Search Results

The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after symptom onset or after potential exposure as a sample collected earlier may return a negative result. If testing is needed after day 8 and results are negative, testing must be repeated one week later. Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.

Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory results. Zika IgM levels over the course of illness are not well characterized. Zika IgM levels are variable during the course of infection and may be detectable near day 4 post-onset of symptoms and persist up to approximately 12 weeks following initial infection.

Negative results may be seen in specimens collected before day four post-onset of symptoms or after the window of detectable IgM closes and therefore do not preclude the possibility of Zika virus infection, past or present.

The Chembio DPP Zika IgM System is not indicated for testing blood or plasma donors.

The test cannot be visually interpreted by the operator and must be read on the DPP Micro Reader.

DPP Zika IgM System Control Pack

The Chembio DPP Zika IgM System Control Pack is an external quality control kit for use with the DPP Zika IgM System only. The performance characteristics of the DPP Zika IgM System Control Pack have not been established for any other assay or instrument different from the DPP Micro Reader.

DPP Micro Reader

The DPP Micro Reader is a reflectance reader used to obtain test results from DPP Zika IgM System. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation; the results of DPP Zika IgM System cartridges must be read exclusively with the DPP Micro Reader.

Chembio' s DPP Zika IgM System is a qualitative immunochromatographic assay for the presumptive detection of IgM antibodies to Zika virus. The DPP Zika IgM System is composed of:

• A single-use immunochromatographic test for the presumptive detection of ZIK V 1. IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.

• 2. The DPP Micro Reader to minimize errors from direct visual interpretation.

The document describes the Chembio DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader. The system is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum, plasma, and whole blood specimens.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DPP Zika IgM System are primarily demonstrated through its Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a predicate EUA or FDA-cleared comparator assay, across various sample types. Analytical performance (precision, cross-reactivity, interference, analytical sensitivity, and stability) also forms part of the acceptance.

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

• Serum:
  • Positive Predictive Agreement:
    • 99 samples from symptomatic individuals in Peru (retrospective).
    • 11 samples from individuals in the Dominican Republic (retrospective).
    • 32 samples from 26 individuals in Brazil during arbovirus outbreaks (retrospective).
    • FDA Plasma Zika Panel: 24 Zika IgM positive, 12 negative.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Potassium-EDTA Plasma:
  • Positive Predictive Agreement (Manufacturer Study): 299 IgM antibody samples from 48 individuals (from 50 symptomatic subjects) in the Dominican Republic (archived, confirmed by NAT). Includes 12 pregnant women.
  • Positive Predictive Agreement (External Sites): 171 comparator positive IgM antibody samples from 39 individuals in the Dominican Republic (archived). Also, 49 prospectively collected asymptomatic pregnant women from the continental United States (negative by comparator assay) were interspersed.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Potassium-EDTA Venous Whole Blood:
  • Positive Predictive Agreement (Internal/External Sites): 41 plasma samples (from a plasma replacement study) from 6 individuals in the Dominican Republic; 10 frozen natural whole blood samples from individuals in the Dominican Republic; 171 antibody positive plasma specimens (from plasma replacement study) plus 49 antibody negative specimens from asymptomatic pregnant women from the US.
  • Positive Predictive Agreement (Contrived): 299 subjects for analysis (from 300 "all comers" at 3 US clinics); samples were contrived by potassium-EDTA plasma replacement.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Fingerstick Whole Blood:
  • Positive Predictive Agreement (Contrived): 372 subjects for analysis (from 375 adult subjects across 4 US near-patient sites, "all comers" basis); samples were pre-spiked to create contrived samples.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Cross-Reactivity: 329 specimens for various organisms/conditions.
• Interference: Low reactive (n=3) and normal human plasma samples (n=3) for each interfering substance.
• Analytical Sensitivity: Dilution series of WHO 1st International standard.
• Assay Cut-off: 569 natural serum samples (US, Mexico); 184 natural plasma samples (US, Peru); 215 natural venous whole blood samples (US); 102 natural capillary whole blood samples (US).
• Precision/Reproducibility: A blinded panel of four plasma samples (negative, high negative, low positive, moderate positive) tested with 3 lots of the system.
• DPP Zika IgM Control Kit Precision: Moderate positive, low positive, and negative control samples.

Data Provenance: Studies include samples from Peru, Dominican Republic, Brazil, and the United States. Many samples are retrospective (archived, historical data), while some are prospectively collected (e.g., negative predictive agreement studies).

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

The document does not explicitly state the "number of experts" or their specific "qualifications" used to establish ground truth in the traditional sense of multiple human readers independently adjudicating images/cases.

Instead, the ground truth for clinical performance studies (PPA and NPA) was established by:

• Comparison with an EUA (Emergency Use Authorization) or FDA-cleared comparator assay.
• In some cases, samples were confirmed positive by RT-PCR assay for Zika virus (e.g., Peruvian and Brazilian serum samples).
• Consensus results were provided for the FDA Plasma Zika Panel, and these are stated to be the responsibility of the FDA.
• For contrived samples (venous whole blood, fingerstick whole blood), the "ground truth" was based on expected results from spiking with known positive or negative material, corroborated by comparator testing.

4. Adjudication Method for the Test Set

The primary method for "adjudication" (or reference standard determination) appears to be comparison with another laboratory assay (EUA or FDA-cleared comparator assay). For Negative Percent Agreement, results were compared against an FDA Cleared Comparator and an Additional EUA Test, and "Both FDA Cleared and EUA tests" where results from both were in agreement. There is no mention of a traditional expert consensus or adjudication panel (e.g., 2+1, 3+1) for clinical performance in this document.

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 study focuses on the standalone performance of the DPP Zika IgM System against reference methods/comparator assays, not on how human readers improve with or without AI assistance. The DPP Micro Reader is an integral part of the device, reading results from the immunochromatographic assay, and is not an AI tool assisting human interpretation. The document explicitly states the test "cannot be visually interpreted by the operator and must be read on the DPP Micro Reader," meaning it's not a human-in-the-loop scenario.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The document provides extensive data on the performance of the DPP Zika IgM System (algorithm only, as it's an automated reader) in detecting Zika virus IgM antibodies across various sample types and clinical scenarios, independently compared to established reference standards (comparator assays, RT-PCR, or expected reactivity from spiked samples).

