Cleared Special

K011300 - EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229

K011300 is an FDA 510(k) clearance for EMIT II PLUS CANNABINOID ASSAY, manufactured by Syva Co., Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Special 510(k) pathway after a 17-day FDA review.

K011300 · Syva Co., Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
17d
Days
Class 2
Risk

K011300 is an FDA 510(k) clearance for the EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 17, 2001 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - the FDA toxicology device 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 - K011300

510(k) Number K011300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2001
Decision Date May 17, 2001
Days to Decision 17 days
Submission Type Special
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
70d faster than avg
Panel avg: 87d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K011300.
AMEDITECH IMMUTEST DRUG SCREEN THC
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K012541 · Branan Medical Corp. · Sep 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
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ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
PROFILE II ER
K010138 · Medtox Diagnostics, Inc. · Feb 2001
LIVESURE THC SCREEN TEST
K010001 · Pan Probe Biotech, Inc. · Feb 2001
K011300 · EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
Download PDF FDA Summary Syva Co., Dade Behrin…