Cleared Traditional

K902243 - TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

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

K902243 · Technicon Instruments Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Technicon Instruments Corp. devices

Submission Details

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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K902243.
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · Syva Co. · Sep 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · Instrumentation Laboratory CO · Apr 1991
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
K901510 · Diagnostic Chemicals, Ltd. (Usa) · Jun 1990
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
VISION THEOPHYLLINE II
K896927 · Abbott Laboratories · Jan 1990