7. The Type of Ground Truth Used

The ground truth used various forms:

• Comparator Assay Results: Results from an EUA or FDA-cleared Zika IgM comparator assay.
• RT-PCR Confirmation: For some positive samples, PCR confirmation for Zika virus was used.
• Consensus Data: For the FDA Plasma Zika Panel, consensus results were utilized.
• Expected Reactivity from Spiked Samples: For contrived samples (venous whole blood, fingerstick whole blood), the ground truth was based on the known positive or negative status of the spiked material.

8. The Sample Size for the Training Set

The document does not explicitly specify a "training set" in the context of machine learning. The DPP Micro Reader and assay are likely developed based on extensive R&D and optimization, but the provided performance data relates to validation studies, not an explicit training set for a distinct AI model. The product is an in-vitro diagnostic device that produces quantitative results read by a device, not a machine learning algorithm requiring a separate training dataset in the typical sense.

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

Since an explicit "training set" for a machine learning model is not described, the method for establishing its ground truth is not applicable or detailed in this document. The development of the assay and the Micro Reader's algorithm would have involved internal validation and optimization using various samples, but these are part of product development rather than a defined, separate "training set" for regulatory evaluation in the context of this 510(k) summary.

Ask a specific question about this device

The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for decreased levels of GALT enzyme activity, and not for monitoring purposes.

The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements.

These devices are intended for use by trained, qualified laboratory personnel.

SPOTCHECK Neonatal GALT Microplate Reagent Kit - 60 Plate: Four enzyme mediated reactions are employed in the determination of GALT activity. GALT activity is determined by measuring the colored formazan produced by the addition of the color reagent to the incubated blood/substrate mixture. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a standard 96 well microplate. A buffered enzyme mixture is added to each well and the plate is incubated at 37 °C for 120 minutes on a plate shaker/incubator. Following incubation, an aliquot of the mixture from each well is transferred to the corresponding wells on a clean 96 well microplate. Color reagent is added to each well, the color is developed over the course of 10 minutes, and the absorbance of each sample is determined on the plate reader. A blank absorbance reading is made prior to the addition of the color reagent to correct for endogenous sample color. The color developed is proportional (1:1) to the GALT activity in the sample. A standard curve prepared from a stock NADH solution is used to quantitate the results. Results are expressed as units of GALT enzyme activity per gram of hemoglobin or U/g Hb.

SPOTCHECK Pro: INSTRUMENT COMPONENTS: Tecan Freedom EVO and accessories necessary for assay.

This is a 510(k) premarket notification for a medical device, not an AI/ML device, therefore, some of the requested information (e.g., number of experts, adjudication method, MRMC study, sample size for training set) is not applicable or cannot be extracted from the provided text. The document describes the device's technical characteristics, performance studies performed to demonstrate substantial equivalence to a predicate device, and its intended use.

Here's an analysis of the provided information, tailored to what is available in the regulatory submission format:

1. Table of Acceptance Criteria (Performance Goals) and Reported Device Performance

The acceptance criteria are generally implied by the comparative studies to the predicate device and established CLSI guidelines for analytical performance. The studies aim to show the SPOTCHECK Kit performs comparably or better than the predicate device across various metrics.

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

• Automated and Manual Performance Comparison:

  • Test Set Sample Size: 128 newborn patient dried blood spot samples, plus dried blood spot controls (manufactured to mimic newborn specimens) and dried specimens of mixed adult blood. A total of 216 samples were analyzed.
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific state). The samples are referred to as "newborn patient dried blood spot samples" and "mixed adult blood," suggesting they are from human subjects, but the geographical origin is not specified. The study was retrospective, as existing dried blood spots were analyzed.

• Expected Values and Clinical Cutoff Determination (Automated Processing):

  • Test Set Sample Size: 1752 routine samples and 53 known GALT deficient samples (controls, retrospective galactosemic neonates, and galactosemic non-neonates).
  • Data Provenance: From a "state screening laboratory," indicating US origin and retrospective collection.

• Screening Using Manual Processing:

  • Test Set Sample Size: 247 newborn patient dried blood spot samples, plus dried blood spot controls (with newborn hematocrit) and dried specimens of mixed adult blood. A total of 292 samples were analyzed.
  • Data Provenance: Not explicitly stated, likely similar to the automated comparison study (retrospective human samples, likely US state screening program).

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

• Not applicable as this is a chemical reagent kit for GALT activity measurement, not an AI/ML device relying on human expert image interpretation or similar.
• The "ground truth" for GALT deficiency or normal activity was established by:
  • Analysis using the predicate device.
  • "Known GALT deficient samples" which included "retrospective galactosemic neonates and galactosemic non-neonates," meaning their clinical status was previously established.
  • "Routine neonatal screening by the state DOH classified all but one of these specimens (as well as the specimens classified as negative) to be presumptive negative for galactosemia." For some samples, the reference came from a state Department of Health (DOH) screening classification.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" was established based on predicate device results and previously classified clinical samples, not through a consensus or adjudication process among multiple human readers for a primary diagnostic task.

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 not an AI/ML device, and no human reader study with or without AI assistance was performed.

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

• This device is a standalone diagnostic kit (the "algorithm" here being the chemical assay and spectrophotometric measurement, interpreted by trained lab personnel). The studies described (linearity, sensitivity, precision, comparison to predicate) are effectively standalone performance evaluations. The SPOTCHECK Pro (instrument) automates the process, meaning the "algorithm" (assay) performs without manual intervention during the assay process itself, aside from initial setup and final interpretation.

