510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172402Substantially Equivalent

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

Luminex Corporation, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172402 is the FDA 510(k) clearance record for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit, a class II device, cleared for Luminex Corporation 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 34 510(k) clearances for Luminex Corporation, from to . As of , FDA records show one recall naming K172402.

Clearance record

Decision date
Received
(82 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
Luminex Corporation 12212 Technology Blvd., Austin TX
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