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510(k) Data Aggregation
(195 days)
MEDTOX DIAGNOSTICS, INC.
The MEDTOX Buprenorphine Test uses immunochromatographic test strips for the rapid, qualitative detection of buprenorphine and its metabolites in human urine. It is intended for prescription use only. The MEDTOX Buprenorphine Test is not for overthe-counter sale. It is not intended for use in point-of-care settings.
MEDTOX Buprenorphine detects buprenorphine and its metabolites at the following cutoff concentrations:
Buprenorphine (Buprenorphine) BUP 10 ng/mL
The MEDTOX Buprenorphine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result.
The MEDTOX® Buprenorphine Test is a rapid, single use, one-step qualitative immunochromatographic screening assay for the detection of Buprenorphine and its metabolites in human urine.
Acceptance Criteria and Device Performance for MEDTOX® Buprenorphine Test
This document outlines the acceptance criteria and the studies conducted to demonstrate the performance of the MEDTOX® Buprenorphine Test, a rapid, qualitative immunochromatographic screening assay for Buprenorphine and its metabolites in human urine.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from various studies detailed in the submission, primarily focusing on analytical sensitivity, specificity, and accuracy around the defined cutoff. Due to the qualitative nature of the test and the reporting style, acceptance criteria are inferred from the study design and expected performance for a screening device.
For the purposes of this summary, the primary acceptance criterion for a diagnostic test like this is typically to correctly identify drug-positive samples at or above the cutoff and drug-negative samples below the cutoff, with minimal false positives or false negatives.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (Precision): | For a qualitative test around a cutoff, there should be a clear distinction between negative and positive results between 50% and 150% of the cutoff concentration. Specifically, samples below the cutoff should be predominantly negative, and samples above the cutoff should be predominantly positive. Ideally, 100% agreement at 0 ng/mL and 150% of cutoff, and a gradient of positive detection between 75% and 125% of cutoff. | At Cutoff of 10 ng/mL: |
- 0 ng/mL: 45/45 Negative (100%)
- 2.5 ng/mL (25%): 45/45 Negative (100%)
- 5.0 ng/mL (50%): 45/45 Negative (100%)
- 7.5 ng/mL (75%): 28 Negative, 17 Positive (37.8% Positive)
- 12.5 ng/mL (125%): 4 Negative, 41 Positive (91.1% Positive)
- 15.0 ng/mL (150%): 45/45 Positive (100%)
This demonstrates appropriate sensitivity around the cutoff. |
| Analytical Specificity (Cross-Reactivity): | The device should generally not cross-react with structurally similar compounds at high concentrations, or with common medications/endogenous substances, to avoid false positives. Related Buprenorphine metabolites are expected to show some level of cross-reactivity. | Related Compounds:
- Buprenorphine-glucuronide: Positive at 7.5 ng/mL (133% cross-reactive)
- Norbuprenorphine: Positive at 50 ng/mL (20% cross-reactive)
- Norbuprenorphine-glucuronide: Positive at 75 ng/mL (13% cross-reactive)
Non-Reacting Opiates: All listed (Codeine, Diacetylmorphine, Hydrocodone, etc.) showed "None Detected" at 100,000 ng/mL (or highest level tested). These non-reactive opiates also did not affect expected results when spiked with Buprenorphine at 5 ng/mL and 15 ng/mL.
Non-Crossreactive Endogenous Compounds & Common Drugs: None of the 13 endogenous compounds or 16 common drugs tested at high concentrations (typically 100 µg/mL) affected the expected Buprenorphine results at 5 ng/mL and 15 ng/mL. This indicates high specificity. |
| Interference (pH & Specific Gravity): | The device's performance should not be significantly affected by variations in urine pH or specific gravity within typical physiological ranges encountered in clinical samples. | pH: No interference observed; samples fortified to 5 ng/mL (negative) and 15 ng/mL (positive) gave expected results across pH 5.0, 6.0, 7.0, and 8.0.
Specific Gravity: No interference observed; samples fortified to 5 ng/mL (negative) and 15 ng/mL (positive) gave expected results across specific gravity 1.003, 1.015, and 1.030. |
| Clinical Accuracy/Agreement (with LC/MS/MS): | High agreement expected with a confirmatory method (LC/MS/MS), particularly for samples near and above the cutoff. Low false positive rate for negative samples. | Overall Agreement: - Positive Agreement: 100% (72 High Positive + 8 Near Cutoff Positive = 80 samples correctly identified as Positive).
