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The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Cocaine Metabolite 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 Emit II Plus Cocaine Metabolite assay is a homogeneous enzyme immunoassay that qualitatively and semiquantitatively measures benzoylecgonine. The assay has cutoffs of 150 ng/mL and 300 ng/mL benzoylecgonine.

The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.

The Emit II Plus Cocaine Metabolite Assay consists of two ready-to-use reagents:

Antibody/Substrate Reagent 1
Sheep polyclonal antibodies to benzoylecgonine (2.2 µg/mL), bovine serum albumin, G6P (15 mM), NAD (12 mM), preservatives, and stabilizers

Enzyme Reagent 2
Benzoylecgonine labeled with bacterial G6PDH (0.46 U/mL), HEPES buffer, bovine serum albumin, preservatives, and stabilizers

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the method comparison studies. However, the reported "Result" for agreement percentages can be interpreted as the performance achieved. Similarly, for precision studies, "Results" indicate the number of negative/positive determinations. For linearity, it's % recovery.

Table 1: Acceptance Criteria and Reported Device Performance

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The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Monoclonal Cocaine Metabolite 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-ofabuse test result, particularly when preliminary positive results are used.

Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human urine.

Here's a breakdown of the acceptance criteria and study information for the Syva Company - Dade Behring Inc. Emit® II Plus Cocaine Metabolite Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria, but demonstrates a high percentage agreement with the Gas Chromatography/Mass Spectrometry (GC/MS) method, implying that high concordance is the de facto acceptance criterion.

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

• 150 ng/mL Cutoff: The number of samples is not explicitly stated, but the provided table shows:
  • 2 samples testing positive by GC/MS (123 and 140 ng/mL) but negative by the device.
  • 7 samples testing positive by GC/MS (150, 151, 157, 162, 164, 166, and 190 ng/mL) and positive by the device.
  • The total number of samples where an agreement or disagreement is reported (excluding the header rows) is 9. However, the full sample size for the agreement percentage calculation is not provided.
• 300 ng/mL Cutoff: The number of samples is not explicitly stated, but the provided table shows:
  • 6 samples testing positive by GC/MS (218, 241, 261, 294, 295, and 298 ng/mL) but negative by the device.
  • 1 sample testing positive by GC/MS (354 ng/mL) and positive by the device.
  • Similar to the 150 ng/mL cutoff, the full sample size for the agreement percentage calculation is not provided, only the cases of disagreement and agreement mentioned.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not applicable for this type of device. The ground truth is established by a reference chemical/analytical method (GC/MS), not by human experts.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth is established by a single, definitive chemical method (GC/MS), not by human interpretation or consensus that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is an in-vitro diagnostic (IVD) device for chemical analysis, not an AI-powered diagnostic imaging or interpretation device that would involve human readers.

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

• Yes, this is a standalone device. The device's performance is measured directly against the GC/MS reference method. It performs the analysis of benzoylecgonine in human urine without human interpretation affecting the direct assay output. The text states: "The Emit® II Plus Monoclonal Cocaine Metabolite 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." This indicates the Emit® II Plus provides its own result which is then compared, and if positive, needs GC/MS for confirmation.

7. The Type of Ground Truth Used

• Reference standard/Gold Standard: Gas Chromatography/Mass Spectrometry (GC/MS) is specified as the "preferred confirmatory method" and the method against which the Emit® II Plus assay results are compared.

8. The Sample Size for the Training Set

• The document does not provide any information about a training set size. This assay is a homogeneous enzyme immunoassay, not a machine learning model that typically requires a distinct training set. The "method comparison" describes validation, not necessarily model training.

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

• Not applicable, as no training set for a machine learning model is mentioned or implied.

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The Emit® II Plus Cocaine Metabolite Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit ® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Cocaine Metabolite 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 judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecognine (cocaine metabolite) in human urine. The Emit® II Plus Cocaine Metabolite Assay and has been found to be equivalent to the predicate device: Emit® II Cocaine Metabolite Assay with regard to intended use, assay sample, and overall performance characteristics.

