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Syntron's QuikPac II One Step Opiates assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 2000 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 QuikPac II 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 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 2000 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 acceptance criteria and study detailed in the provided text for the QuikPac II One Step Opiate Test:

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size (Test Set): 829 samples were used in clinical trials.
• Data Provenance: The text does not explicitly state the country of origin. It conducted "in-house testing" and "clinical trials," and mentions "independent clinical trial." It does not specify whether the data was retrospective or prospective, though clinical trials typically imply prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

• The text does not explicitly state the number of experts used.
• Qualifications of Experts: Not specified. The reference methods (Syva EMIT® II and GC/MS) serve as the primary ground truth, which are laboratory methods rather than expert human interpretation in this context.

4. Adjudication Method for the Test Set

• None directly applicable. For this type of chemical assay, adjudication methods like 2+1 or 3+1 are not typically used for establishing ground truth. The ground truth was established by objective laboratory methods (Syva EMIT® II and GC/MS). The text states: "All positive samples by either screening method were confirmed by GC/MS." This implies a confirmatory approach rather than expert adjudication of the screening results.

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

• No, an MRMC study was not done. This device is a standalone diagnostic test for chemical analysis (drug detection), not an imaging or interpretive device that would involve human readers.

6. Standalone Performance Study

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The performance metrics (sensitivity, specificity, accuracy) are for the device itself when compared against established laboratory methods.

7. Type of Ground Truth Used

• Laboratory Reference Methods: The primary ground truth was established by:
  • Syva EMIT® II (Enzyme Multiplied Immunoassay Technique)
  • Gas Chromatography/Mass Spectrophotometry (GC/MS) – specifically used to confirm all positive samples from either screening method.

8. Sample Size for the Training Set

• Not specified. The document mentions "in-house testing" but does not detail a separate training set size. For this type of immunoassay, extensive "training set" data for algorithm development in the modern sense is less common; rather, the device is developed and optimized based on biochemical principles and then validated.

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

• Not specified as a distinct training set. The development and calibration would typically rely on known positive and negative samples, likely characterized by reference laboratory methods similar to those used for validation (e.g., GC/MS). The text focuses on the performance of the final device, implying that any internal development or "training" would have used similarly robust methods for ground truth if applicable.

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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 2000 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 2000 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 Opiates Test, based on the provided 510(k) submission:

Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state numerical "acceptance criteria" but rather presents the achieved performance. Based on the 100% agreement and accuracy reported, it can be inferred that these values met or exceeded the internal acceptance criteria set by the manufacturer.

Study Information

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 829 samples in clinical trials.
• Data Provenance: Not explicitly stated, but "In-house testing" and "Clinical trials" are mentioned. Given the sponsor is located in Carlsbad, California, it's highly probable the in-house testing was in the USA. The clinical trials' location is also not specified but likely within the USA. The data is retrospective, as it involves testing previously collected urine samples.

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

• The document does not explicitly state the number or qualifications of experts involved in establishing the ground truth. The ground truth was established by "Syva EMIT® II or GC/MS run at 2000 ng/ml" for screening, with all positive samples confirmed by GC/MS. This indicates a reliance on established laboratory methods rather than human expert interpretation of the test results themselves for ground truth.

4. Adjudication method for the test set:

• Not applicable in the traditional sense of human adjudication. The ground truth was established by comparison to other analytical methods (EMIT® II and GC/MS). All samples positive by either screening method were then confirmed by GC/MS. This acts as a definitive, objective confirmation rather than an adjudication between human readers.

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. This is a diagnostic device for qualitative testing of Opiates in urine, not an AI-powered image analysis tool or a device requiring human interpretation in a MRMC study.

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

• Yes, this is a standalone device. The QuikStrip One Step Opiates Test is a chromatographic absorbent device that produces a visible color band. Its performance is evaluated as a standalone test system compared to reference methods. While a human reads the final result (presence/absence of color band), the performance metrics (sensitivity, specificity, accuracy) relate to the device's inherent ability to detect the Opiates. The "algorithm" here is the biochemical reaction within the strip itself.