7. The Type of Ground Truth Used

• Comparative Reference Standard: The primary ground truth for evaluating the SPOTCHECK Kit was the performance of a legally-marketed predicate device (Bio-Rad Quantase Neonatal GALT Test). The studies explicitly compare the SPOTCHECK Kit's results to the predicate device's results.
• Clinical Diagnosis/Known Status: For validation of clinical classification, "known GALT deficient samples" (retrospective galactosemic neonates and non-neonates) were used. This indicates a form of outcomes data or pre-established clinical diagnosis.
• State DOH Screening Classification: In some instances, the "routine neonatal screening by the state DOH" provided a classification (presumptive positive/negative) which served as a reference for comparison.

8. The Sample Size for the Training Set

• Not applicable in the context of AI/ML. The device is a chemical reagent kit. There wasn't a "training set" in the machine learning sense. The device's calibration curve is established using NADH standards, which are analytical controls, not a training dataset for an algorithm.

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

• Not applicable as there is no "training set" in the AI/ML context. The calibration curve is established analytically using NADH standards, which have known concentrations. These standards are foundational to quantifying the GALT activity, not for training a predictive model.

Ask a specific question about this device

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOX Scan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. PROFILE®-V MEDTOXScan® Test Devices cannot be visually read.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations:

AMP Amphetamine (d-Amphetamine) 500 ng/mL
BAR Barbiturates (Butalbital) 200 ng/mL
BUP Buprenorphine (Buprenorphine) 10 ng/mL
BZO Benzodiazepines (Nordiazepam) 150 ng/mL
COC Cocaine (Benzoylecgonine) 150 ng/mL
MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL
MTD Methadone (Methadone) 200 ng/mL
OPI Opiates (Morphine) 100 ng/mL or 2000 ng/mL
OXY Oxycodone (Oxycodone) 100 ng/mL
PCP Phencyclidine (Phencyclidine) 25 ng/mL
PPX Propoxyphene (Norpropoxyphene) 300 ng/mL
THC Cannabinoids (11-nor-9-carboxy-r9-THC) 50 ng/mL
TCA Tricyclic Antidepressants (Desipramine) 300 ng/mL

Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drug. Test Devices will have an opiate cutoff of either 100 ng/mL or 2000 ng/mL. Refer to specific product labeling for the combination of drug tests included on that test device.

THE PROFILE®-V MEDTOXScan® DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY / MASS SPECTROMETRY (GC/MS), HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) OR LIQUID CHROMATOGRAPHY / TANDEM MASS SPECTROMETRY (LC/MS/MS) ARE THE PREFERRED CONFIRMATORY METHODS. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.

The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan ® Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScar® Test Devices and the MEDTOXScam® Reader. The MEDTOX Scan® Reader is an instrument used as an aid in determining the presence of a colored line associated with the PROFILE®-V MEDIOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazenines, Buprenorphine, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine. Propoxyphene, THC (Cannabinoids) and Tricyclic Antidepressants or their metabolites. All analytes were previously cleared for the test system (K091454) except for the buprenorphine and opiates with the 2.000 ng/mL cutoff (OPI 2k). OPI 2K was previously cleared for visual use (K992111).

The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read. the analyte(s) associated with the device and whether the presence or absence of a line is associated with a negative or positive result. The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed.

Acceptance Criteria and Device Performance Study for PROFILE®-V MEDTOXScan® Drugs of Abuse Test System

This document outlines the acceptance criteria and details the studies conducted to demonstrate the substantial equivalence of the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System.

1. Table of Acceptance Criteria and Reported Device Performance

The device is intended for the rapid, qualitative detection of drugs of abuse in human urine. The acceptance criteria for performance are derived from the analytical and clinical studies demonstrating agreement with GC/MS or LC/MS/MS reference methods, particularly around the drug cutoff concentrations.

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

• Clinical Test Set:
  • Buprenorphine (BUP 10 ng/mL): 40 Negative samples (No Drug) + 4 Near Cutoff Negative samples + 4 Near Cutoff Positive samples + 36 High Positive samples = 84 samples
  • Opiates (OPI 2,000 ng/mL): 40 Negative samples (No Drug) + 4 Low Negative samples + 3 Near Cutoff Negative samples + 4 Near Cutoff Positive samples + 36 High Positive samples = 87 samples
  • Overall for Both Drugs: 171 samples (80 Negative, 4 Low Negative, 7 Near Cutoff Negative, 8 Near Cutoff Positive, 72 High Positive).
• Sensitivity/Precision/Distribution of Random Error Test Set:
  • For each drug (Opiates 2,000 ng/mL and Buprenorphine 10 ng/mL), 5 different concentrations were tested. Each concentration was tested in triplicate on 5 different intervals, resulting in 45 observations per concentration.
  • Total observations for this study: 5 concentrations * 45 observations/concentration * 2 drugs = 450 observations.
• Data Provenance:
  • The clinical urine samples were obtained from MEDTOX Laboratories.
  • The data is retrospective, as it refers to "clinical urine samples containing varying concentrations of drugs" that were "obtained from MEDTOX Laboratories" and subsequently "assayed" and "compared to GC/MS or LC/MS/MS results." The description implies these were pre-existing samples.

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

The ground truth for the clinical test set was established by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS), which are instrumental analytical methods, not human expert interpretation.

For the sensitivity/precision study and cross-reactivity/interference studies, standard drug solutions were diluted in drug-free urine or reference standards were prepared in negative urine samples. The precise concentration was confirmed by GC/MS or LC/MS/MS methods. Therefore, the ground truth was also established via these analytical methods.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or applicable, as the ground truth was established by objective instrumental methods (GC/MS or LC/MS/MS) rather than subjective human interpretation. The MEDTOXScan® Reader automatically interpreted results at ten minutes.

