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510(k) Data Aggregation
(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 |
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