# K051638: Inverness Medical Testpack + Plus Strep a with Obc

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: Dec 6, 2005 after 169 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- 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) QuickVue Dipstick Strep A Test: named in the summary without a submission number

## Indications for use
The Inverness Medical TestPack + Plus Strep A with OBC Test is intended for the qualitative detection of Group A Streptococcal (Group A Strep) antigen in throat swab specimens from patients with suspected Group A Strep associated pharyngitis and for confirmation of presumptive Group A Strep colonies isolated on culture plates. The test is intended for Professional and Laboratory Use only.

Source page: https://510kreport.com/device/K051638
Methodology: https://510kreport.com/methodology