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

No MRMC comparative effectiveness study was done. The device, the PROFILE®-V MEDTOXScan® Reader, is an instrument that interprets and reports results. It replaces visual reading by humans, and thus, a study comparing human readers with and without AI assistance is not applicable in the traditional sense. The device automates the reading process.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The "PROFILE®-V MEDTOXScan® Drugs of Abuse Test System" essentially operates as a standalone algorithm/instrument. The device includes the MEDTOXScan® Reader which utilizes "software algorithms" to identify the device, analyte, and interpret the presence or absence of a line to determine positive or negative results. The results are "displayed on the MEDTOXScan® screen or optionally can be printed." The description explicitly states: "PROFILE®-V MEDTOXScan® Test Devices cannot be visually read," meaning the device's performance is entirely dependent on its automated reading capability.

7. Type of Ground Truth Used

The type of ground truth used was Instrumental Confirmatory Methods (GC/MS or LC/MS/MS). For the clinical studies, "Drug concentrations were assayed by GC/MS or LC/MS/MS." These are considered the gold standard for drug confirmation. For the analytical studies (sensitivity, precision, cross-reactivity), drug solutions or reference standards were prepared, and their concentrations were confirmed by these methods.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. The studies described are performance validation studies for the device itself, comparing its output to confirmatory methods. It's implied that the software algorithms for the MEDTOXScan® Reader were developed and possibly internally validated prior to these submission studies. However, details regarding the training data for the internal algorithms are not provided in this 510(k) summary.

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

As the document does not specify a training set or its sample size, it also does not describe how the ground truth for any potential training set was established. While the clinical and analytical validation studies use GC/MS or LC/MS/MS as ground truth, information regarding the ground truth establishment for the development or training of the device's internal algorithms (e.g., line detection, interpretation logic) is not disclosed in this summary.

Ask a specific question about this device

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOX Scan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. PROFILE®-V MEDTOXScan® Test Devices cannot be visually read.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations:

AMP Amphetamine (d-Amphetamine) 500 ng/mL
BAR Barbiturates (Butalbital) 200 ng/mL
BZO Benzodiazepines (Nordiazepam) 150 ng/mL
COC Cocaine (Benzoylecgonine) 150 ng/mL
MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL
MTD Methadone (Methadone) 200 ng/mL
OPI Opiates (Morphine) 100 ng/mL
OXY Oxycodone (Oxycodone) 100 ng/mL
PCP Phencyclidine (Phencyclidine) 25 ng/mL
PPX Propoxyphene (Norpropoxyphene) 300 ng/mL
THC Cannabinoids (11-nor-9-carboxy-Δ9-THC) 50 ng/mL
TCA Tricyclic Antidepressants (Desipramine) 300 ng/mL

Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drug. Refer to specific product labeling for the combination of drug tests included on that test device.

THE PROFILE -V MEDTOXScan® DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL . METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY / MASS SPECTROMETRY (GC/MS), HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) OR LIQUID CHROMATOGRAPHY / TANDEM MASS SPECTROMETRY (LC/MS/MS) ARE THE PREFERRED CONFIRMATORY METHODS. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.

The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan® Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used as an aid in determining the presence or absence of a colored line associated with the PROFILE®-V MEDTOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids) and Tricyclic Antidepressants or their metabolites. All analytes were previously cleared (K080635) except for the oxycodone, propoxyphene, and tricyclic anti-depressant analytes.

The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read, the analyte(s) associated with the device and whether the presence or absence of a line is associated with a negative or positive result. The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for PROFILE®V MEDTOXScan® Drugs of Abuse Test System

The primary acceptance criteria for the PROFILE®V MEDTOXScan® Drugs of Abuse Test System, as demonstrated in the clinical studies, revolve around its analytical agreement with GC/MS or LC/MS/MS methods for detecting drugs of abuse in urine samples.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" as a distinct section with specific numerical targets (e.g., "sensitivity must be >95%"). However, the clinical study results implicitly define the performance expected for substantial equivalence. The key performance metric is the percentage agreement with confirmed analytical methods (GC/MS or LC/MS/MS) across different concentration ranges.

The relevant performance metrics for the newly added analytes (Oxycodone, Propoxyphene, and Tricyclic Antidepressants) are derived from the clinical accuracy study (Table 5) and the sensitivity/precision study (Table 2).

Implicit Acceptance Criteria and Reported Device Performance (Focus on new analytes):

Summary of Discordant Results (Table 6):

• OXY (100 ng/mL): 1 false negative at 102 ng/mL (just above cutoff). The clinical study had 1 "near cutoff positive" sample (between cutoff and +50%) that tested negative.
• PPX (300 ng/mL): 4 false positives for samples between 182-271 ng/mL (all below cutoff). The clinical study had 4 "near cutoff negative" samples (between 50% and cutoff) that tested positive.
• TCA (300 ng/mL): 3 false positives for samples between 194-287 ng/mL (all below cutoff). The clinical study had 3 "near cutoff negative" samples (between 50% and cutoff) that tested positive.

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

• Clinical Test Set (Table 5):
  • Total samples: 125 (Negative) + 6 (Low negative) + 11 (Near Cutoff Negative) + 12 (Near Cutoff Positive) + 112 (High Positive) = 266 samples across all drugs (OXY, PPX, TCA).
  • For Oxycodone (OXY): 40 (No Drug) + 3 (Low Negative) + 4 (Near Cutoff Negative) + 3 (Near Cutoff Positive) + 36 (High Positive) = 86 samples.
  • For Propoxyphene (PPX): 45 (No Drug) + 1 (Low Negative) + 2 (Near Cutoff Negative) + 4 (Near Cutoff Positive) + 40 (High Positive) = 92 samples.
  • For Tricyclic Antidepressants (TCA): 40 (No Drug) + 2 (Low Negative) + 1 (Near Cutoff Negative) + 4 (Near Cutoff Positive) + 36 (High Positive) = 83 samples.
• Sensitivity/Precision Test Set (Table 2):
  • Each drug (OXY, PPX, TCA) was tested with 45 observations per concentration level.
  • There were 6 concentration levels for OXY and 5 for PPX and TCA, resulting in 270 observations for OXY and 225 observations for PPX and TCA each in this specific study.
• Data Provenance: The document states, "The samples were obtained from MEDTOX Laboratories." It doesn't specify the country of origin, but Medtox Diagnostics, Inc. is located in North Carolina, USA, suggesting the data is likely from the USA. The study is described as evaluating a "panel of blind coded clinical urine samples," which indicates it was a retrospective evaluation of existing samples, albeit with the device testing being prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The ground truth for the clinical test set was established by "GC/MS or LC/MS/MS results." These are instrumental analytical methods and do not typically involve human "experts" in the sense of physicians or clinical reviewers for direct interpretation of the primary result. The interpretation of these assays is based on established chemical analysis protocols.
• Therefore, the number of experts is not applicable in the traditional sense of clinical opinion, and their specific qualifications are not relevant here, as the comparison is against another laboratory-based analytical method.

