Cleared Traditional

K800674 - SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER

K800674 is the FDA 510(k) clearance for SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER by Diagnostic Solutions, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K800674 · Diagnostic Solutions, Inc. · Chemistry device
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May 1980
Decision
63d
Days
Class 2
Risk

K800674 is an FDA 510(k) clearance for the SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Diagnostic Solutions, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 63 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 Diagnostic Solutions, Inc. devices

Submission Details

510(k) Number K800674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1980
Decision Date May 28, 1980
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
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 82
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K800674.
TOTAL PROTEIN TEST
K811673 · King Diagnostics, Inc. · Jun 1981
IL TOTAL PROTEIN REAGENT
K802310 · Instrumentation Laboratory CO · Oct 1980
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
K801749 · Beckman Instruments, Inc. · Sep 1980
SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
K792138 · Fisher Scientific Co., LLC · Nov 1979
TOTAL PROTEIN
K781774 · Gilford Diagnostics · Nov 1978
REAGENT SET, TOTAL PROTEIN
K781722 · Medical Analysis Systems, Inc. · Nov 1978