# K023766: Acon Strep a Twist Test Device

- Pathway: 510(k) (Traditional)
- Applicant: Acon Laboratories Co.
- Decided: Feb 10, 2003 after 90 days
- Product code: GTY (Antigens, 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
Longest line of descent: 1 generation back to K954257 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954257: Quickvue in-Line One Step Strep a Test (Modification), Quidel Corp. (1995) Summary page 2.

## Recalls of this device
- Sep 1, 2011 · Not classified · Z-1075-2012: Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product tha

## Indications for use
The ACON Strep A Twist Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

Source page: https://510kreport.com/device/K023766
Methodology: https://510kreport.com/methodology