Cleared Traditional

K863301 - DEMAND TOTAL PROTEIN

K863301 is the FDA 510(k) clearance for DEMAND TOTAL PROTEIN by Cooper Biomedical, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K863301 · Cooper Biomedical, Inc. · Chemistry device
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Sep 1986
Decision
32d
Days
Class 2
Risk

K863301 is an FDA 510(k) clearance for the DEMAND TOTAL PROTEIN. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Cooper Biomedical, Inc. (Malvern, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 32 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cooper Biomedical, Inc. devices

Submission Details

510(k) Number K863301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date September 26, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 79
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K863301.
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371 · Trace Scientific , Ltd. · Aug 1987
BIURET (COLORIMETRIC), TOTAL PROTEIN
K864743 · Tech-Co, Inc. · Jan 1987
TOTAL PROTEIN PROCEDURE
K863258 · Data Medical Associates, Inc. · Sep 1986
TOTAL PROTEINS
K863074 · J. D. Assoc. · Sep 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · Em Diagnostic Systems, Inc. · Aug 1986
WAKO MICRO TP
K861508 · Wako Chemicals USA, Inc. · Aug 1986