# K042576: Coatest SP Fviii

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 2, 2004 after 71 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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
- K193204: Cryocheck Chromogenic Factor VIII (2020), 1 descendant of its own
- K251440: CRYOcheck Chromogenic Factor VIII (2025), 0 descendants of its own

## Indications for use
Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when 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/K042576
Methodology: https://510kreport.com/methodology