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Pan Probe Blotech (PPB), Inc. LiveSure™ Human Chorionic Gonadotropin (LiveSure™ hCG) Rapid Urinary Pregnancy Test Strip and Test Card Immunoassay Devices are in vitro diagnostic (IVD) qualitative screening lateral flow chromatographic immunoassays that are designed for rapid detection of placental hCG related to pregnancy at an expected value cut-off level of 20 mlU of hCG/ml of human urine. These LiveSure™ IVD immunoassay devices for urinary hCG pregnancy screening are neer non to give visual, qualitative results and are intended for professional use only. The PPB LiveSure™ hCG Test Strip and Test Card Devices are not intended for quantitative results, nor over-the-counter sales, but provide only professional use preliminary screening data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result, and to rule c: I any non-pregnancy diseases that can also result in elevated hCG. Clinical considerations and professional judgment should be applied to any test result, particularly when preliminary positive results are indicated.

The PPB LiveSure™ hCG Screen (i.e., LiveSure™ hCG) Test Strip and Test Card Devices are rapid qualitative lateral flow chromatographic IVD immunoassays and are intended for professional IVD use only. The Pan Probe Biotech LiveSure™ hCG Test Strip & Test Card Devices provide only preliminary analytical data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result. Each test device consists of a sample reaction unit, a pink colored colloidal gold conjugate unit pre-labeled with hGC-spec fic mouse-monoclonal antibody, and a chromatographic membrane was precoated with mouse-antialpha-hCG capture antibodies at the test band region and goat-antibody at the process control band region. During the test, the human urine specimen is allowed to react with hCG-specific mouse-monocloral antibodycolloid gold conjugate, which has been predried on the test component of each device. The mixture then moves chromatographically upward on the capillary action. For a pregnancy-positive specimen, gold conjugate complex binds to hCG at a level of 20 mlU/ml or greater, forming an antibody-antigen complex. This complex binds to hCG antibody as captured regents on the Test Region and produces a colored band when hCG concentration is equal to or greater than 20 mlU/ml. Absence of this colored band in the Test Region suggests a negative result Summarizing, negative urine will produce only one pink colored band in the control region, while positive urine will produce two pink colored bands, in both the control and test regions.

Here's an analysis of the provided text to extract the requested information concerning the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance

Study Details

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

• External Clinical Lab: 252 urine samples with clinically confirmed diagnoses.
  • Data Provenance: Retrospective (implied, as samples had "clinically confirmed diagnoses" prior to testing).
• In-house Testing: 136 urine samples with clinically confirmed diagnoses.
  • Data Provenance: Retrospective (implied, as samples had "clinically confirmed diagnoses" prior to testing).

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

• The document states "clinical lab data on diagnoses of pregnancy" and "clinically confirmed diagnoses." It also mentions testing performed "by several licensed technologists" at the external lab.
• Number of experts: At least "several licensed technologists" were involved in running tests and presumably contributing to or validating the "clinical lab data on diagnoses of pregnancy." The exact number of specialists (e.g., physicians, pathologists) who established the initial clinical diagnoses is not specified, but it implies medical professionals.
• Qualifications of experts: "Licensed technologists" for performing tests, and "medical professional" for clinical diagnosis. Specific specializations (e.g., radiologist, obstetrician) are not provided.

3. Adjudication method for the test set:

• The document implies that the ground truth was established by "clinically confirmed diagnoses" or "clinical lab data on diagnoses of pregnancy." The test results from the LiveSure™ hCG devices (and predicate devices) were then compared against this established clinical truth. There is no explicit mention of an adjudication method like 2+1 or 3+1 among multiple readers for the test results themselves, rather the device's accuracy was assessed against a pre-existing clinical ground truth.

4. 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 was not a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a rapid diagnostic immunoassay intended for professional use, but it does not involve human readers interpreting complex images or data assisted by AI. The comparison was device-to-device and device-to-clinical diagnosis.

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

• The LiveSure™ hCG device itself is a "standalone" rapid test strip/card. It produces a visual result (one or two pink bands). While a "professional" interprets the result, the device's performance metrics (sensitivity, specificity, accuracy) are reported for the device purely based on its output against the ground truth. It's an "algorithm only" in the sense that the chemical and physical reactions within the strip determine the outcome, without complex human interpretation of raw data. However, it requires a human to visually read the result. Therefore, it's a "device only" performance study.