- Negative Agreement: 96.1% (70 No Drug + 4 Near Cutoff Negative = 74 samples correctly identified as Negative). The report indicates 3 "Near Cutoff Negative" samples (between -50% and cutoff, i.e., between 5 and 10 ng/mL) were reported as positive by the device (potentially false positives or very low positives for a screening test). The three specific discordant samples were: total buprenorphine at 5 ng/mL, 7 ng/mL, and 9 ng/mL, all reported as positive by the MEDTOX test. Since the cutoff is 10 ng/mL, detecting positives below the cutoff represents a level of sensitivity for a screening test. The device had 0 false positives for samples with no drug. |
2. Sample Sizes and Data Provenance
-
Analytical Sensitivity (Precision) Test Set:
- Sample Size: 6 concentrations x 45 observations (triplicate testing on 5 different intervals by 3 operators) = 270 total observations.
- Data Provenance: Drug-free urine spiked with standard drug solutions. This is laboratory-controlled, not human patient data.
-
Analytical Specificity (Cross-Reactivity) Test Set:
- Sample Size:
- Cross-reacting metabolites: Tested with standards, results expressed as minimum concentration for positive result.
- Non-reacting opiates: Tested at 100,000 ng/mL, then spiked into Buprenorphine-containing urine (5 ng/mL and 15 ng/mL) in triplicate by in-house operators.
- Endogenous Compounds & Common Drugs: Spiked into Buprenorphine-containing urine (5 ng/mL and 15 ng/mL) in triplicate by in-house operators.
- Data Provenance: Laboratory-controlled samples using reference standards and drug-free urine.
- Sample Size:
-
Interference (pH & Specific Gravity) Test Set:
- Sample Size: 4 pH levels x 3 replicates; 3 specific gravity levels x 3 replicates. Each fortified with Buprenorphine at 5 ng/mL and 15 ng/mL.
- Data Provenance: Laboratory-controlled samples.
-
Clinical Accuracy Test Set:
- Sample Size: Total not explicitly stated, but derived from the table: 70 (No Drug) + 7 (Near Cutoff Negative) + 8 (Near Cutoff Positive) + 72 (High Positive) = 157 clinical urine samples.
- Data Provenance: Retrospective clinical urine samples obtained from MEDTOX® Laboratories. The country of origin is not specified but implicitly assumed to be the USA, given the FDA submission.
3. Number of Experts for Ground Truth and Qualifications
- Analytical Studies: "in-house operators" are mentioned. Their specific qualifications (e.g., years of experience, specific certifications) are not detailed.
- Clinical Accuracy Study: The ground truth was established by LC/MS/MS results. While LC/MS/MS is a highly precise analytical method, the interpretation of these results might involve expert toxicologists or lab personnel. The number and qualifications of such "experts" for LC/MS/MS confirmation are not provided, as the method itself serves as the objective reference standard.
4. Adjudication Method for the Test Set
- Analytical Studies: No formal "adjudication" is described beyond reporting the direct visible results observed by "in-house operators."
- Clinical Accuracy Study: No multi-reader adjudication method (like 2+1 or 3+1) was used for the device's interpretation. The device's visual results were compared directly against the LC/MS/MS results. The "in-house operators" interpreted the results visually at five (5) minutes, and also at 15 minutes with identical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or described. This submission focuses on the standalone performance of the device relative to established analytical methods. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be provided.
6. Standalone Performance
Yes, extensive standalone performance was done. All studies described (analytical sensitivity, specificity, interference, and clinical accuracy) evaluate the algorithm's (in this case, the immunochromatographic test strip's visual output) performance without human-in-the-loop assistance in the sense of a diagnostic interpretation aid. The "in-house operators" merely read and recorded the visible bands, they were not "assisted" by an algorithm for diagnosis. The device itself is a standalone screening tool.
7. Type of Ground Truth Used
- Analytical Studies (Sensitivity, Specificity, Interference): Laboratory-prepared spiked samples with known concentrations of Buprenorphine and other substances.
- Clinical Accuracy Study: Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) results, which is a highly sensitive and specific confirmatory analytical method for drug detection.
