Cleared Traditional

K821544 - DETECTION OF THEOPHYLLINE

K821544 is the FDA 510(k) clearance for DETECTION OF THEOPHYLLINE by Electro-Nucleonics Laboratories, Inc.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K821544 · Electro-Nucleonics Laboratories, Inc. · Toxicology device
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Jun 1982
Decision
17d
Days
Class 2
Risk

K821544 is an FDA 510(k) clearance for the DETECTION OF THEOPHYLLINE. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 10, 1982 after a review of 17 days - a notably fast clearance cycle.

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: 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 Electro-Nucleonics Laboratories, Inc. devices

Submission Details

510(k) Number K821544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1982
Decision Date June 10, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 87d · This submission: 17d
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 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K821544.
THEOPHYLLINE TEST PACK ACA
K831934 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
EMIT AAD THEOPHYLLINE ASSAY
K832034 · Syva Co. · Aug 1983
EMIT QST THEOPHYLLINE ASSAY
K831272 · Syva Co. · May 1983
A-GENT THEOPHYLLINE
K812003 · Abbott Laboratories · Jul 1981
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578 · Beckman Instruments, Inc. · Mar 1981
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066 · Immunotech Corp. · Oct 1980