Cleared Traditional

ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS (K993029) - FDA 510(k) Clearance

Also marketed or referenced as:
MODELS 1E09 AND 6E89

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993029 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
140d
Days
Class 2
Risk

K993029 is an FDA 510(k) clearance for the ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 140 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 Syva Co. devices

Submission Details

510(k) Number K993029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1999
Decision Date January 27, 2000
Days to Decision 140 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
53d slower than avg
Panel avg: 87d · This submission: 140d
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 70
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K993029.
EMIT CAFFEINE ASSAY
K042407 · Dade Behring, Inc. · Oct 2004
ROCHE ONLINE THEOPHYLLINE
K020740 · Roche Diagnostics Corp. · Apr 2002
CEDIA THEOPHYLLINE ASSAY
K961462 · Boehringer Mannheim Corp. · Jun 1996
IMMULITE THEOPHYLLINE
K954569 · Diagnostic Products Corp. · Nov 1995
IL TEST THEOPHYLLINE
K943979 · Instrumentation Laboratory CO · Jan 1995
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994