(79 days)
The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.
| Test | Calibrator | Cutoff (ng/ml) |
|---|---|---|
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Cocaine metabolite (COC150) | Benzoylecgonine | 150 |
This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).
This test is used to obtain a visual, qualitative result and is intended for professional use.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.
This document is a 510(k) clearance letter from the FDA for a multi-drug screen device. It acknowledges the device's substantial equivalence to legally marketed predicate devices. However, the provided text does not contain the acceptance criteria or a study detailing the device's performance against such criteria. It only describes the product, its intended use, and cutoff concentrations for the substances it detects.
Therefore, I cannot extract the information required in your request from the provided text.
To provide the requested details, I would need a different document that outlines a performance study, including:
- A table of acceptance criteria and reported device performance (sensitivity, specificity, accuracy, etc.)
- Details on sample size, data provenance, ground truth establishment, and expert qualifications.
§ 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).