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Syntron's QuikStrip One Step Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip One Step Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites:

Syntron's QuikStrip One Step Benzodiazepine Test 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 up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 200 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The submission does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets). Instead, it presents the device's performance metrics from an internal study and a clinical trial. However, the FDA's acceptance of the 510(k) submission implies that these reported performances were deemed sufficient for substantial equivalence.",
    "Reported Device Performance (Internal Testing)": {
      "Relative Sensitivity (agreement within positive samples)": "1.000 (100%)",
      "Relative Specificity (agreement within negative samples)": "0.9740 (97.40%)",
      "Accuracy": "98.54%"
    },
    "Reported Device Performance (Clinical Trial)": {
      "Relative Sensitivity": "100%",
      "Relative Specificity": "95.42%",
      "Accuracy": "97.69%"
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Test Set Sample Size": "303 samples (for the clinical trial)",
    "Data Provenance": "The document does not specify the country of origin of the data. It mentions 'Clinical Trial' which typically implies prospective data collection, even if the samples themselves might be collected over time. No explicit statement about retrospective or prospective is given for the 303 samples, but 'clinical trial' strongly suggests prospective."
  },
  "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)": "The ground truth for the test set was established using Gas Chromatography/Mass Spectrophotometry (GC/MS) for all positive samples from either screening method. GC/MS is a laboratory analytical technique and typically does not involve 'experts' in the same way as medical imaging interpretation. The document does not specify the number or qualifications of personnel operating the GC/MS or interpreting its results, assuming standard laboratory protocols.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable in the conventional sense for this type of test. The ground truth (presence/absence of benzodiazepines above a certain cutoff) was determined by GC/MS, an objective analytical method. There's no indication of multiple readers or an adjudication process for the GC/MS results themselves.",
  "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 a standalone diagnostic test (QuikStrip) and not an AI-assisted interpretation tool for human readers. There is no mention of a human-in-the-loop component or a MRMC study.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, standalone performance was done. The QuikStrip One Step Benzodiazepine Test is a qualitative immunoassay designed to provide a direct visual result (presence or absence of a color band) without human interpretation beyond reading the band. The presented sensitivity, specificity, and accuracy are for the device's performance on its own.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth was established by Gas Chromatography/Mass Spectrophotometry (GC/MS). This is an objective analytical method considered the 'gold standard' for confirming the presence and concentration of drugs and their metabolites.",
  "8. The sample size for the training set": "The document does not explicitly state a 'training set' sample size. It refers to 'in-house testing' and a 'clinical trial'. For the performance evaluation, 303 samples were used in the clinical trial. The device mechanism (competitive binding immunoassay) is not typically 'trained' in the same way a machine learning algorithm is.",
  "9. How the ground truth for the training set was established": "As there is no explicitly defined 'training set' for a machine learning model, this question is not directly applicable. For the samples used in the performance evaluation (in-house and clinical trial), the ground truth for benzodiazepine presence and concentration was established by GC/MS."
}

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Syntron's QuikPac II One Step Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites.

Syntron's QuikPac II One Step Benzodiazepine Test 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 labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 200 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for accuracy, sensitivity, or specificity that the device had to meet. Instead, it presents the results of studies and implies that these results were deemed acceptable for substantial equivalence. The predicate device (Syva EMIT® II) is used as a comparator, and GC/MS is used as the gold standard for confirmation.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • In-house testing: Not explicitly stated, but the performance metrics (1.000 agreement for positive, 0.9740 for negative, 98.54% accuracy) were derived from testing against "samples documented to be positive by GC/MS(200)". The number of false positives (2) is mentioned for the in-house testing.
  • Clinical Trial: 303 samples.
• Data Provenance: The document does not explicitly state the country of origin.
  • In-house testing: Performed by Syntron Bioresearch, Inc. (the sponsor).
  • Clinical Trial: The samples were presumably collected as part of a clinical trial, implying prospective data collection, though not explicitly stated as such. It mentions "The testing performed by both the sponsor and the Clinical Trial site." This suggests some clinical trial data.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth was established by laboratory methods, not by human expert interpretation of images or other subjective data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was established through Gas Chromatography/Mass Spectrophotometry (GC/MS) at a specific cutoff (200 ng/ml), which is a definitive laboratory technique, not requiring human adjudication of differing interpretations.

