(523 days)
For in vitro diagnostic use.
The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol Urine HEIA™ provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol Urine HEIA™ provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
The document describes the performance characteristics of the Immunalysis Tapentadol Urine HEIATM, a homogeneous enzyme immunoassay intended for qualitative and semi-quantitative analysis of tapentadol in human urine.
Here's an breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside the "reported device performance" in a single, consolidated table. However, the performance characteristics section (G) details various studies with implicit acceptance criteria and their corresponding results. I've compiled this information into a table format based on the presented data:
| Study/Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision - Qualitative (Concentrations Relative to Cutoff) | Samples at -100%, -75%, -50%, -25% of cutoff should be Negative. Samples at +25%, +50%, +75%, +100% of cutoff should be Positive. Sample at Cutoff (200 ng/mL) expected to show a mix of positive/negative. | Lot 1: |
| -100% to -25%: 80 Negative | ||
| Cutoff: 41 Neg / 39 Pos | ||
| +25% to +100%: 80 Positive | ||
| Lot 2: | ||
| -100% to -25%: 80 Negative | ||
| Cutoff: 35 Neg / 45 Pos | ||
| +25% to +100%: 80 Positive | ||
| Lot 3: | ||
| -100% to -25%: 80 Negative | ||
| Cutoff: 42 Neg / 38 Pos | ||
| +25% to +100%: 80 Positive | ||
| Precision - Semi-Quantitative (%CV) | %CV should be within acceptable limits (typically |
§ 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).