# K043007: Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105

- Pathway: 510(k) (Traditional)
- Applicant: Hyphen Biomed
- Decided: Nov 7, 2005 after 371 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
Longest line of descent: 1 generation back to K915083 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915083: Coamate (R) Antithrombin Chromogenic Assay, Kabi Pharmacia, Inc. (1992) Summary page 1.

## Indications for use
BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

Source page: https://510kreport.com/device/K043007
Methodology: https://510kreport.com/methodology