# K972257: N-Assay Tia Antithrombin Iii Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Oct 20, 1997 after 125 days
- Product code: DDQ (Antigen, Antiserum, Control, Antithrombin Iii)
- Device class: 2
- Regulation: 21 CFR 864.7060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT-III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-III is also helpful in monitoring heparin therapy.

Source page: https://510kreport.com/device/K972257
Methodology: https://510kreport.com/methodology