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The QuikScreen™ Multi (MDMA and OPI) Drug Cup Test consists of competitive binding , lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for OTC and prescription use.

QuikScreen ™ Multi (MDMA and OPI) Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder, which is able to hold the Strip of MDMA and OPI within the container. The membrane of the MDMA test strip is coated with goat anti-mouse antibody and MDMA-Bovine serum albumin conjugate. The membrane of the OPI test strip is coated with goat anti-mouse antibody and OPI-Bovine serum albumin conjugate. The sample pad of the MDMA test strip contains a colloidal gold-labeled mouse monoclonal anti-MDMA antibody. The sample pad of the OPI test strip contains a colloidal gold-labeled mouse monoclonal anti-OPI antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of drug (500ng/ml of MDMA or 300ng/ml of OPI), Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A color line will always appear at the control region. A negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the test result shows 1 line (preliminary positive) you should send the sample for laboratory testing.

Here's a breakdown of the acceptance criteria and the study details for the QuikScreen™ Multi (MDMA and OPI) Drug Cup Test:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • For Total Precision and Cutoff Determination, "positive and negative spiked samples across three (3) different lots of test device" were used. Specific numbers are not provided, but it implies a statistically significant sample to assess reproducibility.
  • For Accuracy, "positive and negative specimens" were used. A specific number is not provided, but the statement "correlated very well" implies a sufficient sample for comparison.
  • For Cross-interference study, "MDMA (500ng/ml cutoff), OPI (300ng/ml cutoff) Strip into the QuikScreen™ Multiple 11 drug cup device" was used. The number of samples tested for cross-interference is not specified.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the context of manufacturing in Tianjin, China (Submitter address), it's likely the studies were conducted there. The samples are human urine.

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

• The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., interpreting results).
• Instead, reference methods (GC/MS or LC/MS) are stated as the confirmatory methods for analytical results. Therefore, the "ground truth" is established by these laboratory-based chemical methods, not by human experts interpreting the device's output.

4. Adjudication Method for the Test Set:

• No explicit adjudication method (e.g., 2+1, 3+1) is described. This is expected given that the device is a rapid diagnostic test, and ultimate confirmation is by instrumental chemical analysis (GC/MS or LC/MS) rather than expert consensus on its visual output.

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 MRMC study was done. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool. Human "reading" is limited to observing color bands, and the focus is on the device's analytical accuracy compared to reference methods. The document does not mention any AI component or human-in-the-loop performance improvement.

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

• This is inherently a standalone performance study of the immunoassay device itself. The "algorithm" is the biochemical reaction and visual readout. The performance characteristics (sensitivity, precision, cutoff determination, accuracy against reference methods, cross-interference) are all evaluated for the device operating independently of any human interpretation beyond simply observing the presence or absence of a line.

7. The Type of Ground Truth Used:

• The primary ground truth used is analytical confirmation by reference methods, specifically GC/MS or LC/MS. For the precision and cutoff determination studies, this would involve comparing the device's visual results to the known concentrations of spiked drug samples, which are analytically verified. For accuracy, it's a comparison against the results of GC/MS or LC/MS for actual specimens.

8. The Sample Size for the Training Set:

• Not applicable / Not explicitly mentioned. This device is a lateral flow immunoassay, not a machine learning model that requires a "training set." Its operating principles are based on biochemistry and antibody-antigen reactions. The "development" of such a device involves optimizing reagents and manufacturing processes, but not training in the AI sense.

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

• Not applicable. As explained above, there is no "training set" for this type of device.

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The ForSure One Step Buprenorphine Drug Cup Test Device is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at cutoff level of 10 ng/mL. The test is intended for prescription and overthe-counter use.

The buprenorphine assay will yield preliminary positive results when buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The ForSure One Step Buprenorphine Drug Cup Test Device shows the drug was or was not present at the cutoff level. The assay provides only a preliminary analytical test result.

A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

ForSure" One Step Buprenorphine Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder which is able to hold the QuikStrip of Buprenorphine within the container. The membrane of the test strip is coated with goat anti-mouse antibody and Buprenorphine-Bovine serum albumin conjugate. The sample pad contains a colloidal gold-labeled mouse monoclonal anti-Buprenorphine antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 ng/ml of Buprenorphine. Unbound colloidal gold labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A Negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to visually read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the Buprenorphine result shows 1 line (preliminary positive) you should send the sample for laboratory testing.

