Cleared Traditional

K781774 - TOTAL PROTEIN

K781774 is the FDA 510(k) clearance for TOTAL PROTEIN by Gilford Diagnostics. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K781774 · Gilford Diagnostics · Chemistry device
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Nov 1978
Decision
40d
Days
Class 2
Risk

K781774 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 Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 40 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 Gilford Diagnostics devices

Submission Details

510(k) Number K781774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1978
Decision Date November 22, 1978
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 77
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K781774.
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
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