(619 days)
The Randox Laboratories Ltd. Cannabinoid Assay is an in vitro diagnostic test for the detection of 11-nor-d -THC-9-COOH (THC) in human urine on the Rx imola and Rx Daytona. The cut off for 11-nor-A-THC-9-COOH (THC) is 50ng/ml, 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 Cannabinoid Calibrator Set consists of liquid calibrators containing 11-nor-Δ2-THC-9-COOH (THC). There are 5 levels of calibrator. They have been developed for use in the calibration of THC assays on the X day to na™ and Anmond analysers. This in vitro diagnostic device is intended for prescription use only.
The Randox Cannabinoid Controls, level 1 and 2 are liquid controls containing 11-nor-A -THC-9-COOH (THC). There are 2 levels of controis. They have been developed for use in the quality control of the THC assay on the X day to na™ and Amond analysers. This in vitro diagnostic device is intended for prescription use only.
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Here's an analysis of the provided text, focusing on acceptance criteria and study information:
Acceptance Criteria and Device Performance for Randox Cannabinoids Assay
Based on the provided document, the Randox Cannabinoids Assay is an in vitro diagnostic test for the detection of 11-nor-d-THC-9-COOH (THC) in human urine. The key performance aspect described is its ability to detect THC relative to a specified cutoff.
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states one critical acceptance criterion, which is a cutoff level. While it doesn't provide a comprehensive table of all acceptance criteria (e.g., sensitivity, specificity, accuracy against a reference method, precision statistics), it does state the primary analytical threshold.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Cut-off for 11-nor-Δ9-THC-9-COOH (THC) | 50 ng/ml |
Note: The document describes the intended use and the cutoff for the assay. It does not provide detailed performance metrics (like sensitivity, specificity, or accuracy) derived from a specific study within these pages. Therefore, a comprehensive "reported device performance" against a full suite of acceptance criteria cannot be extracted solely from this text. The statement "This assay provides only a preliminary analytical result" implies that further confirmatory testing (like GC/MS) is required, highlighting its role as a screening test.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This information would typically be found in a detailed study report that supports the 510(k) submission, which is not present here.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided document does not specify the number of experts used to establish ground truth or their qualifications. Given that the device is a chemical assay for a biomarker, the ground truth would likely be established through a definitive analytical method rather than subjective expert interpretation (like in imaging).
4. Adjudication Method for the Test Set
The provided document does not specify any adjudication method for a test set. This is consistent with a chemical assay where results are quantifiable and less subject to subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or discussed in the provided document. This type of study is typically relevant for interpretative devices (e.g., medical imaging AI) where multiple human readers are involved. The Randox Cannabinoids Assay is an in vitro diagnostic test that provides a quantitative or semi-quantitative result; therefore, an MRMC study is not applicable.
6. Standalone Performance Study
The document implies that standalone performance was evaluated in terms of establishing the 50 ng/ml cutoff. However, the details of the study (e.g., sensitivity, specificity, accuracy against a reference method) that demonstrate this standalone performance are not provided in this extract. The device's nature as an "in vitro diagnostic device" performing a "test for the detection" inherently means its performance without human intervention (beyond operating the instrument) is what is being assessed.
7. Type of Ground Truth Used
The type of ground truth used for this device would almost certainly be a more specific and definitive analytical method, such as Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method," indicating it serves as the gold standard for confirmation. While not explicitly stated as the ground truth for the preliminary assay's development, it is the implied standard against which the assay's performance would be compared for validation.
8. Sample Size for the Training Set
The provided document does not specify the sample size for any training set. This information would be found in a detailed study report. For an in vitro diagnostic assay, the "training" aspect might relate to the development and optimization of the assay reagents and conditions, rather than a machine learning training set in the typical AI sense.
9. How the Ground Truth for the Training Set Was Established
The provided document does not specify how the ground truth for any training set was established. Similar to point 8, if a "training set" were relevant, the ground truth would likely be established using a definitive analytical method like GC/MS.
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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
Re: K092269
Trade Name: Randox Cannabinoids Assay, Cannabinoid Calibrator Set, Cannabinoid Controls, Level 1 & 2 Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid Test System. Regulatory Class: Class II Product Codes: LDJ, JIT, JJX Dated: March 29, 2011 Received: March 31, 2011
APR C 3 2511
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 (OS) 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 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
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
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name:
CANNABINQIDS ASSAY, CALIBRATOR SET AND CONTROLS LEVEL 1 & 2
Indication For Use:
Randox Cannabinoids Assay
The Randox Laboratories Ltd. Cannabinoid Assay is an in vitro diagnostic test for the detection of 11-nor-d -THC-9-COOH (THC) in human urine on the Rx imola and Rx Daytona. The cut off for 11-nor-A-THC-9-COOH (THC) is 50ng/ml, 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.
K092269
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 Cannabinoid Calibrator Set
The Randox Cannabinoid Calibrator Set consists of liquid calibrators containing 11-nor-Δ2-THC-9-COOH (THC). There are 5 levels of calibrator. They have been developed for use in the calibration of THC assays on the X day to na™ and Anmond analysers. This in vitro diagnostic device is intended for prescription use only.
Randox Cannabinoid Controls, Level 1 & 2
The Randox Cannabinoid Controls, level 1 and 2 are liquid controls containing 11-nor-A -THC-9-COOH (THC). There are 2 levels of controis. They have been developed for use in the quality control of the THC assay on the X day to na™ and Amond analysers. This in vitro diagnostic device is intended for prescription use only.
Prescription Use (21 CFR Part 801 Subpart D)
Over the Coun
(21 CE)
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)
And/Or
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092269
Page 1 of 1
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).