Cleared Traditional

LABOTECH AUTOMATED MICROTITER ANALYZER (K922081) - FDA 510(k) Clearance

Class I Chemistry device.

K922081 · Innovative Medical Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 257
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K922081.
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
K943595 · Instrumentation Laboratory CO · Nov 1994
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
K932778 · Boehringer Mannheim Corp. · Nov 1993
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
K932467 · Instrumentation Laboratory CO · Nov 1993
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K921180 · Roche Diagnostic Systems, Inc. · Jul 1992
AMERLITE PROCESSING CENTER
K915680 · Eastman Kodak Company · Mar 1992
MICROTAK PLUS
K913840 · Syva Co. · Sep 1991