(278 days)
The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users. This test system has not been evaluated for use with other user populations or with hair specimens other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and is not intended for sale to anyone
The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
The document is a 510(k) clearance letter from the FDA for the Quest Diagnostics HairCheck-DT (Opiates) device. It states that the device is substantially equivalent to legally marketed predicate devices. It describes the intended use and indications for use, but it does not detail a study conducted by Quest Diagnostics to establish performance against pre-defined acceptance criteria.
Specifically, the requested information points cannot be extracted from this document:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size used for the test set and data provenance: Not present. The document refers to "head hair samples from chronic heroin users" but does not provide details on the sample size or origin of data from a specific study.
- Number of experts used to establish ground truth and qualifications: Not present.
- Adjudication method: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of test system.
- Standalone performance: The document states the test system "provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed result." This implies it's not truly standalone for a definitive diagnosis.
- Type of ground truth used: It mentions that GC-MS/MS is the preferred method for confirmation, indicating that this might serve as a form of "ground truth" for confirmed results, but it doesn't detail how ground truth was established for a specific validation study.
- Sample size for the training set: Not present.
- How ground truth for the training set was established: Not present.
The document is primarily a regulatory clearance, not a scientific study report. To find the information requested, one would typically need to consult a detailed validation study report submitted as part of the 510(k) application, which is not included in these pages.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 6 - 2005
James A. Bourland, Ph.D. Technical Director Quest Diagnostics, Inc. 4230 Burnham Ave. Las Vegas, NV 89119
Re: K042725
Trade/Device Name: The Quest Diagnostics HairCheck-DT (Opiates) Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: March 4, 2005 Received: May 4, 2005
Dear Dr. Bourland:
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 yours,
Carol C. Benson
Carol C. Benson, M.A. 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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510 (k) Number: K042725 Device Name: Quest Diagnostics HairCheck-DT (Opiates)
Indications for use:
- Intended Use and Indications for Use of the Subject Device:
The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users. This test system has not been evaluated for use with other user populations or with hair specimens other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and is not intended for sale to anyone
The QUEST DIAGNOSTICS HairCheck-DT (Opiates) provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter-Use (Optional Format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostk Device Evaluation and Safety
510(k) K042725
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).