MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

K060417 · Quantimetrix Corp. · DIF · Mar 21, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060417
• Device Name: MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
• Applicant: Quantimetrix Corp.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The Urine Drugs of Abuse Control is intended for use as an assayed quality control material to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

Device Story

Urine Drugs of Abuse Control; liquid-based quality control material; used in clinical laboratories to monitor precision of toxicology testing procedures; modification adds Lysergic Acid Diethylamide (LSD) to existing control panel; device provides known concentrations of analytes to verify assay performance; healthcare providers use results to validate accuracy/precision of patient drug screening tests.

Clinical Evidence

No clinical data provided; device is a quality control material for in vitro diagnostic use. Bench testing only.

Technological Characteristics

Liquid control material for urine toxicology screening. Formulated to contain specific drugs of abuse for performance monitoring of screening assays. Standalone product; no software or electronic components.

Indications for Use

Indicated for use as an assayed quality control material for monitoring precision of laboratory urine toxicology testing procedures for clinical laboratory personnel.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 1 2006

Mr. Jack Coggan Director of Operations Ouantinmetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278

Re: k060417

> Trade/Device Name: Quantinmetrix Drug of Abuse Urine Screen Control Regulation Number: 21 CFR§ 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: February 16, 2006 Received: February 21, 2006

Dear Mr. Coggan:

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) I ms lotter with and would be finding of substantial equivalence of your device to a legally premaired 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

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 STATEMENT

204

510(k) Number (if known):

#### Device Name:

Quantimetrix Drug of Abuse Urine Screen Control

#### Indication for Use:

The Quantimetrix Corp. Drug of Abuse Urine Screen Control is intended to be used as a means of monitoring the performance of Abuscreen ONLINE, AxSYM, Triage and other drugs of abuse screening methods used for detecting drugs in unknown urine specimens.

Prescription Use X (Per 21 CFR 801. 109) OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation (OIVD)

Carl Jensen
Division Sign-Off

**Office of In Vitro Diagnostic Device Evaluation and Safety**

\$10(k) K060417

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