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

• MRMC Study: No. This is a diagnostic device for substance detection in urine, not an imaging device that requires human interpretation or assistance. Therefore, an MRMC study is not relevant.
• Effect size of human readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes. The "QuikPac II One Step Benzodiazepine Test" is a standalone device. Its performance metrics (agreement, accuracy) were measured directly against a comparator (EMIT® II) and a confirmatory gold standard (GC/MS). The results reported are the standalone performance of the device. There is no human-in-the-loop component for the device's operation or interpretation of its direct output (color band).

7. Type of Ground Truth Used

• Type of Ground Truth: Chemical analysis and confirmed presence/absence of benzodiazepines. Specifically, Gas Chromatography/Mass Spectrophotometry (GC/MS) at a cutoff level of 200 ng/ml was used as the definitive method to establish the true presence or absence of the drug and its metabolites.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not provide information about a separate "training set" or its size. This type of diagnostic device (immunoassay) is typically developed and validated using known samples rather than machine learning algorithms requiring a distinct training phase. The "in-house testing" and "clinical trial" refer to the validation/testing of the final device.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as a distinct training set is not mentioned for this type of device. The development process likely involved using samples of known benzodiazepine concentration (established by methods like GC/MS) to calibrate the assay's sensitivity and specificity, but these wouldn't typically be referred to as a "training set" in the context of AI/ML. The "in-house testing" used "samples documented to be positive by GC/MS(200)."

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TCPI's One Step™ Urine Drug of Abuse Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.

TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test 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 up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the cutoff level of 200 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Since this refers to a 510(k) submission for a laboratory test, the term "device" refers to the "One Step™ Urine Drug of Abuse Barbiturate Test." The "algorithm" is the test itself, which is a qualitative competitive binding immunoassay.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state quantitative acceptance criteria prior to reporting results (e.g., "sensitivity must be >95%"). Instead, it presents the results as evidence of performance compared to established methods.

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

• Test Set Sample Size:
  • In-house testing: Not explicitly stated, but performed against Syva EMIT® II on an unspecified number of "samples documented to be positive by GC/MS."
  • Clinical Trial: 296 samples.
• Data Provenance: The document does not specify the country of origin. It indicates the data is retrospective as the samples were collected and then tested. The samples were "documented to be positive by GC/MS" (for in-house testing) or "All positive samples by either screening method were confirmed by GC/MS" (for the clinical trial), implying these were pre-existing samples.

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

There were no human "experts" establishing the ground truth in the traditional sense of medical image interpretation (e.g., radiologists). The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemistry technique considered the "gold standard" for drug confirmation. Therefore, the "qualification" of the expert is the GC/MS instrument and the analytical chemists operating it.

4. Adjudication Method for the Test Set

Not applicable in the human expert sense. For the clinical trial, any sample that was positive by either the One Step™ test or the predicate screening method (Syva EMIT® II) was confirmed by GC/MS. This acts as a definitive adjudicator for discrepancies or initial positives.

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, an MRMC study was not done. This device is an in-vitro diagnostic test (a chemical assay), not an AI-powered diagnostic imaging tool that would typically involve human readers (like radiologists) interpreting results with or without AI assistance. The "reader" is the test itself, which provides a qualitative "positive" or "negative" result.

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

Yes, the performance reported for the "One Step™ Urine Drug of Abuse: Barbiturate Test" is its standalone performance. This device is a rapid, qualitative immunoassay that produces a visual result (color band absence/presence), effectively acting as an "algorithm" (chemical reaction yielding a result) without direct human interpretation beyond reading the positive/negative indicator. Humans don't "interpret" the raw chemical reaction; they observe the final, designed output.

7. The Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) confirmation. For the in-house testing, it was also compared against the Syva EMIT® II assay as a predicate, with GC/MS as a confirmatory "ground truth" for those initial positives.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This is a chemical immunoassay, not an AI/ML model that undergoes a training phase with a distinct dataset. The development and optimization of the assay would involve various experiments, but these are not typically referred to as a "training set" in this context.

