# K173653: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

- Pathway: 510(k) (Dual Track)
- Applicant: Alere Scarborough, Inc.
- Decided: May 2, 2018 after 155 days
- Product code: PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 866.2680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN140005 (2014). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141757: Alere I Strep a, Alere Scarborough, Inc. (2015) Summary page 4.

## Most influential descendants
- K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (2022), 2 descendants of its own
- K232775: ID NOW Influenza A & B 2 (2023), 1 descendant of its own
- K262747: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 (2026), 0 descendants of its own

## Indications for use
Alere i Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

Source page: https://510kreport.com/device/K173653
Methodology: https://510kreport.com/methodology