(581 days)
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No
The summary describes a standard in vitro diagnostic assay for drug detection, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
This device is an in vitro diagnostic test for the detection of MDMA in human urine, used for analytical purposes, not for treating or diagnosing a disease in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MDMA in human urine..." This phrase indicates that the device is used to diagnose or detect a substance (MDMA) for medical purposes. Additionally, the text repeatedly refers to it as an "in vitro diagnostic device."
No
The device is an in vitro diagnostic test, which involves chemical reagents and laboratory analysers, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states:
- "The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test..."
- "This in vitro diagnostic device is intended for prescription use only."
- "This in vitro diagnostic device in the daily as a line a for prescription use only." (referring to the calibrator set)
- "This in quality control of the ebstay of the only." (referring to the controls, although the sentence is incomplete, the context strongly suggests it's also an IVD).
The intended use also clearly describes a test performed on a human sample (urine) outside of the body to provide information about a medical condition (presence of MDMA).
N/A
Intended Use / Indications for Use
Randox Ecstasy Assay
The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MDMA in human urine with a cut off concentration of 500ng/ml, for use on the Unean of the uneath of Mondal analysers in qualitative or semi-quantititive mode. The assay is calibrated against MDMA. 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 difution 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 chromations chemic spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the proliminary result is positive.
Randox Ecstasy Calibrator Set
The Randox Ecstasy Calibrator Set consists of liquid calibrators containing MDMD. There are 5 levels of calibrator. They have been developed for use in the calibration of Ecstasy assays on the J X day to na" and Amela" analysers. This in vitro diagnostic device in the daily as a line a for prescription use only.
Randox Ecstasy Controls, Level 1 & 2
The Randox Ecstasy Controls, level 1 and 2 are liquid controls containing MDMA. There are 2 levels of controls. They have been developed for use in the quality control of the Ecstasy assay on the a X day to na" and annual analysers. This in quality control of the ebstay of the only.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, 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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§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
Public Health Service
Randox Laboratories, Ltd c/o Dr. Pauline Armstrong Regulatory Affairs 55 Diamond RD. Crumlin, County Antrim United Kingdom BT29 4QY Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAR 0 1 2011
Re: K092275
Trade Name: Randox Ecstasy (MDMA) Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: DKZ, DLJ, LAS Dated: February 22, 2011 Received: February 24, 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).
1
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney C. Harper, Ph.D.
Courtney Q. Harper, Ph.D. Acting 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):
Device Name:
ECSTASY ASSAY, CALIBRATOR SET AND CONTROLS LEVEL 1 & 2
".
. . .
Indication For Use:
Randox Ecstasy Assay
The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MDMA in human urine with a cut off concentration of 500ng/ml, for use on the Unean of the uneath of Mondal analysers in qualitative or semi-quantititive mode. The assay is calibrated against MDMA. 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 difution 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 chromations chemic ടpectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the proliminary result is positive.
Randox Ecstasy Calibrator Set
The Randox Ecstasy Calibrator Set consists of liquid calibrators containing MDMD. There are 5 levels of calibrator. They have been developed for use in the calibration of Ecstasy assays on the J X day to na" and Amela" analysers. This in vitro diagnostic device in the daily as a line a for prescription use only.
Randox Ecstasy Controls, Level 1 & 2
The Randox Ecstasy Controls, level 1 and 2 are liquid controls containing MDMA. There are 2 levels of controls. They have been developed for use in the quality control of the Ecstasy assay on the a X day to na" and annual analysers. This in quality control of the ebstay of the 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) K092275