Cleared Traditional

EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS (K913123) - FDA 510(k) Clearance

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

K913123 · Syva Co. · Toxicology device
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Sep 1991
Decision
66d
Days
Class 2
Risk

K913123 is an FDA 510(k) clearance for the EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on September 19, 1991 after a review of 66 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 Syva Co. devices

Submission Details

510(k) Number K913123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1991
Decision Date September 19, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 87d · This submission: 66d
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 70
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K913123.
EMIT CAFFEINE ASSAY
K042407 · Dade Behring, Inc. · Oct 2004
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993
VISION THEOPHYLLINE II
K896927 · Abbott Laboratories · Jan 1990
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · Syva Co. · Mar 1989