8. Sample Size for the Training Set
The document does not describe explicit "training" of an algorithm in the modern sense of machine learning. For an immunochromatographic assay, the "training" (development and optimization) would involve experimental iterative refinements of the test strip components (antibodies, reagents, membrane) based on laboratory performance data. No specific sample size for such an iterative development process is provided, nor is it typically reported for this type of device. The reported studies represent the validation of the final device.
9. How the Ground Truth for the Training Set was Established
As noted above, no explicit "training set" with ground truth in the context of an algorithm or AI is described. The development of such a device relies on established chemical and immunological principles, with performance optimized through iterative laboratory testing using known concentrations of analytes and controls (similar to how the analytical studies were conducted for validation).
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(90 days)
MEDTOX DIAGNOSTICS, INC.
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.
| Drug / Specific Drug Cutoff Concentration | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance (Agreement with Confirmatory Methods) |
|---|---|---|
| Buprenorphine (10 ng/mL) | Ability to distinguish negative, near cutoff negative, near cutoff positive, and high positive samples with high accuracy. | Positive: 100% agreement for Near Cutoff Positive (4/4) and High Positive (36/36) samples. |
| Negative: 100% agreement for No Drug (40/40) and Near Cutoff Negative (4/4) samples. | ||
| Opiates (2,000 ng/mL) | Ability to distinguish negative, near cutoff negative, near cutoff positive, and high positive samples with high accuracy. | Positive: 100% agreement for Near Cutoff Positive (4/4) and High Positive (36/36) samples. |
| Negative: 98% agreement for No Drug (40/40), Low Negative (4/4), and Near Cutoff Negative (3/4) samples. (One discordant result: OPI positive at 1,375 ng/mL Morphine, below 2,000 ng/mL cutoff) | ||
| Overall Accuracy (Buprenorphine & Opiates combined) | High overall agreement with confirmatory methods. | Positive: 100% agreement (72+8/80 = 80/80). |
| Negative: 99% agreement (80+4+7/91 = 91/91 for negative results). | ||
| Sensitivity/Precision/Distribution of Random Error (Opiates 2,000 ng/mL) | Expected positive rates at and above cutoff, and negative rates below cutoff. | 0 ng/mL: 45/45 Negative (100%) |
| 1,000 ng/mL (50%): 45/45 Negative (100%) | ||
| 1,500 ng/mL (75%): 31/45 Negative, 14/45 Positive (31% Positive) | ||
| 2,500 ng/mL (125%): 45/45 Positive (100%) | ||
| 3,000 ng/mL (150%): 45/45 Positive (100%) | ||
| Sensitivity/Precision/Distribution of Random Error (Buprenorphine 10 ng/mL) | Expected positive rates at and above cutoff, and negative rates below cutoff. | 0 ng/mL: 45/45 Negative (100%) |
| 5.0 ng/mL (50%): 45/45 Negative (100%) | ||
| 7.5 ng/mL (75%): 30/45 Negative, 15/45 Positive (33% Positive) | ||
| 12.5 ng/mL (125%): 45/45 Positive (100%) | ||
| 15.0 ng/mL (150%): 45/45 Positive (100%) | ||
| Cross-Reactivity (Buprenorphine) | Limited or no cross-reactivity with specified related compounds. | Buprenorphine-glucuronide (50%), Norbuprenorphine (4%), Norbuprenorphine-glucuronide (2%) showed cross-reactivity. Other listed compounds (e.g., Codeine, Morphine) showed None Detected cross-reactivity at 100,000 ng/mL. |
| Cross-Reactivity (Opiates 2,000 ng/mL) | Expected cross-reactivity with opiate-related compounds, limited or no with non-opiates. | Codeine (222%), Diacetylmorphine (80%), Dihydrocodeine (53%), Ethylmorphine (333%), Hydrocodone (143%), Hydromorphone (105%), Levorphanol (40%), 6-Monoacetylmorphine (53%), Morphine 3-β-D-Glucuronide (40%), Morphine 6-β-D-Glucuronide (33%), Norcodeine (5%), Thebaine (80%) showed cross-reactivity. Other listed compounds (e.g., Apomorphine, Naloxone) showed None Detected cross-reactivity at 100,000 ng/mL. |
| Interference (pH, Specific Gravity, Common Drugs) | No interference (affecting expected results) from varying pH, specific gravity, and common drugs. | All pH samples (4.0, 7.0, 9.0 ± 0.1) and specific gravity samples (1.003, 1.015, 1.030 ± 0.001) gave expected negative and positive results when fortified. None of the listed common drugs (e.g., Acetylsalicylic Acid, Acetaminophen) affected the expected results. |
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.
