Cleared Traditional

K981897 - ROCHE COBAS INTEGRA ALKALINE PHOSPHATAS...

K981897 is the FDA 510(k) clearance for ROCHE COBAS INTEGRA ALKALINE PHOSPHATAS... by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K981897 · Roche Diagnostic Systems, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
86d
Days
Class 2
Risk

K981897 is an FDA 510(k) clearance for the ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE .... Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 26, 1998 after a review of 86 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 K981897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1998
Decision Date August 26, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
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 K981897.
MODIFICATION TO ALKP
K023807 · Abbott Laboratories · Dec 2002
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · Diagnostic Chemicals , Ltd. · Nov 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · Teco Diagnostics · Jan 2000
ALKP
K981806 · Abbott Laboratories · Jun 1998
ALKALINE PHOSPHATASE (ALKP)
K981245 · Abbott Laboratories · May 1998
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316 · Diagnostic Chemicals , Ltd. · Feb 1998