Cleared Traditional

ADX(TM) ANALYZER (K864566) - FDA 510(k) Clearance

Class I Chemistry device.

K864566 · Abbott Laboratories · Chemistry device
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Feb 1987
Decision
77d
Days
Class 1
Risk

K864566 is an FDA 510(k) clearance for the ADX(TM) ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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

Submission Details

510(k) Number K864566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date February 04, 1987
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 53
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K864566.
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · Helena Laboratories · Nov 1987
SYVA Q-SPEC PHOTOMETER
K871307 · Syva Co. · May 1987
CIBA CORNING MAGIC LITE ANALYZER II
K871874 · Ciba Corning Diagnostics Corp. · May 1987
OHMEDA 6000 MULTI-GAS MONITOR
K863959 · Ohmeda Medical · Jan 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · Terumo Medical Corp. · Jan 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986