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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).

Device Description

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.

AI/ML Overview

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 <10-20% for immunoassays depending on concentration).	%CV ranged from 3.6 to 9.7 for all lots tested.
Specificity and Cross-Reactivity (Qualitative)	Structurally and functionally similar compounds (except known metabolites) should not cross-react (i.e., yield negative results or equivalent concentration <200 ng/mL).	All tested compounds (e.g., Chlorpromazine, Clomipramine, Tramadol) showed < 0.2% cross-reactivity and were negative, except for N-desmethyl tapentadol (15.7% cross-reactivity) and tapentadol glucuronide (0.5% cross-reactivity), which are expected metabolites and showed positive results at equivalent concentrations.
Specificity and Cross-Reactivity (Semi-Quantitative % Cross-Reactivity)	% of cross-reactivity for structurally and functionally similar compounds (except known metabolites) should be low.	% of cross-reactivity was < 0.2% for all compounds tested except for N-desmethyl tapentadol (15.7%) and tapentadol glucuronide (0.5%).
Interference – Structurally Unrelated Compounds	No interference observed at specified concentrations.	No interference observed for all 90+ listed compounds at the tested concentrations (mostly 100,000 ng/mL, some 50,000 ng/mL).
Interference – Endogenous Compounds and Urine Preservatives	No interference observed at specified concentrations.	No interference observed for listed endogenous compounds (e.g., Acetone, Bilirubin, Glucose) and urine preservatives (Sodium Azide, Sodium Fluoride) at specified concentrations. Boric acid showed no interference at ±50% of cutoff.
Interference – pH	No positive or negative interference over the tested pH range.	No positive or negative interference observed at urine pH values ranging from 3.0 to 11.0.
Interference – Specific Gravity	No positive or negative interference over the tested specific gravity range.	No positive or negative interference observed at urine specific gravity values ranging from 1.000 to 1.030.
Linearity/Recovery	The assay should demonstrate linearity and acceptable recovery over the specified range.	Confirmed linear range 100-1100 ng/mL. Assay drug recovery percentage ranged from 95.8 to 110.4%.
Calibration Duration	Maintain performance for the recommended calibration frequency.	Test results met acceptance criteria up to 14 days, supporting a recommended 14-day calibration frequency.
Tapentadol Stability in Urine	Tapentadol samples should remain stable for a specified duration under defined storage conditions.	Urine samples stable for up to 14 days stored at 2°C - 8°C.
Method Comparison (Qualitative & Semi-Quantitative)	High agreement (PPA, NPA) with LC-MS/MS.	PPA: 100% (95/95) and NPA: 100% (65/65) for both qualitative and semi-quantitative modes.

2. Sample size used for the test set and the data provenance

Precision Study:
- Sample Size: 9 panel members (concentrations from 0 to 400 ng/mL, including drug-free negative and spiked concentrations relative to the 200 ng/mL cutoff). Each panel member was tested in 80 replicates (20 days, 2 runs/day, 2 replicates/run), across 3 lots of reagent.
- Data Provenance: Drug-free negative urine was used as the base sample. Spiked concentrations were confirmed by mass spectrometry (LC-MS/MS). The document does not explicitly state the country of origin of the data, nor whether it was retrospective or prospective, but precision studies are typically prospective laboratory experiments.
Specificity and Cross-Reactivity:
- Sample Size: Varies per compound tested (implied multiple replicates to determine exact cross-reactivity percentage). Compounds were spiked into drug-free urine.
- Data Provenance: Laboratory study using spiked samples.
Interference (Structurally Unrelated Compounds, Endogenous Compounds, Urine Preservatives, pH, Specific Gravity):
- Sample Size: Varies per compound/condition. Potential interferents were spiked into drug-free urine containing tapentadol at ±25% of the cutoff (and ±50% for boric acid).
- Data Provenance: Laboratory study using spiked samples.
Linearity/Recovery:
- Sample Size: A drug-free urine pool and a pool spiked with high concentration of tapentadol. Serially diluted to achieve 12 concentrations (0 to 1100 ng/mL). Each pool was tested in triplicate.
- Data Provenance: Laboratory study using spiked samples.
Calibration Duration:
- Sample Size: Drug-free negative urine spiked with tapentadol at ±25% of the cutoff. Tested at multiple time points up to 14 days.
- Data Provenance: Laboratory study using spiked samples.
Tapentadol Stability in Urine:
- Sample Size: Urine samples from 4 participants who reported taking tapentadol.
- Data Provenance: Clinical samples, stored and tested over time.
Method Comparison:
- Sample Size: 160 de-identified remnant unaltered clinical urine samples.
- Data Provenance: Retrospective; samples obtained from clinical testing laboratories. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is an in vitro diagnostic (IVD) assay for substance detection, not an AI/imaging device requiring expert interpretation for ground truth.

For the precision, specificity, linearity, and interference studies, the ground truth was established by known concentrations of analytes/compounds prepared in the laboratory, often confirmed by mass spectrometry (LC-MS/MS), which is considered a gold standard analytical method. No human experts were involved in establishing this type of ground truth.
For the method comparison study, the Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) acted as the reference method (ground truth). This is an analytical chemistry technique, not dependent on expert visual interpretation. The document references "Agilent 6430 Liquid Chromatography-Tandem Mass Spectrometry" as the instrument used.

Therefore, the concept of "number of experts" and "qualifications of those experts" does not apply in the same way it would for imaging-based AI diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The ground truth for this chemical assay is primarily based on quantitative analytical methods (LC-MS/MS for confirmation/comparison) and precisely prepared spiked samples with known concentrations. There is no human interpretation or subjective assessment that would require an adjudication method among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, an MRMC study or a study on human reader improvement with AI assistance was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone immunoassay (a chemical test) that provides a result (qualitative or semi-quantitative). Its performance is evaluated directly against analytical ground truth (LC-MS/MS). The concept of "algorithm only" or "human-in-the-loop" isn't directly applicable in the same way it is for AI-driven software where human input might influence the output. The assay generates a quantifiable signal which is then interpreted against a cutoff, which is an automated process on a clinical chemistry analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The primary type of ground truth used was:

Known concentrations/preparations: For precision, specificity, interference, linearity, calibration duration.
Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS): Considered a gold standard confirmatory method for drug testing, used as the reference method (ground truth) for the method comparison study.

8. The sample size for the training set

This document describes a traditional in vitro diagnostic immunoassay, not an AI/machine learning model. Therefore, there is no "training set" in the context of machine learning. The assay's performance characteristics are inherent to its chemical/biological design and reagents, not learned from data.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for a traditional immunoassay.

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