(139 days)
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No
The provided text describes an in vitro diagnostic assay and associated calibrators and controls for detecting cocaine metabolites in urine. It focuses on the chemical analysis and the use of specific laboratory analyzers (RX series). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device is described as an "in vitro diagnostic test" for detecting Cocaine in human urine, and its use is for diagnosis and treatment decisions, not for direct therapeutic intervention.
Yes
The "Randox Cocaine Metabolite Assay" is explicitly stated as an "in vitro diagnostic test" and its results "can be utilized in the diagnosis and treatment of Cocaine use or overdose." The "Randox Multidrug Calibrator Set" and "Randox Multidrug Controls, Level 1 & 2" are also described as "in vitro diagnostic device[s]," and while they are for calibration and quality control, they serve to support the accuracy and reliability of diagnostic testing.
No
The device is an in vitro diagnostic test kit, which includes reagents (calibrators and controls) and is intended for use on specific hardware analyzers (RX series). This clearly indicates it is not a software-only device.
Based on the provided text, the following devices are explicitly stated to be In Vitro Diagnostics (IVDs):
- Randox Cocaine Metabolite Assay: The text clearly states, "The Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test..." and "This in vitro diagnostic device is intended for prescription use only."
- Randox Multidrug Calibrator Set: The text states, "This in vitro diagnostic device is intended for prescription use only."
- Randox Multidrug Controls, Level 1 & 2: The text states, "This in vitro diagnostic device is intended for prescription use only."
Therefore, yes, all three devices described in the provided text are IVDs.
N/A
Intended Use / Indications for Use
The Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semiquantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzovlecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Cocaine use or overdose. The Randox Cocaine 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 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 Multidrug Calibrator Set consists of liquid calibrators containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Cocaine and Methadone 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 Multidrug Controls, level 1 and 2 are liquid controls containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Cocaine and Methadone 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.
Product codes (comma separated list FDA assigned to the subject device)
DIO, DLJ, and 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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a bird, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Randox Laboratories Ltd. c/o Pauline Armstrong 55 Diamond Road Crumlin, County Antrim BT29 4QY United Kingdom
MAY - 8 2012
K113751 Re:
RT13131 Randox' Multidrug Calibrator Set Randox Multidrug Controls, Level 1 & 2 Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Codes: DIO, DLJ, and LAS Dated: March 30, 2012 Received: April 02, 2012
Dear Ms. Armstrong:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We nave reviewed your Section 510(x) premier is substantially equivalent (for the referenced above and nave atternment and actived predicated predicated in
indications for use stated in the enclosure to the marketed in indications for use stated in the cheosure/ to regars ment date of the Medical Device interstate commerce prior to May 20, 1970, the sideed in accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approval of a p Amendments, of to devices that have been router approval of approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require, systems to the general the Federal Food, Drug, and COSIlienc Act (related the device, subject to the general
approval application (PMA). You may, therefore, market the devices subject to the gener approval application (1 MA). Tou may, increased controls provisions of the Act include controls provisions of the Act. The general of any of devices, good manufacturing practice,
requirements for annual registration, listing of devices on lequirements for annual is against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III
ns affective If your device is classified (see above) into chine major regulations affecting
(PMA), it may be subject to such additional controls. Existing (CFR), Parts 800 to 895 (PMA), it may be subject to Such adultional Concern Concerner (CFR), Partis 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Partis 800 to your device can be found in Title 21, Code of Peacharts (1 - 1) - )
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 Please be advised that FDA s Issuanter of a stuck complies with other requirements
mean that FDA has made a determination odministared by other Federal agencies. mean that FDA has made a delemination mat your and result was and registration of the Act or any Federal statues and tegulations and limited to: registration
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with all the Act Sicquitently more 801 and 809); medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFR Part 807); fabeting (21 CFR rans ovents) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); and good reporting (reporting of medical device-related adverse overse) (22 =========================================================================================================== CFR Part 820).
1
Page 2
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/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 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 yours,
N
Courtney 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):
UNKNOWN
Device Name:
COCAINE METABOLITE ASSAY, MULTIDRUG CALIBRATOR SET AND MULTIDRUG CONTROLS LEVEL 1 & 2
Indication for Use:
Randox Cocaine Metabolite Assay
The Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semiquantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzovlecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Cocaine use or overdose. The Randox Cocaine 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 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 consists of liquid calibrators containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Cocaine and Methadone 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.
Randox Multidrug Controls, Level 1 & 2
The Randox Multidrug Controls, level 1 and 2 are liquid controls containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Cocaine and Methadone 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.
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)
DSA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k 113 71