4. Adjudication Method for the Test Set

• The ground truth was established by GC/MS or LC/MS/MS results. These are definitive chemical confirmatory methods. There is no mention of a human adjudication process (like 2+1, 3+1 consensus) for the ground truth itself, as the chemical analysis provides the "ground truth" concentrations. The device's results were then compared to these confirmed chemical values.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an automated reader for immunoassay test strips, and its output is a qualitative positive or negative result. The study involved comparison of the device's automated reading to reference chemical methods (GC/MS or LC/MS/MS), not a comparison of human readers' performance with and without AI assistance. The study explicitly states, "PROFILE®-V MEDTOXScan® Test Devices cannot be visually read."

6. Standalone Performance Study

• Yes, a standalone study was done. The entire clinical accuracy study and the sensitivity/precision study (Tables 2 & 5) describe the performance of the algorithm only (the device in its intended use, without human-in-the-loop decision making regarding the test line interpretation). The device "scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read... The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed." Human operators run the test, but the interpretation is solely by the instrument's algorithm.

7. Type of Ground Truth Used

• The ground truth used was instrumental laboratory confirmatory methods: Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). This is a highly accurate and widely accepted method for confirming the presence and concentration of drugs and their metabolites in biological samples. The text refers to it as the "preferred confirmatory methods."

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. The performance studies described are for validation of the device, implying that development and training (if a machine learning component were involved, though this is a rule-based algorithm) would have occurred prior to these studies. The existing analytes (Amphetamines, Barbiturates, etc.) were "previously cleared (K080635)," and "Performance studies have been conducted for the addition of Oxycodone, Propoxyphene, and Tricyclic Antidepressants through Medtox's internal Design Control process." This implies new studies for the added analytes, but no specific training set size is provided.

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

• Since the training set size and details are not provided, the method for establishing its ground truth is also not explicitly stated in this document. Given it's a diagnostic device for drugs of abuse, it's highly probable that ground truth for any training would also be established using gold-standard analytical methods like GC/MS or LC/MS/MS, similar to the validation set.

Ask a specific question about this device

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOXScan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine and THC (Cannabinoids) or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. The PROFILE®-V MEDTOXScan® Test Devices cannot be visually read.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations:

AMP Amphetamine (d-Amphetamine) 500 ng/mL

BAR Barbiturates (Butalbital) 200 ng/mL

BZO Benzodiazepines (Nordiazepam) 150 ng/mL

COC Cocaine (Benzoylecgonine) 150 ng/mL

MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL

MTD Methadone (Methadone) 200 ng/mL

OPI Opiates (Morphine) 100 ng/mL

PCP Phencyclidine (Phencyclidine) 25 ng/mL

THC Cannabinoids (11-nor-9-carboxy-C9-THC) 50 ng/mL

Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed drug analytes.

THE PROFILE®-V MEDTOXScan® Drugs of Abuse Test System provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan® Positive and Negative OC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS) and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively remaved any contamination.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used as an aid in determining the presence of a colored line associated with the PROFILE®-V MEDTOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamine, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates. Barbiturates, Phencyclidine, and THC (Cannabinoids) or their metabolites.

The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read, the analyte(s) associated with the device and whether the presence or absence of a line is associated with a negative or positive result. The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed. The PROFILE® V MEDTOXScan® Test Devices cannot be visually read.

Here's a breakdown of the acceptance criteria and the study details for the PROFILE® V MEDTOXScan® Drugs of Abuse Test System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its ability to accurately detect the presence or absence of specific drugs of abuse at defined cutoff concentrations. The performance is reported as the percentage agreement with GC/MS or LC/MS/MS results for clinical urine samples.

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

The "Clinical Tests" section describes the evaluation of a "panel of blind coded clinical urine samples." The sample sizes for each drug are:

• AMP: 40 negative, 5 low negative, 0 near cutoff negative, 4 positive (between -50% and cutoff), 5 positive (between cutoff and +50%), 41 high positive = 95 samples
• BAR: 40 negative, 3 low negative, 2 near cutoff negative, 3 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 36 high positive = 88 samples
• BZO: 40 negative, 3 low negative, 3 near cutoff negative, 1 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 41 high positive = 92 samples
• COC: 56 negative, 1 low negative, 5 near cutoff negative, 2 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 52 high positive = 120 samples
• mAMP: 40 negative, 4 low negative, 3 near cutoff negative, 1 positive (between -50% and cutoff), 3 positive (between cutoff and +50%), 40 high positive = 91 samples
• MTD: 40 negative, 4 low negative, 2 near cutoff negative, 2 positive (between -50% and cutoff), 3 positive (between cutoff and +50%), 40 high positive = 91 samples
• OPI: 46 negative, 2 low negative, 3 near cutoff negative, 3 positive (between -50% and cutoff), 5 positive (between cutoff and +50%), 44 high positive = 103 samples
• PCP: 40 negative, 0 low negative, 1 near cutoff negative, 0 positive (between -50% and cutoff), 2 positive (between cutoff and +50%), 20 high positive = 63 samples
• THC: 40 negative, 0 low negative, 4 near cutoff negative, 0 positive (between -50% and cutoff), 7 positive (between cutoff and +50%), 30 high positive = 81 samples

Data Provenance: The samples were obtained from MEDTOX Laboratories. The study is retrospective, as it uses a "panel of blind coded clinical urine samples" which implies pre-collected samples. The country of origin is not explicitly stated, but MEDTOX Diagnostics, Inc. is located in North Carolina, USA, and MEDTOX Laboratories is a US-based company, suggesting the data is likely from the USA.

