GFO · Activated Partial Thromboplastin
Hematology · 21 CFR 864.7925 · Class 2
Overview
| Product Code | GFO |
|---|---|
| Device Name | Activated Partial Thromboplastin |
| Regulation | 21 CFR 864.7925 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | Jan 9, 2026 | SESE |
| K193556 | Cryocheck Hex LA | Precision Biologic | Oct 23, 2020 | SESE |
| K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | Mar 16, 2016 | SESE |
| K053111 | STA-CEPHASCREEN KIT | Diagnostica Stago, Inc. | May 4, 2006 | SESE |
| K060688 | HEMOSIL SYNTHASIL | Instrumentation Laboratory CO | Apr 13, 2006 | SESE |
| K050221 | HEMOSIL SILICA CLOTTING TIME | Instrumentation Laboratory CO | Mar 30, 2005 | SESE |
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | Vital Scientific N.V. | Nov 1, 2002 | SESE |
| K014028 | CARESIDE APTT | Careside Hemotology, Inc. | Feb 8, 2002 | SESE |
| K014008 | HEMOCHRON JR. CITRATE APTT CUVETTE | Itc, Inc. | Jan 24, 2002 | SESE |
| K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 | Sigma Diagnostics, Inc. | Dec 6, 1999 | SESE |
| K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 | Sigma Diagnostics, Inc. | Dec 6, 1999 | SESE |
| K972831 | HEMOCHRON CITRATE APTT | International Technidyne Corp. | Nov 20, 1997 | SESE |
| K973306 | IL TEST APTT-SP | Instrumentation Laboratory CO | Nov 4, 1997 | SESE |
| K961892 | SPECKTIN-LA TEST SET | Analytical Control Systems, Inc. | Mar 7, 1997 | SESE |
| K955638 | SYNTHAFAX APTT REAGENT | Ortho Diagnostic Systems, Inc. | Apr 23, 1996 | SESE |
| K955450 | PATHROMTIN SL | Behring Diagnostics, Inc. | Apr 19, 1996 | SESE |
| K953981 | SYNTHASIL APTT REAGENT | Ortho Diagnostic Systems, Inc. | Nov 30, 1995 | SESE |
| K935169 | APTT-ES | Helena Laboratories | Dec 2, 1994 | SESE |
| K934351 | APTT-ES REAGENT | Medical Diagnostic Technologies, Inc. | Dec 6, 1993 | SESE |
| K932011 | PATHROMTIN | Behring Diagnostics, Inc. | Oct 25, 1993 | SESE |
Top Applicants
- International Technidyne Corp. — 5 clearances
- Analytical Control Systems, Inc. — 5 clearances
- Instrumentation Laboratory CO — 4 clearances
- Medical Diagnostic Technologies, Inc. — 3 clearances
- Sigma Diagnostics, Inc. — 2 clearances
