Cleared Traditional

K935373 - AXSYM THEOPHYLLINE

K935373 is an FDA 510(k) clearance for AXSYM THEOPHYLLINE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K935373 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
225d
Days
Class 2
Risk

K935373 is an FDA 510(k) clearance for the AXSYM THEOPHYLLINE. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 225 days - an extended review cycle.

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 Abbott Laboratories devices

FDA 510(k) Submission Details - K935373

510(k) Number K935373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1993
Decision Date June 21, 1994
Days to Decision 225 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
138d slower than avg
Panel avg: 87d · This submission: 225d
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 58
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K935373.
IMMULITE THEOPHYLLINE
K954569 · Diagnostic Products Corp. · Nov 1995
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · Diagnostic Reagents, Inc. · Aug 1995
IL TEST THEOPHYLLINE
K943979 · Instrumentation Laboratory CO · Jan 1995
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685 · Baxter Diagnostics, Inc. · Sep 1993
VIDAS THEOPHYLLINE(THEO)
K933258 · Biomerieux Vitek, Inc. · Aug 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993