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 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) → GGC — Control, Plasma, Abnormal # GGC · Control, Plasma, Abnormal _Hematology · 21 CFR 864.5425 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC ## Overview - **Product Code:** GGC - **Device Name:** Control, Plasma, Abnormal - **Regulation:** [21 CFR 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) ## Identification A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays. ## Classification Rationale Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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 control intended for use with a multipurpose system for in vitro coagulation studies 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 40) Showing 20 most recent of 40 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K102552](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K102552.md) | HEMOSIL LA POSITIVE CONTROL | Instrumentation Laboratory CO | Apr 5, 2011 | SESE | | [K100103](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K100103.md) | SPECIALTY ASSAYED CONTROL-2 | Helena Laboratories | Dec 15, 2010 | SESE | | [K062306](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K062306.md) | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | R2 Diagnostics, Inc. | Mar 16, 2007 | SESE | | [K061803](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K061803.md) | STA - CONTROL LA 1+2 | Diagnostica Stago, Inc. | Jul 28, 2006 | SESE | | [K032804](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K032804.md) | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | Precision Biologic | Nov 3, 2003 | SESE | | [K023312](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K023312.md) | CONTROL PLASMA P | Dade Behring, Inc. | Nov 1, 2002 | SESE | | [K020878](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K020878.md) | LYPHOCHEK HEMOSTASIS, MODELS 798, 799 | Bio-Rad | Apr 15, 2002 | SESE | | [K020109](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K020109.md) | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Sigma Diagnostics, Inc. | Feb 6, 2002 | SESE | | [K012422](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K012422.md) | K-ASSAY D-DIMER CONTROLS | Kamiya Biomedical Co. | Aug 21, 2001 | SESE | | [K003329](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K003329.md) | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Sigma Diagnostics, Inc. | Mar 1, 2001 | SESE | | [K993332](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K993332.md) | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | Gradipore , Ltd. | Feb 16, 2000 | SESE | | [K984131](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K984131.md) | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Pacific Hemostasis | Dec 1, 1998 | SESE | | [K984130](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K984130.md) | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Pacific Hemostasis | Dec 1, 1998 | SESE | | [K961370](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K961370.md) | LA POSITIVE CONTROL PLASMA | Medical Diagnostic Technologies, Inc. | May 24, 1996 | SESE | | [K955040](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K955040.md) | AT-III CONTROL PLASMA KIT | American Bioproducts Co. | Jan 31, 1996 | SESE | | [K952623](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K952623.md) | CRYO CHECK LUPUS PLASMA | Precision Biologicals, Inc. | Nov 6, 1995 | SESE | | [K952624](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K952624.md) | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | Precision Biologicals, Inc. | Oct 30, 1995 | SESE | | [K945856](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K945856.md) | POSITIVE LUPUS ANTICOAGULANT PLASMA | George King Bio-Medical, Inc. | Oct 5, 1995 | SESE | | [K952338](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K952338.md) | STA-COAG CONTROL [P] PLUS KIT | American Bioproducts Co. | Sep 21, 1995 | SESE | | [K941872](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K941872.md) | SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 | Helena Laboratories | Nov 21, 1994 | SESE | ## Top Applicants - American Bioproducts Co. — 5 clearances - Analytical Control Systems, Inc. — 4 clearances - Medical Diagnostic Technologies, Inc. — 4 clearances - Behring Diagnostics, Inc. — 3 clearances - Helena Laboratories — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC) **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. 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