# K972342: Reaads Protein C Antigen Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Reaads Medical Products, Inc.
- Decided: Oct 6, 1997 after 104 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Helena Protein C Antigen Rocket EID Method: named in the summary without a submission number

## Indications for use
The REAADS Protein C Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of plasma levels of human Protein C (as a percent of normal concentration) by enzyme linked immunosorbent assay (ELISA). Plasma levels of Protein C may be used in conjunction with other assays as an aid in diagnosing congenital or acquired Protein C deficiencies associated with thrombotic disease. The REAADS Protein C Antigen Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K972342
Methodology: https://510kreport.com/methodology