Cleared Traditional

K993987 - SYVA EMIT II PLUS BARBITURATE ASSAY

K993987 is the FDA 510(k) clearance for SYVA EMIT II PLUS BARBITURATE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code KLT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K993987 · Syva Co. · Toxicology device
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Jan 2000
Decision
64d
Days
Class 2
Risk

K993987 is an FDA 510(k) clearance for the SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - 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 K993987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 87d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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 - KLT Enzyme Immunoassay, Carbamazepine

All 38
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K993987.
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K000903 · Bayer Corp. · May 2000
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
K000007 · Diagnostic Products Corp. · Feb 2000
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028 · Syva Co. · Jan 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · Beckman Instruments, Inc. · Feb 1997
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964068 · Bayer Corp. · Dec 1996
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644 · Beckman Instruments, Inc. · Feb 1996