6. The type of ground truth used:

• The ground truth was primarily based on expert clinical diagnoses of pregnancy.
• Additionally, quantitative Abbott's Axsym™ hCG ElA assay determinations served as a comparative ground truth for analytical performance, though the document explicitly states clinical pregnancy diagnoses superseded some EIA results (e.g., when EIA gave low negative values for clinically pregnant patients).

7. The sample size for the training set:

• The document does not specify a separate training set size. The described studies focus on testing the finished device against clinical samples. This type of immunoassay development typically involves extensive internal R&D, calibration, and optimization (which can be considered analogous to "training") with internal controls and characterized samples, but a distinct "training set" in the machine learning sense is not detailed in this submission summary.

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

• As no explicit training set is described in the provided summary, the method for establishing its ground truth is also not specified. Device development and calibration would have relied on characterized hCG samples and known positive/negative clinical samples, but these are not formally presented as a "training set" in this context.

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The Pan Probe Biotech (PPB), Inc LiveSure™ Methadone Screen Test Card & Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow competitive immuno-chromatographic urinary screening devices intended for detection of Methadone, its analogs and metabolites (collectively termed: screening at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Health Services Administration) cut-off level of 300 ng MED/ml of human urine. These PPB Mcharl Featur bervices Hand & Test Strip IVD immunoassay devices are designed for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for quanuative berealling) for presentativeSure™ Methadone Test Card & Test Strip devices provide only ovel ate commal (or o) creening data for use to aid in the diagnosis of drug abuse or over use. A premium y quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the result. NDTT and of micel considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Methadone Screen Test Card and Test Strip (i.e., LiveSure™ Methadone) which are rapid qualitative chromatographic IVD immunoassays, in which chemically labeled drug conjugate competes with any Methadone (MED) drugs, analogs or metabolites that may be in the conjugure comples for limited specific antibody binding sites. LiveSure™ Methadone devices prescient in test annual bas been pre-coated both with a Methadone (MED-)drug conjugate at the test band, and is followed by a built-in reference band with a second antibody as a system control band. A test colored anti-MED monoclonal antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of MED drugs, analogs or metabolites in urine, pink colored antibody-colloidal gold conjugates move chromatographically along with the urinary samples on the membrane by capillary ection. Antibody-colloidal gold conjugate binds to MED-drug conjugate, forming an antibody-antigen complex. This antibody-MED-drug conjugate appears as second visible pink colored band and captured reagent at the test region. Any MED present in a sample urine act as antigens, competing with MED-drug reagon at the test band region for limited MED-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary MED drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockage-binding process prevents attachment of anial colored antibody-colloidal gold conjugate at the MED-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of the presence of MED in urine samples. Thus, negative urine samples produce two pink colored bands, while positive urine samples produce only one pink colored band.

Here's an analysis of the provided text regarding the Pan Probe Biotech LiveSure™ Methadone Screen Test Card & Test Strip, structured according to your request:

Acceptance Criteria and Device Performance Study

The information provided describes the performance of the Pan Probe Biotech LiveSure™ Methadone Screen Test Card & Test Strip against a predicate device (EMIT® II) and a gold standard (GC/MS).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the GC/MS gold standard. The document doesn't explicitly state quantitative acceptance criteria in a formal "pass/fail" sense prior to presenting results, but rather demonstrates "substantial equivalence." However, we can infer the desired equivalency based on the reported performance.

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

• Sample Size for Test Set: 301 urine samples.
• Data Provenance: Independent clinical testing at an external reference laboratory. The country of origin is not explicitly stated, but the overall context of an FDA 510(k) submission for a US market suggests it was likely US-based or conducted under US regulatory standards. The study was prospective in the sense that the samples were tested against the new device (LiveSure™ Methadone), the predicate device (EMIT® II), and the confirmatory method (GC/MS) in the context of this evaluation.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). Therefore, the "experts" in this context are the trained laboratory personnel who perform and interpret GC/MS results. The number of such personnel is not specified, nor are their individual qualifications beyond the implication that they operate an "external reference laboratory" providing professional GC/MS quantitative results. GC/MS is considered the definitive method for drug confirmation.

4. Adjudication Method for the Test Set

There was no explicit "adjudication method" in the typical sense (e.g., 2+1 expert review). The GC/MS results served as the definitive quantitative ground truth against which all other results (LiveSure™ Methadone and EMIT® II) were compared. Any discrepancies between the rapid tests and GC/MS would be resolved by the GC/MS result being the accepted truth.

