Search Results

The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

AMP Amphetamine 500 ng/ml
BAR Secobarbital 300 ng/ml
BUPG Buprenorphine Glucuronide 10 ng/ml
BZO Oxazepam 300 ng/ml
COC Benzoylecgonine 150 ng/ml
MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml
MET Methamphetamine 500 ng/ml
MTD Methadone 300 ng/ml
OPI Morphine 300 ng/ml
OXY Oxycodone 100 ng/ml
PCP Phencyclidine 25 ng/ml
PPX Propoxyphene 300 ng/ml
TCA Nortriptyline 1000 ng/ml
THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in single drug analyte cassette dip format and/or double drug analyte cassette dip format. It is intended for prescription point-of-care and overthe-counter consumer use.

These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when a preliminary positive result is indicated.

The ToxCup® Drug Screen Cup is based on the principle of highly specific immunochemical reactions between antigens and antibodies. It utilizes a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. The ToxCup® Drug Screen Cup device consists of individual test strips, in single drug analyte cassette dip format and/or double analyte cassette dip format, assembled into separate chambers of a plastic insert and can detect up to 14 drugs in human urine at various cutoff concentrations. The presence of a color band at a specific test region indicates a negative result for that particular test. The absence of a color band at a specific test region indicates presumptive positive result for that particular test.

A control band at the control region should always appear regardless of the presence of the drug or its metabolites. The presence of the control band during testing serves as a built in control which indicates that the test has completed and is valid.

The provided text describes the ToxCup® Drug Screen Cup, a qualitative lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine. The acceptance criteria and the study performance reported are based on Method Comparison studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion specified for the Method Comparison is a total % agreement of ≥ 95%. The text states that the predicate device (Amedica Home Drug Test Cup) had a total % agreement of ≥ 93%. While the specific percentages for the ToxCup® Drug Screen Cup are not detailed in the provided excerpt, the "Differences" table (Page 5) implies that the new device meets or exceeds this threshold, as it lists "≥ 95%" for "Method Comparison Total % agreement". The conclusion explicitly states: "The performance characteristics studies performed demonstrate substantial equivalency between the ToxCup® Drug Screen Cup, the predicate kit Amedica Home Drug Test Cup."

Important Note: The provided text only explicitly states the acceptance criterion for "Method Comparison Total % agreement" in the "Differences" table between the subject device and the predicate device. It does not provide specific numerical results for each drug analyte or for other performance characteristics like stability, optimal read time, precision/reproducibility, or specificity/interference, beyond listing that these studies were performed.

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

The provided summary does not explicitly state the sample size used for the test set in the Method Comparison study, nor does it mention the country of origin of the data or whether the study was retrospective or prospective.

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

The document does not provide information about experts used to establish ground truth for the test set. Drug screening tests like this typically use laboratory-confirmed quantitative methods (e.g., GC/MS) as the gold standard for ground truth, rather than expert interpretation of the rapid test results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. This type of device provides a visual qualitative result (presence or absence of a color band) and the "ground truth" is typically established by an independent, more definitive laboratory method.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study (MRMC) is generally more relevant for imaging devices where human interpretation is a primary factor. The ToxCup® is a rapid immunoassay for drugs in urine.

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

The device itself is a standalone, qualitative lateral flow immunoassay. Its performance characteristics, such as the Method Comparison, are evaluated based on the device's ability to produce a correct visual result (positive or negative) compared to a gold standard. Human interpretation of the result is part of how the device is used (reading the presence or absence of a color band), but the performance studies focus on the accuracy of the test itself. There is no "algorithm only" component in the traditional sense of AI/image analysis without human-in-the-loop performance, as the device's output is the visual result.

7. The Type of Ground Truth Used

The ground truth for preliminary positive results is established by a "more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS)." This is explicitly stated: "For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used." This is a gold standard laboratory method for drug detection and quantification.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. Immunoassays like the ToxCup® are designed and optimized through a development process, but they don't typically involve "training sets" in the same way machine learning algorithms do. The performance studies described (Precision/reproducibility, Method Comparison, Specificity and Interference, Consumer Study, etc.) are verification and validation studies of the developed product.

