Cleared Traditional

TRUST RPR CARD TEST #65144 (K832479) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832479 · Emd Chemicals, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1983
Decision
48d
Days
Class 2
Risk

K832479 is an FDA 510(k) clearance for the TRUST RPR CARD TEST #65144. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.3820 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emd Chemicals, Inc. devices

Submission Details

510(k) Number K832479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date September 12, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 113d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Hematology devices follow this clearance model.

Regulatory Peers - GMQ Antigens, Nontreponemal, All

All 31
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K832479.
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K250249 · Gold Standard Diagnostics, LLC · Oct 2025
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
RPR CARD TEST SYSTEM
K810658 · Beckman Instruments, Inc. · Mar 1981