Cleared Traditional

K993029 - ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS

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

K993029 is an FDA 510(k) clearance for ABBOTT AEROSET THEOPHYLLINE ASSAY AND C..., manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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

FDA 510(k) Submission Details - K993029

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.

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 K993029.
RANDOX THEOPHYLLINE
K011771 · Randox Laboratories, Ltd. · Jan 2002
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · Bayer Corp. · Oct 2001
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
K011166 · Syva Co., Dade Behring, Inc. · May 2001
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
K973583 · Schiapparelli Biosystems, Inc. · Nov 1997
ACCUMETER THEOPHYLLINE TEST
K972495 · Chemtrak, Inc. · Oct 1997
CEDIA THEOPHYLLINE ASSAY
K961462 · Boehringer Mannheim Corp. · Jun 1996