Cleared Traditional

K771926 - TOTAL PROTEIN SET, ITEM NO. 64010

K771926 is an FDA 510(k) clearance for TOTAL PROTEIN SET, manufactured by Harleco. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K771926 · Harleco · Chemistry device
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Nov 1977
Decision
28d
Days
Class 2
Risk

K771926 is an FDA 510(k) clearance for the TOTAL PROTEIN SET, ITEM NO. 64010. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on November 11, 1977 after a review of 28 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 Harleco devices

FDA 510(k) Submission Details - K771926

510(k) Number K771926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1977
Decision Date November 11, 1977
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 100
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K771926.
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
TOTAL PROTEIN
K771841 · Gamma Enterprises, Inc. · Oct 1977
MULTISTAT III TOTAL PROTEIN TEST
K771476 · Instrumentation Laboratory CO · Sep 1977
AUTO TOTAL PROTEIN FOR ANALYZER
K770887 · Harleco · Jul 1977