(248 days)
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No
The summary describes a standard in vitro diagnostic assay for detecting opiates in urine using chemical methods and laboratory analyzers. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is an in vitro diagnostic test (assay, calibrator set, and controls) for analyzing Opiates in human urine, used for diagnosis and monitoring, and does not directly provide therapy.
Yes
The Randox Opiates Assay is explicitly stated as an "in vitro diagnostic test" for the "diagnosis and treatment of Opiate use or overdose."
No
The device is an in vitro diagnostic test kit, which includes reagents (assay, calibrators, controls) and is intended for use on specific hardware analyzers (RX series). It is not solely software.
Yes, all three devices described are explicitly stated to be In Vitro Diagnostic (IVD) devices.
Here's why:
- Randox Opiates Assay: The intended use statement clearly says, "The Randox Laboratories Ltd. Opiates Assay is an in vitro diagnostic test..." and later, "This in vitro diagnostic device is intended for prescription use only."
- Randox Multidrug Calibrator Set: The description states, "This in vitro diagnostic device is intended for prescription use only."
- Randox Multidrug Controls, Level 1 & 2: The description states, "This in vitro diagnostic device is intended for prescription use only."
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment. All three devices fit this description as they are used to analyze human urine for the presence of specific substances (opiates, methamphetamine, secobarbital, methadone, and morphine) for diagnostic and quality control purposes.
N/A
Intended Use / Indications for Use
Randox Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/ml for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates 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 test 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 Multidrug Calibrator Set: The Randox Multidrug Calibrator Set is for use on human urine samples. They are liquid calibrators containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. 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 for use on human urine samples. They are liquid controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only.
Product codes
DJG, 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories; Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Randox Laboratories Limited c/o Pauline Armstrong 55 Diamond Road Crumlin, County Antrim, BT29 4QY United Kingdom
K113747 Re:
Trade Name: Randox Opiates Assay Randox Multidrug Calibrator Set Randox Multidrug Controls, Level 1 and Level 2 Regulation Number: 21 CFR § 862.3650 Regulation Name: Opiate test system
Regulatory Class: Class II Product Codes: DJG, DLJ, LAS Dated: July 5, 2012 Received: July 13, 2012
Dear Dr Armstrong:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Sector 310(x) pecimatice is substantially equivalent (for the referenced above and have detemmed the device is succedicate devices marketed in
indications for use stated in the enclosure) to legally marketed in
the enclose of use stated indications for use stated in the enclosure) to regality mannel date of the Medical Device in interstate commerce prior to May 25, 1976, the enactive with the provisions of
Amendments, or to devices that have been recurse approval of a premarks Amendments, or to devices that have been recurse worker approval of a premaikst
the Federal Food, Drug, and Cosmetic Act (Act ) that do not require approval of a premailse the Federal Food, Drug, and Cosmetic Act (Act) that do horio sports of the general
approval application (PMA). You may, therefore, market the device, subject to the general approval application (PMA). The general controls provisions of the Act include controls provisions of the Act. Lie general controls provides, good manufacturing practice,
requirements for annual registration, listing of devices, good manufacturing requirements for annual registration, noming and adulteration.
Iabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III)
Controls (see and collicion) control litianal controls. Existing major regulat If your device is classified (see above) into elife) in (Openar or regulations affecting
(PMA), it may be subject to such additional controls. Existings (CFR), Parts 800 to (PMA), it may be subject to such additions: Existing institutions (CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 your device can be found in Title 21, Code of Federal Negallatons (Cris)
In addition, FDA may publish further announcements concerning your device in the Escient Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not
he months and and to mination that your device complies with other requirement Please be advised that FDA's issuance of a substance complies with other requirement's
mean that FDA has made a determination that your device with other requires. mean that FDA his made a determination into continues and processor in the Federal agencies.
of the Act or any Federal des and regulations administered by not limited to: reg of the Act or any Federal stantes and regulations administered by out not limited to: registration
You must comply with all the Act's requirements, including, but not limited You must comply with all the Act S requirements, including of the more
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFR Part 807); labeling (21 CFR rats 803 mln.) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); regulation reporting (reporting of medical device-related adverse evenis) (21 UN 000), and go
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
AUG 2 4 2012
1
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific ad view 10. Jour es . Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 proase note the regulation villance, "Milion news arrestlance, please contact CDRB is Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Surveinance and Droinears of (SD) of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may obtain 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.html
Sincerely yours,
V
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indication for Use
510(k) Number (if known): K113747
Device Name: OPIATES ASSAY AND THE RANDOX MULTIDRUG CALIBRATOR SET AND MULTIDRUG CONTROLS LEVEL 1 & LEVEL 2
Indication For Use:
Randox Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/ml for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates 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 test 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 Multidrug Calibrator Set: The Randox Multidrug Calibrator Set is for use on human urine samples. They are liquid calibrators containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. 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 for use on human urine samples. They are liquid controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only.
Prescription Use マ (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)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)