Cleared Traditional

K790808 - PROTEIN ASSAY KIT

K790808 is the FDA 510(k) clearance for PROTEIN ASSAY KIT by Specialty Medical Industries, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K790808 · Specialty Medical Industries, Inc. · Chemistry device
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Nov 1979
Decision
193d
Days
Class 2
Risk

K790808 is an FDA 510(k) clearance for the PROTEIN ASSAY KIT. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Specialty Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Specialty Medical Industries, Inc. devices

Submission Details

510(k) Number K790808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1979
Decision Date November 05, 1979
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 88d · This submission: 193d
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 79
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K790808.
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
ULTRACHEM TOTAL PROTEIN, #64974
K772155 · Harleco · Dec 1977