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Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine 25 ng/ml of Phencyclidine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the "Forsure One Step Multiple (Up to Six) Drug Screen Test Card":

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics. However, the implicit acceptance criteria are that the device is "substantially equivalent" to predicate devices (Monitect Multiple Drug Screen MOR2000/MET/THC/COC/PCP and GC/MS) for the qualitative determination of specific drugs at defined cut-off concentrations in human urine. The "reported device performance" is the claim of substantial equivalence.

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

The provided document does not report specific sample sizes for a test set used to evaluate the Forsure One Step Multiple Drug Screen Test Card. It describes the device and claims substantial equivalence to predicate devices and GC/MS, implying that performance data was collected to justify this claim, but the details of such a study (sample size, data provenance like country of origin, retrospective/prospective) are not included in this summary.

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

The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The ground truth for confirming results is stated to be Gas Chromatography/Mass Spectrometry (GC/MS).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. This type of device relies on a chemical "ground truth" (GC/MS) rather than expert consensus 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

This question is not applicable to the described device. The Forsure One Step Multiple Drug Screen Test Card is a qualitative immunoassay device, not an AI-assisted diagnostic tool for which MRMC comparative effectiveness studies with human readers would typically be conducted. There is no mention of AI or human-in-the-loop assistance.

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

This question is not applicable in the context of an immunoassay test with visual interpretation. The device's performance is inherently standalone in the sense that the test strip itself produces the result (presence/absence of a line), which is then visually interpreted. There is no complex algorithm involved in 'standalone' performance as understood in AI-driven diagnostics.

7. The Type of Ground Truth Used

The primary ground truth explicitly mentioned for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate analytical method used to identify and quantify substances in a sample, making it a robust reference standard for drug testing.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. As an immunoassay device, it does not involve machine learning or AI that would typically require a "training set" in the computational sense. The device's components and assays are developed based on chemical and biological principles, not statistical training data.

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

Since there is no "training set" in the context of machine learning, this question is not applicable. The underlying scientific principles and calibration of the immunoassay are established through chemical and biological validation, rather than a data-driven training process with established ground truth.

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The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cutoff concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.

The Accu-Stat™ Home Drug Test for Marijuana, Cocaine, Amphctamine, Methamphetamine, Opiates, and Phencyclidine, like other commercially available drug screening tests, qualitatively measures the presence or absence of THC, COC, AMP, mAMP, OPI, PCP and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and the other drugs being tested for, if below the cut-off levels stated above, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana, cocaine, or other listed drug conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above the 50 ng/ml because it will saturate all the binding sites of antimarijuana antibodies. The same holds true for cocaine and the other drugs if the level is above the cut-off. It will saturate all the binding sites of anticocaine (or other drug) antibodies and therefore the colored line will not form in the test region.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

The provided text describes a 510(k) premarket notification for the Accu-Stat™ Home Drug Test. It details the device's intended use and the basis for its substantial equivalence to predicate devices, but it does not contain a study or data proving the device meets specific acceptance criteria in the format requested.

The document discusses "consumer studies" that demonstrate "excellent overall performance in the hands of lay users" and states that "the data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests." However, it does not provide the specifics of these studies, such as sample size, methodology, or detailed results, nor does it define explicit acceptance criteria with corresponding performance metrics.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format (e.g., sensitivity, specificity thresholds) or present a table of device performance against such criteria. It generally claims "excellent overall performance."

The cut-off concentrations for the drugs are specified, which act as de facto performance targets:

• Marijuana: 50 ng/ml
• Cocaine: 300 ng/ml
• Amphetamine: 1000 ng/ml
• Methamphetamine: 1000 ng/ml
• Opiates: 2000 ng/ml
• Phencyclidine: 25 ng/ml

The operating principle described is that if the drug level is above the cut-off, a line will not form (positive result), and if below, a line will form (negative result).

Reported Device Performance:
The document states: "The consumer studies using the Accu-Stat™ Home Drug Test... demonstrates that the test exhibits excellent overall performance in the hands of lay users." No quantitative data like sensitivity, specificity, or accuracy percentages are provided to back this claim in the given text.

