(20 days)
Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3". It acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It is a regulatory approval document, not a performance study report.
Therefore, I cannot provide the requested information based on the input text. The elements you asked for (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are typically found in a clinical study report or a technical performance document, which this is not.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 9 1998
Scot D. Kinghorn Director, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058
Re : K982024 Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3 Regulatory Class: I Product Code: DIF Dated: June 5, 1998 Received: June 9, 1998
Dear Mr. Kinghorn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ್ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MEDICAL ANALYSIS SYSTEMS, INC.
510(k) Number: K982024 Device Name: Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3
STATEMENT OF INDICATIONS FOR USE
Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.
Carol C. Benson / Alfred Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982024
\Prescription Use
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§ 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.