Cleared Traditional

K904990 - EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS

K904990 is an FDA 510(k) clearance for EMIT CONVENIENCE PACK, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code LBZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K904990 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K904990

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.

LBZ Device Classification - Class 2, Special Controls

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.
INNOFLUOR QUINIDINE ASSAY SYSTEM
K955568 · Oxis Intl., Inc. · Apr 1996
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · Roche Diagnostic Systems, Inc. · Jul 1994
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · Syva Co. · Aug 1992
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
K900705 · Innotron of Oregon, Inc. · Apr 1990
INNOFLUOR(TM) QUINIDINE REAGENT SET
K892208 · Innotron of Oregon, Inc. · Jun 1989
TDXR FLECAINIDE
K872175 · Abbott Laboratories · Aug 1987