Search Results

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.

Ask a specific question about this device

The MP RapidOXY Test Strip is an immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml. The MP RapidOXY Test Strip 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 (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The MP RapidBUP Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine, buprenorphine-3-beta-d-glucuronide, in human urine specimens at cut-off level of 10 ng/ml. The MP RapidBUP Test Strip 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 (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The MP RapidOXY Test Strip and the MP RapidBUP Test Strip are based on the principle of specific immunochemical reaction between antibody and antigen to analyze particular compounds in human urine specimens. The assays rely on the competition for binding antibody between drug conjugate and free drug which may be present in urine. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibodydve conjugate. When the amount of drug is equal or more than the cut-off (i.e., 100 ng/ml oxycodone or 10 ng/ml buprenorphine-3-beta-d-glucuronide, or B-3-beta-d-G), it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line is present in the test window to work as procedural control in both assays. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.

The provided text describes two drug-of-abuse test kits: the MP RapidOXY Test Strip (for oxycodone) and the MP RapidBUP Test Strip (for buprenorphine). However, the document does not contain explicit "acceptance criteria" in the typical sense of performance metrics (e.g., sensitivity, specificity thresholds) that a study aims to meet. Instead, the document outlines the "intended use" and "cut-off levels" which serve as the functional definitions for the device's performance. The "study" referenced within the document is implicitly the submission of "Performance Data and the Accuracy Data" to the FDA, but the details of these studies (e.g., specific methodologies, results, sample sizes, ground truth establishment) are not provided in the given text.

Therefore, I will populate the table and answer the questions based on the information available in the provided text, and explicitly state when information is not present.

Acceptance Criteria and Device Performance

Detailed Study Information (Based on Provided Text):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified in the provided text. The document mentions "Performance Data and the Accuracy Data" but does not detail the sample sizes for these studies.
   • Data Provenance: Not specified in the provided text.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Number of Experts: Not specified in the provided text.
   • Qualifications of Experts: Not specified in the provided text.
   • The document states that Gas Chromatography/Mass Spectrometry (GC/MS) "has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA)" and is recommended for follow-up. This implies GC/MS results would likely be the basis for ground truth, which is an analytical method rather than expert consensus.

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

   • Not specified in the provided text.

4. 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/Not specified. This is a point-of-care immunoassay "Test Strip" for qualitative determination, not a system involving "human readers" or "AI assistance" in the typical sense of diagnostic imaging or complex analytical interpretation. The device provides a visual, qualitative result.

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

   • Yes, implicitly. The devices (test strips) are designed to provide a "preliminary analytical test result" qualitatively and visually. This implies a standalone performance without human interpretation or adjustment being part of the primary result generation, although a human reads the visual result. The device itself is an "algorithm" in the sense of a chemical reaction with a defined output.

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

   • The document explicitly states that Gas Chromatography/Mass Spectrometry (GC/MS) is the "preferred confirmatory method." This indicates that analytical confirmation (GC/MS) would be the ground truth for the studies supporting the device's accuracy.

7. The sample size for the training set

   • Not specified in the provided text. As these are immunoassays (chemical tests), the concept of a "training set" in the context of machine learning or AI is not directly applicable in the same way. Performance data would typically involve testing against known positive and negative samples, and samples spiked with controlled concentrations of the target analyte.

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

   • Not specified in the provided text. Assuming "training set" refers to samples used to optimize the test's performance characteristics (e.g., cut-off, cross-reactivity), the ground truth for such samples would likely also be established through analytical methods like GC/MS or by preparing samples with known concentrations of the drug/metabolite.

Ask a specific question about this device