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(67 days)
MEDTOX DIAGNOSTICS, INC.
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):
| Metric / Analytes (Cutoff) | Implicit Acceptance Standard (Desired Performance based on context) | Reported Device Performance (Clinical Accuracy, Table 5) | Reported Device Performance (Sensitivity/Precision, Table 2) |
|---|---|---|---|
| Overall Agreement (Positive) | High agreement with confirmatory methods for samples at or above the cutoff. | OXY (100 ng/mL): 98% (3 positives in near cutoff positive, 36 in high positive matched positive) | Not directly applicable; this table focuses on detection rates at specific concentrations relative to cutoff. Values like "0" negatives at 125% and 150% of cutoff, and "45" positives at these levels, indicate high sensitivity above the cutoff. |
| Overall Agreement (Negative) | High agreement with confirmatory methods for samples below the cutoff. | OXY (100 ng/mL): 100% (40 no-drug negatives, 3 low negative, 4 near cutoff negative matched negative). | Not directly applicable; "45" negatives at 0 ng/mL and 25% of cutoff indicate high specificity below these levels. |
| PPX (300 ng/mL): 100% (4 positives in near cutoff positive, 40 in high positive matched positive) | PPX (300 ng/mL): 92% (45 no-drug negatives, 1 low negative, 2 near cutoff negative matched negative). Note: There are 4 "near cutoff negative" samples that tested "Positive" by the device, and 2 "near cutoff positive" samples that tested "Negative" by the device (Table 6 clarifies the latter as 2 false negatives above cutoff). | ||
| TCA (300 ng/mL): 100% (4 positives in near cutoff positive, 36 in high positive matched positive) | TCA (300 ng/mL): 93% (40 no-drug negatives, 2 low negative, 1 near cutoff negative matched negative). | ||
| Performance near Cutoff (Sensitivity) | Demonstrate high positive detection rate for samples at or above the cutoff concentration (e.g., >80% at 75% cutoff, 100% at 125% cutoff). | For Oxycodone, Propoxyphene, and TCA, all "High Positive (greater than +50%)" samples (total 112) were correctly identified as positive. | OXY (100 ng/mL): 75% cutoff (26/45 Pos), 125% cutoff (45/45 Pos), 150% cutoff (45/45 Pos) |
| Performance near Cutoff (Specificity) | Demonstrate high negative detection rate for samples below the cutoff concentration (e.g., 100% at 0 ng/mL, |
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(344 days)
MEDTOX DIAGNOSTICS, INC.
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.
| Drug / Analyte (Cutoff) | Acceptance Criteria (Implicit) | Reported Device Performance (% Agreement) | Notes |
|---|---|---|---|
| AMP Amphetamine (500 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 96% | |
| Negative: 92% | Some discordance near cutoff. | ||
| BAR Barbiturates (200 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 94% | Some discordance near cutoff. | ||
| BZO Benzodiazepines (150 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 98% | Some discordance near cutoff. | ||
| COC Cocaine (150 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 97% | |
| Negative: 97% | Some discordance near cutoff. | ||
| MAMP Methamphetamine (500 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 98% | |
| Negative: 98% | Some discordance near cutoff. | ||
| MTD Methadone (200 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 98% | |
| Negative: 96% | Some discordance near cutoff. | ||
| OPI Opiates (100 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 94% | Some discordance near cutoff. | ||
| PCP Phencyclidine (25 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 93% | Some discordance near cutoff. | ||
| THC Cannabinoids (50 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 96% | Some discordance near cutoff. | ||
| All Drugs Combined | Overall high agreement with GC/MS or LC/MS/MS. | Positive: 98.5% | |
| Negative: 95.3% |
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.
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(88 days)
MEDTOX DIAGNOSTICS, INC.
The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription point-of-care use including physician office laboratories and central laboratory settings. It is also intended for workplace settings, criminal justice or forensic settings, and drug rehabilitation centers. MEDTOX® OXYCODONE is not for over-the-counter sale. The test detects oxycodone at concentrations 100 ng/mL and above. THE MEDTOX® OXYCODONE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT.
