Cleared Traditional

K901527 - BIURET (COLORMETRIC), TOTAL PROTEIN

K901527 is an FDA 510(k) clearance for BIURET (COLORMETRIC), manufactured by American Research Products Co.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

FDA 510(k) Submission Details - K901527

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
Combination Product No
PCCP Authorized No
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.

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 100
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K901527.
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
COULTER TOTAL PROTEIN REAGENT
K897166 · Coulter Electronics, Inc. · Feb 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230 · Roche Diagnostic Systems, Inc. · Feb 1990
CLINISTAT TOTAL PROTEIN REAGENT TEST
K896916 · Heraeus Kulzer, Inc. · Jan 1990