Cleared Traditional

K790808 - PROTEIN ASSAY KIT

K790808 is an FDA 510(k) clearance for PROTEIN ASSAY KIT, manufactured by Specialty Medical Industries, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K790808

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.

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 101
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K790808.
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
K801749 · Beckman Instruments, Inc. · Sep 1980
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
K800674 · Diagnostic Solutions, Inc. · May 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