Each test strip contains antibody colloidal gold, a drug conjugate and a control line. A mouse monoclonal antibody specific to oxycodone is mixed with colloidal gold and applied to the sample well pad of the strip. Drug is conjugated to protein and immobilized at the test line. Strips have an anti-mouse immunoglobulin antibody immobilized at the control line. The anti-mouse antibody binds the mouse antibody coated on the colloid gold, When urine is applied to the sample well of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strip carrying the red antibody-colloidal gold with it.
MEDTOX® OXYCODONE Test System: Acceptance Criteria and Performance Study Summary
This document describes the acceptance criteria and performance study results for the MEDTOX® OXYCODONE Test System, an immunochromatographic test strip for the rapid, qualitative detection of oxycodone in human urine. The information is extracted from the 510(k) summary K060351.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| 75% below cutoff (25 ng/mL) | Consistent negative results | 100% negative results |
| 50% below cutoff (50 ng/mL) | Majority negative results | 93% negative results |
| At cutoff (100 ng/mL) | Majority positive results (or clear distinction at cutoff) | 93% positive results |
| 25% above cutoff (125 ng/mL) | Consistent positive results | 98% positive results |
| 50% above cutoff (150 ng/mL) | Consistent positive results | 100% positive results |
| Point-of-Care (POC) Precision | Similar performance to in-house professional study | "Similar to the professional study" for most levels; consistent at 0 and 150 ng/mL |
| **Analytical Specificity | ||
| (Cross-Reactivity)** | Oxycodone: Positive at 100 ng/mL (100% reactivity) | |
| Oxymorphone: Significant cross-reactivity expected (compared to predicate) | ||
| Other opiates/compounds: Low or no cross-reactivity | Oxycodone: Positive at 100 ng/mL (100% reactivity) | |
| Oxymorphone: Positive at 200 ng/mL (50% reactivity) | ||
| Codeine: Positive at 5,000 ng/mL (2%) | ||
| Ethylmorphine: Positive at 5,000 ng/mL (2%) | ||
| Dihydrocodeine: Positive at 10,000 ng/mL (1%) | ||
| Hydrocodone: Positive at 75,000 ng/mL ( |
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(251 days)
MEDTOX DIAGNOSTICS, INC.
The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine. It is intended for prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings. SURE-SCREEN is not for over-the-counter sale.
The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine.
Here's an analysis of the provided text regarding the Sure-Screen® Drugs of Abuse Test System, focusing on acceptance criteria, study details, and ground truth establishment:
Disclaimer: The provided text is a 510(k) premarket notification letter and the "Indications for Use" section. It's important to note that this document describes the device and its intended use, but it does not contain a detailed study report that would typically include comprehensive acceptance criteria, specific performance metrics, or a breakdown of a validation study with sample sizes, expert qualifications, or adjudication methods in the granular detail requested. The information below is extracted and inferred from the provided text to the best extent possible.
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "cutoff concentrations" which act as a key performance criterion for qualitative drug tests. The device's performance is described in terms of its ability to detect these drug classes at or below these specified cutoffs.
| Drug Class (Analyte) | Acceptance Criterion (Cutoff Concentration) | Reported Device Performance (Implied) |
|---|---|---|
| Amphetamines (d-Amphetamine) | 300 ng/mL | Detects at 300 ng/mL |
| Benzodiazepines (Nordiazepam) | 200 ng/mL | Detects at 200 ng/mL |
| Cocaine (Benzoylecgonine) | 100 ng/mL | Detects at 100 ng/mL |
| Methamphetamine (d-Methamphetamine) | 300 ng/mL | Detects at 300 ng/mL |
| Methadone (Methadone) | 200 ng/mL | Detects at 200 ng/mL |
| Opiates (Morphine) | 100 ng/mL | Detects at 100 ng/mL |
| Phencyclidine (Phencyclidine) | 25 ng/mL | Detects at 25 ng/mL |
| Cannabinoids (11-nor-9-carboxy-Δ9-THC) | 40 ng/mL | Detects at 40 ng/mL |
Note on "Reported Device Performance": The document states these are the "cutoff concentrations" at which the device detects the drug classes. It also mentions: "Additionally, many of these tests are positive at levels significantly below the claimed cutoff concentration." This implies that the device is at least as sensitive as, if not more sensitive than, the stated cutoffs. However, specific sensitivity or specificity percentages against a ground truth are not provided in this document excerpt.