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

• Laboratory Reference Methods: The primary ground truth was established using
  • Syva EMIT® II (Enzyme Multiplied Immunoassay Technique)
  • Gas Chromatography/Mass Spectrophotometry (GC/MS)
  • All positive samples by either EMIT® II or the QuikStrip test were confirmed by GC/MS. GC/MS is generally considered the "gold standard" for drug confirmation in forensic and clinical toxicology.

8. The sample size for the training set:

• Not explicitly stated. The document mentions "In-house testing" yielding 1.000 sensitivity, specificity, and 100% accuracy, and then "clinical trials" with 829 samples. It's common for device development to involve internal testing and optimization (akin to a training/development phase) before larger clinical trials (test set), but the exact size of any such developmental "training set" isn't detailed.

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

• Similar to the test set, the ground truth for any "in-house testing" (which would serve as an internal training/development set) was established by comparison to Syva EMIT® II and confirmed by GC/MS for positive 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 300 ng/ml (NIDA screening cutoff is 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 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 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 a breakdown of the acceptance criteria and study information for the QuikPac II One Step Cocaine Test based on the provided text:

Acceptance Criteria and Device Performance

Note on Acceptance Criteria: The document primarily reports the device performance and then states that it "yielded" those results or that "the combined data yielded" them. The exact explicit acceptance criteria are not formally listed, but they are implied by the high performance metrics themselves, suggesting the device successfully met the sponsor's internal standards and what would be expected for a device of this type.

Study Information

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

• Sample Size: 318 samples (for the clinical trial).
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "in-house testing" and a "clinical trial." Given Syntron Bioresearch, Inc. is located in Carlsbad, California, it's reasonable to infer the "in-house" testing was done in the USA and the clinical trial likely also involved US-based samples, though this is not explicitly stated. The nature of the samples for the clinical trial is implied to be urine samples from individuals, presumably collected prospectively or retrospectively and then anonymized. The text does not specify if the clinical trial data was retrospective or prospective.

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

• The document does not mention the use of experts to establish the ground truth for the test set in the traditional sense of human review.
• Instead, the ground truth was primarily established through laboratory methods: "All positive samples by either screening method were confirmed by GC/MS."

3. Adjudication Method for the Test Set:

• The primary adjudication method involved GC/MS confirmation for all positive samples from either the QuikPac II or the commercial EIA test.
• For discrepant samples, the text notes an analysis of "2 discrepant samples" where "Two samples were positive by both GC/MS and QuikPac II, but negative for Cocaine by Emit II." This suggests further investigation and comparison with the definitive GC/MS result to understand the nature of discrepancies among the screening methods.

4. 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, qualitative, competitive binding immunoassay, which does not involve human "readers" interpreting results in the same way an imaging device or diagnostic tool typically would. The "reading" is a simple visual interpretation of color bands, and the focus is on the agreement with laboratory reference methods.

  • Effect Size of Human Readers: Not applicable since an MRCM study was not performed.

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

• Yes, the performance reported is essentially a "standalone" or "device-only" performance when compared to reference methods. While a human visually interprets the color bands, the device's inherent sensitivity, specificity, and accuracy are being evaluated against the gold standard (GC/MS) and a predicate device (commercial EIA). There's no "human-in-the-loop" AI component to evaluate.

6. The Type of Ground Truth Used:

• Gas Chromatography/Mass Spectrometry (GC/MS): This was the definitive ground truth for confirming the presence or absence of cocaine and its metabolites, especially for positive samples and discrepant results.
• Commercial EIA Test for Cocaine: This served as a comparative screening method against which the QuikPac II device's performance was initially measured. While not the absolute ground truth, it was used as a benchmark, with GC/MS as the ultimate arbiter for confirmation.

7. The Sample Size for the Training Set:

• The document does not provide information regarding a separate "training set" size. This type of immunoassay device is developed and validated through laboratory testing and clinical trials rather than through machine learning models that require distinct training and test sets.

8. How the Ground Truth for the Training Set was Established:

• Since there's no explicitly mentioned "training set" in the context of a machine learning model, this question is not applicable. The device's development would have involved extensive R&D and optimization based on known concentrations of cocaine and its metabolites, with performance verified against laboratory standards (likely including GC/MS) throughout the design and optimization phases, which could be considered an iterative development process rather than a formal "training set."

