Cleared Traditional

K771841 - TOTAL PROTEIN

K771841 is the FDA 510(k) clearance for TOTAL PROTEIN by Gamma Enterprises, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K771841 · Gamma Enterprises, Inc. · Chemistry device
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Oct 1977
Decision
34d
Days
Class 2
Risk

K771841 is an FDA 510(k) clearance for the TOTAL PROTEIN. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977 after a review of 34 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 Gamma Enterprises, Inc. devices

Submission Details

510(k) Number K771841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1977
Decision Date October 25, 1977
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K771841.
REAGENT SET, TOTAL PROTEIN
K781722 · Medical Analysis Systems, Inc. · Nov 1978
ULTRACHEM TOTAL PROTEIN, #64974
K772155 · Harleco · Dec 1977
TOTAL PROTEIN SET, ITEM NO. 64010
K771926 · Harleco · Nov 1977
MULTISTAT III TOTAL PROTEIN TEST
K771476 · Instrumentation Laboratory CO · Sep 1977
AUTO TOTAL PROTEIN FOR ANALYZER
K770887 · Harleco · Jul 1977
PROTEIN PROCEDURE, TEKPOINT TOTAL
K770452 · Icn Pharmaceuticals, Inc. · May 1977