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

As there is no mention of a "training set" in the context of machine learning, there is no description of how ground truth for such a set was established. The development of such an immunoassay would involve standard laboratory practices and analytical chemistry to determine appropriate antibody and antigen concentrations and reaction conditions to achieve desired sensitivity and specificity.

Ask a specific question about this device

The Fastect® II PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL.

The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
COC Benzoylecgonine 300 ng/ml
OPI Morphine 300 ng/ml
MET Methamphetamine 500 ng/ml
AMP Amphetamine 1000 ng/ml
PCP Phencyclidine 25 ng/ml
BZO Oxazepam 300 ng/ml
BAR Secobarbital 300 ng/ml
MTD Methadone 300 ng/ml
TCA Nortriptyline 1000 ng/ml
MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml
OXY Oxycodone 100 ng/ml
BUP Buprenorphine 10 ng/ml
PPX Propoxyphene 300 ng/ml

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to non-professionals.

These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickTox® Drug Screen Dipcard, Fasted® II Drug Screen Dipstick or Fasted® II PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.

The Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene contain multiple drugs and drug metabolites in addition to Propoxyphene. Propoxyphene is added as a new analyte. The Fastect® II PPX Drug Screen Dipstick only contains the propoxyphene analyte. All dipstick and dipcard devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and all devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites.

The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Propoxyphene in human urine at a cutoff concentration of 300 ng/ml. These tests can be performed without the use of any additional instruments.

A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.

The provided document describes the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard devices, which are lateral flow immunoassays for the qualitative detection of Propoxyphene (PPX) and other drugs in human urine at specified cutoff concentrations.

1. Table of Acceptance Criteria and Reported Device Performance (Focus on Propoxyphene as it's the new analyte):

The document does not explicitly state "acceptance criteria" through numerical thresholds for sensitivity, specificity, or accuracy in a traditional sense. Instead, the acceptance criterion for regulatory approval appears to be demonstrating substantial equivalency to a predicate device (ACON® multi-CLINTM Drug Screen Test Device K041685) for the detection of Propoxyphene at a 300 ng/ml cutoff. The "Performance Specifications" section outlines the types of analytical studies conducted to establish this equivalency.

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

The document lists the types of performance characteristic studies performed (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) but does not provide details on the sample sizes used for these test sets.

The data provenance (e.g., country of origin, retrospective or prospective) is not specified in this summary.

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

This information is not provided in the document. For drug screening tests like these, ground truth is typically established through a reference method (like GC/MS or LC/MS), not through a panel of experts interpreting results.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. When a reference method like GC/MS is used to establish ground truth, there isn't typically an "adjudication method" involving multiple human readers interpreting the output of the reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study evaluates the performance of human readers, sometimes with and without AI assistance. The described devices are in vitro diagnostic tests that provide a visual qualitative result, intended for direct use by a professional without a complex interpretation process that would typically involve multiple readers. The document highlights the need for confirmation by GC/MS or LC/MS for preliminary positive results, indicating that human interpretation of the dipstick is a preliminary step, not a diagnostic endpoint requiring complex reader studies.

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

Yes, the performance studies described are essentially standalone performance evaluations. The devices are immunochromatographic tests that yield a visual result (presence or absence of a line). The "performance characteristics studies" (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) evaluate the inherent analytical performance of the device itself, independent of human interpretation variability after the preliminary visual reading. The device's "algorithm" is the biochemical reaction and the visual readout mechanism.

7. The Type of Ground Truth Used:

The document states: "All preliminary positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS or LC/MS confirmatory analysis." This strongly implies that Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) would be the gold standard or "ground truth" used to validate the performance of these devices in a method comparison study. These are highly sensitive and specific analytical techniques for drug detection and quantification.

