Cleared Traditional

K914750 - ROCHE COBAS AMMONIA AND ETHANOL CALIBRATOR

K914750 is the FDA 510(k) clearance for ROCHE COBAS AMMONIA AND ETHANOL CALIBRATOR by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K914750 · Roche Diagnostic Systems, Inc. · Chemistry device
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Nov 1991
Decision
31d
Days
Class 2
Risk

K914750 is an FDA 510(k) clearance for the ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K914750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date November 22, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 183
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