(650 days)
Not Found
Not Found
No
The document describes a standard in vitro diagnostic assay for detecting Methamphetamine in urine. There is no mention of AI, ML, or any computational methods beyond basic analytical processing of assay results.
No
This device is an in vitro diagnostic test for detecting Methamphetamine in human urine. Its purpose is for diagnosis and to aid in treatment decisions by providing analytical test results, not to directly treat or prevent a disease or condition.
Yes
The text explicitly states, "This in vitro diagnostic device is intended for prescription use only." This phrase directly indicates its diagnostic purpose.
No
The device is an in vitro diagnostic test that analyzes human urine using specific analysers, indicating it is a hardware-based system with associated reagents and controls, not solely software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section begins with: "The Randox Laboratories Ltd. Methamphetamine Assay is an in vitro diagnostic test..."
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body, to detect diseases, conditions, or infections. This device tests human urine for Methamphetamine.
- Intended Use: The intended use is for the "qualitative and semi-quantitative detection of Methamphetamine in human urine," which is a diagnostic purpose.
- Prescription Use Only: The text states it is an "in vitro diagnostic device is intended for prescription use only," further reinforcing its classification as a medical device used for diagnosis.
The description of the calibrators and controls also supports this, as these are components typically used with IVD assays for calibration and quality control.
N/A
Intended Use / Indications for Use
Randox Methamphetamine Assay
The Randox Laboratories Ltd. Methamphetamine Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Methamphetamine in numan urine at the cut off of 1000ng/ml. The assay is calibrated against methamphetamine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Methamine use or overdose. The Randox Methamphetamine Assay has been developed for use on the form analysers, which includes the And the annound " and the annound" 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 consists of liquid calibrators containing Methamphetamine, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Methamphetamine, Benzodiazepines and Methadone assays for use on the Drawn analysers, which includes the _________________________________________________________________________________________________________________________________________________________________ use only.
Randox Multidrug Controls, Level 1 & 2
The Randox Multidrug Controls level 1 and 2 are liquid controls containing Methamphetamine. Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Methamphetamine, Benzodiazepines and Methadone assays for use on the Oxecure analysers, which includes the JX day to na™ and the forman". This in vitro diagnostic device is intended for prescription use only.
Product codes
LAF, DKB, DIF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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): 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.
Not Found
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
Not Found
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Randox Laboratories, Ltd. c/o Dr. Pauline Armstrong 55 Diamond RD. Crumlin County Antrim United Kingdom BT29 4QY
Re: K092266
Trade/Device Name: Randox Methamphetamine Assay and Randox MultiDrug Calibrator and Controls 1 & 2 Regulation Number: 21 CFR 862.3619 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF, DKB and DIF Dated: April 20, 2011 Received: May 05, 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 máy, 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).
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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDR4'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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
2
Indication for Use
510(k) Number (if known):
METHAMPHETAMINE ASSAY, RANDOX MULTIDRUG CALIBRATOR
Device Name:
SET AND MULTIDRUG CONTROLS LEVEL 1 & 2
Indication For Use:
Randox Methamphetamine Assay
The Randox Laboratories Ltd. Methamphetamine Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Methamphetamine in numan urine at the cut off of 1000ng/ml. The assay is calibrated against methamphetamine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Methamine use or overdose. The Randox Methamphetamine Assay has been developed for use on the form analysers, which includes the And the annound " and the annound" 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 consists of liquid calibrators containing Methamphetamine, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Methamphetamine, Benzodiazepines and Methadone assays for use on the Drawn analysers, which includes the _________________________________________________________________________________________________________________________________________________________________ use only.
Randox Multidrug Controls, Level 1 & 2
The Randox Multidrug Controls level 1 and 2 are liquid controls containing Methamphetamine. Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Methamphetamine, Benzodiazepines and Methadone assays for use on the Oxecure analysers, which includes the JX day to na™ and the forman". 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)
:
C. A
Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): K092266