Cleared Traditional

K904603 - QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM

K904603 is an FDA 510(k) clearance for QUANTIMETRIX QUAN TEST-RED PROTEIN ASSA..., manufactured by Quantitative Medicine, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K904603

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.

CEK Device Classification - Class 2, Special Controls

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 101
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K904603.
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · Em Diagnostic Systems, Inc. · Jul 1991
TOTAL PROTEIN REAGENT SET
K905790 · Biochemical Trade, Inc. · Feb 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