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

The document mentions "consumer studies" but does not specify the sample size, the country of origin of the data, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for any test sets. The tests are for OTC consumer use, and the "two-step process" includes "confirmatory testing of preliminary positive results" by a laboratory, implying the ground truth for positive cases would be lab-confirmed, but details on this are absent.

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

Not specified in the provided text. The "two-step process" implies an external lab confirmation for positive results, which serves as a form of adjudication for those specific results, but the method for the initial screening interpretations is not detailed.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a rapid chromatographic immunoassay, not an AI-based system. Therefore, the question about human readers improving with AI assistance is not applicable.

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

This is a qualitative immunoassay test, not an algorithm. Its performance is inherent in its chemical reaction. The "standalone" performance is essentially its ability to react correctly to drug levels. The primary "human-in-the-loop" aspect is the consumer's interpretation of the line, which the document claims is "excellent overall performance in the hands of lay users." However, no specific study data for this standalone performance is provided.

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

The ground truth implicitly used for positive results would be laboratory confirmatory testing. For negative results, it's the absence of the drug below the cut-off. The document states: "intended for over-the-counter (OTC) consumer use as the first step in a two-step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided."

8. The sample size for the training set

The document does not refer to a "training set" as this is not an AI/machine learning device.

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

Not applicable, as there is no "training set" for this type of device.

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The AMPH Flex® reagent cartridge used on the Dimension clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500 or 1000ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.

The AMPH method 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) 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 Dade Behring Dimension® AMPH method is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.

The provided document does not explicitly state acceptance criteria in a quantitative format as commonly seen for medical device performance. Instead, it presents performance data by comparing the Dimension® Urine Amphetamines/Methamphetamine Screen Flex® (AMPH Flex®) reagent cartridge against a predicate device (Syva® Emit® II Plus Amphetamine Assay) and a reference method (GC/MS) at three different cutoffs (300, 500, and 1000 ng/mL). The "acceptance criteria" are implied by the agreement rates shown in the comparison tables.

Here's an analysis of the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria (e.g., "must achieve >95% agreement") are not stated, the table below reflects the observed performance against the reference method (GC/MS). The implied acceptance is that the device demonstrates comparable or acceptable agreement with the gold standard (GC/MS).

Implied Acceptance Criteria and Reported Device Performance for AMPH Flex® Reagent Cartridge vs. GC/MS

Note on missing data: The tables for cutoffs 500 ng/mL and 1000 ng/mL comparing AMPH Flex® to GC/MS are significantly corrupted in the provided text, making it impossible to fully populate the performance metrics. For example, for the 500 ng/mL cutoff against GC/MS there's a row 0 | | | | | Amer | A ARA (C (C) (C) (C) AN ANNUAL (C) 21 | and the same and the state of the states | | - | ---------------------------------------------------------------------------- 8 ! . instead of proper counts. The 1000 ng/mL cutoff against GC/MS similarly has corrupted table data.

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

• Sample Size:
  • For 300 ng/mL cutoff: 129 native urine specimens
  • For 500 ng/mL cutoff: 129 native urine specimens
  • For 1000 ng/mL cutoff: 169 native urine specimens (with 129 having separate amphetamine and methamphetamine values suitable for SAMHSA confirmation guidelines)
• Data Provenance: The data consists of "native urine specimens." No country of origin is specified. The study is retrospective, as it analyzes existing urine specimens.

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

• The document does not explicitly state the number of experts or their qualifications for establishing the ground truth.
• The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). While GC/MS is a laboratory method, expert interpretation of GC/MS results (e.g., "Positives by GC/MS were determined by using the criteria...") is implied. However, the document does not detail the personnel or their qualifications involved in this interpretation.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method involving human reviewers for discrepancies between the AMPH Flex® result and the GC/MS result. Discrepant values are simply listed with their GC/MS and AMPH Flex® (and sometimes predicate device) readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with or 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 study effectively represents a standalone performance. The AMPH Flex® reagent cartridge on the Dimension® clinical chemistry system is an automated in-vitro diagnostic device. Its performance is evaluated directly against the reference method (GC/MS) without human interpretation affecting the device's analytical result. The results ("Positives" or "Negatives" by AMPH Flex®) are direct outputs of the automated system.

