Cleared Traditional

K902243 - TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

K902243 is an FDA 510(k) clearance for TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES, manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with product code KLS cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K902243 · Technicon Instruments Corp. · Chemistry device
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Jul 1990
Decision
48d
Days
Class 2
Risk

K902243 is an FDA 510(k) clearance for the TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 5, 1990 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3880 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K902243

510(k) Number K902243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1990
Decision Date July 05, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 89d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLS Device Classification - Class 2, Special Controls

Product Code KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 70
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K902243.
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · Syva Co. · Sep 1991
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
K911060 · Immunomatrix · May 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · Instrumentation Laboratory CO · Apr 1991
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
K901510 · Diagnostic Chemicals, Ltd. (Usa) · Jun 1990
BIOTRACK THEOPHYLLINE TEST CARTRIDGE
K900373 · Biotrack, Inc. · May 1990
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
K902243 · TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
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