# K972482: Reaads Protein S Antigen Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Reaads Medical Products, Inc.
- Decided: Aug 13, 1997 after 42 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 S Antigen Rocket EID Method: named in the summary without a submission number
- (no number) Helena Free Protein S Reagent: named in the summary without a submission number

## Most influential descendants
- K983914: Reaads Monoclonal Free Protein S Antigen Test Kit (1998), 0 descendants of its own

## Recalls of this device
- Apr 4, 2017 · Class II · Z-0106-2019: Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.

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

Source page: https://510kreport.com/device/K972482
Methodology: https://510kreport.com/methodology