(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.
§ 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).