(189 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "evidence® Barbiturate Assay" and "evidence® Drugs of Abuse Calibrators." It does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for an AI/device performance study.
The letter states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means it met the regulatory requirements for clearance based on its similarity to existing devices, not necessarily through novel performance studies against specific acceptance criteria.
Therefore, most of the information you've requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this document.
Here's what can be extracted based on the provided text, and where your requested information is not applicable (N/A):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A (Not provided in this document as specific performance criteria for clinical validation) | N/A (This document confirms substantial equivalence to predicate devices, not specific performance metrics against novel criteria.) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): N/A (Not specified in this regulatory clearance letter.)
- Data Provenance: N/A (Not specified. This document only confirms regulatory clearance based on substantial equivalence.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: N/A (Not relevant for this type of regulatory clearance document.)
- Qualifications of Experts: N/A
4. Adjudication method for the test set:
- Adjudication Method: N/A (Not relevant for this type of regulatory clearance document.)
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No (This device is an in-vitro diagnostic assay and calibrator, not an AI system assisting human readers. An MRMC study is not applicable.)
- Effect Size: N/A
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: N/A (This is a laboratory assay, not an AI algorithm. Its performance would be evaluated as a diagnostic test, not an algorithm's standalone performance.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: N/A (For an in-vitro diagnostic, the "ground truth" for method validation typically involves using reference methods (like GC/MS as mentioned in the indications) or known sample concentrations for analytical performance characterization, rather than expert consensus on images or outcomes data. However, the specific validation data is not included in this clearance letter.)
8. The sample size for the training set:
- Sample Size (Training Set): N/A (Not specified as this is not an AI/machine learning device requiring a traditional training set.)
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: N/A (Not applicable, as this is not an AI/machine learning device.)
Additional Information from the text:
- Device Name: evidence® Barbiturate Assay and evidence® Drugs of Abuse Calibrators
- Intended Use of Barbiturate Assay: Qualitative detection of barbiturates in urine using a cutoff of 200 ng/ml.
- Purpose of Barbiturate Assay: Used in the diagnosis and treatment of barbiturate use or overdose.
- Confirmation Method: Preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.
- User Qualification: Must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
- Calibrators: Liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, and phenobarbital, across 9 levels, for calibration of the evidence® system.
In summary, this document is a regulatory approval letter based on "substantial equivalence" to existing devices, and therefore does not detail performance studies with pre-defined acceptance criteria as one would expect for a novel device or AI system requiring independent performance validation.
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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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Page 2 -
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
§ 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).