Cleared Traditional

K802066 - ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY

K802066 is the FDA 510(k) clearance for ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY by Immunotech Corp.. It is a Class 2 Immunology device (product code KLS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K802066 · Immunotech Corp. · Immunology device
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Oct 1980
Decision
57d
Days
Class 2
Risk

K802066 is an FDA 510(k) clearance for the ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Immunotech Corp. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3880 - the FDA immunology 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: 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 Immunotech Corp. devices

Submission Details

510(k) Number K802066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1980
Decision Date October 23, 1980
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 104d · This submission: 57d
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 Immunology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K802066.
DETECTION OF THEOPHYLLINE
K821544 · Electro-Nucleonics Laboratories, Inc. · Jun 1982
A-GENT THEOPHYLLINE
K812003 · Abbott Laboratories · Jul 1981
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578 · Beckman Instruments, Inc. · Mar 1981
APPLICATION OF EMIT THEOPHYLLINE ASSAY
K801476 · Syva Co. · Jul 1980
AMES TDA THEOPHYL-LINE TEST
K800646 · Miles Laboratories, Inc. · Apr 1980
EMIT THEOPHYLLINE ASSAY
K790256 · Syva Co. · Mar 1979