Activated Partial Thromboplastin
FDA product code GFO · Class II (moderate risk) · 21 CFR 864.7925 · Hematology
52510(k) clearances
0PMA approvals
8recalls
Manufacturers
- International Technidyne Corp. 5
- Analytical Control Systems, Inc. 5
- Instrumentation Laboratory CO 4
- Medical Diagnostic Technologies, Inc. 3
- Hyland Therapeutic Div., Travenol Laboratories 2
- Behring Diagnostics, Inc. 2
- Helena Laboratories 2
- Ortho Diagnostic Systems, Inc. 2
- Sigma Chemical Co. 2
- Elite Diagnostic , Ltd. 2
- Sigma Diagnostics, Inc. 2
- Pacific Hemostasis 1
- Cardiovascular Diagnostic Services 1
- Instrumentation Laboratory (IL) Co. 1
- Precision Biologicals, Inc. 1
- King Diagnostics, Inc. 1
- Theratest Laboratories, Inc. 1
- Sclavo, Inc. 1
- Creative Laboratory Products, Inc. 1
- Ortho Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253957 | HemosIL Silica Clotting TimeGFO · Special | Instrumentation Laboratory (IL) Co. | 01/09/2026SE |
| K193556 | Cryocheck Hex LAGFO · Traditional | Precision Biologic | 10/23/2020SE |
| K160445 | HemosIL Silica Clotting TimeGFO · Special | Instrumentation Laboratory CO | 03/16/2016SE |
| K053111 | Sta-Cephascreen KitGFO · Traditional | Diagnostica Stago, Inc. | 05/04/2006SE |
| K060688 | Hemosil SynthasilGFO · Special | Instrumentation Laboratory CO | 04/13/2006SE |
| K050221 | Hemosil Silica Clotting TimeGFO · Traditional | Instrumentation Laboratory CO | 03/30/2005SE |
| K022021 | Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional | Vital Scientific N.V. | 11/01/2002SE |
| K014028 | Careside ApttGFO · Traditional | Careside Hemotology, Inc. | 02/08/2002SE |
| K014008 | Hemochron Jr. Citrate Aptt CuvetteGFO · Special | Itc, Inc. | 01/24/2002SE |
| K992712 | Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional | Sigma Diagnostics, Inc. | 12/06/1999SE |
| K992711 | Sigma Diagnostics Alexin HS, Models A0969, A1094GFO · Traditional | Sigma Diagnostics, Inc. | 12/06/1999SE |
| K972831 | Hemochron Citrate ApttGFO · Traditional | International Technidyne Corp. | 11/20/1997SE |
| K973306 | Il Test Aptt-SpGFO · Traditional | Instrumentation Laboratory CO | 11/04/1997SE |
| K961892 | Specktin-La Test SetGFO · Traditional | Analytical Control Systems, Inc. | 03/07/1997SE |
| K955638 | Synthafax Aptt ReagentGFO · Traditional | Ortho Diagnostic Systems, Inc. | 04/23/1996SE |
| K955450 | Pathromtin SLGFO · Traditional | Behring Diagnostics, Inc. | 04/19/1996SE |
| K953981 | Synthasil Aptt ReagentGFO · Traditional | Ortho Diagnostic Systems, Inc. | 11/30/1995SE |
| K935169 | Aptt-EsGFO · Traditional | Helena Laboratories | 12/02/1994SE |
| K934351 | Aptt-Es ReagentGFO · Traditional | Medical Diagnostic Technologies, Inc. | 12/06/1993SE |
| K932011 | PathromtinGFO · Traditional | Behring Diagnostics, Inc. | 10/25/1993SE |
| K926012 | Acs Apct Reagent, ModifiedGFO · Traditional | Analytical Control Systems, Inc. | 04/27/1993SE |
| K924637 | Hemochron Citra Onestep Aptt/Fac Vi Singshot ApttGFO · Traditional | International Technidyne Corp. | 01/27/1993SE |
| K924638 | Hemochron Direct Draw Aptt/Fac Vi Vacu-ApttGFO · Traditional | International Technidyne Corp. | 01/14/1993SE |
| K923731 | Staclot la Test KitGFO · Traditional | American Bioproducts Co. | 12/23/1992SE |
| K921396 | Platelin LGFO · Traditional | Organon Teknika Corp. | 10/19/1992SE |
| K921223 | Acs Freeze-Dried Aptt ReagentGFO · Traditional | Analytical Control Systems, Inc. | 08/18/1992SE |
| K921118 | Acs Apct ReagentGFO · Traditional | Analytical Control Systems, Inc. | 07/28/1992SE |
| K915418 | Ellagic Acid Aptt ReagentGFO · Traditional | Helena Laboratories | 02/14/1992SE |
| K915344 | Hemochron Onestep Aptt TestGFO · Traditional | International Technidyne Corp. | 02/11/1992SE |
| K911994 | Hemochron(R) Aptt, ModificationGFO · Traditional | International Technidyne Corp. | 07/17/1991SE |
| K903531 | Anticardiolipin Antibody Test SystemGFO · Traditional | Medical Innovations Corp. | 01/25/1991SE |
