Cleared Traditional

K884002 - ANALYST THEOPHYLLINE ROTOR

K884002 is an FDA 510(k) clearance for ANALYST THEOPHYLLINE ROTOR, manufactured by The DU Pont Co.. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

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

FDA 510(k) Submission Details - K884002

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.

KLS Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K884002.
CEDIA THEOPHYLLINE ASSAY
K884358 · Microgenics Corp. · Feb 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002 · Diagnostic Products Corp. · Jan 1989
BEHRING POLAROID OPUS THEOPHYLLINE
K885044 · Pb Diagnostic Systems, Inc. · Dec 1988
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257 · Immunotech Corp. · May 1988
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · Syva Co. · Nov 1987
DART THEOPHYLLINE REAGENT SYSTEM
K870736 · Coulter Electronics, Inc. · Apr 1987