(131 days)
The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens for the purpose of identifying chronic marijuana use. This process is intended exclusively for in-house professional use only. The process has not been evaluated for use with hair specimens other than head. Clinical consideration and professional judgement should be applied to any drug of abuse test result.
The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens.
This document is a 510(k) clearance letter for a drug test, not an AI/ML medical device. Therefore, the questions regarding AI/ML device performance, ground truth, expert involvement, and training/test sets are not applicable to the provided text.
The document discusses the substantial equivalence of the "Quest Diagnostics Haircheck-DT (THC)" device to legally marketed predicate devices for screening and quantifying THC-COOH in hair specimens.
Here's the information that can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or report device performance in a table format. It states that the device is "substantially equivalent" to predicate devices. This implies that its performance is considered acceptable based on comparison to existing, legally marketed tests for the same purpose.
2. Sample size used for the test set and the data provenance:
Not applicable. This is a 510(k) clearance for a laboratory test, not an AI/ML device requiring a specific test set in the context of algorithm evaluation. The letter refers to the "Indications for Use" which describes what the device does.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in the context of an AI/ML medical device is not relevant here. The device itself is a test to determine the presence and quantity of THC-COOH.
4. Adjudication method for the test set:
Not applicable.
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:
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a laboratory test, not an algorithm.
7. The type of ground truth used:
Not applicable. The "ground truth" for a drug test would be the actual presence/absence and concentration of the substance in the specimen, as determined by a reference method, but this document does not detail the validation studies beyond stating "substantial equivalence."
8. The sample size for the training set:
Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established:
Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo is circular, with text around the perimeter. In the center of the circle is an image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 4 2004
Dr. James Bourland Technical Director Quest Diagnostics, Inc. 4230 Burnham Ave. Las Vegas, NV 89119
K040257 Re:
Trade/Device Name: Quest Diagnostics Haircheck-DT (THC) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: April 28, 2004 Received: May 5, 2004
Dear Dr. Bourland:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four becamed the device is substantially equivalent (for the indications ferenced above and in the enclosure) to legally marketed predicate devices marketed in interstate for use surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to they 2011-12-11 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 r ou may, morelory, mains 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 your device is trademical controls. Existing major regulations affecting your device it may oc subject to bach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 I lease be advised that I Dr over device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I cacal statutes and regarments, 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 his letter with anow you to begin milities of your device of your device to a legally premarket notification: "The Pro Print of Stification 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, II you desire specific information as vertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Ville Diagliostic De Hose Wina by reference to premarket notification" (21CFR Part 807.97). Tegulation childed, "Misormation on your responsibilities under the Act from the Tod inay oodain other generational 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,
Jean M. Cooper, MS, DVM.
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
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Appendix 4
Indications for Use
510(k) Number (if known): K040257
Quest Diagnostics Haircheck-DT (THC) Device Name:
Indications For Use:
The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device TIC QUEST DITIONOBE iso nunosorbent assay (ELISA) for qualitative screening at employing of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass r.o pgring of TTC OOOT and Oast and the final quantitative reporting of Speculometry (OO Mb MB) 201 oles for the purpose of identifying chronic marijuana ITIC-COOT in halfall has on evaluated for use with hair specimens other than head. use. This process is intended exclusively for in-house professional use only. The process I his process is michaea eneraler copy in Clinical consideration and professional judgement should be applied to any drug of abuse test result.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Counter Use (Part 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-The-
(21 CFR 807
(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
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k)
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).