Cleared Traditional

K913123 - EMIT 2000 THEOPHYLLINE ASSAY/CALIBRATORS

K913123 is the FDA 510(k) clearance for EMIT 2000 THEOPHYLLINE ASSAY/CALIBRATORS by Syva Co.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

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 49
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K913123.
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685 · Baxter Diagnostics, Inc. · Sep 1993
VIDAS THEOPHYLLINE(THEO)
K933258 · Biomerieux Vitek, Inc. · Aug 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · Instrumentation Laboratory CO · Apr 1991
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243 · Technicon Instruments Corp. · Jul 1990
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
K901510 · Diagnostic Chemicals, Ltd. (Usa) · Jun 1990