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

As explained above, there isn't a "training set" in the AI/ML sense for this device. The development of the assay would have been based on established chemical principles for antibody-antigen binding and optimized for specificity and sensitivity to barbiturates, calibrated against known concentrations of barbiturates, likely using GC/MS or other established analytical methods to confirm concentrations of these known samples.

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Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 150 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.

Syntron's QuikPac II One Step Cocaine Test 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 labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 150 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here's a breakdown of the acceptance criteria and study details for the QuikPac II One Step Cocaine Test based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, and accuracy. Instead, it presents the calculated performance against a commercial EIA test, with GC/MS confirmation for positive samples. We can infer that the reported values met the internal standards for the device to be submitted.

Note: The document also mentions "In-house testing" results (sensitivity 1.000, specificity 0.9839, accuracy 99.03%) when tested against a commercial EIA and "samples documented to be positive by GC/MS." However, the clinical trial data are generally considered more robust for regulatory submission, so the clinical trial results are presented here.

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

• Sample Size: 304 samples
• Data Provenance: Not explicitly stated, but the submission is from Syntron Bioresearch, Inc. in Carlsbad, California, suggesting the study was conducted in the United States. The study is a prospective clinical trial as distinct from "in-house testing".

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth was established by comparison to a commercial EIA test, with positive results confirmed by GC/MS. This suggests the experts involved were likely laboratory personnel or clinicians interpreting the results of these established methods.

4. Adjudication Method (for the test set)

• Adjudication Method: The primary comparison was against a commercial EIA test. For all positive samples by either screening method (QuikPac II or EIA), confirmation was done by GC/MS. This acts as a definitive adjudicator for positive results. For negative results where both screening methods agreed, no further adjudication (like GC/MS) is mentioned, implying agreement between the two screening methods was sufficient for negative calls.

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

• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This device is a rapid diagnostic test, not an imaging analysis device where multiple human readers would typically be involved in interpreting the output in the same way. The performance is assessed based on the device's output compared to a reference method.

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

• Yes, a standalone study was done. The clinical trial explicitly measures the performance of the "QuikPac II One Step Cocaine Test" itself in detecting cocaine and its metabolites in urine, comparing its results directly to established reference methods (commercial EIA and GC/MS). This is a standalone performance assessment.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for positive samples was established by gas chromatography/mass spectrophotometry (GC/MS), which is a highly accurate and definitive method for drug identification and quantification. For negative samples, the agreement of a commercial EIA test with the QuikPac II test served as an initial ground truth, implicitly supported by the absence of GC/MS confirmation if both were negative.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated in the provided text. The document focuses on the performance of the device in a clinical trial, which typically uses a separate, independent test set. In-house testing is mentioned, which may have contributed to development and refinement, but no specific number or details about a formal training set are given.

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

• Ground Truth for Training Set: Not explicitly stated. Given the "in-house testing" mention, it's reasonable to infer that similar methods (commercial EIA and GC/MS) were used to establish ground truth during the development and optimization phases, but no specific details are provided.

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Syntron's QuikStrip One Step Opiates assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 300 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikStrip One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.

Syntron's QuikStrip One Step Opiates Test 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 up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 300 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here's an analysis of the provided text regarding the QuikStrip One Step Opiates Test, structured to answer your questions:

Acceptance Criteria and Device Performance Study for QuikStrip One Step Opiates Test

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, and accuracy. Instead, the device performance is reported and implied to meet the necessary standards for substantial equivalence.

Note: The acceptance criteria are "implied" because the document states the results of the study (100% for all metrics) and then concludes that these results did not show any false positives or negatives, suggesting these perfect scores were sufficient for acceptance.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set:
  • Clinical Trial: 298 samples.
  • In-house testing: The exact number of samples for in-house testing is not specified, but it was conducted prior to the clinical trial. It states "samples documented to be positive by GC/MS," suggesting a subset of confirmed positive samples were used.
• Data Provenance: The document does not explicitly state the country of origin. Given the company is Syntron Bioresearch, Inc. (Carlsbad, California) and the consultant is also US-based, it is highly probable the data is of US origin. The study was prospective in the sense of a clinical trial, but the confirmation by GC/MS would have been performed after the initial screening.

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

The document does not directly mention the use of "experts" to establish ground truth in the traditional sense of medical image or diagnosis interpretation. Instead, the ground truth was established by laboratory methods.

