# K983914: Reaads Monoclonal Free Protein S Antigen Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Corgenix, Inc.
- Decided: Dec 22, 1998 after 48 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 K972482 (1997). 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)
- K972482: Reaads Protein S Antigen Test Kit, Reaads Medical Products, Inc. (1997) Summary page 1.

## Indications for use
The REAADS Monoclonal Free Protein S Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of Free Protein S levels in human citrated plasma (as a percent of normal concentration) by enzyme-linked immunosorbant assay (ELISA). The REAADS Monoclonal Free Protein S Antigen Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K983914
Methodology: https://510kreport.com/methodology