Cleared Traditional

K926245 - ABBOTT VISION THEOPHYLLINE IIA

K926245 is an FDA 510(k) clearance for ABBOTT VISION THEOPHYLLINE IIA, 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 143-day FDA review.

K926245 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
143d
Days
Class 2
Risk

K926245 is an FDA 510(k) clearance for the ABBOTT VISION THEOPHYLLINE IIA. 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 May 6, 1993 after a review of 143 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K926245

510(k) Number K926245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date May 06, 1993
Days to Decision 143 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
56d slower than avg
Panel avg: 87d · This submission: 143d
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 K926245.
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685 · Baxter Diagnostics, Inc. · Sep 1993
VIDAS THEOPHYLLINE(THEO)
K933258 · Biomerieux Vitek, Inc. · Aug 1993
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · Syva Co. · Sep 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · Instrumentation Laboratory CO · Apr 1991
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243 · Technicon Instruments Corp. · Jul 1990