7. The Type of Ground Truth Used

• The ground truth used is Gas Chromatography/Mass Spectrometry (GC/MS), which is considered the preferred confirmatory method for amphetamines in urine. The criteria for defining a positive by GC/MS are explicitly stated for each cutoff level (e.g., "amphetamine plus methamphetamine > 300 ng/mL" for the 300 ng/mL cutoff). This can be classified as a definitive laboratory method (gold standard).

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set or its sample size. This type of regulatory submission (510(k)) for a laboratory diagnostic test typically focuses on validation data to demonstrate substantial equivalence, rather than detailing the internal development and training of a machine learning algorithm.

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

• As no information about a training set is provided, the method for establishing its ground truth is also not described.

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The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose.

The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites.

The Amphetamine/Methamphetamine assay 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) 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.

Amphetamine/Methamphetamine is an in vitro diagnostic assay for the qualitative analysis of amphetamine/methamphetamine in human urine. The assay is a homogeneous enzyme immunoassay with a 1,000 ng/mL cutoff. 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.

The Abbott Laboratories Amphetamine/Methamphetamine assay is a qualitative in vitro diagnostic assay used for the detection of amphetamine/methamphetamine in human urine.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion for this device is substantial equivalence to a legally marketed predicate device. The study explicitly states the goal of demonstrating similar performance characteristics.

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

• Test Set Size: The document does not explicitly state the total number of clinical specimens used for the comparative performance studies. It mentions that "The clinical specimens tested ranged from 826 to 1,994 ng/mL," which suggests a range of concentrations rather than a sample size. However, given the context of concordance tables, it can be inferred that a set of clinical specimens was used to compare the new assay against the predicate and GC/MS. The number of samples for each comparison is not provided.
• Data Provenance: Not specified in the provided text (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:

• Number of Experts: Not applicable, as the ground truth was established by either a predicate device or a confirmatory chemical method (GC/MS), not by human expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The comparisons were made directly to the predicate device's results and GC/MS results. There's no mention of a human adjudication process to resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No, there is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an in vitro diagnostic assay, meaning its performance is assessed against analytical methods rather than human reader interpretation. Therefore, quantifying improvement with AI vs. without AI assistance is not relevant in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study: Yes, the performance characteristics described (concordance, precision, limit of detection) represent the standalone performance of the Amphetamine/Methamphetamine assay (algorithm only). It does not involve a human in the loop for interpretation of the assay's direct output. The subsequent step for a preliminary positive result is confirmation by GC/MS, rather than human interpretation of the initial assay result.

7. Type of Ground Truth Used:

• Type of Ground Truth:
  • Predicate Device Results: For the primary substantial equivalence claim, the results from the Emit® II Monoclonal Amphetamine/Methamphetamine assay (K920507) were used as a comparative ground truth.
  • Confirmatory Method: For additional correlation, Gas Chromatography/Mass Spectrometry (GC/MS) was used as a superior analytical chemical method, considered the "preferred confirmatory method" and thus a more definitive ground truth.

8. Sample Size for the Training Set:

• The document does not provide information on the sample size for a training set. As this is a traditional immunoassay, it likely does not involve machine learning or AI models that require explicit training sets in the same way. The assay's performance is driven by its biochemical reagents and protocol.

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

• As there is no mention of a training set or a machine learning component, this information is not applicable. The assay's "training" would be through its development and optimization process in the lab, which is not detailed here.

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The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/ml cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. These reagents are packaged specifically for use on a variety of Olympus® analyzers.

The Emit® II Plus Monoclonal Amphetamine 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 modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

The provided text is a 510(k) summary for the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. It establishes the device's substantial equivalence to a predicate device and states its intended use. However, it does not include detailed acceptance criteria, a study demonstrating performance against those criteria, or the specific information requested in the prompt regarding sample sizes, ground truth establishment, or clinical study designs.

Therefore, most of the information requested cannot be extracted from this document. The document primarily focuses on regulatory approval based on equivalence rather than presenting a performance study with detailed acceptance criteria.

Here's what can be inferred or explicitly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity thresholds) nor report detailed performance metrics against such criteria. It states that the "assay performance characteristics" are the same as the predicate device, implying that the predicate device's performance would be the reference, but no specific numbers are given.