• Number of Experts: Not applicable in this context.
• Qualifications of Experts: Not applicable, as the ground truth was based on laboratory assays, not expert interpretation.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used when human interpretation is involved, especially in cases of disagreement. Since the ground truth for this device (an immunoassay for opiates) was established by laboratory comparison to a predicate device (Syva EMIT® II) and then confirmed by a gold standard method (GC/MS), an "adjudication method" as you've defined it is not applicable. Any disagreements between the QuikStrip and EMIT II would have been resolved by GC/MS.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that are interpreted by human readers (e.g., radiologists, pathologists) to assess how human performance is affected by the device (e.g., AI assistance). The QuikStrip test is a rapid, qualitative immunoassay that provides a direct result (visual color band), not requiring human interpretation in a way that would lend itself to an MRMC study.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire study described evaluates the QuikStrip device's performance (an "algorithm" in a broad sense, meaning the assay's biochemical mechanism) independently. Its results are compared to the predicate device (Syva EMIT® II) and a gold standard (GC/MS) without human-in-the-loop performance influencing the primary metrics of sensitivity, specificity, and accuracy. The device itself produces the qualitative result.

7. Type of Ground Truth Used

The ground truth for the test set was established using a hierarchical approach:

• Primary Comparison: Against the Syva EMIT® II assay (a legally marketed predicate device).
• Confirmation Standard (Gold Standard): All positive samples (by either screening method) were confirmed by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is considered the definitive gold standard for drug detection and quantification in forensic and clinical toxicology.

8. Sample Size for the Training Set

The document does not provide information regarding a distinct "training set" for the device. For a rapid immunoassay like the QuikStrip, the development process might involve initial R&D and optimization using various samples, but it's not typically structured with separate, formally defined "training," "validation," and "test" sets in the same way an AI/ML algorithm would be. The reported data relates to the final performance evaluation of the device.

9. How Ground Truth for the Training Set Was Established

As no distinct training set is identified, the method for establishing its ground truth is not mentioned in the provided text. If an implicit training was involved during product development, it would likely have relied on similar analytical methods (e.g., GC/MS or other established methods) to ensure the assay's reagents and design performed as intended during optimization.

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Syntron's QuikPac II One Step Opiate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiate in urine at the cutoff level of 300 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Opiate Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiate and its metabolites.

Syntron's QuikPac II One Step Opiate Test 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 labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 300 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here's an analysis of the provided text regarding the QuikPac II One Step Opiate Test, focusing on acceptance criteria and supporting study data:

Acceptance Criteria and Device Performance for QuikPac II One Step Opiate Test

The QuikPac II One Step Opiate Test is a rapid, qualitative, competitive binding immunoassay intended for the determination of Opiate in urine at a cutoff level of 300 ng/ml. The device's performance was evaluated through in-house testing and a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "Sensitivity must be >95%"). Instead, it presents the achieved performance. Based on the "Summary of Safety and Effectiveness," the implied acceptance criteria were likely perfect or near-perfect agreement with the predicate device (Emit II®) and confirmation by GC/MS.

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

• Sample Size (Clinical Trial): 298 samples.
• Data Provenance: The text refers to "in-house testing" and "a clinical trial" as well as an "independent clinical trial." It does not explicitly state the country of origin but given the submitting company (Syntron Bioresearch, Inc.) is in Carlsbad, California, and the FDA submission, it's highly likely the data is from within the United States. The studies appear to be retrospective, as samples were "documented to be positive by GC/MS" and then tested with the device and a predicate.

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 the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The ground truth appears to be established by comparison to Syva EMIT® II and confirmed by GC/MS.

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

No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (lateral flow immunoassay), not an image-based or interpretation-based diagnostic device that typically involves multiple human readers. The comparison was device-to-device (QuikPac II vs. Emit II®) with GC/MS confirmation.

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

Yes, the performance presented is for the device operating in a standalone manner. While the test is read visually, the performance metrics (sensitivity, specificity, accuracy) relate to the device's ability to correctly identify the presence or absence of opiates in comparison to reference methods, without considering a human reader's interpretive variability as a primary outcome. The context implies a direct, objective readout based on the presence or absence of a color band.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• Comparison to a predicate device: Syva EMIT® II.
• Confirmatory method: Gas Chromatography/Mass Spectrometry (GC/MS) for all positive samples from either screening method. GC/MS is considered a "gold standard" for drug confirmation.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The reported study appears to be the primary validation study, potentially serving as both internal evaluation and external validation.