8. The Sample Size for the Training Set:

This information is not provided as these are not machine learning/AI devices in the traditional sense that require a "training set." The development of such immunoassay devices involves laboratory testing and optimization of reagents, antibodies, and manufacturing processes, rather than training on a dataset in the way an AI algorithm would be trained.

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

As these are not traditional AI devices with a "training set," this question is not directly applicable. The "ground truth" for optimizing the assay's performance during development would rely on known concentrations of propoxyphene and its metabolites, confirmed by highly accurate analytical methods like GC/MS or LC/MS.

Ask a specific question about this device

The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.

These products are for in vitro diagnostic use and intended for prescription point of care use.

The Orated® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect® Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.

The Oratect® Oral Fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The test principle is a competitive lateral flow immunochromatographic assay. The presence of analyte will produce a negative signal.

Acceptance Criteria and Device Performance for Oratect® Oral Fluid Drug Screen Devices

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the document consistently uses "Accuracy results against reference method >90%" as the performance metric for the subject device and "Accuracy results against reference method >89%" for the predicate. For the purpose of this summary, we will infer the acceptance criterion to be >90% accuracy against a reference method.

The reported device performance based on the "Accuracy" row in the comparison table is also >90% against reference method.

Ask a specific question about this device

The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are rapid immunochromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. The devices are intended for professional use only. They are not intended for over-the-counter sale to non-professionals.

The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard tests are used to obtain visual, qualitative results. A more specific alternate method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS are the preferred confirmatory methods.

The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are based on the principle of highly specific immunochemical reactions between antigens and antibodies. Both devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. If Buprenorphine is present in the urine, it competes with the immobilized drug conjugate for the limited binding sites on the colored antibody colloidal gold conjugate. When a sufficient amount of drug is present, the drug will saturate the antibodies, and the colored colloidal gold conjugate cannot bind to the drug conjugate immobilized on the membrane. Thus, the absence of the purple-red band at the test region indicates a preliminary positive result. However, if there is no drug present to compete for the binding sites of the colored colloidal gold conjugate, it binds to the immobilized drug conjugate to form a visible purple-red band at the test region of the membrane. Thus, the presence of a purple-red band at the test region indicates a negative result. The Fastect II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. These tests can be performed without the use of any additional instruments.

A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.

The provided text describes the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices, which are immunochromatographic tests for the qualitative detection of Buprenorphine in human urine. The acceptance criteria are based on their accuracy in detecting Buprenorphine at a cut-off concentration of 10 ng/ml compared to GC/MS analysis and a predicate device.

Here's a breakdown of the requested information:

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

The acceptance criteria are implied by the desired agreement with GC/MS and the predicate device. The performance is reported as percent agreement.

Fastect® II BUP Drug Screen Dipstick Test

QuickTox® Drug Screen Dipcard Test

Note: The acceptance criteria are not explicitly stated as numerical targets (e.g., "95% agreement"). Instead, the study reports the observed agreement to demonstrate substantial equivalence.

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

• Sample size: A total of 90 urine specimens were evaluated.
• Data provenance: 50 urine samples were clinical specimens, meaning they were obtained from patients. The remaining samples (40) were likely laboratory-prepared or spiked samples to ensure representation across different concentration ranges. These were previously analyzed by GC/MS.
  • Country of origin: Not specified.
  • Retrospective or prospective: The description states "clinical specimens previously analyzed by GC/MS," which indicates a retrospective collection and analysis for the clinical samples. The preparation of "near-negative" and "near-positive" samples suggests some prospective manipulation of existing samples or creation of new ones.

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

• This information is not provided in the text. The ground truth was established by GC/MS analysis, which is an analytical laboratory method, not human expert consensus.

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

• None in the context of human adjudication. The ground truth was established by GC/MS analysis, an objective laboratory method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. This device is a rapid immunochromatographic test, and its interpretation is typically straightforward (presence or absence of a band). There is no mention of human readers assisting an AI, or vice versa. The comparison was between the device's results, a predicate device, and GC/MS.

