Cleared Traditional

K860341 - TOTAL PROTEIN (BIURET) REAGENT SET

K860341 is an FDA 510(k) clearance for TOTAL PROTEIN (BIURET) REAGENT SET, manufactured by Sterling Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K860341 · Sterling Diagnostics, Inc. · Chemistry device
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Feb 1986
Decision
13d
Days
Class 2
Risk

K860341 is an FDA 510(k) clearance for the TOTAL PROTEIN (BIURET) REAGENT SET. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 11, 1986 after a review of 13 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 Sterling Diagnostics, Inc. devices

FDA 510(k) Submission Details - K860341

510(k) Number K860341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1986
Decision Date February 11, 1986
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 K860341.
TOTAL PROTEIN PROCEDURE
K861663 · Data Medical Associates, Inc. · Jun 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · Em Diagnostic Systems, Inc. · Apr 1986
A-GENT LIQUID TOTAL PROTEIN
K860426 · Abbott Laboratories · Apr 1986
NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928
K854717 · Nobel Scientific Industries, Inc. · Jan 1986
TOTAL PROTEIN REAGENT SET
K855191 · Technostics Intl. · Jan 1986
QUANTTEST TOTAL PROTEIN ASSAY
K853932 · Quantimetrix Corp. · Dec 1985