Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5400](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5400) → GKP — Instrument, Coagulation, Automated # GKP · Instrument, Coagulation, Automated _Hematology · 21 CFR 864.5400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP ## Overview - **Product Code:** GKP - **Device Name:** Instrument, Coagulation, Automated - **Regulation:** [21 CFR 864.5400](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5400) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies. ## Classification Rationale Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Special Controls *Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Recent Cleared Devices (20 of 49) Showing 20 most recent of 49 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242127](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K242127.md) | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | Instrumentation Laboratory (IL) Co. | Aug 16, 2024 | SESE | | [K231031](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K231031.md) | ACL TOP Family 70 Series | Instrumentation Laboratory Company | Jun 21, 2023 | SESE | | [K160276](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K160276.md) | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | Instrumentation Laboratory CO | Mar 3, 2016 | SESE | | [K150877](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K150877.md) | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | Instrumentation Laboratory CO | Dec 13, 2015 | SESE | | [K091980](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K091980.md) | ACL TOP 700 LAS | Instrumentation Laboratory CO | Sep 22, 2009 | SESE | | [K073377](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K073377.md) | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) | Instrumentation Laboratory CO | May 4, 2008 | SESE | | [K063679](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K063679.md) | ACL TOP | Instrumentation Laboratory CO | Jan 12, 2007 | SESE | | [K033414](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K033414.md) | ACL TOP MODEL, TOP | Instrumentation Laboratory CO | Jan 12, 2004 | SESE | | [K031377](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K031377.md) | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | Dade Behring, Inc. | Sep 8, 2003 | SESE | | [K023362](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K023362.md) | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | Fisher Diagnostics | Dec 9, 2002 | SESE | | [K020979](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K020979.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | Dade Behring, Inc. | Jun 27, 2002 | SESE | | [K001645](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K001645.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | Aug 4, 2000 | SESE | | [K001891](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K001891.md) | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | Bio/Data Corp. | Jul 12, 2000 | SESE | | [K001145](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K001145.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | May 11, 2000 | SESE | | [K993299](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K993299.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | Dec 7, 1999 | SESE | | [K993174](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K993174.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | Nov 9, 1999 | SESE | | [K992763](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K992763.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | Sep 21, 1999 | SESE | | [K992423](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K992423.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | Sep 21, 1999 | SESE | | [K992321](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K992321.md) | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | Sep 17, 1999 | SESE | | [K991101](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K991101.md) | COAG-A-MATE MAX | Organon Teknika Corp. | Jun 1, 1999 | SESE | ## Top Applicants - Dade Behring, Inc. — 9 clearances - Instrumentation Laboratory CO — 8 clearances - Helena Laboratories — 5 clearances - Medical Laboratory Automation Systems, Inc. — 5 clearances - American Bioproducts Co. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com