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

• Yes, a standalone study was done. The "accuracy" study directly compared the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices' results against GC/MS analysis, without human interpretation influencing the device's output. The devices themselves produce a visual result (presence/absence of a band) which is then read. While a human reads the band, the "performance" described refers to the device's ability to produce the correct band pattern.

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

• The ground truth was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for confirming the presence and concentration of substances like Buprenorphine in urine.

8. The sample size for the training set

• The text does not explicitly mention a training set sample size. This document describes performance validation for a medical device (screening test), not the development and training of a machine learning model. The devices are based on immunochemical reactions, not algorithms that require training data in the typical sense.

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

• As the device is based on immunochemical principles rather than a machine learning algorithm, the concept of a "training set" and its "ground truth establishment" in the AI/ML context is not applicable. The underlying chemical reactions are inherently designed to detect the target analyte. The performance studies mentioned are for validation and verification, not for training a model.

Ask a specific question about this device

The Monitect® MDMA Drug Screen Cassette Test and the Fastect™ II Drug Screen Dipstick Test are in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine above the cutoff concentration of 500 ng/mL. Both the Monitect® and Fastect™ II devices provide visual, qualitative results only. The devices are intended for in vitro diagnostic use in professional and laboratory settings only. The devices are not intended for over-the-counter sale to lay persons.

Not Found

The provided text describes a 510(k) premarket notification for two drug screen tests, Monitect® MDMA Drug Screen Cassette Test and Fastect™ II MDMA Drug Screen Dipstick Test, designed to detect MDMA in human urine. However, the document is a regulatory approval letter and an indications for use statement; it does not contain a study that proves the device meets specific acceptance criteria.

Therefore, I cannot directly extract the requested information about acceptance criteria and a detailed study from this document. The information typically found in such a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is absent from this regulatory communication.

The document only states that the FDA reviewed the 510(k) and determined the devices are substantially equivalent to legally marketed predicate devices for the stated indications for use. This determination implies that the manufacturer would have submitted data demonstrating performance, but that specific data is not included in this letter.

Ask a specific question about this device

The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations:

AMP d-Amphetamine 1000 ng/ml
COC Benzoylecgonine 300 ng/ml
MET500 d-Methamphetamine 500 ng/ml
OPI2000 Morphine 2000 ng/ml
OPI300* Morphine 300 ng/ml
PCP Phencyclidine 25 ng/ml
THC 11-nor-Delta^9 -Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml

*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated.

The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-ofabused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Not Found

This looks like information from a 510k submission to the FDA for a drug screening cup. The document is primarily an FDA clearance letter and an "Indications For Use" statement. It does not contain the detailed study information needed to describe acceptance criteria and device performance in the way requested.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance beyond the cutoff concentrations. While it lists the cutoff concentrations, it doesn't give sensitivity, specificity, accuracy, or other performance metrics against these cutoffs.
• Sample sizes for the test set or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (this is a physical test device, not an algorithm).
• The specific type of ground truth used (e.g., confirmatory lab results).
• Sample size or ground truth establishment for a training set (again, this is a physical test, not an AI/ML algorithm).

The only relevant information that can be extracted related to "acceptance criteria" (in the sense of target concentrations for detection) is from the "Indications For Use" table:

1. Table of Acceptance Criteria (Cutoff Concentrations) and Reported Device Performance (Implied target for detection):

Regarding the other points, the document provides insufficient information:

2. Sample size used for the test set and the data provenance: 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: Not provided in the document.
4. Adjudication method for the test set: Not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable for this type of device (drug screening cup, not AI assistance for human readers).
6. If a standalone (i.e. algorithm only, without human-in-the loop performance) was done: Not applicable for this type of device (physical test, not an algorithm).
7. The type of ground truth used: Not explicitly stated, but for drug screens, it would typically be confirmed by a more precise analytical method like GC-MS.
8. The sample size for the training set: Not applicable/provided. This is not an AI/ML device that uses a "training set" in that sense.
9. How the ground truth for the training set was established: Not applicable/provided.

