Cleared Traditional

K920109 - IMX INSULIN

K920109 is an FDA 510(k) clearance for IMX INSULIN, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CFP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

FDA 510(k) Submission Details - K920109

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.

CFP Device Classification - Class 1, General Controls

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 18
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K920109.
ALPCO/MERCODIA INSULIN ELISA
K963911 · American Laboratory Products Co., Ltd. · Nov 1996
ACCESS ULTRASENSITIVE INSULIN ASSAY
K953084 · Bio-Rad Laboratories, Inc. · Sep 1995
DSL INSULIN RIA (DSL 1600)
K914820 · Diagnostic Systems Laboratories, Inc. · Jan 1992
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