Cleared Traditional

BIURET (COLORMETRIC), TOTAL PROTEIN (K901527) - FDA 510(k) Clearance

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

K901527 · American Research Products Co. · Chemistry device
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Jul 1990
Decision
108d
Days
Class 2
Risk

K901527 is an FDA 510(k) clearance for the BIURET (COLORMETRIC), TOTAL PROTEIN. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on July 19, 1990 after a review of 108 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 American Research Products Co. devices

Submission Details

510(k) Number K901527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1990
Decision Date July 19, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
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 23
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K901527.
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
COBAS READY TOTAL PROTEIN REAGENT
K896230 · Roche Diagnostic Systems, Inc. · Feb 1990
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · Em Diagnostic Systems, Inc. · Aug 1989
TOTAL PROTEIN REAGENT
K890278 · Sigma Chemical Co. · Mar 1989