Cleared Traditional

K905650 - KINETIC ALKALINE PHOSPHATASE DETERMINATION

K905650 is the FDA 510(k) clearance for KINETIC ALKALINE PHOSPHATASE DETERMINATION by Biochemical Trade, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K905650 · Biochemical Trade, Inc. · Chemistry device
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Feb 1991
Decision
57d
Days
Class 2
Risk

K905650 is an FDA 510(k) clearance for the KINETIC ALKALINE PHOSPHATASE DETERMINATION. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on February 13, 1991 after a review of 57 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 Biochemical Trade, Inc. devices

Submission Details

510(k) Number K905650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date February 13, 1991
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
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 86
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K905650.
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K923527 · Olympus Corp. · Sep 1992
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921 · Em Diagnostic Systems, Inc. · Nov 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639 · Em Diagnostic Systems, Inc. · Apr 1991
ALKALINE PHOSPHATASE
K905684 · Amresco, Inc. · Dec 1990
SYNERMED ALKALINE PHOSPHATASE REAGENT KIT
K904030 · Synermed, Inc. · Sep 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · Roche Diagnostic Systems, Inc. · Jul 1990