Cleared Traditional

K994005 - SYVA EMIT II PLUS METHADONE ASSAY

K994005 is the FDA 510(k) clearance for SYVA EMIT II PLUS METHADONE ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code DJR) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K994005 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
57d
Days
Class 2
Risk

K994005 is an FDA 510(k) clearance for the SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3620 - 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 K994005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date January 20, 2000
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 44
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K994005.
METHADONE
K013001 · Abbott Laboratories · Mar 2002
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · ACON Laboratories, Inc. · Oct 2001
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
K000466 · Dade Behring, Inc. · Apr 2000
ACCUSIGN MTD, BIOSIGN MTD
K991080 · Princeton BioMeditech Corp. · Apr 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153
K982938 · Phamatech · Feb 1999
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703 · Roche Diagnostic Systems, Inc. · Dec 1998