(32 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix Drug of Abuse Urine Screen Control." It is a control material used for monitoring the performance of drug of abuse screening methods.
Unfortunately, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It focuses on regulatory compliance and administrative details, not on a detailed scientific efficacy study report.
Therefore, I cannot provide the requested information based on the input text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
9
§ 862.3280 Clinical toxicology control material.
(a)
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.(b)
Classification. Class I (general controls). 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.