Cleared Traditional

K890278 - TOTAL PROTEIN REAGENT

K890278 is an FDA 510(k) clearance for TOTAL PROTEIN REAGENT, manufactured by Sigma Chemical Co.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K890278 · Sigma Chemical Co. · Chemistry device
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Mar 1989
Decision
50d
Days
Class 2
Risk

K890278 is an FDA 510(k) clearance for the TOTAL PROTEIN REAGENT. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 9, 1989 after a review of 50 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.

FDA 510(k) Submission Details - K890278

510(k) Number K890278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date March 09, 1989
Days to Decision 50 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
39d faster than avg
Panel avg: 89d · This submission: 50d
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 115
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K890278.
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · Em Diagnostic Systems, Inc. · Aug 1989
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
K890618 · Kenlor Industries, Inc. · May 1989
DMA MICROPROTEIN PROCEDURE
K890868 · Data Medical Associates, Inc. · Mar 1989
TOTAL PROTEIN REAGENT
K890317 · Medical Analysis Systems, Inc. · Mar 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · Em Diagnostic Systems, Inc. · Jan 1989
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
K884225 · A-Kem, Inc. · Dec 1988
K890278 · TOTAL PROTEIN REAGENT
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