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) → GGN — Plasma, Coagulation Control # GGN · Plasma, Coagulation Control _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/GGN ## Overview - **Product Code:** GGN - **Device Name:** Plasma, Coagulation Control - **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 99) Showing 20 most recent of 99 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K170864](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K170864.md) | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | Jun 21, 2017 | SESE | | [K163498](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K163498.md) | VALIDATE Heparin Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | Mar 16, 2017 | SESE | | [K161316](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K161316.md) | George King Coumadin Plasma | George King Bio-Medical, Inc. | Feb 23, 2017 | SESE | | [K162705](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K162705.md) | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | Jan 5, 2017 | SESE | | [K152961](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K152961.md) | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | Jun 3, 2016 | SESE | | [K150144](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K150144.md) | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals, Inc. | Mar 6, 2016 | SESE | | [K142132](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K142132.md) | POOL NORM | Diagnostics Stago S.A.S. | Dec 12, 2014 | SESE | | [K133582](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K133582.md) | HEMOSIL D-DIMER HS 500 CONTROL | Instrumentation Laboratory | Aug 15, 2014 | SESE | | [K120977](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K120977.md) | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | International Technidyne Corp. | Jul 3, 2013 | SESE | | [K120900](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K120900.md) | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | Cliniqa Corporation | May 31, 2013 | SESE | | [K120014](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K120014.md) | STA- COAG CONTROL (N+ABN) PLUS | Diagnostica Stago, Inc. | Mar 14, 2013 | SESE | | [K113211](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K113211.md) | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | Instrumentation Laboratory CO | Jan 4, 2012 | SESE | | [K110432](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K110432.md) | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | Affinity Biologicals, Inc. | Oct 20, 2011 | SESE | | [K100716](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K100716.md) | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 | Aalto Scientific, Ltd. | Jun 23, 2011 | SESE | | [K093848](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K093848.md) | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dade Behring, Inc. | Dec 20, 2010 | SESE | | [K103314](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K103314.md) | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL | Medtronic, Inc. | Dec 3, 2010 | SESE | | [K103313](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K103313.md) | HEPARIN ASSAY CONTROLS | Medtronic, Inc. | Dec 1, 2010 | SESE | | [K091284](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K091284.md) | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | Affinity Biologicals, Inc. | Oct 28, 2009 | SESE | | [K090563](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K090563.md) | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) | Instrumentation Laboratory CO | Oct 9, 2009 | SESE | | [K082859](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K082859.md) | HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED | Instrumentation Laboratory CO | Dec 19, 2008 | SESE | ## Top Applicants - Bio-Rad — 7 clearances - Helena Laboratories — 7 clearances - Instrumentation Laboratory CO — 7 clearances - Precision Biologicals, Inc. — 6 clearances - American Bioproducts Co. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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