510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173653Substantially Equivalent

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

Alere Scarborough, Inc., Scarborough ME / Dual Track, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173653 is the FDA 510(k) clearance record for Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit, a class II device, cleared for Alere Scarborough, Inc. on under FDA product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System). FDA's definition for product code PGX reads: "An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients". FDA records list 17 510(k) clearances for Alere Scarborough, Inc., from to . As of , FDA records show no recalls naming K173653.

Clearance record

Decision date
Received
(155 days to decision)
Product code
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Regulation
21 CFR 866.2680
Device class
Class II
Review panel
Microbiology
Applicant
Alere Scarborough, Inc. 10 Southgate Rd., Scarborough ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGX

Trailing 12 months
2 clearances under product code PGX in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PGX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260