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

The ground truth for the clinical test set was established using Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are analytical laboratory methods, not human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" does not directly apply to the primary ground truth determination in this study. The "in-house operators" who performed the testing using the device would be trained laboratory personnel, but their role was to operate the device and not to establish the ground truth.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus with human readers) is mentioned. The ground truth was established by GC/MS or LC/MS/MS, which are considered definitive analytical methods for drug detection and quantification. Discordant results (where the device result didn't match the GC/MS/LC/MS/MS result) are detailed in Table 5, but there's no mention of an adjudication process by human experts for these cases beyond the initial GC/MS or LC/MS/MS determination.

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. This device is an automated reader for an immunoassay, not an AI system designed to assist human readers in image interpretation or diagnosis. The study assessed the device's performance against a gold standard (GC/MS/LC/MS/MS), not its impact on human reader performance.

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

Yes, a standalone performance study was conducted. The PROFILE® V MEDTOXScan® Reader is an automated instrument that interprets the results of the immunochromatographic test devices. The study evaluates the performance of this automated system in interpreting results without human intervention in the interpretation step. The "in-house operators" perform the technical steps of running the test devices and operating the reader, but the result interpretation is done by the reader's software algorithms.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical test set was analytical confirmation by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are considered the gold standard methods for drug detection and quantification in urine.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The studies described are primarily performance evaluation studies (e.g., around cutoff, cross-reactivity, interference, and clinical accuracy). While the device uses "software algorithms," there's no information provided about a specific "training set" used to develop or refine these algorithms. The device likely relies on predefined logic and calibration rather than a machine learning model trained on a large dataset in the typical sense.

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

Since a distinct "training set" with ground truth establishment for algorithm learning is not mentioned in the document, this information is not provided. The device's operation is based on reading relative line intensities using a contact imaging sensor and applying software algorithms, implying fixed logic and potentially factory calibration rather than a learned model from a training set. The "Sensitivity/Precision/Distribution of Random Error" study (Table 2) uses standard drug solutions at various concentrations, which would be known values, and could be considered part of the development and characterization of the device's reading capabilities, analogous to establishing parameters rather than training a machine learning model.

Ask a specific question about this device

StatusFirst™ hCG Serum/Urine test is in vitro diagnostic use for a qualitative detection of Human Chorionic Gonadotropin(hCG) in serum or urine for the detection of pregnancy.
Reflectance photometer for the measurement of concentration of analyte in various assays manufactured by PBM. The concentration is measured by density of light reflectance.
Reflectance photometer for a reading of test signal instead of visual reading in various qualitative assays manufactured by PBM.

StatusFirst™ hCG Serum/Urine is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in serum or urine. The device is used with DXpress™ Reader.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria. Therefore, the "acceptance criteria" here refer to the performance of the predicate device, which the new device aims to match or exceed.

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

• Sample Size: 116 specimens (for both urine and serum combined, or 116 for urine and 116 for serum separately - the wording "when 116 specimens were compared for urine test or for serum test" is slightly ambiguous but implies a significant sample size for comparison).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the context of an FDA submission for a "StatusFirst™ hCG Serum/Urine" device suggests human clinical samples were used.

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

This information is not provided in the document. The comparison is made against a legally marketed predicate device (Icon 25 hCG), implying the predicate's results served as a comparative "ground truth" or reference, rather than independent expert adjudication.

4. Adjudication Method for the Test Set

This information is not provided. The study compares the results of the StatusFirst™ hCG Serum/Urine device with the Icon 25 hCG test. The predicate device's readings served as the reference point. The document notes that "disagreements were shown in the borderline samples," where "StatusFirst™ hCG Serum/Urine read the borderline samples as borderline level, whereas predicate device read most of borderline samples as positive," indicating a direct comparison rather than an adjudication process involving multiple third-party experts.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or described. The device, DXpress™ Reader, is a reader for the hCG test strips, providing an objective reading instead of a visual reading by a human. The comparison is between an automated reading (DXpress Reader) and a visual reading (Icon 25 hCG), not an AI assisting human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The 93% agreement reported is the direct performance of the StatusFirst™ hCG Serum/Urine device (read by the DXpress Reader) when compared against the predicate device. This is the device's performance without human-in-the-loop decision making, as the DXpress Reader automates the result interpretation.

7. Type of Ground Truth Used

The "ground truth" used for comparison was the results obtained from a legally marketed predicate device, the Icon 25 hCG test. This is an existing device comparison rather than an independent gold standard like pathology or clinical outcomes.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes a performance evaluation of the final product, not the development or training of the device.

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

This information is not provided. Given that the document describes the performance of a medical device rather than a machine learning algorithm, the concept of a "training set" and "ground truth for the training set" in the context of AI is not explicitly relevant or discussed here. The device is an immunochromatographic assay read by a reflectance photometer, which implies established chemical/biological principles rather than a machine learning model trained on data.

Ask a specific question about this device

The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The system consists of the UBiT-IR300 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags.

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.

The UBiT-IR300 Infrared Spectrometry System is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The UBiT-IR300 measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as △'3CO2 and expressed as delta per mil (%) or Delta Over Baseline (DOB).

The System consists of the following components:

• UBiT-IR300 Infrared Spectrophotometer -
• UBiT-AS10 Autosampler -
• Otsuka Breath Collection Bags -

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The device was compared against the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method.

Here's the breakdown of the acceptance criteria and study details:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. However, for a device seeking 510(k) clearance by demonstrating substantial equivalence, the expectation is that its performance is comparable to or non-inferior to the predicate device. The presented results clearly indicate a very high level of agreement and correlation, suggesting these metrics met the implicit requirements for substantial equivalence.

