(461 days)
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No
The summary describes a standard in vitro diagnostic assay for ethanol and does not mention any AI or ML components or functionalities.
No
The device is an in vitro diagnostic test used for the quantitative analysis of Ethanol, which aids in the diagnosis and treatment of alcohol intoxication and poisoning. It does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Randox Ethanol Assay is an in vitro diagnostic test..." and "This is an in vitro diagnostic device intended for prescription use only." for both the Randox Ethanol Assay and the Randox Ethanol Control Set.
No
The device is described as an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum, intended for use on specific analysers (hardware). The description focuses on the assay, calibrator set, and control set, which are chemical reagents and materials, not software.
Yes, the provided text explicitly states that the Randox Ethanol Assay, Randox Ethanol Calibrator Set, and Randox Ethanol Control Set are in vitro diagnostic devices.
Here are the specific phrases from the text that confirm this:
- Randox Ethanol Assay: "The Randox Ethanol Assay is an in vitro diagnostic test..." and "This is an in vitro diagnostic device intended for prescription use only."
- Randox Ethanol Calibrator Set: While it doesn't explicitly say "in vitro diagnostic device" for the calibrator set itself, it states it's "intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum..." Since the assay is an IVD, the calibrator set used with it is also considered part of the IVD system.
- Randox Ethanol Control Set: "This is an in vitro diagnostic device intended for prescription use only."
N/A
Intended Use / Indications for Use
Randox Ethanol Assay
The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the forme analysers, which includes the JX day to na™ and the Amota™ analysers.
The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning.
This is an in vitro diagnostic device intended for prescription use only.
Randox Ethanol Calibrator Set
The Randox Ethanol Calibrator Set is intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the December analysers which includes the X day to na™ and the 121mona™.
Randox Ethanol Control Set
The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the forme analysers which includes the Aday to na™ and the Mimola™
This is an in vitro diagnostic device intended for prescription use only.
Product codes
DIC, DLJ, LAS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine and serum
Indicated Patient Age Range
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Intended User / Care Setting
prescription use only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an emblem that appears to be a stylized bird with three wing-like shapes.
Public Health Service
Randox Laboratories, Ltd. c/o Dr. Pauline Armstrong 55 Diamond RD. Crumlin County Antrim United Kingdom BT29 4QY
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K092273
Trade/Device Name: Randox Ethanol Assay and Randox Ethanol Calibrators and Controls Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC, DLJ and LAS · NOV - 1 2010 Dated: September 14, 2010 Received: September 16, 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 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); medical device reporting (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).
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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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
CA
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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Indication for Use
K092273 510(k) Number (if known):
Device Name:
RANDOX ETHANOL ASSAY AND THE RANDOX ETHANOL CALIBRATOR/CONTROL SET
Indication For Use:
Randox Ethanol Assay
The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the forme analysers, which includes the JX day to na™ and the Amota™ analysers.
The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning.
This is an in vitro diagnostic device intended for prescription use only.
Randox Ethanol Calibrator Set
The Randox Ethanol Calibrator Set is intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the December analysers which includes the X day to na™ and the 121mona™.
Randox Ethanol Control Set
The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the forme analysers which includes the Aday to na™ and the Mimola™
This is an in vitro diagnostic device intended for prescription use only.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) ke 092273
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