Cleared Traditional

ANALYST THEOPHYLLINE ROTOR (K884002) - FDA 510(k) Clearance

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

K884002 · The DU Pont Co. · Toxicology device
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Oct 1988
Decision
40d
Days
Class 2
Risk

K884002 is an FDA 510(k) clearance for the ANALYST THEOPHYLLINE ROTOR. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by The DU Pont Co. (Wilmington, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 40 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 The DU Pont Co. devices

Submission Details

510(k) Number K884002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1988
Decision Date October 31, 1988
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
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 40
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K884002.
VISION THEOPHYLLINE II
K896927 · Abbott Laboratories · Jan 1990
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · Syva Co. · Mar 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002 · Diagnostic Products Corp. · Jan 1989
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · Syva Co. · Nov 1987
THEOPHYLLINE FPIA REAGENT SET
K870952 · Sigma Diagnostics, Inc. · Mar 1987
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041 · Em Diagnostic Systems, Inc. · Nov 1986