Study Details

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

   • Sample Size: 320 evaluable subjects.
     • 257 subjects from combined Physician Office Laboratory (POL) sites.
     • 63 subjects from one clinical laboratory site.
   • Data Provenance: The study was a multi-center, prospective study. The country of origin is not explicitly stated, but given the sponsor (Otsuka Pharmaceutical Co., Ltd., Japan) and the contact person's US number, it's likely a US-based or international study with US participant sites. The data is prospective as subjects were recruited and underwent the urea breath test for the study.

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

   • The ground truth in this study was established using the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. The study design directly compares the UBiT-IR300's results to the GIRMS method.
   • Therefore, the "experts" in this context are the established and recognized methodology of GIRMS for 13CO2 enrichment measurement. There's no mention of a separate panel of human experts in the traditional sense (e.g., radiologists) establishing ground truth, as it's a direct analytical comparison.

3. Adjudication Method for the Test Set:

   • Not applicable in the conventional sense. The "adjudication" is inherent in the comparison of the UBiT-IR300 results against the GIRMS method, which serves as the reference standard. Agreement and correlation were calculated based on this direct comparison.

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 an MRMC study. This study evaluated the performance of an analytical device (UBiT-IR300) directly against a reference analytical method (GIRMS) for measuring 13CO2 enrichment, not human reader performance.

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

   • Yes, this study represents a standalone performance evaluation of the UBiT-IR300 Infrared Spectrometry System. It measures the device's ability to accurately measure 13CO2 enrichment independently, with its results then compared to the established GIRMS method.

6. The type of ground truth used:

   • The ground truth was established by the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. This is an established and accepted analytical method for measuring 13CO2 enrichment in breath.

7. The sample size for the training set:

   • The provided summary does not explicitly mention a separate "training set" for the device's development. This is typical for an analytical instrument where performance is often based on the device's physical and algorithmic design, rather than a machine learning model that requires a distinct training phase on clinical data. The clinical study described served as a validation/test set.

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

   • As no explicit training set is mentioned in the summary, this question is not directly applicable. If a training phase existed during device development, the ground truth would likely have been established through controlled experiments and calibrations using known standards for 13CO2 enrichment, analogous to the GIRMS method used for the clinical validation.

Ask a specific question about this device

The ATLAST Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates (newborn children).

The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.

The ATLAST Blood Glucose Monitoring System measures the amount of glucose in capillary whole blood. When whole blood is applied to the ATLAST Test Strip, reagents on the Test Strip react with the blood and a color is formed, the intensity of which is measured by the ATLAST System. The ATLAST Blood Glucose Monitoring System consists of the following components: (1) a reflectance photometer which incorporates a lancing device ("ATLAST System"), (2) glucose reagent test strips ("ATLAST Test Strips") and calibration chip, and (3) sterile lancets ("ATLAST Lancets").

The Amira Medical ATLAST Blood Glucose Monitoring System is a medical device intended for the quantitative measurement of glucose in whole blood for individuals with diabetes mellitus.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria (e.g., specific percentages within a certain glucose range based on an error grid). However, it outlines the general approach to evaluating performance and states that the device met these requirements.

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

• Sample Size: The document does not specify the exact sample size for the "multi-center, subject controlled clinical study."
• Data Provenance: The data was collected through a "multi-center, subject controlled clinical study." This indicates a prospective study where participants were actively recruited and data was collected specifically for the study. The country of origin is not explicitly stated, but the submission is to the US FDA, implying US-based or internationally recognized standards.

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

• The document implies that a "laboratory reference method for measuring blood glucose levels" was used to establish ground truth.
• It does not specify the number of experts or their qualifications for performing this reference method. It can be inferred that these would be licensed clinical laboratory professionals following standard laboratory procedures.

4. Adjudication Method for the Test Set:

• No explicit adjudication method is mentioned for reconciling discrepancies in the ground truth. The ground truth was established by a "laboratory reference method," which typically implies a single, highly accurate measurement serving as the definitive value.

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

• This device is a blood glucose monitoring system, not an imaging or diagnostic device that requires human "readers" or AI assistance in interpretation in the typical sense of an MRMC study.
• The study compared the device's performance when used by lay users (diabetic patients) versus trained technicians. This is a comparison of user groups rather than a human-AI comparison.
• Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI vs. without AI assistance was not applicable and not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• The device is a standalone system. The "ATLAST System" measures glucose, and the results are directly displayed to the user.
• Bench/Laboratory testing was performed to evaluate the system in isolation, and the clinical study evaluated the system's performance both by lay users and trained technicians.
• While human interaction is required to obtain the blood sample and initiate the test, the measurement and calculation of glucose levels are performed solely by the device's internal algorithms. Therefore, a standalone performance evaluation of the "algorithm only" (as part of the finished device) was inherently performed.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• The ground truth for the test set was established using a laboratory reference method for measuring blood glucose levels. This is considered a highly accurate and objective measure in clinical chemistry.

8. The Sample Size for the Training Set:

• The document does not provide information about a separate "training set" or its sample size. The description focuses on the performance testing carried out on the finished device. For a device like a blood glucose meter, the "training" (calibration) is typically done during the device's manufacturing and validation process, often using standardized solutions and internal quality control, not a separate clinical training set in the way AI algorithms are trained.

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

• Since a separate "training set" as understood in AI/machine learning is not explicitly mentioned, the method for establishing its ground truth is also not described. Device calibration and internal validation would rely on established laboratory standards and methods for glucose concentration.

Ask a specific question about this device

The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the clinical setting.

The Lactate Pro™ System consists of Lactate Pro™ Blood Lactate Test Meter, Lactate ProTM Test Strip.

The provided text does not contain a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) premarket notification letter from the FDA, granting clearance for the Lactate Pro™ System based on substantial equivalence to predicate devices. It discusses the device's indications for use and classification but does not include detailed performance data or acceptance criteria that a clinical study would typically provide.

Therefore, for items 1-9, the answer will largely be "Not applicable" or "Information not provided in the document."

