/09\/gqh3yfteurm.jpg 1280w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-fda-510-k-pathway-usa\">FDA 510(k) Pathway (USA)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Classification: Class II medical devices (moderate risk)<\/li>\n\n\n\n<li>Timeline: 90 FDA days target; real-world: 4\u201312 months calendar time (164 days average)<\/li>\n\n\n\n<li>Cost: $100,000\u2013$500,000<\/li>\n\n\n\n<li>Key Requirement: Predicate device (substantially equivalent to cleared analyzer)<\/li>\n\n\n\n<li>Evidence Required: Engineering\/bench testing, biocompatibility, software validation<\/li>\n<\/ul>\n\n\n\n<p>The FDA pathway relies on predicate device strategy. By identifying a cleared analyzer substantially equivalent to your product, manufacturers can avoid expensive clinical trials. Strong predicates include Sysmex XN-series, Beckman Coulter DxH, Abbott CELL-DYN, and Mindray BC-6800. Predicate selection is critical\u2014wrong selection results in Refuse To Accept (RTA) at Day 15, delaying the entire timeline.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-ce-marking-ivdr-pathway-eu\">CE Marking (IVDR) Pathway (EU)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Classification: Class B\u2013D (IVDR system; higher risk classification than prior IVDD)<\/li>\n\n\n\n<li>Timeline: 12\u201318 months average (Notified Body assessment 11\u201318 months)<\/li>\n\n\n\n<li>Cost: \u20ac15,000\u2013\u20ac50,000+ (Notified Body fees + documentation)<\/li>\n\n\n\n<li>Key Requirement: Technical documentation + risk management + clinical evaluation (IVDR Annex XIV)<\/li>\n\n\n\n<li>Evidence Required: Systematic literature review + risk-benefit assessment<\/li>\n<\/ul>\n\n\n\n<p>According to IVDR Annex VIII, <a href=\"https:\/\/ozellemed.com\/en\/multi-functional-analyzer\/\">CBC analyzers<\/a> typically classify as Class B or Class C based on intended use. Class C applies when devices claim capability for detecting infection or malignancy markers; Class D is exceptional and limited to blood donor safety screening. Classification is risk-based per Annex VIII, not determined by disease names.Unlike FDA&#8217;s predicate pathway, CE marking requires comprehensive technical documentation and systematic clinical evaluation per IVDR Annex XIV. This formal evidence hierarchy often proves more stringent than FDA 510(k) requirements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-detailed-fda-510-k-pathway\">Detailed FDA 510(k) Pathway<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-the-510-k-process-four-phases\">The 510(k) Process: Four Phases<\/h3>\n\n\n\n<p>Phase 1: Pre-Submission (Months 0\u20132)<\/p>\n\n\n\n<p>Identify strong predicate device and develop submission package including technical documentation, predicate comparison, and safety\/performance claims. Conduct biocompatibility testing per ISO 10993 and prepare software documentation with validation matrices and cybersecurity assessment. Critical success factor: Wrong predicate = Refuse To Accept at Day 15.<\/p>\n\n\n\n<p>Phase 2: Submission &amp; Acceptance Review (Months 2\u20133)<\/p>\n\n\n\n<p>Submit via eSTAR (FDA electronic system). FDA conducts acceptance review within 15 calendar days and issues Acknowledgement Letter with receipt date and 510(k) number. If deficiency found: Hold Letter issued; 180 calendar days to cure or submission withdrawn.<\/p>\n\n\n\n<p>Phase 3: Substantive Review (Days 16\u201390)<\/p>\n\n\n\n<p>Lead Reviewer conducts full technical safety\/performance review. 60-day substantive review gate typical. Additional Information (AI) requests pause the 90-day clock. Each AI cycle adds 30\u201360 calendar days. This extended timeline explains the real-world average of 164 calendar days including all pauses.