To get the detailed study information regarding sensitivity, specificity, positive predictive value, negative predictive value, exact sample sizes, and how ground truth was established (e.g., confirmatory GC-MS), one would typically need to refer to the full 510(k) submission document or the device's Instructions For Use (IFU). This document is just the FDA clearance letter and indications for use.

Ask a specific question about this device

The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are in vitro screening test devices for the rapid detection of Oxycodone in human urine. The tests are standardized to detect Oxycodone at a cut-off concentration of 100 ng/mL. The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are used to obtain visual, qualitative results. The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. The devices are intended for professional in vitro diagnostic use only. They are not intended for over-the-counter sale to lay users.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a drug screen test. It does not contain the detailed information required to answer the questions about acceptance criteria and the specific study that proves the device meets them. This type of document typically confirms substantial equivalence to a predicate device but does not include the full technical details of performance studies.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine). morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow:

The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Not Found

This document is a 510(k) premarket notification from the FDA for a diagnostic device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria in the typical format of a clinical trial or algorithm validation study.

However, based on the provided text, we can infer some aspects and extract what information is present, and explicitly state what is missing.

Here's an analysis based on your request, focusing on the available information:

Device Name: QuickTox™ Multiple Drug Dipcard - COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA

Indications For Use: The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

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

The provided document lists "cutoff concentrations" for each drug, which serve as the analytical acceptance criteria for detecting the presence of that drug. The document does not provide specific reported device performance metrics (like sensitivity, specificity, accuracy, positive predictive value, negative predictive value) against a gold standard for these cutoffs in a study. It only states the intended cutoffs.

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

This information is not provided in the document. The document is a regulatory clearance letter, not a study report.

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)

This information is not provided in the document. For drug tests, ground truth is typically established by more definitive analytical methods (e.g., GC/MS), not by expert human readers.

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

This information is not provided in the document. Adjudication methods are typically relevant for subjective interpretations (e.g., imaging studies), whereas this device provides visual, qualitative results based on a chemical reaction.

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

An MRMC study is not applicable and was not done as described in the document. This device is an in vitro diagnostic test (a chemical assay), not an AI-assisted diagnostic tool that human readers would interpret. The document refers to "visual, qualitative results for multiple drugs-of-abused in human urine" which implies a direct observation of a color change or line on the dipcard, not interpretation by human readers in the context of an MRMC study.

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

This device itself is a standalone test, but it is not an "algorithm" in the typical sense of a software-based AI system. It's a chemical immunoassay. The device provides "visual, qualitative results," meaning a human visually interprets the presence or absence of lines on the dipcard. So, while it's a standalone test, it's not "algorithm-only" and does involve human visual interpretation. The document does not describe a study to evaluate this "standalone" performance against a gold standard.

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

The document does not explicitly state the type of ground truth used for any validation study. For drug screening tests, the ground truth is typically established by a confirmatory analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS), which provides highly accurate and quantitative measurements of drug concentrations in urine samples.

8. The sample size for the training set

This information is not provided in the document. As an in vitro diagnostic immunoassay, it doesn't typically have a "training set" in the machine learning sense. Its development involves chemical formulation and optimization.

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

This information is not provided in the document, as the concept of a "training set" with established ground truth is not explicitly mentioned or applicable in the AI/machine learning context for this type of device based on the provided text. The development of such a device involves analytical validation, likely using spiked samples and clinical samples confirmed by reference methods.

Ask a specific question about this device

The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow:

The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine.

