Cleared Traditional

K972495 - ACCUMETER THEOPHYLLINE TEST

K972495 is an FDA 510(k) clearance for ACCUMETER THEOPHYLLINE TEST, manufactured by Chemtrak, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K972495

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
Combination Product No
PCCP Authorized No
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.

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 61
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K972495.
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
K011166 · Syva Co., Dade Behring, Inc. · May 2001
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
K973583 · Schiapparelli Biosystems, Inc. · Nov 1997
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