Regarding the Study (Based on available information):
Since this is a 510(k) premarket notification, the FDA determination of "substantial equivalence" is based on the comparison of the device to legally marketed predicate devices. The document implies that performance claims for the Sure-Screen® system were evaluated, but it does not provide a detailed study report regarding a specific clinical trial or validation study with all the requested parameters.
Here’s what can be inferred/not inferred:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It would typically involve urine samples, but the source and collection methodology are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The document states that "Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method." This implies that experts in analytical chemistry or laboratory professionals proficient in these techniques would be involved in establishing the ground truth. No specific number or credential level (e.g., "radiologist with 10 years of experience") is mentioned for clinical interpretation, as the test is primarily analytical.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. For analytical tests like this, adjudication typically refers to the process of confirming results using a gold standard method (GC/MS or LC/MS/MS) rather than expert consensus on visual interpretation.
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
- MRMC Study: Not applicable to this device as described. This is an in vitro diagnostic qualitative rapid test for drug detection, not an AI-powered diagnostic imaging tool that requires human reader interpretation with or without AI assistance. The document refers to "operators" who use the device, but their "improvement with AI" is not a relevant metric here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: This device is a manual, qualitative immunoassay test strip. It doesn't involve an "algorithm" in the sense of AI. Its performance is inherent to the chemical reactions on the strip. The "operators" interpret the visual results. The performance would implicitly be its standalone analytical performance against the cutoff concentrations, but not in the context of an "algorithm."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The document explicitly states: "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."
- Therefore, the ground truth is chemical confirmation using gold-standard analytical methods (GC/MS or LC/MS/MS), which would be interpreted by qualified laboratory personnel.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified. For this type of immunoassay, there wouldn't typically be a "training set" in the machine learning sense. Instead, product development involves optimizing reagents and concentrations, and then validating performance with a series of samples. If "training set" refers to samples used during product development and optimization, that information is not provided.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Similar to point 8, the concept of a "training set" with ground truth as used in AI development is not directly applicable. If samples were used during development to optimize the test's performance, the ground truth for those samples would also be established by reference laboratory methods like GC/MS or LC/MS/MS.
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(25 days)
MEDTOX DIAGNOSTICS, INC.
The 3 Panel TCA/BAR/BZO is a one-step immunochromatographic test for the rapid, qualitative detection of tricyclic antidepressants, barbiturates and benzodiazepines and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations:
Tricyclis antidepressants (Desipramine) - 50 ng/ml
Barbiturates (Phenobarbital)-200 ng/ml
Benzodiazepines (Nordiazepam)-300 ng/mL
This product is not for over-the-counter-sale
The 3 Panel provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result
Not Found
I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as requested by the user. The document is a 510(k) clearance letter from the FDA for a device named Profile® -ER TCA/BAR/BZO, along with its indications for use statement. While it mentions cutoff concentrations for detected substances, it does not outline specific acceptance criteria for a study, nor does it describe the study itself.
Therefore, I cannot extract any of the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- Whether a multi reader multi case (MRMC) comparative effectiveness study was done or its effect size
- Whether a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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(104 days)
MEDTOX DIAGNOSTICS, INC.
Verdict®-II THC/COC/OPI/MAMP-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine (MAMP), and 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations:
Cannabinoids (11 nor-9-carboxy-Δ 9 -THC)-50 ng/ml
Opiates (morphine)-300 ng/ml
Cocaine (benzoylecgonine)-300 ng/mL
Methamphetamine (MAMP)-1000 ng/mL
3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL
This product is not for over-the-counter-sale
Verdict®-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result
Not Found
This is an FDA 510(k) clearance letter for the Verdict®-II THC/OPI/COC/MAMP-MDMA, a rapid, qualitative immunochromatographic test for the detection of various drugs and their metabolites. The provided document details the indications for use but does not contain the specific study data, acceptance criteria, or performance metrics typically requested for a device.
Therefore, many of the requested items cannot be extracted directly from this document.
However, I can extract the indication for use and the cut-off concentrations, which are fundamental to understanding the device's intended performance.
