Cleared Traditional

K923267 - SYSTEMATE TOTAL PROTEIN TEST

K923267 is the FDA 510(k) clearance for SYSTEMATE TOTAL PROTEIN TEST by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K923267 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1992
Decision
69d
Days
Class 2
Risk

K923267 is an FDA 510(k) clearance for the SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 69 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K923267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date September 09, 1992
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
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 76
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K923267.
MICROPROTEIN REAGENT SET
K921412 · Sterling Diagnostics, Inc. · Jan 1993
OLYUMPUS TOTAL PROTEIN REAGENT
K924659 · Olympus Corp. · Dec 1992
SYNCHRON TOTAL PROTEIN TEST --MODIFIED
K922467 · Beckman Instruments, Inc. · Nov 1992
NOVA TOTAL PROTEIN MODULE
K923266 · Nova Biomedical Corp. · Aug 1992
OLYMPUS TOTAL PROTEIN REAGENT
K922361 · Olympus Corp. · Jul 1992
WAKO AUTOKIT MICRO TP
K920531 · Wako Chemicals USA, Inc. · Jul 1992