Cleared Traditional

BECKMAN THEOPHYLLINE REAGENT TEST KIT (K810578) - FDA 510(k) Clearance

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

K810578 · Beckman Instruments, Inc. · Toxicology device
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Mar 1981
Decision
10d
Days
Class 2
Risk

K810578 is an FDA 510(k) clearance for the BECKMAN THEOPHYLLINE REAGENT TEST KIT. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 10 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K810578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date March 13, 1981
Days to Decision 10 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
77d faster than avg
Panel avg: 87d · This submission: 10d
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 39
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K810578.
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
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