Cleared Traditional

K850936 - TOTAL PROTEINS

K850936 is an FDA 510(k) clearance for TOTAL PROTEINS, manufactured by Dilab, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K850936 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
110d
Days
Class 2
Risk

K850936 is an FDA 510(k) clearance for the TOTAL PROTEINS. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 110 days - within the typical 510(k) review window.

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 Dilab, Inc. devices

FDA 510(k) Submission Details - K850936

510(k) Number K850936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 25, 1985
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
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 K850936.
SIGMA 610 FOR PROTEIN IN URINE & CSF
K853681 · Sigma Diagnostics, Inc. · Oct 1985
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
K853244 · Simmler, Inc. · Aug 1985
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
K852844 · American Research Products Co. · Jul 1985
TP BIURET REAGENT
K852006 · Alpkem Corp. · Jun 1985
TOTAL PROTEIN LIQUID STABLE REAGENT SET
K851877 · Medical Analysis Systems, Inc. · May 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
K844331 · Advanced Biomedical Methods, Inc. · Jan 1985