IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS

K051578 · Immunalysis Corporation · DIO · Nov 18, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051578
• Device Name: IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
• Applicant: Immunalysis Corporation
• Product Code: DIO · Clinical Toxicology
• Decision Date: Nov 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The Immunalysis Cocaine/Cocaine Metabolite ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Cocaine/Cocaine Metabolite at a cutoff of 20 ng/mL in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL™ ORAL FLUID COLLECTION DEVICE ONLY. This in vitro diagnostic device is intended for clinical laboratory use only. The Immunalysis Cocaine/Cocaine Metabolite ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

In-vitro diagnostic ELISA test system; detects cocaine/metabolites in oral fluid collected via Quantisal device. Used in clinical laboratories by trained personnel. Provides preliminary qualitative results; requires confirmation by GC-MS. Assists healthcare providers in identifying drug presence; supports clinical decision-making regarding substance abuse. Benefits include rapid screening of oral fluid samples.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzyme Linked Immunoassay (ELISA) technology. Qualitative detection at 20 ng/mL cutoff. Requires Quantisal oral fluid collection device. In-vitro diagnostic format.

Indications for Use

Indicated for qualitative detection of cocaine/cocaine metabolite in oral fluid samples at 20 ng/mL cutoff. Intended for clinical laboratory use for individuals suspected of cocaine use.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image contains the seal for the U.S. Department of Health and Human Services. The seal features a stylized eagle with three tail feathers and a circular border. The text "U.S. Department of Human Services, USA" is written around the border of the seal.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 8 2005

Mr. Michael J. Vincent V.P. Operations Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767

Re: k051578

Trade/Device Name: Immunalysis Cocaine/ Cocaine Metabolite ELISA for Oral Fluids Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: September 10, 2005 Received: September 30, 2005

Dear Mr. Vincent:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K051578

Device Name: Immunalysis Cocaine/Cocaine Metabolite ELISA for Oral Fluids

Indications For Use:

The Immunalysis Cocaine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine and cocaine metabolites at a cutoff of 20 ng/mL in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL™ ORAL FLUID COLLECTION DEVICE ONLY. This in-vitro diagnostic device is intended for clinical laboratory use only.

The Immunalysis Cocaine/Cocaine metabolite ELISA Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method. Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diaanostic Device Evaluation and Safety

510(k) K051578

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