Cleared Traditional

K972495 - ACCUMETER THEOPHYLLINE TEST

K972495 is the FDA 510(k) clearance for ACCUMETER THEOPHYLLINE TEST by Chemtrak, Inc.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K972495 · Chemtrak, Inc. · Toxicology device
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Oct 1997
Decision
99d
Days
Class 2
Risk

K972495 is an FDA 510(k) clearance for the ACCUMETER THEOPHYLLINE TEST. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Chemtrak, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 10, 1997 after a review of 99 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 Chemtrak, Inc. devices

Submission Details

510(k) Number K972495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1997
Decision Date October 10, 1997
Days to Decision 99 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 87d · This submission: 99d
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 K972495.
RANDOX THEOPHYLLINE
K011771 · Randox Laboratories, Ltd. · Jan 2002
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · Bayer Corp. · Oct 2001
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
CEDIA THEOPHYLLINE ASSAY
K961462 · Boehringer Mannheim Corp. · Jun 1996
IMMULITE THEOPHYLLINE
K954569 · Diagnostic Products Corp. · Nov 1995
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · Diagnostic Reagents, Inc. · Aug 1995