Here's a breakdown based on the provided text:

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

The document is a marketing clearance letter, not a performance study report. It does not detail specific acceptance criteria for accuracy, precision, or other performance metrics, nor does it present the results of such testing for the Lactate Pro™ System. The FDA's clearance is based on a determination of substantial equivalence to predicate devices.

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

Information not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Information not provided in the document.

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

Information not provided in the document.

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 device is a blood lactate test system, not an AI-powered diagnostic imaging device that would involve human readers.

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

Information not provided in the document. As a blood lactate test system, its standalone performance would typically refer to its accuracy and precision against a reference method, not an algorithm's performance. The document does not contain this data.

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

Information not provided in the document. For a blood lactate meter, ground truth would typically be established by a laboratory reference method (e.g., a laboratory analyzer). The document does not specify this.

8. The sample size for the training set

Not applicable. This device is a measurement system, not a machine learning algorithm that requires a training set in the conventional sense. Any internal calibration data or development data are not discussed.

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

Not applicable. See reasoning for point 8.

Ask a specific question about this device

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 Clinical Chemistry System is an automated, random access clinical chemistry analyzer that quantifies analytes in physiological fluids using photometry and potentiometry. The device was found substantially equivalent to the ILab 900/1800 Clinical Chemistry System (K932467, K943595) and IL Test assays (K943366, K952646, K943367, K952647).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ILab 600 are implicit in its claim of substantial equivalence to the predicate device, the ILab 900. This means the performance of the ILab 600 must be "statistically similar" to that of the ILab 900 across various analytes and sample types (serum, urine, cerebrospinal fluid).

The reported device performance is demonstrated through method comparison studies and precision studies.

Method Comparison Studies (ILab 600 vs. ILab 900):

Precision Studies (ILab 600):

• Serum Samples: Two levels of serum samples (three for Cholesterol) were tested in triplicate twice a day for 10 days (n=60 total). The Total %CV for most analytes was generally low, indicating good precision. For example:
  • Albumin: Level 1 (1.79%), Level 2 (1.08%)
  • ALT/GPT: Level 1 (1.26%), Level 2 (0.99%)
  • Cholesterol: Level 1 (2.11%), Level 2 (1.35%), Level 3 (1.37%)
  • ISE Sodium: Level 1 (0.94%), Level 2 (0.67%)
• Urine Samples: Two levels of urine samples were tested in triplicate twice a day for 10 days (n=60 total). Similar to serum, Total %CV remained low:
  • Amylase: Level 1 (2.56%), Level 2 (2.02%)
  • Creatinine: Level 1 (2.11%), Level 2 (1.73%)
  • ISE Sodium: Level 1 (1.13%), Level 2 (0.65%)
• Cerebrospinal Fluid Samples: Two levels of CSF samples were tested using IL Test Glucose Oxidase in triplicate twice a day for 5 days (n=30 total).
  • Glucose Oxidase: Level 1 (1.49%), Level 2 (0.98%)

The studies conclude that the ILab 600 and ILab 900 are "statistically similar" for the tests evaluated. The precision studies demonstrate acceptable levels of reproducibility based on the reported Coefficient of Variation (%CV) values for within-run, among-run, among-day, and total precision. No specific numerical thresholds for acceptance criteria were explicitly stated, but the robust statistical similarity and low %CV values imply the device meets the necessary performance standards for clinical use.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):

  • Serum Samples: Sample sizes ranged from a minimum of 64 (Lipase) to a maximum of 137 (Glucose Oxidase).
  • Urine Samples: Sample sizes ranged from 49 (ISE Potassium and Sodium) to 95 (Glucose Hexokinase).
  • Cerebrospinal Fluid Samples: Sample size was 20 (Glucose Oxidase).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

• Test Set (Precision Studies):

  • Serum Samples: n=60 for most analytes (triplicate measurements, twice a day, for 10 days). Cholesterol used n=60 across three levels.
  • Urine Samples: n=60 for all analytes (triplicate measurements, twice a day, for 10 days).
  • Cerebrospinal Fluid Samples: n=30 for Glucose Oxidase (triplicate measurements, twice a day, for 5 days).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document pertains to the performance characteristics of a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" in this context refers to the actual concentration of the analytes in the samples. Clinical chemistry analyzer performance is typically evaluated by comparing results to a reference method (in this case, the predicate device ILab 900) or by using certified reference materials with known concentrations. Therefore, expert interpretation or consensus, as might be used in image-based diagnostic AI, is not applicable here. No mention of human experts defining "ground truth" is provided or expected.

4. Adjudication Method

Not applicable. As described in point 3, this is a quantitative measurement device, not an interpretation task requiring adjudication of expert opinions.

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

Not applicable. The device is a clinical chemistry analyzer, not an AI system assisting human readers in diagnostic interpretation. The study evaluates the analyzer's performance directly against a predicate device and for precision, not the human reader's effectiveness with or without AI.

6. Standalone Performance Study

Yes, standalone performance was done.

• Method Comparison Studies: The performance of the ILab 600 was compared directly to that of the ILab 900 (predicate device). This is a standalone comparison of the new device against an established one.
• Precision Studies: The precision of the ILab 600 was evaluated independently, measuring its reproducibility across different runs and days. This is also a standalone performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used for these studies is the quantitative analytical result obtained from the predicate device (ILab 900) for method comparison studies, and the inherent, measured concentration within the biological samples for precision studies. This is a form of reference method comparison or analytical accuracy assessment, rather than pathology, expert consensus, or outcomes data, which are typically associated with qualitative or interpretative diagnostics. For precision, the ground truth is implicitly the true, stable concentration in the control/patient samples being repeatedly measured.

8. Sample Size for the Training Set

Not applicable. The ILab 600 is a clinical chemistry analyzer, which operates based on established chemical and photometric/potentiometric principles and internal calibration curves. It is not an AI/ML device that requires a "training set" in the sense of supervised learning. Its analytical methods are pre-programmed and validated, not learned from data in the way a machine learning algorithm would be.

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

Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design and standard laboratory calibration procedures, not through a data-driven training process.

Ask a specific question about this device