Cleared Traditional

K922081 - LABOTECH AUTOMATED MICROTITER ANALYZER

K922081 is the FDA 510(k) clearance for LABOTECH AUTOMATED MICROTITER ANALYZER by Innovative Medical Systems, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K922081 · Innovative Medical Systems, Inc. · Chemistry device
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Sep 1992
Decision
120d
Days
Class 1
Risk

K922081 is an FDA 510(k) clearance for the LABOTECH AUTOMATED MICROTITER ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Innovative Medical Systems, Inc. (Warren, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 120 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 Innovative Medical Systems, Inc. devices

Submission Details

510(k) Number K922081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1992
Decision Date September 02, 1992
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
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 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K922081.
OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER
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K921180 · Roche Diagnostic Systems, Inc. · Jul 1992
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K915896 · Dynatech Laboratories, Inc. · May 1992
ENCORE
K915113 · Heraeus Kulzer, Inc. · Mar 1992