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

Since a separate training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided. If the validation samples were also used for any iterative development, the ground truth would have been established as described in point 7.

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Syntron's QuikStrip One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the NIDA recommended cutoff of 150 mg/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.

Syntron's QuikStrip One Step Cocaine Test 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 up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody :antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 150 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here's a breakdown of the acceptance criteria and the study details for the QuikStrip One Step Cocaine Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state 'acceptance criteria' in a formal, numbered list. However, it implicitly uses agreement with a predicate device (Syva EMIT® II) and GC/MS confirmation as benchmarks for performance. I have constructed the "Acceptance Criteria" based on the reported performance that allowed the device to gain 510(k) clearance.

Note: The in-house testing showed slightly different results (sensitivity 1.000, specificity 0.9839, accuracy 99.03%). The table above uses the clinical trial results as they represent a more robust dataset.

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

• Sample Size for Test Set: 304 samples (for the clinical trial).
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved a clinical trial, suggesting prospective data collection, though details on the recruitment process are not provided. Given the nature of a 510(k) submission, it is assumed to be retrospective in terms of analyzing collected samples against existing predicate methods and reference methods.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • The primary ground truth for confirmation was GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical laboratory technique, not a human expert.
  • The comparison was primarily against the Syva EMIT® II predicate device, which is an automated immunoassay.

4. Adjudication Method for the Test Set

• Not applicable in the traditional sense for human-expert interpretation.
• Discrepancies between the QuikStrip and EMIT II® were resolved by GC/MS confirmation. Three specific discrepant samples were further analyzed, revealing adulteration that caused false positives in both screening methods.

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, an MRMC comparative effectiveness study was not done.
• This device is a rapid, qualitative immunoassay for drug screening, not an imaging or diagnostic device requiring human interpretation of complex outputs. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

• Yes, this was a standalone performance study. The QuikStrip One Step Cocaine Test itself is a rapid, self-contained test, and the reported performance metrics (sensitivity, specificity, accuracy) reflect the device's inherent capability to detect cocaine and its metabolites in urine without human "interpretation" beyond reading the color bands according to the instructions. The comparison was to another standalone testing method (EMIT II) and a definitive lab method (GC/MS).

7. The Type of Ground Truth Used

• The ultimate ground truth used for confirmation of positive samples was Gas Chromatography/Mass Spectrometry (GC/MS).
• For the study's initial comparison, the Syva EMIT® II was used as a comparative method, with GC/MS confirming discrepancies.

8. The Sample Size for the Training Set

• The document does not specify a separate training set size. The provided performance data (in-house and clinical trial) likely refer to validation or test sets, not a training set for a machine learning model. This device is a biochemical immunoassay, not an AI/ML algorithm that requires a distinct training phase.

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

• Not applicable, as this device is not an AI/ML algorithm requiring a training set with established ground truth in the conventional sense. The "ground truth" for the development of such assays typically involves known concentrations of analytes and cross-reactants, and then extensive validation against reference methods like GC/MS. The document refers to "in-house testing" which would have been part of the development and initial validation process, where samples with known cocaine status (often confirmed by GC/MS) would be used.

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Syntron's QuikStrip One Step Methamphetamine assay is a rapid, qualitative, competitive binding immunoassay for the determination of methamphetamine in urine. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GCMS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's Quikstrip One Step Methamphetamine Test is not intended to monitor drug levels, but only screen urines for the presence of methamphetamine and its metabolites.

Syntron's QuikStrip One Step Methamphetamine Test 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 up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Acceptance Criteria and Study Details for QuikStrip One Step Methamphetamine Test

The QuikStrip One Step Methamphetamine Test is a qualitative, competitive binding immunoassay for the determination of methamphetamine in urine. Its intended use is for medical/forensic screening.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be implicitly set by the performance observed in the in-house testing and clinical trial, demonstrating high agreement with a reference method (Syva EMIT® II and GC/MS confirmation).