The provided document is a 510(k) clearance letter for the QuickTox™ Multiple Drug Dipcard. It describes the device's intended use and the cutoff concentrations for various drugs, but it does not contain a study or data proving the device meets specific acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the document.
• Sample size used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method: Not provided.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not provided.
• Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable as this is a physical diagnostic device, not an AI algorithm.
• Type of ground truth used: Not provided.
• Sample size for the training set: Not applicable as this is a physical diagnostic device, not an AI algorithm.
• How the ground truth for the training set was established: Not applicable as this is a physical diagnostic device, not an AI algorithm.

What the document does provide:

The document primarily serves as an FDA clearance letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies:

• Trade/Device Name: QuickTox™ Multiple Drug Dipcard-COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA
• Regulation Number and Name: 21 CFR 862.3250, Cocaine and cocaine metabolite test system (and other product codes for the other drugs)
• Regulatory Class: Class II
• Indications For Use: An in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine.
• Cutoff Concentrations (which could be considered part of the "acceptance criteria" for qualitative detection thresholds):

• Intended Use Details: Used to obtain visual, qualitative results for multiple drugs-of-abuse in human urine. Intended for professional in vitro diagnostic use only, not for over-the-counter sale.

To obtain the detailed study information you requested (like sample sizes, ground truth establishment, performance metrics beyond cutoffs), one would typically need to review the original 510(k) submission summary or associated scientific literature, which is not provided in this document. The FDA clearance letter summarizes the regulatory decision, but not the underlying technical validation studies in detail.

Ask a specific question about this device

The Scooper™ Drug/Adulterant Test Cup is an in vitro screen test for the rapid detection. The west The Scooper -- Drug/Adulterail: Test Sup Sup son and phencyclidine in human urine. The cutoff concentrations are as follows:

The Scooper™ Drug/Adulteration Test Cup is used to obtain visual, qualitative results The Scooper - Drug/Additeration 2001 Super-the-counter sale to lay persons.

Not Found

This document is a 510(k) premarket notification from the FDA, approving a drug test cup. It does not contain information about a study with acceptance criteria and device performance in the way typically associated with AI-powered diagnostic devices or other medical imaging/diagnostic tools that require extensive clinical validation studies.

The device described, "Scooper™ Drug/Adulteration Test Cup," is an in vitro diagnostic (IVD) device for rapid detection of specific drugs and adulterants in human urine. The approval is based on "substantial equivalence" to legally marketed predicate devices, not on a new clinical study comparing its performance against a gold standard in a detailed manner as requested in the prompt.

Therefore, most of the requested information cannot be extracted from this document because the described approval process does not involve such a study with the specified acceptance criteria format.

However, I can provide the limited relevant information:

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

The document lists "cutoff concentrations" for various drugs. These act as intrinsic performance specifications for the test cups. The approval indicates that the device meets these cutoffs effectively for its intended use as an in vitro screen test.

Note: This document does not provide a table of "reported device performance" against these cutoffs in terms of sensitivity, specificity, or accuracy based on a clinical study where the device results were compared to a gold standard. The approval is based on substantial equivalence.

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

Not applicable. The document does not describe a clinical study with a test set of this nature. The approval is based on substantial equivalence to predicate devices, implying that the device was tested to perform as expected against its stated cutoffs, but not through a large-scale clinical trial with specified sample sizes and provenance.

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):

Not applicable. The approval process for this type of IVD device typically relies on analytical validation against known concentrations and comparison to predicate devices, rather than expert-established ground truth on a test set in a clinical setting.

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

Not applicable. No such clinical test set or adjudication method is described.

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-powered device, nor is it a device that requires human "readers" in the context of interpretation that would necessitate an MRMC study.

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

Not applicable. This is a point-of-care, visually read test cup, not an algorithm.

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

For this type of device, the "ground truth" during its development and validation would primarily be the known concentrations of target analytes (drugs/metabolites) in synthetic or spiked urine samples, and comparison to established methods or predicate devices. It would not typically involve expert consensus, pathology, or outcomes data in the sense of a clinical trial for a diagnostic image analysis algorithm.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device