Cleared Traditional

K902560 - ROCHE COBAS READY ALKALINE PHOSPHATASE ...

K902560 is the FDA 510(k) clearance for ROCHE COBAS READY ALKALINE PHOSPHATASE ... by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K902560 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jul 1990
Decision
36d
Days
Class 2
Risk

K902560 is an FDA 510(k) clearance for the ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 36 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K902560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1990
Decision Date July 17, 1990
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 76
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K902560.
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K900216 · Coulter Corp. · Feb 1990
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K895250 · Em Diagnostic Systems, Inc. · Oct 1989