# K981038: Coamatic Factor Viii

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 16, 1998 after 28 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- 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 K833892 (1984). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833892: Coatest Factor Viii, Kabivitrum, Inc. (1984) Summary page 1.

## Most influential descendants
- K052825: Visulize Factor Viii Antigen Kit, Model Fviii-AG (2006), 0 descendants of its own

## Indications for use
Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods. The measurement of Factor VIII is used as an aid in identifying factor VIII deficiency or monitoring patients on replacement therapy as well as for potency estimation of FVIII concentrates.

Source page: https://510kreport.com/device/K981038
Methodology: https://510kreport.com/methodology