Cleared Traditional

K910222 - COBAS ALPHA

K910222 is an FDA 510(k) clearance for COBAS ALPHA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Toxicology device with product code JJG cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K910222 · Roche Diagnostic Systems, Inc. · Toxicology device
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Feb 1991
Decision
40d
Days
Class 1
Risk

K910222 is an FDA 510(k) clearance for the COBAS ALPHA. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on February 27, 1991 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2140 - the FDA toxicology device 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

FDA 510(k) Submission Details - K910222

510(k) Number K910222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1991
Decision Date February 27, 1991
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

JJG Device Classification - Class 1, General Controls

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

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