(189 days)
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No
The summary describes a qualitative immunoassay for detecting barbiturates in urine, which is a standard laboratory test method and does not mention any AI or ML components.
No
The device is an assay for qualitative detection of barbiturates for diagnostic purposes, not for therapy. It aids in diagnosis and treatment, but does not itself provide treatment.
Yes
The text states, "Qualitative results obtained can be utilized in the diagnosis and treatment of barbiturate use or overdose." This indicates its role in identifying a medical condition.
No
The device is described as an "assay" for use on an "evidence® analyser". This strongly suggests a chemical or biological test kit and associated hardware, not a software-only device. The description of calibrators further supports this.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of barbiturates, in urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Sample Type: The assay uses urine, which is a biological sample.
- Purpose: The results are used in the "diagnosis and treatment of barbiturate use or overdose." This directly relates to providing information for medical purposes.
- Setting: The assay is performed by "suitably qualified laboratory personnel under appropriate laboratory conditions," which is typical for IVD testing.
The description of the calibrators also reinforces that this is a system designed for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The evidence® Barbiturate assay has been designed for use only on the evidence® analyser for qualitative detection of barbiturates, in urine using a cutoff of 200 ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of barbiturate use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The Barbiturate 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 and phenobarbital. 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 (comma separated list FDA assigned to the subject device)
DIS, 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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§ 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 Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 5 2004
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K041143
Trade/Device Name: evidence® Barbiturate Assay evidence® Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS, DKB Dated: October 26, 2004 Received: November 1, 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. Ilsting 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) I mis letter wilf anow you to oogin inding of substantial equivalence of your device to a legally prematicate 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, If you desire specific institution and advertising of your device, please contact the Office of In of quostic Device Evaluation and Safety at (301) 594-3084. 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 Tou may other builts getain onal 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelia B. Parks
Cornelia B. Rooks, MA Acting 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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Indications for Use
(041143 NOT KNOWN 510(k) Number (if known): evidence® BARBITURATE ASSAY AND Device Name: evidence® DRUGS OF ABUSE CALIBRATORS
Indications For Use:
The evidence® Barbiturate assay has been designed for use only on the evidence® analyser for qualitative detection of barbiturates, in urine using a cutoff of 200 ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of barbiturate use or overdose.
This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.
The Barbiturate 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 and phenobarbital. 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)
V
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 C @RH, Office of In_Vitro Diagnostic Devices (OIVD)
Albert Schitz
Division Sign-Off
lvision Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041143