# K952802: Visuwell Reagin II

- Pathway: 510(k) (Traditional)
- Applicant: Biomira Diagnostics, Inc.
- Decided: May 23, 1996 after 339 days
- Product code: GMQ (Antigens, Nontreponemal, All)
- Device class: 2
- Regulation: 21 CFR 866.3820
- 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) Venereal Disease Research Laboratory (VDRL) Slide Test: named in the summary without a submission number
- (no number) Rapid Plasma Reagin (RPR) Card Test: named in the summary without a submission number
- (no number) Reagin Screen Test (RST): named in the summary without a submission number

## Indications for use
Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies as a screening test in syphilis serology. It is not intended for use in screening blood or plasma donors.

Source page: https://510kreport.com/device/K952802
Methodology: https://510kreport.com/methodology