Cleared Traditional

TRACE MICROPROTEIN REAGENT (K925794) - FDA 510(k) Clearance

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

K925794 · Trace America, Inc. · Chemistry device
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Mar 1993
Decision
133d
Days
Class 2
Risk

K925794 is an FDA 510(k) clearance for the TRACE MICROPROTEIN REAGENT. Classified as Turbidimetric, Total Protein (product code JGQ), Class II - Special Controls.

Submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on March 29, 1993 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Trace America, Inc. devices

Submission Details

510(k) Number K925794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date March 29, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGQ Turbidimetric, Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 Chemistry devices follow this clearance model.

Regulatory Peers - JGQ Turbidimetric, Total Protein

All 12
Devices cleared under the same product code (JGQ) and FDA review panel - the closest regulatory comparables to K925794.
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · Roche Diagnostics Corp. · Oct 2007
UPRO
K981295 · Abbott Laboratories · Oct 1998
UPRO
K981682 · Abbott Laboratories · Sep 1998
URINARY/CSF PROTEIN
K913615 · Boehringer Mannheim Corp. · Sep 1991
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
K903914 · Baxter Healthcare Corp · Oct 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
K901083 · Em Diagnostic Systems, Inc. · Apr 1990