Note: The document does not explicitly state numerical acceptance criteria prior to presenting the results. The 100% and near 100% performance suggests that these high levels of agreement were deemed acceptable for the device's intended use as a screening tool.

2. Sample Size and Data Provenance

• Test Set (Clinical Trial): 305 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the description of "clinical trial" suggests prospective data collection in a clinical setting. The reference to "in-house testing" implies internal data for initial validation.

3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth

The ground truth was established by comparison to reference methods, not directly by human expert interpretation of the device's results.

• Number of Experts: Not applicable in the context of human interpretation of the device.
• Qualifications of Experts: Not applicable.
• Adjudication Method: Not applicable.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This device is an in-vitro diagnostic (IVD) test where the result is determined by the test strip itself (presence or absence of a color band), not by human interpretation or reading that would vary between individuals needing such a study.
• Effect size of AI vs. without AI assistance: Not applicable. The device is a standalone chemical/immunological test, not an AI-assisted diagnostic tool.

5. Standalone Performance Study

• Was a standalone study done? Yes. Both the "in-house testing" and the "clinical trial" represent standalone performance evaluations of the QuikStrip One Step Methamphetamine Test. The results presented in the table above reflect this standalone performance against reference methods.

6. Type of Ground Truth Used

• Type of Ground Truth:
  • Syva EMIT® II: This is a widely accepted immunoassay for drug screening, serving as an initial comparative method.
  • GC/MS (Gas Chromatography/Mass Spectrophotometry): This is the gold standard for confirmatory drug testing, offering highly accurate and specific identification and quantification of substances. All positive samples by either screening method (QuikStrip or EMIT) were confirmed by GC/MS. This indicates GC/MS was the ultimate ground truth for positive samples.

7. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" in the context of an algorithm or machine learning device. For an immunoassay, the "training" usually refers to the development and optimization of the reagents and assay parameters through iterative laboratory testing. The sample sizes mentioned (in-house and clinical trial) are for validation and performance assessment.

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

• As above, the concept of a "training set" ground truth for an immunoassay is not directly applicable in the same way as for an AI/ML algorithm. The assay's performance characteristics (e.g., cutoff concentration, cross-reactivity) are established during development and verified against known samples (either spiked samples or characterized clinical specimens) using reference methods like GC/MS.

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Syntron's QuikStrip One Step Amphetamine assay is a rapid, gualitative, competitive binding immunoassay for the determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS). Clinical chroilatograppyrinass opesional judgment should be applied to any considerations and professarioularly when preliminary positive drug of abuse teated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.

Syntron's QuikStrip One Step Amphetamine Test 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 up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here's a breakdown of the acceptance criteria and study details for the QuikStrip One Step Amphetamine Test, based on the provided 510(k) submission:

Acceptance Criteria and Device Performance

Note: The document phrasing "yielded a relative sensitivity or agreement within positive samples and relative specificity or agreement within negative samples of 1.00 and an accuracy of 100%" for in-house testing, and "a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100%" for the clinical trial, strongly suggests these high percentages were the de facto acceptance criteria.

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • In-house testing: Not explicitly stated, but performed against samples "documented to be positive by GC/MS."
  • Clinical Trial: 308 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Syntron Bioresearch, Inc. in Carlsbad, California, implying the study was likely conducted in the USA.
• Retrospective or Prospective: Not explicitly stated. Given the context of a 510(k) submission for an existing product type and comparison to a predicate device, it's possible it was retrospective, using archived samples or newly collected samples for the purpose of the submission.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not applicable/not specified. The ground truth was established by laboratory methods (GC/MS and EMIT II®), not by human experts interpreting results.
• Qualifications of Experts: N/A.

4. Adjudication Method (Test Set)

• Adjudication Method: Not applicable. Results were compared against a reference method (EMIT II®) and a confirmatory method (GC/MS). Discrepancies were resolved by GC/MS.

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

• Was an MRMC study done? No. This device is an in-vitro diagnostic (IVD) test where the result is read directly from the test strip (presence/absence of a color band). Human reader variability is not a primary concern for its performance evaluation in this context. The study focuses on comparing the device's output to other analytical methods.

