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The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.

The Immunalysis Buprenorphine Urine Enzyme Immunoassay Kit 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 / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis Buprenorphine Urine Controls:

The Immunalysis Buprenorphine Urine Controls are used as control materials in the Immunalysis Buprenorphine Urine Enzyme Immunoassay.

Immunalysis Buprenorphine Urine Calibrators:

The Immunalysis Buprenorphine Urine Calibrators are used as calibrators in the Immunalysis Buprenorphine Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Buprenorphine in urine on automated clinical chemistry analyzers.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes rabbit antibodies to Buprenorphine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes buprenorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use

The buprenorphine calibrator and controls consists of a single calibrator at 5ng/mL, a control set containing a LOW control at 3.75ng/mL and a HIGH control at 6.25ng/mL and a calibrator set containing a negative calibrator, a Level 1 calibrator at 5ng/mL, a Level 2 calibrator at 10ng/mL, a Level 3 calibrator at 20ng/mL and a Level 4 calibrator at 40ng/mL.

Here's a breakdown of the acceptance criteria and study details for the Immunalysis Buprenorphine Urine Enzyme Immunoassay, based on the provided 510(k) summary:

This device is an in-vitro diagnostic (IVD) test, not an AI/ML-based device that interprets images or signals using algorithms learned from data. Therefore, many standard AI/ML evaluation criteria, such as MRMC studies, expert adjudication, or separate training/test sets with human-in-the-loop performance, are not applicable here. The "acceptance criteria" for this device are defined by its analytical performance metrics, which show it functions as intended for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets in the same clear format as for an AI/ML device (e.g., "sensitivity > 90%"). Instead, the acceptability is demonstrated by the device meeting certain performance characteristics (precision, specificity, linearity, non-interference) that are deemed adequate for its intended use as a qualitative and semi-quantitative drug test. The FDA's substantial equivalence determination implies these criteria were met.

The performance studies and their results serve as the "reported device performance" and, by implication, demonstrate meeting the acceptance criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision/Cutoff Characterization: 80 determinations per concentration level (20 days, 2 runs per day in duplicate) for 9 concentration levels resulting in a total of 720 measurements.
• Specificity and Cross-Reactivity: Not explicitly stated as a "sample size" of patient samples, but structurally similar compounds and other drugs were spiked into drug-free urine. Around 30+ compounds were tested at specific concentrations.
• Interference: Not explicitly stated as a "sample size" of patient samples, but various non-similar compounds, endogenous compounds, and different pH/specific gravity levels were tested by spiking into drug-free urine containing target analyte at ±25% of cutoff. Around 90+ non-similar compounds and 17 endogenous compounds were tested. pH was tested at 9 levels, and specific gravity at 8 levels.
• Linearity/Recovery: A drug-free urine pool spiked with a high concentration, then serially diluted to create 11 different concentration levels.
• Method Comparison: 80 "unaltered, anonymous and discarded clinical urine samples" (40 positive, 40 negative based on LC/MS).
• Stability Studies: Conducted with a sufficient number of replicates over timepoints to support the claimed stability. Specific "sample sizes" (e.g., number of batches or vials) are not detailed but the methodology (e.g., "replicates") implies sufficient testing.

Data Provenance:

• Country of Origin: Not explicitly stated for patient samples. The manufacturer, Immunalysis Corporation, is based in Pomona, CA, USA.
• Retrospective or Prospective:
  • Precision, Specificity, Interference, Linearity: Lab-based studies, likely prospective, using controlled spiked samples.
  • Method Comparison: "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This suggests retrospective use of existing clinical samples.
  • Stability: Prospective, controlled lab studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable in the typical sense for this IVD device.

For IVD devices like this immunoassay, the "ground truth" for the test set is established by:

• Preparation of controlled samples: For precision, specificity, interference, and linearity studies, samples are prepared in a laboratory with known concentrations of the analyte or interfering substances. This is the "ground truth" for these studies.
• Reference Method Analysis: For method comparison, the "ground truth" is established by a more definitive analytical method, in this case, Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are established analytical chemistry techniques, not subject to expert interpretation in the same way as, for example, a radiological image. Therefore, human experts are not used to establish this kind of ground truth.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth is established by known sample concentrations or definitive analytical methods (GC-MS/LC/MS), there is no need for human expert adjudication.

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 device is an automated in-vitro diagnostic immunoassay for chemical analysis of urine, not an AI/ML-based diagnostic aid for human readers (e.g., radiologists, pathologists). It does not involve "human readers" interpreting results that would then be assisted by AI. The device provides a direct analytical result.

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

Essentially, yes, but not for an "algorithm" in the AI sense. The primary performance data (Precision, Specificity, Interference, Linearity, Method Comparison) demonstrates the device's analytical performance on its own, producing qualitative and semi-quantitative results for Buprenorphine in urine. It operates as a "standalone" analytical instrument providing results.

7. The Type of Ground Truth Used

• Controlled Spike-ins: For Precision, Specificity/Cross-Reactivity, Interference, and Linearity, the ground truth was established by manufacturing urine samples with known, precisely measured concentrations of Buprenorphine or other compounds.
• Reference Standard (LC/MS Confirmation): For the Method Comparison study, the ground truth was established by Liquid Chromatography / Mass Spectrometry (LC/MS), which is considered the preferred confirmatory method for drug testing in urine.

8. The Sample Size for the Training Set

Not applicable in the AI/ML sense. This is a traditional enzyme immunoassay, not an AI/ML device that requires a training set to learn relationships from data. Its "training" involves chemical reagent formulation and instrument calibration.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the AI/ML sense. For a chemical assay, the equivalent of "establishing ground truth for training" would involve:

• Chemical Formulation: Developing the immunoassay reagents (antibodies, enzymes, substrates) based on known chemical principles to specifically react with Buprenorphine.
• Calibration: Using precisely measured standard solutions (calibrators) with known concentrations of Buprenorphine to establish the assay's response curve. The document states: "Calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are out of the acceptable range, then the calibrator or control is adjusted and retested. Values are assigned to the calibrator and controls once the Mass spectrometry results are within the acceptable ranges." This process essentially establishes the "ground truth" for the device's internal calibration.

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