Cleared Traditional

K881742 - BIOTROL ALKALINE PHOSPHATASE

K881742 is the FDA 510(k) clearance for BIOTROL ALKALINE PHOSPHATASE by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K881742 · Biotrol, USA, Inc. · Chemistry device
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Jul 1988
Decision
77d
Days
Class 2
Risk

K881742 is an FDA 510(k) clearance for the BIOTROL ALKALINE PHOSPHATASE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Malvern, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 K881742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1988
Decision Date July 08, 1988
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 85
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K881742.
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