Cleared Traditional

K900373 - BIOTRACK THEOPHYLLINE TEST CARTRIDGE

K900373 is an FDA 510(k) clearance for BIOTRACK THEOPHYLLINE TEST CARTRIDGE, manufactured by Biotrack, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K900373

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.

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 Toxicology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 62
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