Cleared Traditional

K812003 - A-GENT THEOPHYLLINE

K812003 is an FDA 510(k) clearance for A-GENT THEOPHYLLINE, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code KLS cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K812003 · Abbott Laboratories · Chemistry device
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Jul 1981
Decision
13d
Days
Class 2
Risk

K812003 is an FDA 510(k) clearance for the A-GENT 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 July 27, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3880 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K812003

510(k) Number K812003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1981
Decision Date July 27, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
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 Chemistry 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 K812003.
EMIT AAD THEOPHYLLINE ASSAY
K832034 · Syva Co. · Aug 1983
EMIT QST THEOPHYLLINE ASSAY
K831272 · Syva Co. · May 1983
DETECTION OF THEOPHYLLINE
K821544 · Electro-Nucleonics Laboratories, Inc. · Jun 1982
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578 · Beckman Instruments, Inc. · Mar 1981
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066 · Immunotech Corp. · Oct 1980
FIAX TEST KIT FOR THEOPHYLLINE QUANT.
K801642 · Intl. Diagnostic Technology · Aug 1980