Cleared Traditional

IMX INSULIN (K920109) - FDA 510(k) Clearance

Class I Chemistry device.

K920109 · Abbott Laboratories · Chemistry device
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May 1992
Decision
118d
Days
Class 1
Risk

K920109 is an FDA 510(k) clearance for the IMX INSULIN. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 7, 1992 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1405 - 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

Submission Details

510(k) Number K920109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1992
Decision Date May 07, 1992
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFP Radioimmunoassay, Immunoreactive Insulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1405
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 - CFP Radioimmunoassay, Immunoreactive Insulin

All 7
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K920109.
ENZYMUN TEST(R) INSULIN
K901135 · Boehringer Mannheim Corp. · Apr 1990
REP(TM) SPE PLUS-30 PROCEDURES
K896572 · Helena Laboratories · Jan 1990
PHARMACIA INSULIN RIA
K851071 · Pharmacia, Inc. · Apr 1985
WAKO INSULIN TEST
K823939 · Wako Chemicals USA, Inc. · Jan 1983
COAT-A-COUNT INSULIN KIT
K821861 · Diagnostic Products Corp. · Jul 1982
ARIA II INSULIN RIA
K811144 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1981