510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143651Substantially Equivalent

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

DiaSorin Molecular LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143651 is the FDA 510(k) clearance record for Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack, a class II device, cleared for Focus Diagnostics, 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 32 510(k) clearances for DiaSorin Molecular LLC, from to . As of , FDA records show one recall naming K143651.

Clearance record

Decision date
Received
(85 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
Focus Diagnostics, Inc. 11331 Valley View St., Cypress CA
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