Cleared Traditional

K904603 - QUANTIMETRIX QUAN TEST-RED PROTEIN ASSA...

K904603 is the FDA 510(k) clearance for QUANTIMETRIX QUAN TEST-RED PROTEIN ASSA... by Quantitative Medicine, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K904603 · Quantitative Medicine, Inc. · Chemistry device
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Jan 1991
Decision
107d
Days
Class 2
Risk

K904603 is an FDA 510(k) clearance for the QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Quantitative Medicine, Inc. (Hawthorne, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 107 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 Quantitative Medicine, Inc. devices

Submission Details

510(k) Number K904603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1990
Decision Date January 25, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEK Biuret (colorimetric), 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 - CEK Biuret (colorimetric), Total Protein

All 80
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K904603.
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
K913978 · Beckman Instruments, Inc. · Oct 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · Em Diagnostic Systems, Inc. · Jul 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661 · Em Diagnostic Systems, Inc. · Jan 1991
SYNERMED TOTAL PROTEIN REAGENT KIT
K903511 · Synermed, Inc. · Sep 1990
BIURET (COLORMETRIC), TOTAL PROTEIN
K901527 · American Research Products Co. · Jul 1990
COULTER TOTAL PROTEIN REAGENT
K897166 · Coulter Electronics, Inc. · Feb 1990