<\/p>\n\n\n\n<p>Phase 4: FDA Decision (Day 90 target)<\/p>\n\n\n\n<p>Substantially Equivalent (SE) determination = Clearance \u2713<\/p>\n\n\n\n<p>Not Substantially Equivalent (NSE) = Reclassification, additional data, or redesign required<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-fda-510-k-cost-breakdown\">FDA 510(k) Cost Breakdown<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td class=\"has-text-align-left\" data-align=\"left\">Cost Component<\/td><td class=\"has-text-align-left\" data-align=\"left\">Range<\/td><td class=\"has-text-align-left\" data-align=\"left\">Notes<\/td><\/tr><tr><td>FDA User Fee<\/td><td>$30,000\u2013$44,000<\/td><td>Fixed; required at submission<\/td><\/tr><tr><td>Technical Documentation<\/td><td>$30,000\u2013$100,000<\/td><td>Literature review, risk analysis, design history<\/td><\/tr><tr><td>Testing &amp; Validation<\/td><td>$20,000\u2013$150,000<\/td><td>Biocompatibility, software, bench testing<\/td><\/tr><tr><td>Regulatory Consulting<\/td><td>$30,000\u2013$100,000<\/td><td>Predicate selection, FDA strategy, interactions<\/td><\/tr><tr><td>Clinical Study (if required)<\/td><td>$50,000\u2013$300,000+<\/td><td>Avoid through strong predicate strategy<\/td><\/tr><tr><td>Total Median<\/td><td>$100,000\u2013$500,000+<\/td><td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Cost Optimization Strategy: Avoid clinical trials by selecting strong predicate device; leverage bench testing and published literature for claims support. Real-world success rates show ~90% of 510(k)s achieve SE determination per FDA MDUFA V goals, with ~40\u201350% receiving at least one AI request cycle extending timeline 30\u201390 days.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Detailed CE Marking (IVDR) Pathway<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"720\" height=\"476\" src=\"https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/11\/10.png\" alt=\"CBC Hematology Analyzer Buyers Guide: How to Choose the Right Analyzer\" class=\"wp-image-8017\" srcset=\"https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/11\/10.png 720w, https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/11\/10-300x198.png 300w, https:\/\/ozellemed.com\/wp-content\/uploads\/2025\/11\/10-18x12.png 18w\" sizes=\"(max-width: 720px) 100vw, 720px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">CE Marking Process: Four Phases<\/h3>\n\n\n\n<p>Phase 1: Technical Documentation Preparation (Months 0\u20133)<\/p>\n\n\n\n<p>Compile technical documentation per IVDR Annexes II &amp; III. Develop risk management plan (ISO 13485 QMS). Prepare clinical evaluation per IVDR Annex XIV including systematic literature review and clinical performance data. Assign Unique Device Identifier (UDI). Identify Notified Body with available capacity\u2014currently capacity-constrained with 18+ month backlogs.<\/p>\n\n\n\n<p>Phase 2: Notified Body Submission (Months 3\u20136)<\/p>\n\n\n\n<p>Submit conformity assessment application to Notified Body. Fee payment (~\u20ac15,000\u2013\u20ac50,000 depending on complexity). Notified Body conducts acceptance review. Critical: Applicants must sign agreement by Sept 26, 2024.<\/p>\n\n\n\n<p>Phase 3: Notified Body Assessment (Months 6\u201318)<\/p>\n\n\n\n<p>EU QMS Certification (quality management audit): 11\u201318 months<\/p>\n\n\n\n<p>EU Technical Documentation Assessment (TDA): 12\u201318 months (varies by Notified Body)<\/p>\n\n\n\n<p>Requests for Additional Information (CAR\/OBN cycles) may extend timeline 3\u20136 months per cycle<\/p>\n\n\n\n<p>Notified Body capacity remains a significant constraint; as of 2025, approximately 19 Notified Bodies are designated under IVDR, but functional capacity varies by assessment workload and device class. Current timelines for EU QMS assessment average 11\u201318 months, with manufacturers advised to engage early with their chosen Notified Body.<\/p>\n\n\n\n<p>Phase 4: CE Mark Issuance (Months 18\u201324)<\/p>\n\n\n\n<p>Notified Body issues certificates upon satisfactory assessment. Manufacturer signs EU Declaration of Conformity (Annex IV). CE mark + Notified Body number affixed to device\/labeling. Post-market surveillance (PMS) &amp; vigilance reporting plan implementation required.