510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250249Substantially Equivalent

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Gold Standard Diagnostics, LLC, Davis CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250249 is the FDA 510(k) clearance record for Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, a class II device, cleared for Gold Standard Diagnostics, LLC on under FDA product code GMQ (Antigens, Nontreponemal, All). FDA records list 15 510(k) clearances for Gold Standard Diagnostics, LLC, from to . As of , FDA records show no recalls naming K250249.

Clearance record

Decision date
Received
(256 days to decision)
Product code
GMQ Antigens, Nontreponemal, All
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Applicant
Gold Standard Diagnostics, LLC 2795 2nd St. Suite 300, Davis CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GMQ

Trailing 12 months

FDA records hold no clearances under product code GMQ in the trailing twelve months.

FDA records show no clearances under product code GMQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GMQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260