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The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.

The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Rapid Diagnostics MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of amphetamines, barbiturates, benzodiazenines, buprenorphine, cocaine, methadone, methamphetamine, opiates, oxycodone and phencyclidine, in human urine samples. MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup detects each of the analytes on separate strips. A positive urine sample will not generate a colored line for the specific drug tested in the designated region. A negative urine sample containine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methamphetamine, opiates, oxycodone or phencyclidine below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored line will always appear at the control region.

The provided document describes the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup, which are in-vitro immunochromatographic assays for drug detection in human urine. Here's a breakdown of the acceptance criteria and the study details:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance were based on a comparison study to verify that there is no performance difference between the DOA Test Strips and DOA Test Cups when exposed to a human urine specimen for 20 seconds vs. 5 minutes. The specific acceptance criteria are implied by the reported results:

Note: The document states "per the pre-defined study acceptance criteria" but does not explicitly list the criteria themselves. However, the 100% pass rate implies that the devices met the full performance expectations in this comparison study.

An additional study on interfering drug analytes also demonstrated no interference at 5 and 10 minutes following the addition of specimens at different concentrations.

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

Since this document describes a pre-market notification (510k), it refers to validation studies rather than external test sets in the typical AI/ML context.

• Comparison Study:

  • For each device format (DOA Test Strips, MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup), three lots of product were tested.
  • Each lot was tested over three drug cut-off concentration levels (-50%, +50%, +300%), including a negative specimen.
  • Total tests: 432 for DOA Test Strips, 360 for MP DOA-10 Panel Test Cups, and 396 for MP DOA-11 Panel Test Cups.
  • Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective, but given it's a device for use with "human urine," it's prospective data collected from prepared samples for internal validation.

• Interfering Drug Analyte Study:

  • 198 MP DOA-11 Panel Test Cups (divided into 2 groups) were used.
  • 180 MP DOA-10 Panel Test Cups (divided into 2 groups) were used.
  • Tested over 3 lots of DOA Test Cups.
  • Cut-off concentrations (-50%, +50%, +300%) for each drug analyte were assessed.
  • Data Provenance: Similar to the comparison study, this would likely be prospective data collected from controlled laboratory settings.

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

This type of device (immunochromatographic in-vitro test) does not typically involve human experts in the way an AI diagnostic imaging device would. The "ground truth" for the test set (urine samples with specific drug concentrations) is established through precise laboratory preparation of known concentrations of drug substances and negative specimens.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. The results are based on a chemical reaction producing a visible line, not subjective interpretations requiring 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 is not an AI-based device that assists human readers. It's a standalone in-vitro diagnostic test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations of the device itself. The device (test cup) functions without continuous human intervention to interpret the chemical reaction. While a human reads the result (presence or absence of a line), the detection mechanism is entirely within the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is based on known, controlled concentrations of drug analytes in urine samples prepared in a laboratory setting. For example, samples were prepared at -50%, at cut-off, +50%, and +300% of the specified cut-off levels for each drug. Negative control samples were also used.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's operational characteristics are determined by its chemical and physical design, which is developed and refined, but not "trained" with data like a machine learning model.

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

Not applicable. There is no training set as this is not an AI/ML device. The performance is based on the inherent chemical and immunological properties of the test strips and cups.

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