# K033631: Modification to Coatest Factor Viii

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 15, 2003 after 26 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.
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)
- K833892: Coatest Factor Viii, Kabivitrum, Inc. (1984) Summary page 1.

## Indications for use
Coatest Factor VIE was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIff activity in citrated plasma. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K033631
Methodology: https://510kreport.com/methodology