Acceptance Criteria and Reported Device Performance (Based on provided information):
The document defines the cut-off concentrations for detecting the major metabolites of the specified drugs. While it doesn't explicitly state "acceptance criteria" in a table format, these cut-off levels inherently define the performance target for the device's qualitative detection. It does not provide data on the device's actual performance against these cut-offs (e.g., sensitivity, specificity, accuracy).
| Analyte (Metabolite) | Cut-off Concentration (ng/ml) | Reported Device Performance (N/A – not in document) |
|---|---|---|
| Cannabinoids (11 nor-9-carboxy-Δ⁹-THC) | 50 | Not provided |
| Opiates (morphine) | 300 | Not provided |
| Cocaine (benzoylecgonine) | 300 | Not provided |
| Methamphetamine (MAMP) | 1000 | Not provided |
| 3,4-methylenedioxymethlyamphetamine (MDMA) | 1500 | Not provided |
Since the provided document is a 510(k) clearance letter, it primarily states that the device is substantially equivalent to a predicate device and provides its intended use and general characteristics. It does not include the detailed study report that would contain the specific information requested for points 2 through 9.
Therefore, for the following points, the answer is "Not provided in the document."
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
- 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): Not provided in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- 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 for this type of diagnostic test (which is not an AI-assisted imaging device). Not provided in the document.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an immunochromatographic test, not an algorithm. Its performance is inherent to the chemical reaction. Not provided in the document.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. For drug tests, ground truth typically involves a confirmatory method like GC/MS. The document specifies GC/MS as the preferred confirmatory method but doesn't detail how it was used in a study.
- The sample size for the training set: Not applicable (not an AI device). Not provided in the document.
- How the ground truth for the training set was established: Not applicable (not an AI device). Not provided in the document.
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(28 days)
MEDTOX DIAGNOSTICS, INC.
Verdict®-II Propoxyphene/Methamphetamine-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of methamphetamine (MAMP), 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites; propoxyphene, and its main metabolite norpropoxyphene. The test detects the major metabolites of these drugs at the following cutoff concentrations:
Methamphetamine (MAMP)-1000 ng/mL
3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL
Norpropoxyphene (Main metabolite of propoxyphene)-300 ng/mL
This product is not for over-the-counter-sale
Verdict®-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a device called "Verdict®-II Propoxyphene/Methamphetamine-MDMA." This document does not contain a detailed study report with the specific acceptance criteria and performance data requested. It primarily focuses on the regulatory approval process and the intended use of the device.
Therefore, I cannot provide the requested information based on the given input, as the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or their data provenance.
- Information about experts, adjudication methods, MRMC studies, or standalone algorithm performance.
- Details on how ground truth was established for training or test sets, or the sample size for the training set.
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(52 days)
MEDTOX DIAGNOSTICS, INC.
VERDICT® II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/ MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.
VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (VERDICT®-II PROPOXYPHENE ) |
|---|---|
| Rapid, qualitative detection of propoxyphene and its metabolite (norpropoxyphene) in human urine. | The device provides rapid, qualitative detection of propoxyphene and norpropoxyphene in human urine. |
| Detection of norpropoxyphene at 300 ng/mL. | The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The adjudication method is not mentioned in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size of human reader improvement with AI assistance, is provided in the document. This is an in vitro diagnostic device, and such studies are typically not performed for this type of product.
6. Standalone Performance (Algorithm Only)
The device, VERDICT®-II PROPOXYPHENE, is described as a "one-step immunochromatographic test." This indicates it's a physical test kit, not an algorithm, and therefore the concept of standalone (algorithm-only) performance does not apply. The document does state that the test provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result" (e.g., GC/MS). This implies the device's performance is as a screening tool, not a definitive standalone diagnostic.
7. Type of Ground Truth Used
The document explicitly states that the device provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GAS CHROMATOGRAPHY/ MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD." This indicates that the ground truth for validating the device's performance would be established by a "gold standard" confirmatory method like GC/MS.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document focuses on the device's indications for use and substantial equivalence to a predicate device. It does not detail the specific methodology for establishing ground truth for any training set. However, given the nature of the device (a rapid screening test for drug detection) and the mention of GC/MS as a confirmatory method, it's highly probable that samples with known concentrations of propoxyphene and norpropoxyphene (likely confirmed by methods like GC/MS) would be used to develop and validate such a test.
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