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

• Cannot be provided. The document does not describe a new performance study with a test set. The submission is based on the device being substantially equivalent to a predicate device, with minor changes primarily related to packaging and compatibility with different analyzers.

3. 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)

• Cannot be provided. No new test set is described, so no information on experts or ground truth establishment for such a set is present.

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

• Cannot be provided. No new test set or adjudication method is described.

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

• Cannot be provided. This device is an in-vitro diagnostic (IVD) assay for drug detection, not an AI-assisted diagnostic tool that would involve human readers interpreting results in a comparative effectiveness study.

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

• Cannot be provided. While an IVD assay functions "standalone" without human interpretation in the sense of a clinical reader, the document does not present results of a standalone performance study with specific metrics. It relies on the substantial equivalence to an existing device.

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

• Cannot be provided for a new study. For drug-of-abuse assays, the "ground truth" for confirming positive results typically involves more specific analytical methods like Gas Chromatography/Mass Spectrometry (GC/MS). The document mentions GC/MS as the preferred confirmatory method for preliminary positive results, implying how clinical ground truth would be established for patient samples, but not for a specific device validation study described in this document.

8. The sample size for the training set

• Not applicable/Cannot be provided. This is an enzyme immunoassay, not a machine learning model. There is no concept of a "training set" in the context of this device.

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

• Not applicable/Cannot be provided. As above, no training set.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence for a minor modification (packaging and analyzer compatibility) of an existing in-vitro diagnostic device. It does not describe or report the outcomes of a new performance study that would establish new acceptance criteria or detailed performance metrics.

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The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Monoclonal Amphetamine/Methamphetamine 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 Monoclonal Amphetamine/ Methamphetamine Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of amphetamines urine.

Here's the breakdown of the acceptance criteria and study information for the Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a standalone, in-vitro diagnostic assay and its performance testing to demonstrate substantial equivalence to a predicate device.

2. Sample Sizes used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not explicitly state the total number of samples (e.g., individual urine specimens) used in the comparative analysis, spiked sample recovery, or precision studies. It mentions "samples" and "specimens" without providing a specific count.
• Data Provenance: The studies were conducted using "human urine" and "negative human urine specimens" which were then spiked. The country of origin for the data is not specified, but the manufacturer is based in San Jose, CA, USA, suggesting the studies were likely conducted in the USA. The data is retrospective in the sense that real-world patient data was not prospectively collected for this specific device evaluation; rather, spiked samples and existing controls were used.

3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is an in-vitro diagnostic device that measures chemical concentrations. The "ground truth" for the test set was established by the known concentrations of spiked analytes in the samples, or by comparison to a predicate device, rather than through expert human interpretation.

4. Adjudication method for the test set:

• Not Applicable. As this is an assay measuring chemical concentrations, there is no human adjudication process involved in establishing the ground truth for the test set.

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 assay, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

• Yes. This entire evaluation focuses on the standalone performance of the assay (the chemical analysis device). It inherently operates without human-in-the-loop performance in the interpretation of the initial chemical reaction, providing a quantitative or qualitative result directly.

7. The type of ground truth used:

• The ground truth for most of the reported studies was based on:
  • Known concentrations of spiked analytes: For qualitative and semiquantitative spiked sample recovery, the ground truth was the precisely known amount of d-methamphetamine added to the urine samples.
  • Predicate device comparison: For the comparative analysis, the ground truth was the result obtained from the legally marketed Syva Emit® II Monoclonal Amphetamine/Methamphetamine Assay. This serves as a reference standard.
  • Defined cutoffs/controls: For precision, the ground truth was derived from the expected values of control materials and cutoff calibrators.

8. The sample size for the training set:

• Not Applicable. This is an enzyme immunoassay, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The assay's performance is based on its chemical and enzymatic reactions, not on being trained on a dataset.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

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Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine.

Reference Material for Amphetamine/Methamphetamine in Human Urine

The provided text is a 510(k) clearance letter from the FDA for a diagnostic reference material, not an AI device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI device meets these criteria.

The document discusses:

• The FDA's determination of substantial equivalence for a "Reference Material for Amphetamine/Methamphetamine in Human Urine."
• Regulatory classifications and general controls for medical devices.
• Requirements under CLIA-88 (Clinical Laboratory Improvement Amendments of 1988).
• Contact information for various FDA departments.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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