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 done. The LiveSure™ Methadone device is a "rapid qualitative chromatographic IVD immunoassay" designed for visual interpretation. While technicians would read the results, the study focuses on the device's accuracy against a gold standard, not on the variability or improvement in human reader performance with or without AI assistance. The device itself is not described as having an AI component to assist human readers.

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

Yes, the study primarily presents standalone performance of the device. The LiveSure™ Methadone device itself (the test card/strip) is tested as an algorithm for detecting methadone. Its "algorithm" is the biochemical reaction and visual readout. There is no complex digital algorithm or "human-in-the-loop" described beyond a technician visually interpreting the bands. The performance metrics (sensitivity, specificity, accuracy) are for the device's inherent ability to produce a correct result.

7. The Type of Ground Truth Used

The primary and definitive ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry) quantitative results. This is considered the "gold standard" for drug testing, providing objective, confirmatory, and quantitative data.

8. The Sample Size for the Training Set

The document does not explicitly state a training set sample size. The text describes "In-house testing" preceding the independent clinical testing, but it doesn't quantify this in-house testing as a separate "training set" in the machine learning sense. The device is a chemical immunoassay, not a machine learning algorithm that typically requires a large, separate training dataset. The development and internal validation of such a device involve optimization and testing, but these are generally considered part of the design process rather than a discrete "training set" for statistical model fitting.

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

Since a distinct "training set" is not detailed or quantified in the provided text as it would be for AI/ML, the method for establishing its ground truth is also not explicitly stated. However, given the nature of the device and the later clinical study, it's highly probable that "in-house testing" and development would have also relied on GC/MS or similar confirmatory methods to validate prototype performance and optimize the assay parameters (e.g., antibody concentrations, cutoff levels) against known positive and negative samples. The document states "under Good Laboratory Practices guidelines," implying rigorous internal validation processes.

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The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary rapid in Thiro didinestion of Phencyclidine, analogs and metabolites (collectively: PCP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental at the Nizes (national motified of 25 ng PCP/ml. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative visual, qualifative Screening, Tor prorocolonial ass "Chily" and PCP Screen Tests for PCP provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid qualitative competitive chromatographic IVD immunoassays, in which a chemically labeled drug obligate competes for limited specific antibody binding sites. LiveSure™ PCP devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is used is pre-labeled with specific monoclonal antibody from mouse directed against Indicator that is used to pro labora will opists of a membrane absorbent pad having a gold-probe-POr . Each rest othp and Toot ours control ontibody from mouse that is directed against PCP, Conjugate pre labolou with openits monecoated with a chemically modified PCP-conjugate as a and a chromatographio mombrare pro oats device has been layered with PCP-conjugate as a 11 capture reagent, while the Process Control region has been pre-coated with a first molledge and capture Teagent derived from goat. A pink colored anti-PCP monoclonal antibody-colloidal gold anabody reagent derivou from goal. A phe test strip. In the absence of PCP drug, analogs or conjugate paa is placed to sample, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the membrane by capillary action. Antibodycolloidal gold conjugate binds to PCP-drug conjugate, forming an antibody-antigen complex. This collondar gold conjugate appears as second visible pink colored band and captured reagent at the test region. Any PCP drug, analogs or metabolites that are present in sample urine act as the test region. Any PCP-drug conjugate at the test band region for limited PCP-antibody amigone, oomponing min-reloidal gold conjugate. When a sufficient concentration of urinary PCP blog, analogs or metabolites are present, these analytes block the limited antibody binding sites. This andy, and oge of measons of pink colored antibody-colloidal gold conjugate to the PCPblookugo binding provents d at the test band region. To serve as a procedural control, a pink colored arag control region will always appear regardless of the presence of PCP in urinary samples. band in a ountrol rogion will amays appear of an and while positive urine samples produce only one pink colored band.

Here's an analysis of the acceptance criteria and study detailed in the provided 510k submission for the LiveSure™ PHENECYCLINE (PCP) SCREEN TESTS:

Acceptance Criteria and Device Performance Study for LiveSure™ PHENECYCLINE (PCP) SCREEN TESTS

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on comparative performance against a predicate device (EMIT® II Assay) and a gold standard (GC/MS). While explicit "acceptance criteria" are not numerically stated in the provided text as pass/fail thresholds before the study, the reported performance against these benchmarks implicitly serves as the criteria for demonstrating substantial equivalence. The key performance metrics presented are agreement rates and accuracy.