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Syntron's DrugCheck X Multidrug Screening Device (the X may be replaced by 2. 3. 4. 5. 6. 7. or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide 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 DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.

Syntron's DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) consists of two to eight (2-8) individual chromatographic absorbent devices 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 for each drug. 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, different for each drug, 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 specified by SAMHSA for GC/MS. 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. Each of the test strips in the holder functions independently and is read independently.

The provided text describes a 510(k) submission for the "QuikStrip DrugCheck X Multidrug Screening Device" by Syntron Bioresearch, Inc. This device is a strip holder for multiple immunoassay strips designed to detect drugs of abuse in urine.

Here's an analysis of the provided information against your requested criteria:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state specific acceptance criteria (e.g., a predefined sensitivity or specificity threshold). However, it implies the acceptance criterion is that the device's performance should not be significantly different from established methods like Emit II or GC/MS.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 565 clinical samples.
• Data Provenance: Clinical samples (prospective, as it's a "clinical trial"). The country of origin is not explicitly stated, but the company is located in Carlsbad, California, USA, suggesting the data is likely from the USA.

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 the ground truth.

4. Adjudication method for the test set

The document does not describe an adjudication method. It states that "All positive samples by either screening method were confirmed by GC/MS," implying GC/MS served as the definitive reference method, not an adjudicated consensus.

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

This is not applicable as the device is a diagnostic test kit for drugs of abuse, not an AI-assisted diagnostic tool that requires human reader interpretation in the context of an MRMC study.

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

This is a standalone diagnostic device. The results (color bands) are read directly from the strips without an intermediate algorithm or human-in-the-loop interpretation being evaluated in the customary sense of an AI/human reader study. The "reading" of the strip is a direct visual assessment.

7. The type of ground truth used

• For positive samples: Gas Chromatography/Mass Spectrophotometry (GC/MS) was used for confirmation. This is a highly accurate and widely accepted gold standard for drug detection.
• For negative samples: The document doesn't explicitly state how negative ground truth was established, but typically this would also involve GC/MS or a panel of known negative samples.

8. The sample size for the training set

The document does not mention a separate "training set" in the context of machine learning. This is a traditional immunoassay device, not an AI/ML-based system that would typically have a distinct training and test set. In-house testing for interference and inappropriate reactions would have been part of the development and initial validation, but not a "training set" as understood in AI studies.

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

Not applicable, as there is no mention of a training set as defined in AI/ML contexts. For the "in-house testing" mentioned, ground truth would have been established through controlled spiking of samples with known drug concentrations and confirmation with GC/MS.

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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 300 ng/ml by GC/MS. (NIDA screening cutoff is 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 indicatedf. 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 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 Cocaine Test, structured to address your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state acceptance criteria as numerical thresholds. However, the high performance metrics (near 100%) demonstrated in both in-house and clinical trials strongly imply that high accuracy, sensitivity, and specificity were the desired acceptance criteria for this screening device. The comparison against a gold standard (GC/MS) further reinforces this.

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

• Sample Size for Clinical Trial Test Set: 318 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is referred to as a "clinical trial," implying it's prospective, but this isn't explicitly stated either. The "in-house testing" would likely be retrospective or controlled laboratory settings.

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

This information is not provided in the document. The ground truth method (GC/MS) is mentioned, but not the number or qualifications of experts interpreting or validating those GC/MS results, or any subsequent adjudication.

4. Adjudication Method for the Test Set

This information is not provided in the document. The text states: "All positive samples by either screening method were confirmed by GC/MS." and "The results on the 2 discrepant samples clearly demonstrated similar errors by the Emitt II method. Two samples were positive by both GC/MS and QuikStrip, but negative for Cocaine by Emit II®." This indicates comparison to a gold standard and analysis of discrepent results, but not a formal adjudication process involving multiple human readers for consensus.

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 chemical detection, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, a standalone performance evaluation was done. The QuikStrip One Step Cocaine Test is itself a standalone device that provides a qualitative result (presence or absence of a color band, indicating positive or negative for cocaine). Its performance (sensitivity, specificity, accuracy) was measured directly against a gold standard (GC/MS) or a predicate device (Syva EMIT® II), indicating a standalone assessment of its output. There isn't a "human-in-the-loop" interpretation for the device itself; it produces a visual result.

