Cleared Traditional

K881267 - BIOTROL CK MONOEACTIF

K881267 is an FDA 510(k) clearance for BIOTROL CK MONOEACTIF, manufactured by Biotrol, USA, Inc.. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K881267 · Biotrol, USA, Inc. · Chemistry device
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May 1988
Decision
53d
Days
Class 2
Risk

K881267 is an FDA 510(k) clearance for the BIOTROL CK MONOEACTIF. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Malvern, US). The FDA issued a Cleared decision on May 16, 1988 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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

FDA 510(k) Submission Details - K881267

510(k) Number K881267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1988
Decision Date May 16, 1988
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHX Device Classification - Class 2, Special Controls

Product Code JHX Fluorometric Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 38
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K881267.
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TITAN GEL REP CPK-6 HV
K874144 · Helena Laboratories · Nov 1987
TITAN GEL CPK REP SYSTEM
K873399 · Helena Laboratories · Oct 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
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