| K905301 | The Theratest Aca TestGFO · Traditional | Theratest Laboratories, Inc. | 01/14/1991SE |
| K904341 | Aptt ReagentGFO · Traditional | Sigma Chemical Co. | 11/08/1990SE |
| K902556 | Acs Activated Partial Thromboplastin Time TestGFO · Traditional | Analytical Control Systems, Inc. | 08/06/1990SE |
| K900049 | Aptt-Ea Reagent, an Ellagic Acid Activated ReagentGFO · Traditional | Medical Diagnostic Technologies, Inc. | 01/25/1990SE |
| K896545 | Activated Partial Thromboplastin Time (Aptt)GFO · Traditional | Sigma Chemical Co. | 12/01/1989SE |
| K895255 | Aptt-P Reagent, a Particle Activated ReagentGFO · Traditional | Medical Diagnostic Technologies, Inc. | 10/06/1989SE |
| K892209 | Aptt by Hemochron(R)GFO · Traditional | Intensive Technology, Inc. | 06/22/1989SE |
| K891015 | COAG-1 Aptt Test CardGFO · Traditional | Cardiovascular Diagnostic Services | 05/22/1989SE |
| K891337 | Thromboscreen Aptt ReagentGFO · Traditional | Pacific Hemostasis | 04/21/1989SE |
| K890859 | Edl Global Activated Partial Thromboplastin TimeGFO · Traditional | Elite Diagnostic , Ltd. | 04/21/1989SE |
| K890619 | Edl Activated Partial Thromboplastin Time ReagentGFO · Traditional | Elite Diagnostic , Ltd. | 03/15/1989SE |
| K890052 | Biotrack Aptt Reagent CartridgeGFO · Traditional | Biotrack, Inc. | 02/24/1989SE |
| K884856 | Aptt ReagentGFO · Traditional | Precision Biologicals, Inc. | 01/30/1989SE |
| K884702 | Easy-Test Partial Thromboplastin Time PTT #16629GFO · Traditional | Em Diagnostic Systems, Inc. | 01/27/1989SE |
| K884485 | KD Activated Partial Thromboplastin Time ReagentGFO · Traditional | King Diagnostics, Inc. | 12/28/1988SE |
| K882325 | Unifast Activated Partial Thromboplastin Time TestGFO · Traditional | Sclavo, Inc. | 08/25/1988SE |
| K881068 | CLP Activated Partial Thromboplastin Time TestGFO · Traditional | Creative Laboratory Products, Inc. | 03/23/1988SE |
| K820835 | Alumina Silica-Activated Partial ThromGFO · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/26/1982SE |
| K781104 | Plasma Coagulation Cont., AbnormalGFO · Traditional | Ortho Diagnostics, Inc. | 08/10/1978SE |
| K760918 | Heparin Control PlasmaGFO · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 01/10/1977SE |
| K760318 | Actin, Activated Cephaloplastin ReagentGFO · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1095-2026 Class II | The product is used for the evaluation of the intrinsic coagulation pathway, APTT…Potential for microbial contamination. | Instrumentation Laboratory | 12/11/2025Open, Classified |
| Z-0938-2026 Class III | HemosIL SynthAFax. Partial Thromboplastin Time Tests.Recalled lots were manufactured with double the amount of preservative concentration. | Instrumentation Laboratory | 11/18/2025Open, Classified |
| Z-1108-2021 Class II | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo…Intermittent potential for shorter than expected clot times. | Helena Laboratories, Corp. | 01/05/2021Terminated |
| Z-0611-2019 Class II | Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems…There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the… | Diagnostica Stago, Inc. | 11/14/2018Terminated |
| Z-0610-2019 Class II | Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems…There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the… | Diagnostica Stago, Inc. | 11/14/2018Terminated |
| Z-2761-2019 Class II | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label…Some of the cards show occasional shorter clot times than the expected variation resulting in a potential… | Helena Laboratories, Corp. | 12/07/2017Terminated |
| Z-1703-2015 Class II | Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma…Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or… | Siemens Healthcare Diagnostics, Inc. | 03/25/2015Terminated |
| Z-0937-2014 Class II | Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test…ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal… | ITC-Nexus Dx | 12/19/2013Terminated |