Cleared Traditional

K920559 - ABBOTT VERTEX ANALYZER

K920559 is an FDA 510(k) clearance for ABBOTT VERTEX ANALYZER, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code JJJ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K920559 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
41d
Days
Class 1
Risk

K920559 is an FDA 510(k) clearance for the ABBOTT VERTEX ANALYZER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K920559

510(k) Number K920559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1992
Decision Date March 19, 1992
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
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: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 29
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K920559.
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K874094 · Lkb Instruments, Inc. · Nov 1987
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1208 BETACORD AND 1208 BETCORD M
K852434 · Lkb Instruments, Inc. · Aug 1985
MICROSTAT GAMMA COUNTER
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CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · Corning Medical & Scientific · Mar 1984
NML-5010/5020 MULTI-DETECTOR SYSTEM
K832002 · Nuclear Medical Laboratories, Inc. · Aug 1983