7. The Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "compared against Syva EMIT® II on samples documented to be positive by GC/MS" and "All positive samples by either screening method were confirmed by GC/MS." GC/MS is considered a definitive confirmatory method for drug concentration.

8. The Sample Size for the Training Set

The document does not provide any information about a specific training set or its size. This device is a chemical immunoassay, not a machine learning model, so the concept of a "training set" in the context of AI/ML is not directly applicable. The "in-house testing" likely served a developmental and validation purpose, but a distinct "training set" as understood in AI is not mentioned.

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

As there's no mention of a traditional "training set" for an AI/ML model, this question is not applicable in the context of this device. The development process would have involved internal validation and optimization against known samples, likely with GC/MS confirmation, but this isn't presented as a distinct "training set" with established ground truth in the way a machine learning model would have.

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Syntron's QuikStrip DipScan X Multidrug Screening Device (the X is replaced by 2, 3, 4, 5, or 6) is a holder for up to six rapid, qualitative, competitive, binding immunoassay strips for the detection of drugs of abuse and their metabolites in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DipScan are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrometry (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 DipScan X Multidrug Screening Device is not intended to monitor drug levels, but only to screen for the presence of drugs of abuse and their metabolites.

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlsbad, California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a Strip Holder that will accommodate 2 to 6 of the company's cleared drugs of abuse strips for the qualitative detection of drugs of abuse and their metabolites in a quick, simple, easy to read, screening format. Test strips available for inclusion in the DipScan X also comprises Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

Syntron's QuikStrip DipScan X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, or 6) consists of two to six (2-6) individual test strips on which the drug or drug metabolites in the chromatographic absorbent device is immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up the support the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex, different for each drug, competes with immobilized antigen conjugate in the test zone and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS (Note the cutoff for opiates used in the opiate test strips was 300 ng/ml instead of the new cutoff of 2000 ng/ml for opiates and in the conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. Each of the test strips in the holder functions independently and is read independently. Test strips available for inclusion in the DipScan X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

Here's a breakdown of the acceptance criteria and study information for the QuikStrip DipScan X Multidrug Screening Device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to its ability to detect specific drugs of abuse or their metabolites in urine at SAMHSA (Substance Abuse and Mental Health Services Administration) designated GC/MS cutoff levels. The "reported device performance" is a general statement about the device's intended function rather than specific metrics in this document.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: The text states "In-house testing," suggesting the data was generated internally by Syntron Bioresearch, Inc. The country of origin is implicitly the USA, where Syntron Bioresearch is located (Carlsbad, California). The study is retrospective in the sense that the data was generated prior to the 510(k) submission, but it's not explicitly stated if it was a retrospective analysis of existing samples or prospective testing.

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

   • Not specified. The ground truth for cutoff levels is referenced to SAMHSA designated GC/MS cutoff levels, implying that these established external standards (likely from expert consensus or validated methods) serve as the ground truth.

3. Adjudication method for the test set:

   • Not applicable/specified. The device is a qualitative diagnostic test that directly produces a positive/negative result based on a chemical reaction. The "ground truth" reference to SAMHSA GC/MS cutoffs suggests a comparison against an objective, established standard rather than human adjudication of interpretive results.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC study was not done. The device is a "screening device" that provides a "quick, simple, easy to read, screening format" with a direct visual output (presence or absence of a magenta band). It is designed for individual use and interpretation, not for complex medical imaging interpretation or scenarios where multiple human readers might disagree and benefit from AI assistance. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

   • Yes, the device's basic "in-house testing" provides standalone performance. The device itself performs the detection without human interpretive input beyond reading the color band. The description of how the device functions (antibody-dye conjugate binding, competition with immobilized antigen conjugate, magenta band indication) is a description of its standalone mechanistic operation.

6. The type of ground truth used:

   • The primary ground truth referenced is SAMHSA designated GC/MS cutoff levels. This implies comparison to a highly accurate and standardized analytical method (Gas Chromatography/Mass Spectrometry), which is considered a gold standard for drug detection and quantification. The document mentions an exception for Opiates (300 ng/ml cutoff was used instead of a new cutoff), which suggests adherence to a specific, recognized standard.

