Cleared Traditional

COBAS ALPHA (K910222) - FDA 510(k) Clearance

Class I Toxicology device.

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

Submission Details

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.

Device Classification

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

All 29
Devices cleared under the same product code (JJG) and FDA review panel - the closest regulatory comparables to K910222.
COBAS FARA II CENTRIFUGAL ANALYZER
K893854 · Roche Diagnostic Systems, Inc. · Aug 1989
COBAS FARA CENTRIFUGAL ANALYZER
K893641 · Roche Diagnostic Systems, Inc. · Jul 1989
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.
K871973 · Instrumentation Laboratory CO · Jun 1987
COBAS FLUORESCENCE POLARIZATION MODULE
K843914 · Roche Diagnostic Systems, Inc. · Nov 1984
PDA SYSTEM
K842522 · Abbott Laboratories · Aug 1984
IL MODEL 773 FLUORESCENCE LIGHT SCATTER
K801026 · Instrumentation Laboratory CO · May 1980