Search Results

Ask a specific question about this device

The Emit® II Plus Methaqualone Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methaqualone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Methaqualone Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Syva Emit® II Plus Methaqualone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methaqualone in human urine.

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Based on the provided 510(k) summary, the device is an in-vitro diagnostic assay, not an AI device or one that involves human interpretation in the way the questions usually imply (e.g., radiologists interpreting images). Therefore, many of the requested fields (like number of experts, adjudication methods, MRMC studies) are not applicable in this context. The acceptance criteria and performance are focused on the analytical performance of the assay itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Comparative Analysis: Not explicitly stated how many specimens were used, but the summary refers to "specimens" from which 98% agreement was observed.
• Sample Size for Spiked-Sample Recovery: "Negative human urine" was spiked, but the number of unique samples or total tests is not specified.
• Sample Size for Precision: Controls and cutoff calibrator were used, but the specific number of runs or repetitions is not specified.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective laboratory studies conducted by the manufacturer, rather than retrospective analysis of existing clinical data.

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

N/A. This is an in-vitro diagnostic assay. The "ground truth" for the test set is established by the known concentrations of methaqualone in spiked samples or by the results of a predicate method, not by human expert interpretation.

4. Adjudication Method for the Test Set

N/A. Adjudication is not applicable as this involves quantitative and qualitative chemical analysis, which relies on objective measurements rather than subjective human interpretation needing consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not applicable to an in-vitro diagnostic assay that performs chemical analysis. It's typically used for imaging or diagnostic aids that involve human interpretation.

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

Yes, in essence. The studies described (comparative analysis, spiked-sample recovery, precision, sensitivity) assess the performance of the assay itself as a standalone diagnostic tool, without human intervention in the result generation or interpretation to improve its core output. The assay produces a direct qualitative (positive/negative) or semiquantitative result. The "human-in-the-loop" aspect for such devices typically refers to the clinician's overall judgment in interpreting the test result in the context of a patient's condition, which is a broader clinical practice rather than an integral part of the device's performance study for regulatory approval.

7. The Type of Ground Truth Used

• Comparative Analysis: The results from the predicate device (Syva Emit® II Methaqualone Assay) served as the reference or "ground truth" for comparison.
• Spiked-Sample Recovery: The known, pre-determined concentrations of methaqualone spiked into negative human urine served as the ground truth.
• Precision: Internal controls and calibrators with known values were used.
• Sensitivity: Established by statistical methods comparing assay response to 0 ng/mL.

8. The Sample Size for the Training Set

N/A for this type of device. There isn't a "training set" in the context of machine learning or AI. The assay's chemical formulation and parameters are developed through laboratory optimization processes, not through training on a dataset in the AI sense.

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

N/A. See explanation in point 8.

Ask a specific question about this device

The SYNCHRON Systems Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX6 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

The SYNCHRON Methaqualone Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of Methaqualone and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.

This document describes the performance of the SYNCHRON Systems Methaqualone Reagent, an enzyme immunoassay for the qualitative determination of Methaqualone in human urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct targets in the provided text. However, the study aims to demonstrate substantial equivalence to the predicate device (Emit II Methaqualone Assay) and highlights specific performance metrics. Below is a table summarizing the reported device performance, which implicitly serves as the 'met' acceptance criteria given the submission of the summary of safety and effectiveness.

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

• Test Set Sample Size: 103 samples.
• Data Provenance: Not explicitly stated, but the study compares the SYNCHRON Methaqualone Reagent to the Emit II Reagent and also mentions a comparison with GCMS. The nature of the samples (e.g., patient samples, spiked samples) and their geographical origin (e.g., country) are not specified. It is likely retrospective as it involves comparison to existing methods.

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

• The document does not mention the use of human experts or readers to establish the ground truth for the test set.
• The ground truth reference methods mentioned are the Emit II Reagent (a predicate device) and GCMS (Gas Chromatography-Mass Spectrometry).

4. Adjudication Method for the Test Set

• No human adjudication method is described, as the ground truth was established by laboratory methods (Emit II and GCMS).
• The study implicitly uses the Emit II Reagent as a primary comparitor, and GCMS as a confirmatory method for discordant results (as indicated by "Number of Disconcordant w/ GCMS: 0").

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is an automated laboratory assay (enzyme immunoassay) for drug detection, not an AI-assisted diagnostic imaging or classification tool that would involve human readers. Therefore, the concept of human reader improvement with/without AI assistance does not apply.

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

• Yes, the performance metrics reported (Overall Agreement, Relative Sensitivity, Relative Specificity, Imprecision, Stability) are indicative of standalone performance of the SYNCHRON Systems Methaqualone Reagent as an algorithm/assay.
• The device is an automated chemical analyzer component, and its reported performance reflects its intrinsic capability without direct human intervention in the result interpretation after the sample is processed by the instrument.

7. The Type of Ground Truth Used

• The primary ground truth for comparison in the "Relative Sensitivity and Specificity Study Results" was the Emit II Methaqualone Reagent (a predicate enzyme immunoassay).
• For discordant results, a more definitive analytical method, GCMS (Gas Chromatography-Mass Spectrometry), was used as a confirmatory ground truth. The fact that there were "0" discordant results with GCMS suggests GCMS was considered the gold standard for verifying the true status of the "disconcordant" samples when compared to Emit II.

8. The Sample Size for the Training Set

• The document does not mention a "training set" or "training data." This is because the device is a chemical reagent and assay system, not a machine learning model that requires a training phase.
• The described studies are performance validation studies for a diagnostic assay.

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

• As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this device.

Ask a specific question about this device