Cleared Traditional

K925794 - TRACE MICROPROTEIN REAGENT

K925794 is an FDA 510(k) clearance for TRACE MICROPROTEIN REAGENT, manufactured by Trace America, Inc.. The device is a Class 2 Chemistry device with product code JGQ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K925794 · Trace America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K925794

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
Combination Product No
PCCP Authorized No
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.

JGQ Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (JGQ) and FDA review panel - the closest regulatory comparables to K925794.
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · Roche Diagnostics · Sep 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