Cleared Traditional

K900373 - BIOTRACK THEOPHYLLINE TEST CARTRIDGE

K900373 is the FDA 510(k) clearance for BIOTRACK THEOPHYLLINE TEST CARTRIDGE by Biotrack, Inc.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K900373 · Biotrack, Inc. · Toxicology device
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May 1990
Decision
124d
Days
Class 2
Risk

K900373 is an FDA 510(k) clearance for the BIOTRACK THEOPHYLLINE TEST CARTRIDGE. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 30, 1990 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3880 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotrack, Inc. devices

Submission Details

510(k) Number K900373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1990
Decision Date May 30, 1990
Days to Decision 124 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 87d · This submission: 124d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 56
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K900373.
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · Instrumentation Laboratory CO · Apr 1991
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243 · Technicon Instruments Corp. · Jul 1990
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
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · Syva Co. · Mar 1989