# K971522: Abbott Testpack Plus Strep a with on Board Controls (Obc) II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 3, 1998 after 312 days
- Product code: GTZ (Antisera, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- 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.
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) Isolation of Group A Strep colonies on sheep blood agar medium followed by a serological grouping of presumptive Group A Strep: named in the summary without a submission number

## Recalls of this device
- Jun 11, 2004 · Not classified · Z-1048-04: False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control.

## Indications for use
Abbott TestPack Plus Strep A with On Board Controls (OBC) I is a rapid immunoassay 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.

Source page: https://510kreport.com/device/K971522
Methodology: https://510kreport.com/methodology