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">CE Marking Cost Breakdown<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td class=\"has-text-align-left\" data-align=\"left\">Cost Component<\/td><td class=\"has-text-align-left\" data-align=\"left\">Cost Range<\/td><td class=\"has-text-align-left\" data-align=\"left\">Notes<\/td><\/tr><tr><td>Notified Body Fee<\/td><td>\u20ac15,000\u2013\u20ac50,000<\/td><td>Variable by class &amp; complexity<\/td><\/tr><tr><td>Technical Documentation<\/td><td>\u20ac20,000\u2013\u20ac60,000<\/td><td>Literature review, risk analysis<\/td><\/tr><tr><td>Clinical Evaluation<\/td><td>\u20ac30,000\u2013\u20ac100,000+<\/td><td>Systematic review + performance data<\/td><\/tr><tr><td>ISO 13485 Certification<\/td><td>\u20ac15,000\u2013\u20ac40,000<\/td><td>If not already certified<\/td><\/tr><tr><td>Regulatory Consulting<\/td><td>\u20ac20,000\u2013\u20ac60,000<\/td><td>IVDR\/MDR strategy, documentation<\/td><\/tr><tr><td>Total Median<\/td><td>\u20ac120,000\u2013\u20ac310,000<\/td><td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Extended Transition Periods Impact: Class D devices: deadline extended to December 2027; Class C devices: December 2028; Class B &amp; sterile Class A: December 2029. Manufacturers can delay IVDR transition; legacy IVDD devices saleable under transitional provisions until 2027\u20132029.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Strategic Comparison: Which Pathway First?<\/h2>\n\n\n\n<p>Timeline Hierarchy (Fastest to Slowest)<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>FDA 510(k): 4\u201312 months (fastest with strong predicate)<\/li>\n\n\n\n<li>CE Marking: 12\u201318 months (depends on Notified Body capacity)<\/li>\n<\/ol>\n\n\n\n<p>Cost Hierarchy (Lowest to Highest)<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>FDA 510(k): $100,000\u2013$500,000 (median $150\u2013250k with consulting)<\/li>\n\n\n\n<li>CE Marking: \u20ac120,000\u2013\u20ac310,000 (~$130,000\u2013$340,000 USD)<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">Recommended Global Launch Sequence<\/h2>\n\n\n\n<p>Year 1: FDA 510(k) Clearance (USA Market)<\/p>\n\n\n\n<p>Rationale: Fastest timeline; largest market demand ($2.1B hematology analyzer market); abundant predicates; highest willingness-to-pay<\/p>\n\n\n\n<p>Cost: $150\u2013250k all-in<\/p>\n\n\n\n<p>Strategy: Select strong predicate (Sysmex XN, Beckman Coulter DxH); focus on bench testing vs. clinical trials<\/p>\n\n\n\n<p>Outcome: Establish FDA credibility; leverage for subsequent approvals<\/p>\n\n\n\n<p>Year 2: CE Marking (EU Market)<\/p>\n\n\n\n<p>Rationale: Second-fastest; EU predicate landscape similar to FDA; $1.2B market opportunity<\/p>\n\n\n\n<p>Cost: $150\u2013250k (reuse FDA documentation and clinical data)<\/p>\n\n\n\n<p>Strategy: Reuse FDA technical documentation; emphasize existing FDA clearance credibility<\/p>\n\n\n\n<p>Timeline: Submit Q1; expect approval Q3\u2013Q4<\/p>\n\n\n\n<p>Outcome: Access EU, UK, and ASEAN markets through regulatory harmonization<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Clinical Evidence Requirements Comparison<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td class=\"has-text-align-left\" data-align=\"left\">Evidence Type<\/td><td class=\"has-text-align-left\" data-align=\"left\">FDA 510(k)<\/td><td class=\"has-text-align-left\" data-align=\"left\">CE Mark (IVDR)<\/td><\/tr><tr><td>Predicate Device<\/td><td>Required (substantial equivalence)<\/td><td>Not required<\/td><\/tr><tr><td>Clinical Trials<\/td><td>Typically avoided<\/td><td>Typically avoided (Class C)<\/td><\/tr><tr><td>Published Literature<\/td><td>Extensively used<\/td><td>Systematic review (Annex XIV)<\/td><\/tr><tr><td>Bench Testing<\/td><td>Biocompatibility, software, performance<\/td><td>ISO 13485 documentation<\/td><\/tr><tr><td>Analytical Validation<\/td><td>Comparison to reference methods<\/td><td>Performance evaluation<\/td><\/tr><tr><td>Real-World Clinical Data<\/td><td>Only for novel claims<\/td><td>Systematically required (Annex XIV)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Key Insight: All pathways moving toward clinical evidence over trials. FDA uses predicate as proxy; IVDR uses systematic literature review. Both increasingly accept published predicate device data instead of requiring expensive new clinical studies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Post-Approval Compliance &amp; Change Management<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">FDA Post-Approval<\/h3>\n\n\n\n<p>Annual registration listing updates; minor design changes via 510(k) supplemental (60\u201390 days); major changes requiring new 510(k) or PMA pathway; MedWatch adverse event reporting mandatory (15 days for serious events); post-market surveillance if required by device class.