6. Standalone Performance Study

• Was a standalone study done? Yes. The entire study describes the standalone performance of the QuikStrip One Step Amphetamine Test by comparing its results directly to established reference methods (EMIT II® and GC/MS) without human readers interpreting its output in combination with other information.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • Primary Comparison: Syva EMIT® II (Enzyme Multiplied Immunoassay Technique), which is itself a screening assay.
  • Confirmatory Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). All positive samples by either screening method (QuikStrip or EMIT II®) that were used to determine the true positive/negative status were confirmed by GC/MS. This is considered a gold standard for drug detection.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. As a lateral flow immunoassay, the device itself is not a machine learning algorithm that requires a "training set" in the computational sense. The "training" of the device is inherent in its chemical and biological formulation and manufacturing process, which would have been refined during development. The provided document only details the validation (test set) performance.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there isn't a "training set" in the context of a machine learning algorithm. For traditional IVDs, the "ground truth" during development involves iterative testing and refinement against known positive and negative samples, often using methods like GC/MS to characterize those samples. However, the specific details for the "training set" are not provided in this 510(k) summary.

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This device is intended for professional medical/forensic screening of urine.

The trade name of the device is QuikPac II One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR paragraph 862.3100. Syntron's QuikPac II One Step Amphetamine Test 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 labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here is the analysis of the provided text regarding the QuikPac II One Step Amphetamine Test:

Acceptance Criteria and Device Performance Study

The QuikPac II One Step Amphetamine Test is a device for the qualitative testing of urine for the presence of Amphetamine and its metabolites.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the document states the device yielded these percentages, suggesting these met the sponsor's internal thresholds for acceptable performance. The target detection level is 500 ng/ml.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 308 samples were used in the clinical trial.
• Data Provenance: The document does not explicitly state the country of origin. It describes "in-house testing" which often implies samples collected or processed by the manufacturer, followed by a "clinical trial." The nature of the samples being compared to Syva EMIT® II and GC/MS suggests they are human urine samples. It is a retrospective analysis in that the samples already had existing results from EMIT® II and were subsequently confirmed by GC/MS.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth for positive samples by either screening method (QuikPac II or EMIT® II) was confirmed by GC/MS, which is a laboratory analytical technique rather than a human expert interpretation. For the discrepant samples, GC/MS identified the specific interfering substances.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated as a formal multi-reader adjudication process. However, the document describes a clear hierarchical adjudication:
  1. Initial screening by QuikPac II and EMIT® II.
  2. Any sample positive by either screening method was then confirmed by GC/MS. This acts as the final arbiter for true positivity.
  3. Discrepant samples (positive by screening, negative by GC/MS) were further analyzed by GC/MS to identify interfering substances.

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

• Was an MRMC study done? No. This device is an in-vitro diagnostic test, not an imaging or interpretation system requiring human readers. Therefore, an MRMC study is not applicable.
• Effect size of human readers with/without AI assistance: Not applicable, as there are no human readers involved in the interpretation of this device's output.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes. The entire description of the clinical trial and in-house testing refers to the performance of the QuikPac II device itself, without human interpretation beyond reading the color bands (which is a direct output of the device's biochemical reaction). The device provides a direct positive or negative result.

7. Type of Ground Truth Used

• Type of Ground Truth: Gold Standard Laboratory Confirmation (GC/MS) for all positive samples and for identifying interfering substances in discrepant samples. GC/MS (Gas Chromatography/Mass Spectrometry) is a highly accurate and widely accepted method for confirming the presence and concentration of drugs and metabolites.

8. Sample Size for the Training Set

• Sample Size: Not explicitly stated as a separate training set. The "in-house testing" mentioned might have involved some form of internal development and testing, analogous to a training or validation set. However, the document only explicitly reports the results of the final "clinical trial" of 308 samples as the primary performance evaluation. It's common for IVD devices to have internal validation performed by the manufacturer, which would implicitly involve data for training/optimization, but this data is not detailed as a distinct "training set" with its size specified.

9. How Ground Truth for the Training Set was Established

• How Ground Truth was Established: Not explicitly detailed for a training set. However, based on the approach for the test set, it is highly probable that any internal development or optimization (analogous to training) would have also relied on GC/MS confirmation for ground truth where applicable. The statement "documented to be positive by GC/MS" for in-house testing samples supports this.

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