Cleared Traditional

TOTAL PROTEIN REAGENT SET (K855191) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K855191 · Technostics Intl. · Chemistry device
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Jan 1986
Decision
19d
Days
Class 2
Risk

K855191 is an FDA 510(k) clearance for the TOTAL PROTEIN REAGENT SET. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 19 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 Technostics Intl. devices

Submission Details

510(k) Number K855191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
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 26
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K855191.
VISION TOTAL PROTEIN
K861798 · Abbott Laboratories · 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
SIGMA 610 FOR PROTEIN IN URINE & CSF
K853681 · Sigma Diagnostics, Inc. · Oct 1985
SYSTEMATE TOTAL PROTEIN 67218
K843107 · Em Diagnostic Systems, Inc. · Aug 1984
RA-1000 SYSTEM ADD'L ANALYTES PHASE III
K820913 · Technicon Instruments Corp. · May 1982