Cleared Traditional

EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS (K904990) - FDA 510(k) Clearance

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

K904990 · Syva Co. · Toxicology device
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Feb 1991
Decision
90d
Days
Class 2
Risk

K904990 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on February 4, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K904990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1990
Decision Date February 04, 1991
Days to Decision 90 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
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBZ Enzyme Immunoassay, Quinidine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - LBZ Enzyme Immunoassay, Quinidine

All 26
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K904990.
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · Syva Co. · Aug 1992
TDXR FLECAINIDE
K872175 · Abbott Laboratories · Aug 1987
EMIT QUINIDINE ASSAY
K862214 · Syva Co. · Jun 1986
TDX DISOPYRAMIDE
K842713 · Abbott Laboratories · Aug 1984
EMIT CAD QUINIDINE ASSAY FOR USE W/
K832096 · Syva Co. · Aug 1983
EMIT QST QUINIDINE ASSAY
K831355 · Syva Co. · Jun 1983