Cleared Traditional

KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME (K821154) - FDA 510(k) Clearance

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

K821154 · Jay Rau, Technical Suppprt · Chemistry device
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May 1982
Decision
17d
Days
Class 2
Risk

K821154 is an FDA 510(k) clearance for the KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Jay Rau, Technical Suppprt (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982 after a review of 17 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 Jay Rau, Technical Suppprt devices

Submission Details

510(k) Number K821154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1982
Decision Date May 13, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · 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 Chemistry devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 40
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K821154.
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
APPLICATION OF EMIT THEOPHYLLINE ASSAY
K801476 · Syva Co. · Jul 1980