Diag. Kit for Total Antithrombin Iii
by Abbott Laboratories 510(k)
Active
510(k) K771669
Overview
This device is a diagnostic kit for the quantitation of total Antithrombin III, classified under the nomenclature for Antithrombin III Quantitation. It is designed to measure levels of Antithrombin III in blood samples, a critical protein involved in blood coagulation and anticoagulation pathways. The assay aids in the diagnosis and monitoring of conditions affecting hemostasis, such as hereditary Antithrombin III deficiency or acquired thrombotic disorders. Results assist clinicians in assessing bleeding or thrombotic risks and guiding therapeutic decisions.
The kit is supplied as an in vitro diagnostic reagent intended for laboratory use only. It is regulated under FDA 510(k) clearance (K771669) and falls under Class II medical devices, with a product code of JBQ. The device is not described as single-use or reusable in the specifications, though typical diagnostic kits of this nature are intended for one-time use per sample. No MRI safety information or sterility requirements are specified in the provided data. Storage conditions and shelf life are not detailed but are typically governed by manufacturer guidelines for in vitro diagnostics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771669 | Date9 Nov 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JBQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7060
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Antithrombin III Quantitation Kit used for?
This kit measures total Antithrombin III levels in blood samples, a protein essential for blood coagulation and anticoagulation. It helps diagnose hereditary Antithrombin III deficiency and acquired thrombotic disorders, enabling clinicians to evaluate bleeding or thrombotic risks and guide treatment decisions.
Is the kit intended for single-use or reusable applications?
While the specifications do not explicitly state single-use or reusable, diagnostic kits of this type are typically designed for one-time use per sample. This ensures accuracy and prevents cross-contamination, which is critical for reliable test results.
What regulatory approval does this diagnostic kit hold?
The kit holds FDA 510(k) clearance under the reference number K771669, classifying it as a Class II medical device. This approval confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for in vitro diagnostics.
How should the kit be stored, and what is its shelf life?
Storage conditions and shelf life are not detailed in the provided data, but Abbott Laboratories typically provides manufacturer guidelines for in vitro diagnostics. These guidelines usually specify temperature ranges (e.g., refrigerated or room temperature) and expiration dates to maintain assay performance.
Does this kit require any special handling or sterility measures?
The data does not specify sterility requirements or special handling instructions beyond standard laboratory practices for in vitro diagnostic reagents. As with most diagnostic kits, adherence to manufacturer instructions for preparation, handling, and disposal is essential to ensure accurate and safe testing.