Cleared Traditional

K150358 - Gold Standard Diagnostics AIX1000 Rapid...

K150358 is an FDA 510(k) clearance for Gold Standard Diagnostics AIX1000 Rapid..., manufactured by Gold Standard Diagnostics. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K150358 · Gold Standard Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
273d
Days
Class 2
Risk

K150358 is an FDA 510(k) clearance for the Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test Sy.... Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on November 12, 2015 after a review of 273 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gold Standard Diagnostics devices

FDA 510(k) Submission Details - K150358

510(k) Number K150358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2015
Decision Date November 12, 2015
Days to Decision 273 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMQ Device Classification - Class 2, Special Controls

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GMQ Antigens, Nontreponemal, All

All 17
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K150358.
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
K201438 · Arlington Scientific, Inc. (Asi) · Oct 2020
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
K182391 · Arlington Scientific, Inc. (Asi) · Nov 2018
ASI Evolution
K173376 · Arlington Scientific, Inc. (Asi) · Jun 2018
SYNTHETIC VDRL ANTIGEN
K993633 · Centers For Disease Control and Prevention · Feb 2000
STANBIO SYPHILIS RPR TEST, NO. 1170
K880144 · Stanbio Laboratory · May 1988
SYPH-TRUST
K863368 · I.A.F. Production, Inc. · Dec 1986