Cleared Traditional

K921412 - MICROPROTEIN REAGENT SET

K921412 is an FDA 510(k) clearance for MICROPROTEIN REAGENT SET, manufactured by Sterling Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K921412 · Sterling Diagnostics, Inc. · Chemistry device
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Jan 1993
Decision
303d
Days
Class 2
Risk

K921412 is an FDA 510(k) clearance for the MICROPROTEIN REAGENT SET. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sterling Diagnostics, Inc. devices

FDA 510(k) Submission Details - K921412

510(k) Number K921412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date January 21, 1993
Days to Decision 303 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 88d · This submission: 303d
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 K921412.
DMA MICROPROTEIN PROCEDURE
K942424 · Data Medical Associates, Inc. · Sep 1994
URINARY/CEREBROSPINAL FLUID PROTEIN
K934841 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1994
TOTAL PROTEIN TEST (TPRO)
K935174 · Em Diagnostic Systems, Inc. · Dec 1993
OLYUMPUS TOTAL PROTEIN REAGENT
K924659 · Olympus Corp. · Dec 1992
SYNCHRON TOTAL PROTEIN TEST --MODIFIED
K922467 · Beckman Instruments, Inc. · Nov 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · Em Diagnostic Systems, Inc. · Sep 1992