Cleared Traditional

K912368 - IMX SELECT ANALYZER

K912368 is an FDA 510(k) clearance for IMX SELECT ANALYZER, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K912368 · Abbott Laboratories · Chemistry device
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Sep 1991
Decision
105d
Days
Class 1
Risk

K912368 is an FDA 510(k) clearance for the IMX SELECT ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 11, 1991 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K912368

510(k) Number K912368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date September 11, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 145
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K912368.
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MICROTAK PLUS
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OPUS(R) PLUS ANALYZER
K913295 · Pb Diagnostic Systems, Inc. · Sep 1991
MICROTRAK MANAGER
K912959 · Syva Co. · Jul 1991
CHEM-LINK DATA BASE MANAGER
K912413 · Technicon Instruments Corp. · Jul 1991