Cleared Traditional

K875222 - TOTAL PROTEIN

K875222 is an FDA 510(k) clearance for TOTAL PROTEIN, manufactured by Catachem, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K875222 · Catachem, Inc. · Chemistry device
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Jan 1988
Decision
31d
Days
Class 2
Risk

K875222 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 Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 31 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 Catachem, Inc. devices

FDA 510(k) Submission Details - K875222

510(k) Number K875222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date January 22, 1988
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K875222.
BIOTROL TOTAL PROTEIN H.P.
K882189 · Biotrol, USA, Inc. · Jul 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
K880312 · Wako Chemicals USA, Inc. · Mar 1988
TOTAL PROTEIN REAGENT SET
K880677 · Tech-Neal Scientific, Inc. · Mar 1988
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · Em Diagnostic Systems, Inc. · Nov 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371 · Trace Scientific , Ltd. · Aug 1987
MULTICHEM TOTAL PROTEIN REAGENT #S0928
K871975 · Simmler, Inc. · Jun 1987