Cleared Traditional

K874578 - EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY

K874578 is the FDA 510(k) clearance for EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code KLS) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K874578 · Syva Co. · Chemistry device
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Nov 1987
Decision
18d
Days
Class 2
Risk

K874578 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY. 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 November 24, 1987 after a review of 18 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 Syva Co. devices

Submission Details

510(k) Number K874578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1987
Decision Date November 24, 1987
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
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 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K874578.
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
DART THEOPHYLLINE REAGENT SYSTEM
K870736 · Coulter Electronics, Inc. · Apr 1987
THEOPHYLLINE FPIA REAGENT SET
K870952 · Sigma Diagnostics, Inc. · Mar 1987
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041 · Em Diagnostic Systems, Inc. · Nov 1986