Note: The submission states "295/297 (99.3%) accuracy was obtained with EMIT®II". This implies that EMIT® II was also evaluated against the GC/MS standard, allowing for a three-way comparison.

2. Sample Size and Data Provenance

• Test Set Sample Size: 297 urine samples.
• Data Provenance: The text states "independent clinical testing of 297 urine samples". The country of origin is not explicitly stated, but the submission is for a US FDA 510(k), suggesting the testing likely involved samples relevant to the US population or a US-based independent laboratory. The data is retrospective, as it refers to "samples" being tested, not a live, ongoing collection for the study.

3. Number and Qualifications of Experts for Ground Truth

The text refers to an "independent laboratory" that performed GC/MS quantitative analysis. It does not specify the "number of experts" or their specific "qualifications" (e.g., years of experience for toxicologists performing GC/MS). However, GC/MS is a highly specialized analytical technique, and it is assumed that personnel in such a laboratory are qualified experts in toxicology and analytical chemistry.

4. Adjudication Method for the Test Set

The adjudication method for the test set was GC/MS (Gas Chromatography/Mass Spectrometry), which is the established "preferred confirmatory method" according to NIDA and SAMHSA for drug screening. There is no mention of a human consensus or "2+1, 3+1" type adjudication process for the drug assay results themselves; rather, GC/MS serves as the definitive gold standard.

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

No, a MRMC comparative effectiveness study was not done. This submission describes a diagnostic device (an in vitro diagnostic test for PCP in urine) rather than an imaging or clinical decision support AI tool that human readers would interact with. The "readers" here are the individuals who interpret the test strips/cards, but the study focuses on the device's accuracy against a gold standard and a predicate, not on how the device assists human interpretation or improves human reader performance in a clinical setting.

6. Standalone Performance Study

Yes, a standalone performance study was done. The described "independent clinical testing of 297 urine samples against LiveSure™ Phencyclidine Screen Test Card and Test Strip devices" and the calculation of agreement rates and overall accuracy against GC/MS directly demonstrates the standalone performance of the LiveSure™ devices (both card and strip formats) without human-in-the-loop assistance influencing the device's output. The device itself yields a qualitative positive/negative result.

7. Type of Ground Truth Used

The type of ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry) quantitative results from an independent laboratory. This is a highly objective and recognized analytical gold standard for confirming the presence and quantity of substances like phencyclidine and its metabolites. Outcomes data or expert consensus (in the sense of clinical decision-making) were not the primary ground truth for the device's analytical performance.

8. Sample Size for the Training Set

The submission does not explicitly state the sample size for a training set. The described testing against 297 samples is presented as a validation or clinical evaluation set. For IVD devices, a "training set" in the context of machine learning (AI) is usually not applicable in the same way as for complex algorithms. However, in-house testing against a predicate device (EMIT® II Assay) is mentioned, which may have involved internal development and optimization, but the specific sample size for such internal work is not provided.

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

As no explicit "training set" with separate ground truth establishment is described in the provided text, this question cannot be fully answered. If there was an internal training or development phase, the methods for establishing ground truth for those samples are not detailed. It is highly probable that internal ground truth would have also relied on GC/MS or other established analytical methods to ensure the device was developed to accurately detect PCP.

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The Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip devices are qualitative lateral flow immuno-chromatographic competitive urinary rapid in vitro diagnostic (IVD) qualitative assays for detection of Benzodiazepines drugs, and metabolites (BZD) in human urine at the NIDA (National Institute of Drug Abuse) cut-off of 300 ng BZD/ml. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BZD drug/ml based upon calibration using the parent benzodiazepine/BZD drug, and using Oxazepam standards with a GC/MS method for the quantitation of all the Oxazepam standard and urine test solutions. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe Biotech LiveSure™ BZD Screen Tests for BZD provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA recommends gas chromatography/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip (i.e., LiveSure™ BZD Screen Tests) devices are rapid qualitative competitive chromatographic IVD immunoassays, in which a chemically labeled drug conjugate competes with any Benzodiazepine (BZD) drugs, analogs or metabolites that may be present in test urine samples for limited specific antibody binding sites. LiveSure™ Benzodiazepines devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is pre-labeled with specific monoclonal antibody from mouse directed against BZD drugs. The Test Strip and Test Card consists of a membrane absorbent pad having a gold-probe-conjugate pre-labeled with specific monoclonal antibody from mouse that is directed against BZD drugs, and a chromatographic membrane pre-coated with a chemically modified Benzodiazepine (Oxazepam) drug-conjugate as a capture reagent. The Test region of each device has been layered with a Benzodiazepine [Oxazepam] drug-conjugate as a 1st capture reagent, while the Process Control region has been pre-coated with a 2nd anti-mouse antibody reagent derived from goat. A pink colored anti-BZD monoconal antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of BZD drugs, analogs or metabolites in urine, pink colored antibody-colloidal gold conjugates move chromatographically along with the urinary samples on the membrane by capillary action. Antibody-colloidal gold conjugate binds to BZD-drug conjugate, forming an antibody-antigen complex. This antibody-BZD-drug conjugate appears as second visible pink colored band and captured reagent at the test region. Any BZD drugs, analogs or metabolites that are present in a sample urine act as antigens, competing with BZD-drug conjugate at the test band region for limited BZD-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary BZD drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate at the BZD-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of the presence of BZD in urine samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band.

