(478 days)
The Randox Laboratories Ltd. Methadone Assay Is an in vitro diagnostic test for the qualitative and semiquantitative detection of Methadone in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for methadone. The Randox Methadone Assay has been developed for use on the seems analysers, which includes the day to name and the seemer ". This in vitro diagnostic device is intended for prescription use only.
The semi-quantitative mode is for purposes of
- (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
- or
- (2) permitting laboratories to establish quality control procedures.
This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatographimass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the proliminary result is positive.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. for a Methadone Assay, Multidrug Calibrator Set, and Multidrug Controls. Unfortunately, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets them.
The document primarily focuses on:
- The FDA's determination of substantial equivalence to a predicate device.
- The device's regulation number, product code, and regulatory class.
- General controls provisions of the Act that apply to the device.
- Contact information for various FDA offices.
- The Indications for Use statement for the Methadone Assay, Multidrug Calibrator Set, and Multidrug Controls.
Missing Information
The document does not provide the following crucial details needed to address the request:
- A table of acceptance criteria and the reported device performance: This would typically include metrics like sensitivity, specificity, accuracy, precision, limit of detection, etc., along with the predefined targets for these metrics.
- Sample size used for the test set and the data provenance: There is no mention of the clinical or analytical study design, the number of samples, or their origin.
- Number of experts used to establish the ground truth for the test set and their qualifications: This information is integral to understanding the validation process.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is more common for imaging diagnostics involving human interpretation, which is not the case for an in vitro diagnostic assay like this one. Therefore, it is highly unlikely such a study was performed or would be relevant.
- Standalone performance (algorithm only without human-in-the-loop performance): While the device is an IVD assay and its performance would inherently be "standalone" in terms of measurement, the document does not present the data.
- Type of ground truth used: For an IVD assay, ground truth is usually established by a reference method (e.g., GC/MS), but this is not explicitly detailed with performance data. The "Indications for Use" does state that GC/MS is the preferred confirmatory method, implying it would be used for confirmation if a preliminary positive result is obtained.
- Sample size for the training set: Not applicable for this type of 510(k) submission unless an AI/ML component was specifically part of the device's analytical engine, which is not indicated. These are typically validated through analytical and clinical performance studies, not AI-style training and test sets in the same way.
- How the ground truth for the training set was established: See point 8.
In summary, this document only confirms the FDA's clearance of the device based on substantial equivalence and specifies its intended use and regulatory classification. It does not contain the detailed validation study results or acceptance criteria. To obtain this information, one would typically need to refer to the full 510(k) submission document or the device's labeling (Instructions for Use or Package Insert) which would contain the performance data.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Randox Laboratories, Ltd. c/o Dr. Pauline Armstrong 55 Diamond Road, Crumlin County Antrim, United Kingdom BT29 4QY
Re: K092272
Trade/Device Name: Methadone Assay Regulation Number: 21 CFR 862.3620 1 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DKB, DIF Dated: November 2, 2010 Received: November 4, 2010
NOV 1 8 2010
Dear Dr. Armstrong:
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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, 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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NOW 11 8 2010
Indication for Use
510(k) Number (if known): K092272
Device Name:
METHADONE ASSAY, MULTIDRUG CALIBRATOR SET AND MULTIDRUG CONTROLS LEVEL 1 & 2
Indication For Use:
Randox Methadone Assay
The Randox Laboratories Ltd. Methadone Assay Is an in vitro diagnostic test for the qualitative and semiquantitative detection of Methadone in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for methadone. The Randox Methadone Assay has been developed for use on the seems analysers, which includes the day to name and the seemer ". This in vitro diagnostic device is intended for prescription use only.
The semi-quantitative mode is for purposes of
- (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
- or
12 года при представительные про для собство и присании для по полность композициальности седенского поставления поставления може
- (2) permitting laboratories to establish quality control procedures.
This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatographimass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the proliminary result is positive.
Randox Multidrug Calibrator Set
The Randox Multidrug Calibrator Set consists of liquid calibrators containing Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Benzodiazepine (Oxazeoam) and Methadone assays on the ex-Amount . This in vitro diagnostic device is intended for prescription use only.
Randox Multidrug Controls, Level 1 & 2
The Randox Multidrug Controls, level 1 and 2 are liquid controls containing Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Benzodiazesine and Methadone assays on the forme analysers, which includes the JX day to na" and the ØXmail™ This in vitro diagnostic device is intended for prescription use only.
Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
And/Or
Richard Shaw Officer
- Division Sign-Off Office of In Vitro Diagnostic Device Firaluation and Safety
510(k) K092272
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).