(469 days)
The Randox Laboratories Ltd. Methadone Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-diphenylpyrrolidine (EDDP) in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for EDDP. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of EDDP use or overdose. The Randox Metabolite Assay has been developed for use on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. 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 chromatograph/mass 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 preliminary result is positive.
The Randox EDDP Calibrator Set consists of liquid calibrators containing EDDP. There are 5 levels of calibrator. They have been developed for use in the calibration of EDDP assays on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.
The Randox EDDP Controls, level 1 and 2 are liquid controls containing EDDP. There are 2 levels of controls. They have been developed for use in the quality control of the EDDP assay on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.
Not Found
The provided text is a 510(k) summary for the Randox Methadone Metabolite (EDDP) Assay, EDDP Calibrator Set, and EDDP Controls Level 1 & 2. It outlines the regulatory clearance of the device but does not contain a detailed description of the acceptance criteria nor a comprehensive study report with the specific information requested in your prompt.
Specifically, the text is a letter from the FDA informing Randox Laboratories, Ltd. that their device is substantially equivalent to legally marketed predicate devices. It states the indications for use, regulatory classification, and general controls provisions.
Therefore, I cannot provide the requested information based solely on the provided input. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, training sets, or data provenance.
- Number/qualifications of experts, adjudication methods for ground truth, or details about the ground truth itself (pathology, outcomes data, etc.).
- Information on MRMC studies or standalone algorithm performance.
To obtain the information you're looking for, you would typically need to review the full 510(k) submission document or a more detailed study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Building 66
Food & Drug Administration 10903 New Hampshire Avenue
Silver Spring, MD 20993
Randox Laboratories, Ltd. c/o Dr. Pauline Armstrong 55 Diamond Road, Cromlin County Antrim, United Kingdom BT29 4QY
Re: K092258
Trade/Device Name: Methadone Metabolite (EDDP) Assay Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DKB, DIF Dated: October 21, 2010 Received: October 25, 2010
NOV - 9 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,
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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NOV - 9 2010
Indication for Use
510(k) Number (if known): K092258
Device Name:
METHADONE METABOLITE (EDDP) ASSAY, EDDP CALIBRATOR SET AND EDDP CONTROLS LEVEL 1 & 2
Indication For Use:
Randox Methadone Metabolite (EDDP) Assay
The Randox Laboratories Ltd. Methadone Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-diphenylpyrrolidine (EDDP) in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for EDDP. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of EDDP use or overdose. The Randox Metabolite Assay has been developed for use on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. 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 chromatograph/mass 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 preliminary result is positive.
Randox EDDP Calibrator Set
The Randox EDDP Calibrator Set consists of liquid calibrators containing EDDP. There are 5 levels of calibrator. They have been developed for use in the calibration of EDDP assays on the Rx series analysers, which includes the Rx Daytona and the Rx |mola. This in vitro diagnostic device is intended for prescription use only. .
Randox EDDP Controls, Level 1 & 2
The Randox EDDP Controls, level 1 and 2 are liquid controls containing EDDP. There are 2 levels of controls. They have been developed for use in the quality control of the EDDP assay on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.
V 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 (OVD)
And/Or
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 092258
§ 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).