Cleared Traditional

K881257 - EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY...

K881257 is the FDA 510(k) clearance for EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY... by Immunotech Corp.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K881257 · Immunotech Corp. · Toxicology device
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May 1988
Decision
65d
Days
Class 2
Risk

K881257 is an FDA 510(k) clearance for the EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 65 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 Immunotech Corp. devices

Submission Details

510(k) Number K881257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1988
Decision Date May 27, 1988
Days to Decision 65 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
22d faster than avg
Panel avg: 87d · This submission: 65d
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 K881257.
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
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · Syva Co. · Nov 1987
DART THEOPHYLLINE REAGENT SYSTEM
K870736 · Coulter Electronics, Inc. · Apr 1987
THEOPHYLLINE FPIA REAGENT SET
K870952 · Sigma Diagnostics, Inc. · Mar 1987