Cleared Traditional

K882189 - BIOTROL TOTAL PROTEIN H.P.

K882189 is the FDA 510(k) clearance for BIOTROL TOTAL PROTEIN H.P. by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K882189 · Biotrol, USA, Inc. · Chemistry device
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Jul 1988
Decision
38d
Days
Class 2
Risk

K882189 is an FDA 510(k) clearance for the BIOTROL TOTAL PROTEIN H.P.. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Malvern, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 38 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K882189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date July 01, 1988
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 78
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K882189.
TOTAL PROTEIN REAGENT
K890317 · Medical Analysis Systems, Inc. · Mar 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · Em Diagnostic Systems, Inc. · Jan 1989
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
K881639 · Eastman Kodak Company · Jul 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
K880312 · Wako Chemicals USA, Inc. · Mar 1988
TOTAL PROTEIN
K875222 · Catachem, Inc. · Jan 1988
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · Em Diagnostic Systems, Inc. · Nov 1987