Cleared Traditional

K832480 - TRUST RPR TITRATION CARD TEST #65145

K832480 is the FDA 510(k) clearance for TRUST RPR TITRATION CARD TEST #65145 by Emd Chemicals, Inc.. It is a Class 2 Hematology device (product code GMQ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K832480 · Emd Chemicals, Inc. · Hematology device
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Sep 1983
Decision
48d
Days
Class 2
Risk

K832480 is an FDA 510(k) clearance for the TRUST RPR TITRATION CARD TEST #65145. 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 K832480 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
Combination Product No
PCCP Authorized No
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 12
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K832480.
STANBIO SYPHILIS RPR TEST, NO. 1170
K880144 · Stanbio Laboratory · May 1988
AUTOGROUPER 16C SYS AUTOMATED REAG
K834149 · Technicon Instruments Corp. · Mar 1984
TRUST RPR CARD TEST #65144
K832479 · Emd Chemicals, Inc. · Sep 1983
RAPID REAGIN CARD TEST
K822661 · Oxoid U.S.A., Inc. · Sep 1982
REAGIN ANTIGEN SUSPENSION
K822662 · Oxoid U.S.A., Inc. · Sep 1982
VDRL CARBON ANTIGEN
K812894 · Oxoid U.S.A., Inc. · Nov 1981