Activated Partial Thromboplastin Time Test
by Sigma Diagnostics, Inc. 510(k)
Active
510(k) K915463
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915463 | Date23 Jan 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Activated Partial Thromboplastin Time
- 510(k) Number
- FDA Product Code
- GGW
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7925
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Activated Partial Thromboplastin Time (APTT) Test is an in vitro diagnostic device used to evaluate the intrinsic pathway of the blood coagulation cascade. It measures the time required for plasma to clot following activation with thromboplastin derived from tissue extracts, providing critical diagnostic information for assessing coagulation disorders and monitoring anticoagulant therapy. The test is classified under hematology diagnostics and relies on standardized reagents to minimize variability in results.
This test is performed in clinical laboratory settings using disposable, single-use reagents and plasticware. The device is regulated under FDA 510(k) clearance (K915463) and falls under device class II (GGW product code). Reagents are supplied as lyophilized powders or liquid formulations, requiring reconstitution or dilution before use, and must be stored according to manufacturer instructions to maintain stability and accuracy. No MRI safety or reusable components are specified for this diagnostic test.
Other devices from Sigma Diagnostics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Activated Partial Thromboplastin Time (APTT) Test used for?
The APTT Test is an in vitro diagnostic device designed to assess the intrinsic pathway of blood coagulation. It helps clinicians diagnose coagulation disorders and monitor patients receiving anticoagulant therapy, such as heparin. By measuring how long it takes plasma to clot after activation with thromboplastin, the test provides critical insights into potential bleeding risks or clotting abnormalities.
How is the Sigma APTT Test supplied and prepared for use?
The Sigma APTT Test reagents are supplied as either lyophilized powders or liquid formulations. Before use, lyophilized reagents require reconstitution with a diluent, while liquid reagents may need dilution according to the manufacturer’s instructions. The test is performed using disposable, single-use plasticware to ensure accuracy and prevent cross-contamination.
Is the APTT Test sterile and intended for single-use?
Yes, the Sigma APTT Test is designed for single-use only. The disposable reagents and plasticware are intended to maintain sterility and reliability during testing. Reuse is not recommended, as it could compromise the integrity of the results and introduce contamination risks.
What storage conditions are required for the APTT Test reagents?
The Sigma APTT Test reagents must be stored according to the manufacturer’s instructions to preserve stability and accuracy. Typically, lyophilized powders should be kept in a cool, dry place (e.g., 2–8°C), while liquid reagents may require refrigeration or room-temperature storage depending on the formulation. Always check the packaging for specific storage guidelines.
Does the APTT Test have any reusable components or special handling requirements?
No reusable components are specified for the Sigma APTT Test. The entire procedure relies on single-use reagents and plasticware, eliminating the need for cleaning or reprocessing. This design ensures consistency in results and reduces the risk of contamination or degradation over multiple uses.