Cleared Traditional

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM (K911060) - FDA 510(k) Clearance

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

K911060 · Immunomatrix · Chemistry device
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May 1991
Decision
58d
Days
Class 2
Risk

K911060 is an FDA 510(k) clearance for the IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Immunomatrix (Potomac, US). The FDA issued a Cleared decision on May 8, 1991 after a review of 58 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 Immunomatrix devices

Submission Details

510(k) Number K911060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date May 08, 1991
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
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 34
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K911060.
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · Syva Co. · Sep 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · Instrumentation Laboratory CO · Apr 1991
VISION THEOPHYLLINE II
K896927 · Abbott Laboratories · Jan 1990
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · Syva Co. · Mar 1989