Cleared Traditional

MICROPROTEIN REAGENT SET (K921412) - FDA 510(k) Clearance

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

K921412 · Sterling Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 115
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K921412.
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
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
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
K914885 · Beckman Instruments, Inc. · Jan 1992
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
K913978 · Beckman Instruments, Inc. · Oct 1991