Let's break down the acceptance criteria and study details for the LiveSure™ Benzodiazepines Screen Tests based on the provided 510k submission.

Acceptance Criteria and Device Performance

The provided document describes the performance of the LiveSure™ Benzodiazepines Screen Test Card and Test Strip devices compared to a predicate device (EMIT® II Assay) and a gold standard (GC/MS). While "acceptance criteria" isn't explicitly listed in a numbered format, the submission implies acceptance based on agreement rates and accuracy compared to these benchmarks, particularly around the NIDA/SAMHSA cut-off.

Here's a table summarizing the implied acceptance criteria and reported performance:

Study Details

The submission describes a clinical testing study that supports the device's performance.

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

   • Sample Size: 387 urine samples.
   • Data Provenance: The independent clinical testing was performed at an "external reference laboratory," suggesting the data is derived from a clinical setting, presumably in the country where the external reference laboratory operates (not explicitly stated, but typically assumed to be the US for a 510k submission). The data is retrospective, as existing urine samples were tested.

2. 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 of experts or their qualifications for establishing the ground truth. However, the ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical laboratory method, not a human expert interpretation.

3. Adjudication method for the test set:

   • Not applicable. The ground truth was established by quantitative GC/MS, an objective analytical method, not by expert consensus requiring adjudication.

4. 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 rapid qualitative immunoassay for drug screening, not an AI-assisted diagnostic device that would typically involve a multi-reader, multi-case study. The device is read visually by a professional, and its performance is compared to lab-based methods.

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

   • Yes, in a sense. The LiveSure™ devices are "standalone" in that they provide a qualitative visual result directly from the sample without further human interpretation beyond reading the positive/negative bands. Their performance was evaluated as such. The "human-in-the-loop" is the professional interpreting the visual bands.

6. The type of ground truth used:

   • GC/MS quantitative positive results and GC/MS negative results. GC/MS is widely considered the "gold standard" for confirmatory drug testing due to its high specificity and sensitivity.

7. The sample size for the training set:

   • The submission does not explicitly mention a separate "training set" or its size. The "in-house testing" against the EMIT® II Assay might represent an internal validation or development phase, but it's not detailed as a distinct training set for a machine learning model, which is not applicable here. The primary performance data relies on the 387 clinical samples.

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

   • Not applicable, as a distinct training set (in the context of machine learning) is not described. For any internal development or optimization, the ground truth would likely also be established using GC/MS or similar validated methods, but this is not specified.

