Cleared Traditional

COBAS-BIO CENTRIFUGAL ANALYZER (K792671) - FDA 510(k) Clearance

Class I Chemistry device.

K792671 · Hoffmann-La Roche, Inc. · Chemistry device
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Jan 1980
Decision
21d
Days
Class 1
Risk

K792671 is an FDA 510(k) clearance for the COBAS-BIO CENTRIFUGAL ANALYZER. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - 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 Hoffmann-La Roche, Inc. devices

Submission Details

510(k) Number K792671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1979
Decision Date January 17, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
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 K792671.
COBAS ALPHA
K910222 · Roche Diagnostic Systems, Inc. · Feb 1991
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
K903626 · Beckman Instruments, Inc. · Oct 1990
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
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION
K871838 · Beckman Instruments, Inc. · May 1987