Cleared Special

K012257 - EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229

K012257 is an FDA 510(k) clearance for EMIT II PLUS MONOCLONAL AMPHETAMINE/MET..., manufactured by Syva Co.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Special 510(k) pathway after a 16-day FDA review.

K012257 · Syva Co. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
16d
Days
Class 2
Risk

K012257 is an FDA 510(k) clearance for the EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on August 3, 2001 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012257

510(k) Number K012257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2001
Decision Date August 03, 2001
Days to Decision 16 days
Submission Type Special
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
73d faster than avg
Panel avg: 89d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K012257.
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp. · Nov 2001
DRUGS OF ABUSE MULTI-TEST STRIP
K011952 · Microdiagnostics, Inc. · Oct 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · Microgenics Corp. · Aug 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
K011673 · ACON Laboratories, Inc. · Jul 2001
RAPID DRUG SCREEN
K012159 · American Bio Medica Corp. · Jul 2001
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
K011499 · Sun Biomedical Laboratories, Inc. · Jul 2001
K012257 · EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
Download PDF FDA Summary Syva Co.