(666 days)
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No
The document describes a standard in vitro diagnostic assay for detecting barbiturates in urine using chemical methods and laboratory analyzers. There is no mention of AI or ML in the intended use, device description, or performance studies. The methods described are traditional analytical techniques.
No
The device is an in vitro diagnostic test used for detecting barbiturates in human urine, providing preliminary analytical results for laboratory purposes and quality control, not for direct therapeutic intervention on a patient.
Yes
The text explicitly states multiple times that it is an "in vitro diagnostic device."
No
The device is an in vitro diagnostic test for detecting barbiturates in human urine, which involves chemical assays and laboratory equipment (Rx Imola and Rx Daytona). This is a hardware-based diagnostic system, not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The text explicitly states multiple times that the device is an "in vitro diagnostic test" and an "in vitro diagnostic device."
- Intended Use: The intended use is for the detection of barbiturates in human urine, which is a biological sample tested in vitro (outside the body).
- Purpose: The purpose is for qualitative and semi-quantitative analysis of a substance in a biological sample, which is a core function of IVDs.
- Setting: The intended user is laboratories, which are the typical setting for performing IVD tests.
- Prescription Use: The indication for prescription use is common for IVDs used in clinical settings.
The description of the calibrators and controls also reinforces that these are components used in conjunction with an IVD assay for calibration and quality control purposes.
N/A
Intended Use / Indications for Use
Randox Barbiturates Assay
The Randox Laboratorles Ltd. barbiturates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device Is intended for prescription use only.
The semi-quantitative mode is for purpose of
- (1) enabling laboratories to determine an appropriate dilution of the specimen for
- confirmation by a confirmatory method such as GCMS.
- Or
- .. .. . ... . . . . . . (2) permilting 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 Multidrug Calibrator Set
The Randox Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the JSC and analysers, which includes the a y to na" and the moss™. 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 Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benzodiazepines and Methadone assays for use on the I Kommanalysers, which includes the X day to na™ and the Anmone™. This in vitro diagnostic device is intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
DIS, 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
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Intended User / Care Setting
laboratories
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): 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.
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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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§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Randox Laboratories, LTD c/o Dr. Pauline Armstrong Regulatory Affairs 55 Diamond Road Crumlin, County Antrim, United Kingdom BT29 4QY
MAY 2 5 2011
Re: K092268
Trade Name: Randox Barbiturates Assay, Randox Multidrug Calibrator Set, Randox Multidrug Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Barbiturate Test System. Regulatory Class: Class II Product Codes: DIS, DLJ, LAS Dated: May 23, 2011 Received: May 25, 2011
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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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (27 CFN 7 and 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: 1.1%
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name:
BARBITURATES ASSAY AND THE MULTIDRUG CALIBRATOR/CONTROL SET
Indication For Use:
Randox Barbiturates Assay
The Randox Laboratorles Ltd. barbiturates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device Is intended for prescription use only.
The semi-quantitative mode is for purpose of
- (1) enabling laboratories to determine an appropriate dilution of the specimen for
- confirmation by a confirmatory method such as GCMS.
- Or
- .. .. . ... . . . . . . (2) permilting 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 Multidrug Calibrator Set
The Randox Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the JSC and analysers, which includes the a y to na" and the moss™. 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 Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benzodiazepines and Methadone assays for use on the I Kommanalysers, which includes the X day to na™ and the Anmone™. 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)
$
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092268
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