7. The sample size for the training set:

   • Not specified. The provided text describes the device and its intended use, along with limited "in-house testing" results. There is no mention of a "training set" in the context of machine learning or AI, as this device appears to be a chemical immunoassay, not an AI-driven diagnostic.

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

   • Not applicable, as there is no mention of a "training set" or AI/machine learning aspects for this device. The device's mechanism is based on established immunochemical principles.

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BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.

BeSure Plus OneStep Ovulation Prediction test is a Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine. BeSure Plus OneStep Ovulation Prediction test is based on comparative data with BeSure OneStep Ovulation Predictor test, a qualitative test for the determination of Luteinizing hormone currently being marketed by Syntron Bioresearch, Inc.

The BeSure Plus OneStep Ovulation Prediction Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the urine specimen is added to the reaction device, the gold-sol-anti-B LH antibody conjugate binds to the LH that exists in the urine specimen forming an antibody-antigen complex. This complex then migrates to the positive reaction zone and a LH antibody that is immobilized there by forming an antibody-antibody dye conjugate sandwich, which produces a rose-pink color band. In the absence of LH, there is no rose-pink color band that appears in the positive reaction zone. The remaining dye continues to flow up the absorbent device by passing through the positive reaction zone. This produces a rose-pink color band in the control reaction zone as immobilized antibody captures the unbound dye conjugate, demonstrating that the reagents and device are functioning correctly. This working principle can also be applied for the BeSure OneStep Ovulation Prediction test.

Here's a breakdown of the acceptance criteria and study detailed in the provided text for the BeSure Plus OneStep Ovulation Prediction test:

1. Acceptance Criteria and Reported Device Performance

The provided document defines the acceptance criterion implicitly through the performance of the predicate device and the comparison to a quantitative lab assay. The device is considered acceptable if its performance correlates highly with a commercially available one-step ovulation test and accurately identifies an LH surge at or above 30 mIU/ml, aligning with a quantitative LH EIA test.

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

• Sample Size for Test Set: 100 consumers (patient urine samples).
• Data Provenance: The text does not explicitly state the country of origin. However, the manufacturer, Syntron Bioresearch, Inc., is based in Carlsbad, CA, USA, suggesting the data is likely from the United States. The study appears to be prospective in nature, as it involved "100 consumers using BeSure Plus OneStep Ovulation home test" and their urine being subsequently assayed by laboratory technicians.

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

The term "experts" isn't explicitly used for establishing ground truth from the perspective of interpreting results as an expert would for, say, an image. Instead, the ground truth was established by laboratory technicians using a quantitative reference method.

• Number of Experts/Technicians: Not specified as a quantity, but referred to in plural as "laboratory technicians."
• Qualifications: "trained laboratory technicians." While the specific years of experience or certifications are not provided, the "trained" designation implies they possess the necessary skills and knowledge to accurately perform and interpret the Syntron's Quantitative LH EIA test (K871602/A).

4. Adjudication Method for the Test Set

The adjudication method was essentially a comparison and confirmation process:

1. Initial user interpretation: 100 consumers used the BeSure Plus one-step test.
2. Independent commercial test interpretation: Laboratory technicians independently obtained results using "other commercially available onestep ovulation test" (implied to be the predicate device, K951538).
3. Quantitative confirmation (Ground Truth): Laboratory technicians then assayed the same patient's urine using Syntron's Quantitative LH EIA test (K871602/A) to determine the exact LH concentration. This quantitative assay served as the definitive ground truth for LH levels.

There's no explicit mention of an "X+Y" adjudication method, as the ground truth was derived from a quantitative chemical assay rather than subjective expert interpretation (e.g., of an image). The quantitative EIA test served as the objective measure against which both the consumer results and the independent commercial test results were compared.

Crucially, it notes: "In this study, the laboratory technicians did not know the outcome of the consumer's test results," indicating blinding was employed during the quantitative confirmation to prevent bias.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. This study involves a direct comparison of a new OTC device against a predicate device and a quantitative lab assay, focusing on the device's ability to detect an LH surge. The "AI" aspect is not applicable here as it's a simple, qualitative in-vitro diagnostic test.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm/device only without human-in-the-loop performance initially dictating the result interpretation.