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The Pan Probe Biotech LiveSure™ Barbiturates Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for the detection of Barbiturates (e.g., Amobarbital, Butalbital, Pentobarbital, Secobarbital, Phenobarbital, Phenobarbital, etc.), analogs and metabolites (collectively termed: BAR) in human urine at the NIDA (National Institute on Drug Abuse) modified (Substance Abuse and Mental Health Services Administration) cut-off level of 300 ng BAR/M. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BAR drug/ml based upon calibration using Secobarbital as a prototype Barbiturate/BAR drug, and ng BRK drugmit bagod upen vith a GCMS method for the quantitation of all the Secobarbital standard and urine test solutions. These IVD Tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe Biotech LiveSure™ BAR Screen Tests for BAR provide only preliminary analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. Both NIDA and SAMHSA have established gas chromatography/mass spectrometry (GC/MS) as a preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Barbiturates Screen Test Card and Test Strips (i.e., LiveSure™ Barbiturates) devices are rapid qualitative competitive chromatographic IVD immunoassays, in which chemically labeled drug conjugate competes with any Barbiturate (BAR) drugs, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Barbiturates devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is used is pre-labeled with specific monoclonal antibody from mouse directed against BAR. Each Test Strip and Test Card consists of a membrane absorbent pad having a gold-probe-conjugate pre-labeled with specific monoclonal antibody from mouse that is directed against BAR, and a chromatographic membrane precoated with a chemically modified Barbiturate [Secobarbital] drug-conjugate as a capture reagent. The Test region of each device has been layered with a Barbiturate [Secobarbital] drug-conjugate as a 1" capture region of dail the Process Control region has been pre-coated with a 200 anti-mouse antibody reagent derived from goat. A pink colored antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of BAR drugs, analogs or metabolites in urine, pink colored antibodycolloidal gold conjugates move chromatographically along with a urinary sample on the membrane by capillary action. Antibody-colloidal gold conjugate binds to BAR-drug conjugate, forming an antibodyantigen complex. This antibody-BAR-drug conjugate appears as a second visible pink colored band and as a captured reagent at the test region. Any BAR drugs, analogs or metabolites that are present in a sample urine act as antigens, competing with BAR-drug conjugate at the test band region for limited BAR-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary BAR drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockagebinding prevents attachment of pink colored antibody-colloidal gold conjugate at the BAR-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of presence of BAR in urine samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples only one pink colored band.

Here's a breakdown of the acceptance criteria and study details for the LiveSure™ BARBITURATES SCREEN TESTS, based on the provided 510(k) submission:

Acceptance Criteria and Device Performance Study

The primary study performed was a clinical evaluation comparing the LiveSure™ Barbiturates Screen Test Card and Test Strip devices against a predicate device (EMIT® II Assay) and a confirmatory method (GC/MS).

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly define "acceptance criteria" as a separate, pre-specified table with target values. Instead, the study results are presented as evidence of equivalency and accuracy. Based on the "Summary Statement of Safety and Effectiveness," the implied acceptance criteria are high agreement percentages with GC/MS for both positive and negative results, and equivalency to the predicate EMIT® II Assay.

Note: The phrasing "essentially showing equivalency" and the high agreement percentages suggest an implicit acceptance of very strong correlation and accuracy compared to the gold standard and predicate.

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

• Sample Size: 335 urine samples.
• Data Provenance: The submission does not explicitly state the country of origin. It indicates "independent clinical testing...at an external reference laboratory." It is a prospective study as it involves collecting and testing samples for comparison.

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

• The study used GC/MS (Gas Chromatography/Mass Spectrometry) as the confirmatory method for establishing the ground truth for barbiturates presence and concentration. GC/MS is an analytical chemistry technique, not a human expert. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) does not directly apply here. Instead, it relies on the established accuracy and reliability of the GC/MS method.
• The qualifications of the personnel operating the GC/MS are not specified, but it would typically be conducted by trained laboratory technicians or chemists in a certified laboratory setting.

4. Adjudication Method for the Test Set

• Adjudication, as in multiple human readers resolving discrepancies, is not applicable in this context. The LiveSure™ devices provide a visual qualitative result (presence or absence of a band), and the GC/MS provides a quantitative, definitive result. Discrepancies would be resolved by the GC/MS result being the higher standard.

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

• No, an MRMC comparative effectiveness study was not done. This type of study typically applies to imaging diagnostics where multiple human readers interpret results, and the AI's impact on their performance is measured.
• This submission describes a standalone performance study of an in-vitro diagnostic (IVD) device, compared to a predicate and a gold standard.

6. If a Standalone Performance Study was done

• Yes, a standalone performance study was done. The results reported (e.g., "LiveSure™ Barbiturates Test Card and Test Strip gave overall accuracy results of 335/335 (100%) and 334/335 (99.7%), respectively, versus GC/MS quantitative BAR data") directly reflect the algorithm's (or device's) own performance in identifying barbiturates in urine samples without human interpretation of the device's output. The device itself produces a visual result which is then read.

7. The Type of Ground Truth Used

• The primary ground truth used was GC/MS quantitative data. This is considered a highly reliable and definitive analytical method for drug identification and quantification in toxicology. The submission explicitly states, "Both NIDA and SAMHSA have established gas chromatography/mass spectrometry (GC/MS) as a preferred confirmatory method."