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">CE Mark Post-Approval<\/h3>\n\n\n\n<p>Vigilance reporting: serious incidents within 30 days; non-serious annually; post-market surveillance mandatory per IVDR Annex XV; design changes may require Notified Body re-assessment (3\u20136 months); annual safety update required.<\/p>\n\n\n\n<p>Annual Regulatory Maintenance Cost: Budget $30,000\u201350,000 per region for compliance, safety reporting, and design change management.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2026 Regulatory Updates &amp; Emerging Trends<\/h2>\n\n\n\n<p>FDA 2026 Outlook<\/p>\n\n\n\n<p>Staffing constraints may extend 510(k) timelines beyond 90-day goal. Software validation focus increasing for cybersecurity assessment of cloud-connected devices. AI\/ML devices requiring algorithmic validation and performance monitoring (particularly relevant for AI-powered CBC analyzers).<\/p>\n\n\n\n<p>IVDR 2026 Updates<\/p>\n\n\n\n<p>Extended transition periods: Class D to Dec 2027; Class C to Dec 2028. Notified Body capacity crisis persisting with only 4 designated bodies. Simplified MDR\/IVDR proposal (Jan 2025) with 2027+ implementation likely.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion &amp; Decision Framework<\/h2>\n\n\n\n<p>Five Critical Questions for CBC Manufacturers:<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>What is your primary target market? (USA = FDA first; EU = CE Mark first)<\/li>\n\n\n\n<li>Do strong predicate devices exist? (Yes = optimize strategy; No = budget for clinical evidence)<\/li>\n\n\n\n<li>Is your device AI-powered\/software-intensive? (Yes = extend timeline 20\u201330% for algorithm validation)<\/li>\n\n\n\n<li>What is your timeline pressure? (Urgent = USA first; Strategic = parallel submissions Year 2\u20133)<\/li>\n\n\n\n<li>Can you afford 2\u20133 year regulatory roadmap? (No = single market focus; Yes = parallel submissions to reduce cycle time)<\/li>\n<\/ol>\n\n\n\n<p>Final Recommendation: For maximum market impact with reasonable risk, pursue FDA 510(k) clearance in Year 1 (4\u201312 months), then CE Marking in Year 2 (12\u201318 months). This sequence establishes credibility progressively, enables documentation reuse, and positions your CBC analyzer for global market leadership.<\/p>\n\n\n\n<p>CBC machine suppliers seeking to navigate these pathways with expert guidance can leverage Ozelle&#8217;s global regulatory expertise spanning FDA 510(k), CE Mark, and local certifications\u2014enabling manufacturers to launch strategically in fastest timeframe possible.<\/p>\n\n\n\n<p>For more information on hematology analyzer solutions and regulatory support, visit <a href=\"https:\/\/ozellemed.com\/en\/\">https:\/\/ozellemed.com\/en\/<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulatory approval is essential but structurally different across the US and EU for CBC analyzer suppliers. The FDA&#8217;s 510(k) pathway and EU&#8217;s IVDR CE marking system employ distinct procedural architectures, evidence requirements, and governance models\u2014not simply varying speeds for the same goal. FDA 510(k) achieves clearance via predicate-device equivalence in 4\u201312 months (if strong predicates [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":8602,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[24],"tags":[],"class_list":["post-8322","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-24"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA vs CE Mark: Your Complete Regulatory Pathway for CBC Analyzer Approval<\/title>\n<meta name=\"description\" content=\"Compare FDA 510(k) clearance and CE marking (IVDR Class C\/D) pathways for hematology analyzers. 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