The 99% correlation observed between the consumers' use of the BeSure Plus OneStep and the results obtained by lab technicians using another commercial test, followed by confirmation with a quantitative LH EIA test, demonstrates the standalone performance of the BeSure Plus OneStep device in detecting LH surges. The device's ability to produce a rose-pink band at ≥30 mIU/ml LH and no band at

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Syntron's QuikPac II One Step Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 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 Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

Syntron's QuikPac II One Step Phencyclidine (PCP) 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 25 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 information for the QuikPac II One Step Phencyclidine Test, based on the provided text:

Acceptance Criteria and Device Performance

Note: The reported performance metrics for the clinical trial (agreement within positive samples and agreement within negative samples) are equivalent to relative sensitivity and relative specificity, respectively. "Agreement within positive samples" of 100% means no false negatives relative to the comparator. "Agreement within negative samples" of 100% means no false positives relative to the comparator. The overall accuracy of 100% further supports these interpretations.

Study Details:

1. Sample size used for the test set and the data provenance:

   • In-house testing: 227 samples. Data provenance is not specified beyond "in-house testing" by Syntron Bioresearch, Inc. It's likely retrospective data collected from an internal or readily available sample set.
   • Clinical trial: 286 samples. Data provenance is not specified beyond stating it was a "clinical trial" and "the Clinical Trial site" was involved. It is implied to be prospective collection for the purpose of the trial. Country of origin is not mentioned.

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

   • This information is not provided for either the in-house testing or the clinical trial. The ground truth was established by comparison to the Syva EMIT® IIm device and confirmed by GC/MS. The expertise of those performing the EMIT II or GC/MS analysis is not detailed.

3. Adjudication method for the test set:

   • Not applicable in the traditional sense of human readers/experts adjudicating cases. The comparison was against objective reference methods (Syva EMIT® IIm and GC/MS). Discrepancies were resolved by GC/MS.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This device is an in-vitro diagnostic test, not an imaging or interpretive device that typically involves human readers.

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

   • Yes, this was a standalone performance study. The QuikPac II test is a rapid, qualitative immunoassay that provides a visible color band result. Its performance was evaluated directly without human interpretation influencing the test result itself, although a human is required to observe and record the presence or absence of the color band. The comparison methods (EMIT II and GC/MS) are also standalone laboratory tests.

6. The type of ground truth used:

   • The primary ground truth for initial comparison was the Syva EMIT® IIm.
   • For discrepancies and confirmation, Gas Chromatography/Mass Spectrophotometry (GC/MS) was used as the confirmatory gold standard. The text explicitly states, "All positive samples by either screening method were confirmed by GC/MScs."

7. The sample size for the training set:

   • This information is not explicitly provided. The described testing refers to verification and validation on "test sets" (in-house and clinical trial samples). As this is a chemical assay, rather than a machine learning algorithm, the concept of a "training set" for an algorithm's learning phase is not directly applicable. The device's formulation and manufacturing would have been developed and refined through R&D, but specific "training set" sizes are not reported in this context.

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

   • Not applicable / Not provided as per the explanation above regarding "training set". The development of the assay's reagents and mechanics would have relied on established biochemical principles and extensive internal testing against known concentration standards and spiked samples to achieve the desired cutoff and specificity, but this is not termed a "training set" in the context of an immunoassay.

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Syntron's QuikStrip One Step Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 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 Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

Syntron's QuikStrip One Step Phencyclidine (PCP) 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 25 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.

This question is about a medical device called the "QuikStrip One Step Phencyclidine (PCP) Test" and the study that demonstrates it meets its acceptance criteria.
Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document mentions "The combined data yielded a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100% when compared to Emit II® run at 25 ng/ml." While explicit "acceptance criteria" are not listed in a separate section, these reported performance values (100% for sensitivity, specificity, and accuracy) strongly imply that these were indeed the target acceptance criteria. The discussion of false positives and negatives further supports these implied criteria.

