PT Heparin Adsorbent
510(k) K870771
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870771 | Date23 Apr 1987 | StatusActive |
Recalls
-
- Terminated Z-0934-2008
Erroneous Coagulation Tests
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5425
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The PT Heparin Adsorbent is a System, Multipurpose for In Vitro Coagulation Studies, designed to remove heparin from blood or plasma samples. It functions as an adsorbent material to neutralize heparin activity, facilitating accurate coagulation testing in laboratory settings. This device is classified under the Hematology specialty and is intended for use in diagnostic procedures requiring precise measurement of coagulation parameters.
Supplied as a single-use reagent, the PT Heparin Adsorbent is regulated under FDA 510(k) clearance (K870771) and falls under the classification of a Class II device (Regulation 864.5425). It is intended for in vitro use only and requires proper storage to maintain efficacy. The device was reviewed by the Hematology (HE) Advisory Committee and is authorized for use in coagulation studies where heparin interference must be mitigated.
Other devices from Probe-Tek, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the PT Heparin Adsorbent used for in a clinical or laboratory setting?
The PT Heparin Adsorbent is designed specifically to remove heparin from blood or plasma samples during in vitro coagulation studies. Its purpose is to neutralize heparin activity, ensuring accurate measurement of coagulation parameters like prothrombin time (PT) tests. This is critical in settings where heparin interference could skew diagnostic results, such as in patients receiving anticoagulant therapy.
Is the PT Heparin Adsorbent intended for single-use or repeated use, and how should it be stored?
The PT Heparin Adsorbent is supplied as a single-use reagent, meaning each unit is meant for one-time use only. To maintain its efficacy, it must be stored properly—typically under controlled conditions as specified in the manufacturer’s instructions (e.g., room temperature, protected from moisture or extreme temperatures). Improper storage could compromise its ability to adsorb heparin effectively.
What regulatory pathway was followed for the PT Heparin Adsorbent, and which advisory committee reviewed it?
The PT Heparin Adsorbent was cleared through the FDA 510(k) pathway under the classification of a Class II device (Regulation 864.5425). It was reviewed by the Hematology (HE) Advisory Committee, which evaluates devices intended for coagulation studies. The clearance number is K870771, and the device is authorized for in vitro use only.
Are there multiple sizes or models of the PT Heparin Adsorbent, or is it available in a single format?
The PT Heparin Adsorbent is listed with multiple FEI numbers (e.g., 3015222335, 3010653929), which typically correspond to different lot or batch identifiers rather than distinct physical sizes or models. However, the device itself is described as a single-use reagent system without variations in packaging or formulation. For exact specifications, refer to the manufacturer’s labeling or documentation.