# K972144: Sigma Diagnostics Accucolor Antithrombin Iii

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Jul 25, 1997 after 49 days
- Product code: JBQ (Antithrombin Iii Quantitation)
- 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. The FDA summary names its predicate without a number.
- (no number) Sigma Accucolor Antithrombin II Assay Kit (CRS105A): named in the summary without a submission number
- (no number) Diapharma Coamatic assay: named in the summary without a submission number

## Indications for use
Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

Source page: https://510kreport.com/device/K972144
Methodology: https://510kreport.com/methodology