8. The Sample Size for the Training Set

• The submission does not explicitly state a separate training set sample size. This is common for this type of IVD device where the "training" primarily involves internal development and optimization of the immunoassay components (antibodies, conjugates, cut-off levels) to achieve desired sensitivity and specificity.
• The "in-house testing of LiveSure™ Barbiturates Screen Test Strip devices against EMIT® II Assay" mentioned could be interpreted as part of the development/internal validation process that predates the formal clinical study, but it's not delineated as a distinct "training set" in the context of machine learning.

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

• Since a distinct "training set" is not detailed, the method for establishing its ground truth is also not explicitly described. However, given the context, any internal development or optimization (analogous to 'training') would likely have used:
  • Known spiked samples: Urine samples with precisely known concentrations of barbiturates (e.g., using Secobarbital as a prototype, as mentioned for calibration).
  • Reference methods: Comparison against established laboratory methods, potentially including early GC/MS analyses or other validated techniques, to ensure the device's performance aligned with expected results during development. The mention of using "Secobarbital as a prototype Barbiturate/BAR drug, and with a GCMS method for the quantitation of all the Secobarbital standard and urine test solutions" points to how the calibration and development (training) would have leveraged GC/MS for accuracy.

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The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic urinary assays for detection of D-Amphetamine (AMP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1000 ng AMP/ml. These tests are intended for visual, qualitative IVD screening, and professional use only, and are not intended for quantitative results, nor for over the counter use. These screen tests for Amphetamine, analogs and metabolites provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA recommend gas chromatography/mass spectrometry (GCMS) as the preferred confirmed analytical method. Clinical Considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip (i.e., LiveSure™ Amphetamine Tests) are rapid qualitative chromatographic immunoassays in which a chemically labeled drug conjugate competes with Amphetamine (AMP) drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Amphetamine devices contain a unique membrane that has been pre-coated both with AMP drug conjugate at the test band, and have a built-in reference band with second antibody as a system control band. A pink colored anti-AMP monoclonal antibody-colloidal gold conjugate pad is placed on the test strip. In the absence of AMP drug, analogs or metabolites in the test urine, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the capillary action. The antibody-colloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex. This complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When AMP is present in a test urine, that drug, analog or metabolite antigen competes with AMP conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of urinary AMP drug, analogs or metabolites is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Amphetamine drug conjugate zone located at the LiveSure™ Amphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of AMP in samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip:

Acceptance Criteria and Device Performance Study

The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip (LiveSure™ Amphetamine Tests) are rapid qualitative chromatographic immunoassays for the detection of D-Amphetamine (AMP) in human urine. The study presented aims to demonstrate the substantial equivalence of these devices to a predicate device (EMIT® II Assay) and their performance against a gold standard (GC/MS).

1. Table of Acceptance Criteria and Reported Device Performance

While explicit acceptance criteria (e.g., "must achieve X% sensitivity") are not directly stated, the summary outlines performance comparisons to establish equivalency and superiority against a predicate device and a gold standard. The criteria are implicitly tied to achieving high agreement with the gold standard (GC/MS) and demonstrating comparable or better performance than the predicate (EMIT® II Assay).

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 257 urine samples were used for the independent clinical testing.
• Data Provenance: The study was conducted as "independent clinical testing" at an "external reference laboratory." The source of the urine samples (e.g., country of origin, demographics) is not specified. The study appears to be retrospective, as urine samples were tested against the LiveSure™ devices and the EMIT® II Assay, and then compared to GC/MS results, implying existing samples.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention the number or qualifications of experts used to establish the ground truth. However, the ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly reliable and recognized analytical method in clinical and forensic toxicology. The process for generating GC/MS results would typically involve laboratory technicians or chemists, but the decision on what constitutes a "positive" or "negative" result would be based on established NIDA/SAMHSA cut-off levels (1000 ng AMP/ml).

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparison is directly between the results of the LiveSure™ devices, the EMIT® II Assay, and the GC/MS ground truth. Since the devices provide qualitative results (presence/absence of a band) and GC/MS provides quantitative results which are then interpreted against a cut-off, it's unlikely an adjudication method for interpretations was used in the traditional sense.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The devices are described as "rapid qualitative chromatographic immunoassays" intended for "visual, qualitative (VD) screening." The output is a visual pink colored band or lack thereof, which implies a direct reading rather than complex human interpretation that would necessitate an MRMC study to assess human-in-the-loop performance or improvement with AI assistance. This is an immunoassay, not an AI-assisted diagnostic.

