Cleared Traditional

K884358 - CEDIA THEOPHYLLINE ASSAY

K884358 is the FDA 510(k) clearance for CEDIA THEOPHYLLINE ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K884358 · Microgenics Corp. · Toxicology device
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Feb 1989
Decision
113d
Days
Class 2
Risk

K884358 is an FDA 510(k) clearance for the CEDIA THEOPHYLLINE ASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corp. devices

Submission Details

510(k) Number K884358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1988
Decision Date February 07, 1989
Days to Decision 113 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
26d slower than avg
Panel avg: 87d · This submission: 113d
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 K884358.
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
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
BEHRING POLAROID OPUS THEOPHYLLINE
K885044 · Pb Diagnostic Systems, Inc. · Dec 1988
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257 · Immunotech Corp. · May 1988