(80 days)
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Not Found
No
The summary describes a qualitative immunoassay for detecting phencyclidine in urine using a specific analyzer and calibrators. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the chemical detection method and the intended use in a laboratory setting.
No
The device is for the qualitative detection of phencyclidine in urine, which aids in diagnosis. It does not provide direct treatment or therapy.
Yes
The device is intended for the qualitative detection of phencyclidine in urine, and the results can be "utilized in the diagnosis and treatment of phencyclidine use or overdose," indicating its role in identifying or confirming a medical condition.
No
The device description is not found, but the intended use clearly states the device is a "test" designed for use on an "evidence® analyser" for detecting phencyclidine in urine. This strongly implies a physical test kit and an associated hardware analyzer, not a software-only device.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is for "qualitative detection of phencyclidine in urine". Urine is a biological sample taken from the body.
- Purpose: The purpose is to "be utilised in the diagnosis and treatment of phencyclidine use or overdose". This directly relates to providing information for medical purposes.
- Method: The test is performed "on the evidence® analyser", which implies a laboratory setting and analysis of the biological sample outside of the body.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The evidence® Phencyclidine test has been designed for use only on the evidence® analyser for qualitative detection of phencyclidine in urine, using a cut-off concentration of 25 ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of phencyclidine use or overdose.
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 chromatography / mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Phencyclidine Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, opiates and phencyclidine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.
The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
LCM, DKB
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
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Indicated Patient Age Range
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Intended User / Care Setting
suitably qualified laboratory personnel under appropriate laboratory conditions.
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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N/A
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three curved lines representing the serpent and staff.
JAN 2 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers 55 Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY
K043071 Re:
Trade/Device Name: evidence® Phencyclidine Assay evidence® Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: LCM, DKB Dated: November 5 2004 Received: November 8, 2004
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Sean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: evidence® DRUGS OF ABUSE CALIBRATORS
Indications For Use:
The evidence® Phencyclidine test has been designed for use only on the evidence® analyser for qualitative detection of phencyclidine in urine, using a cut-off concentration of 25 ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of phencyclidine use or overdose.
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 chromatography / mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Phencyclidine Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators.
The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, opiates and phencyclidine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.
The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Division Sign-Off | acting |
|---|---|
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510(k) | K043071 |
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