6. Standalone Performance

Yes, a standalone performance evaluation was conducted for the LiveSure™ Amphetamine Tests. The devices were tested independently against urine samples, and their results were compared to the GC/MS ground truth and the predicate EMIT® II Assay. The reported performance metrics (e.g., 99.2% overall accuracy vs GC/MS) reflect the standalone performance of the device without human interpretation variability being a primary focus.

7. Type of Ground Truth Used

The primary ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry) quantitative results. This method is explicitly identified as the "preferred confirmed analytical method" by NIDA and SAMHSA.

8. Sample Size for the Training Set

The document does not provide any information about a separate training set or its sample size. The description focuses on a single "independent clinical testing" dataset of 257 samples. For these types of immunoassay devices, a distinct "training set" in the machine learning sense is typically not applicable, as the device operates based on chemical reactions rather than a trained algorithm. However, manufacturers would perform extensive in-house testing and development, which implicitly serves a similar purpose to "training" in refining the device's sensitivity and specificity.

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

Since no separate training set is mentioned in the context of this submission, the method for establishing its ground truth is also not provided. The development and validation of such immunoassays typically involve extensive internal testing against characterized samples, with ground truth established through established analytical methods like GC/MS.

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The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for the detection of Methamphetamine (MET) and its analogs or metabolites in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1,000 ng MET/ml. These tests are intended for visual, qualitative IVD screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. These screen tests for Methamphetamine, provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test and Test Strip (i.e., LiveSure™ Methamphetamine) are rapid qualitative competitive chromatographic immunoassays in which a chemically labeled drug conjugate competes with Methamphetamine drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Methamphetamine devices contain a unique membrane that has been pre-coated both with Methamphetamine drug conjugate at the test band, and have a builtin reference band with second antibody as a system control band. A pink colored anti-Methamphetamine monoclonal antibody-colloidal gold conjugate pad is placed on the right side of the test strip. In the absence of Methamphetamine drug, analogs or metabolites in the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the capillary action. The antibodycolloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When Methamphetamine is present in a test urine, that drug, analog or metabolite antigen competes with Methamphetamine conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of unnary Methamphetamine drug is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Methamphetamine drug conjugate zone located at the LiveSure™ Methamphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of Methamphetamine in samples. Thus, negative unne samples produces two pink colored bands, while positive urine samples produce only one pink colored band.

The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip are in vitro diagnostic devices intended for the qualitative detection of Methamphetamine, its analogs, or metabolites in urine samples.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative form (e.g., "sensitivity must be >X%"), but rather implied through a comparison with a predicate device (EMIT® II Assay) and a gold standard (GC/MS). The performance is presented as a comparison to these methods.

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

• Sample Size for Test Set: 300 urine samples.
• Data Provenance: The data was obtained from "independent clinical testing" conducted at an "external reference laboratory." The country of origin is not explicitly stated, but given the submission is to the U.S. FDA, it is likely that the study was conducted within the United States or at a facility that complies with U.S. regulatory standards. The study appears to be retrospective, as a set of 300 urine samples were tested against the new devices, the predicate, and GC/MS.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is a laboratory analytical method and does not involve human experts in the same way as an imaging study. Therefore, the concept of "number of experts" or their "qualifications" for establishing GC/MS ground truth is not applicable. The GC/MS results are considered the definitive, quantitative ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by GC/MS, which is an objective chemical analysis, not a subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in vitro diagnostic device for chemical analysis, not an imaging device or AI-assisted diagnostic tool that involves human readers interpreting results. The device itself provides a qualitative "positive" or "negative" indication.

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. The LiveSure™ Methamphetamine Screen Test Card and Test Strip are designed to provide a direct readout (bands appearing or not appearing), and their performance was assessed directly against reference methods (EMIT® II and GC/MS) without human interpretation affecting the device's output. While a human reads the results from the test strip, the "performance" here refers to the accuracy of the chemical reaction in producing the correct visual outcome.

7. The Type of Ground Truth Used

The primary and most robust ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results, which provided quantitative confirmation of Methamphetamine presence and concentration.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. This is an immunoassay device, not a software algorithm that undergoes a training phase with a dataset. The development and optimization of the immunoassay reagents and design would have involved internal testing and validation, but this is not typically referred to as a "training set" in the way it is for AI/ML.

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

As noted above, the concept of a "training set" with established ground truth is not directly applicable to this type of immunoassay device. The device's performance characteristics (e.g., antibody specificity, cut-off levels) would have been established through internal R&D using various methods and known concentrations of analytes and interferents, but not through a formal "training set" in the data science sense.

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Ask a specific question about this device

Ask a specific question about this device