The provided document describes the Emit® II Plus Cocaine Metabolite Assay, a homogeneous enzyme immunoassay for detecting benzoylecognine (cocaine metabolite) in human urine. The study presented aims to demonstrate the substantial equivalence of this new assay to a predicate device, the Emit® II Cocaine Metabolite Assay, and its correlation with Gas chromatography/mass spectrometry (GC/MS).

Here's an analysis of the acceptance criteria and the study, organized according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative manner (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, it describes performance in terms of "excellent correlation" and "acceptable precision." For the purpose of this table, I will infer the implicit criteria from the reported results and the comparison to the reference methods.

• Within-run %CV for controls and cutoffs (rates) ranged from 0.4% to 0.5%.
• Total precision %CV for controls and cutoffs (rates) ranged from 0.5% to 0.6%. |
  | Precision (Semiquantitative mode): Low variability in repeated measurements of concentrations. | Acceptable.
• Within-run %CV for controls and cutoffs (concentrations) ranged from 3.7% to 10.9%.
• Total precision %CV for controls and cutoffs (concentrations) ranged from 5.1% to 14.9%. |
  | Substantial Equivalence: Overall performance comparable to the predicate device. | The manufacturer concluded the device is "substantially equivalent to the Emit® II Cocaine Metabolite Assay with regard to intended use, assay sample, and overall performance characteristics." This was affirmed by the FDA's 510(k) clearance letter. |

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

• Sample Size for Test Set:

  • For the correlation with GC/MS (150 ng/mL cutoff): The document does not specify the exact number of samples used for the full 100% agreement study. It only mentions that "All positive samples and a portion of negative samples (n=20), as assessed by the Emit® II Plus Cocaine Assay, were analyzed by GC/MS for confirmatory (positive samples) and specificity (negative samples) purposes." This implies at least 20 negative samples plus an unspecified number of positive samples were tested against GC/MS. The number of samples for the 100% agreement claim is not clearly stated.
  • For the correlation with the predicate device (300 ng/mL cutoff): The sample size is not explicitly stated, beyond the mention of "three samples were discordant."
  • For spiked sample recovery (qualitative and semiquantitative): The number of samples (spiked urine) and replicates is not specified.
  • For precision studies: The number of samples/replicates for the precision studies is not specified, only the resulting %CVs.

• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. Given the nature of in-vitro diagnostic assays for drug testing, it's typically prospective testing of collected urine samples, but this is not explicitly stated.

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

Not applicable. This device is an in-vitro diagnostic (IVD) assay for chemical analysis. The "ground truth" is established by a reference chemical method (GC/MS) or by known concentrations in spiked samples, not by expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved. For an IVD device, the "adjudication" of results is based on comparison to the reference chemical method (GC/MS) or expected values for spiked samples. Discordant results are typically investigated to understand the reason (e.g., borderline concentration, interference).

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 device for chemical analysis. It does not involve human readers interpreting cases or AI assistance in the context of diagnostic imaging.

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 Emit® II Plus Cocaine Metabolite Assay. The device (assay) itself produces quantitative or qualitative results, which are then compared to reference methods. While human operators perform the testing, the results are derived directly from the assay's chemical reactions and detection system, without an "algorithm" in the AI sense or a human performing interpretation of the assay's output that would require a human-in-the-loop study design.

7. The Type of Ground Truth Used

The ground truth used in the studies includes:

• Chemical Reference Method: Gas chromatography/mass spectrometry (GC/MS) for confirmation of drug metabolite presence and concentration in real urine samples. GC/MS is considered the gold standard for drug quantification.
• Known Spiked Concentrations: Urine samples spiked with known, precise concentrations of benzoylecognine for evaluating qualitative accuracy (distinguishing positive/negative at specific cutoffs) and semiquantitative recovery.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic assay. The development of such assays involves formulation, optimization, and characterization, but not typically a "training set" in the AI sense.

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

Not applicable, as there is no "training set" for an AI algorithm described for this device. The assay itself relies on established biochemical principles and reagents, not on learning from data in the way an AI model does.

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