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

• Sample Size for Test Set: 286 samples (for the clinical trial).
• Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "clinical trial" which typically implies prospective data collection, but it's not explicitly stated as prospective versus retrospective. It was conducted by a "Clinical Trial site."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The reference methods, Syva EMIT® II and GC/MS, are laboratory tests, implying trained personnel would have performed and interpreted them, but their specific expert qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The primary reference standard for confirmation was GC/MS (Gas Chromatography/Mass Spectrometry) at a 25 ng/ml cutoff. For the initial screening, the device was compared to Syva EMIT® II. Any positive samples by either screening method were confirmed by GC/MS. This suggests GC/MS served as the definitive "ground truth" and likely adjudicated discrepancies, but a formal adjudication process (e.g., 2+1) is not detailed.

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, qualitative immunoassay for PCP. Its output is a presence/absence (positive/negative) result, not highly subjective imaging or diagnostic interpretation that would typically involve multiple human readers. The comparison was between the device's performance and a predicate device (EMIT II) and a confirmatory method (GC/MS).

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

• Yes, a standalone performance study was done. The described testing of "Syntron's QuikStrip One Step Phencyclidine (PCP) Test" involves the device itself generating a result (a magenta color band or absence thereof) which is then interpreted as positive or negative. The performance metrics (sensitivity, specificity, accuracy) are reported for the device's output compared to established reference methods, without explicitly mentioning a human reader's interpretation enhancing or altering the device's direct output. The device itself is designed to provide qualitative results.

7. The Type of Ground Truth Used

• Type of Ground Truth: The primary and definitive ground truth used for confirmation was GC/MS (Gas Chromatography/Mass Spectrometry), specifically at a cutoff of 25 ng/ml. This is an objective analytical chemistry method for identifying and quantifying substances. For initial comparison, Syva EMIT® II was also used as a reference.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated. The document describes "In-house testing" and "A clinical trial consisting of 286 samples." It's common for devices to undergo internal development and testing (which could constitute a training or development set), but the specific size and nature of such a set are not provided. The 286 samples are clearly described as part of the clinical trial for performance evaluation.

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

• How Ground Truth for Training Set Was Established: Not explicitly stated. If there was a distinct training set, the document doesn't detail how its ground truth was established. However, given that GC/MS was used for the clinical trial and "in-house testing," it is highly probable that GC/MS would have been used to establish ground truth for any internal development or training samples as well.

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Syntron's QuikPac II One Step Barbiturate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturate 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 QuikPac II One Step Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites,

Syntron's QuikPac II One Step 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 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 a breakdown of the acceptance criteria and study details for the QuikPac II One Step Barbiturate Test:

1. Acceptance Criteria and Reported Device Performance:

The document states "By non parametric testing the results are not significantly different from one another," suggesting that the performance against the predicate device (Emit II®) was considered acceptable.

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

• Sample Size: 307 samples
• Data Provenance: Not explicitly stated, but implies a clinical trial setting. The document mentions "A clinical trial consisting of 307 samples was run," suggesting prospective data collection. The country of origin is not specified.

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

• Number of Experts: Not explicitly stated how many experts were involved. The ground truth was established by instrumental analysis (GC/MS).
• Qualifications: Not applicable for establishing ground truth as it was based on GC/MS.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated as a formal adjudication process. The primary comparator was Syva EMIT® (200) II, with all positive samples by either screening method (QuikPac II or EMIT II®) then confirmed by GC/MS (200 ng/ml). This acts as a confirmatory "adjudication" for positive results.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a qualitative diagnostic test that provides a visual readout (color band), not an imaging-based interpretation requiring multiple human readers.

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

• Yes, this study is inherently a standalone performance evaluation of the device. The QuikPac II test is designed to provide a direct readout without human interpretation beyond observing the presence or absence of a color band, and then comparing that result to other methods. The performance metrics (sensitivity, specificity, accuracy) are for the device itself.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Gold standard instrumental analysis: Gas Chromatography/Mass Spectrophotometry (GC/MS) at a cutoff of 200 ng/ml.

8. The Sample Size for the Training Set:

• The document does not explicitly mention a separate "training set" or its size. In-house testing was performed, but the number of samples in this phase is not specified. For this type of diagnostic device, development often involves internal validation rather than distinct "training" and "test" sets in the machine learning sense. The 307 samples represent the clinical trial/test set.

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

• As a distinct training set is not explicitly mentioned, the method for establishing ground truth for any in-house testing (development/validation) would likely be similar to the clinical trial: comparison against a reference method (Syva EMIT®) and confirmation of true positives by GC/MS.

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