The provided document describes the ForSure™ One Step Buprenorphine Drug Cup Test Device (K122064). This summary focuses on the acceptance criteria and study information as requested.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "A comparison study of positive and negative specimens with GC/MS was performed" for accuracy, without providing specific numbers of specimens.

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

The document does not mention the number of experts used or their qualifications for establishing ground truth. The ground truth method used (GC/MS) is an objective analytical method, not dependent on expert interpretation in the same way as, for example, image review by radiologists.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The ground truth is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a definitive analytical method and does not typically involve adjudication among human experts for preliminary results.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a "visual read single use" diagnostic, where results are read directly, not through interpretation by multiple human readers that would then be compared to AI assistance.

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

The device itself is a standalone diagnostic tool, as it is a "visual read single use" lateral flow immunoassay. The intended use description explicitly states, "The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine." This indicates its standalone performance provides a preliminary result, with confirmatory testing (GC/MS or LC/MS) recommended for positive findings. The performance metrics (Sensitivity, Precision, Cutoff, Accuracy) are related to this standalone analytical performance.

7. Type of Ground Truth Used

The ground truth used for the accuracy study was Gas Chromatography/Mass Spectrometry (GC/MS). The text states: "A comparison study of positive and negative specimens with GC/MS was performed." It also mentions Liquid Chromatography/Mass Spectrometry (LC/MS) as another preferred confirmatory method.

8. Sample Size for the Training Set

The document does not provide information on a "training set" sample size. This device is a lateral flow immunoassay, which is a chemical and biological test, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its development would involve chemical and biological optimization, not data-driven model training.

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

As there is no "training set" in the context of an AI/machine learning algorithm, this question is not applicable. The development of this immunochromatographic assay relies on established biochemical principles and would involve iterative testing against known concentrations of Buprenorphine and its metabolites, similar to how the performance metrics (sensitivity, cutoff, accuracy) are assessed.

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QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.

The device consists of a plastic housing and test stick containing an immunochromatographic strip. The test pad contain colloidal gold conjugate with mouse monoclonal antibodies against beta subunit of hCG and test strip contain mouse monoclonal antibody against alpha subunit of hCG ( test line )and goat antimouse polyclonal antibodies ( Control line ). The device is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine, in some cases as early as 3 days before the expected period.

The provided text is a 510(k) summary for the "QuikResponse™ One Step Midstream Early Pregnancy Test." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or information about ground truth establishment, expert qualifications, sample sizes for test/training sets, or MRMC studies that would be needed to fully answer your request.

The text only states that "The information provided in this pre-market notification demonstrates that QuikResponse™ One Step Midstream Early Pregnancy Test device is substantially equivalent to Firstresponse Pregnancy Test. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supports substantial equivalence to the predicate device."

This statement implies that analytical and possibly clinical studies were conducted and presented to the FDA to demonstrate this equivalence, but the specifics of those studies (acceptance criteria, performance data, methodology, ground truth, etc.) are not included in this public 510(k) summary document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, data provenance, expert information, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

To obtain that information, one would typically need to review the full 510(k) submission, which is not publicly available in this summarized format. The FDA's letter simply acknowledges the substantial equivalence determination based on the submitted information, without detailing the entire submission's contents.

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The assay provides a simple and rapid analytical screening procedure to detect single or multiple different abused drugs (Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. HPLC is preferred confirmatory method for Tricyclic Antidepressant.

This test is intended for over the counter (OTC) consumer use as the first step in a 2-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding the confirmatory testing - the second step in the process-, along with materials for shipping the urine specimen to the laboratory is included with the test. There are no uniformly recognized levels for Benzodiazepine, Oxycodone, Tricyclic Antidepressant, and Barbiturates. The test is not intended to screen individuals who are prescribed these drugs by a physician; the test my yield positive results for individuals taking such drugs, as prescribed.

New Bay HomeCheck Rapid Single and Multiple(X) Abuse Drug Screen Test Cup Device consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000ng/ml of Amphetamine, 1000ng/ml of Methamphetamine, 50ng of THC, 2000ng/ml of Morphine, 300ng of Benzoylecognine, 25ng/ml of Phencyclidine, 300ng/ml of Benzodiazepine, 300ng/ml of Methadone, 100ng/ml of Oxycodone, 1000ng/ml of Tricyclic Antidepressant, and 300ng/ml of Barbiturates. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided 510(k) summary does not include a detailed study or specific acceptance criteria with reported device performance in the format of a table as requested. This document is a pre-market notification that demonstrates substantial equivalence to existing devices (predicate devices) rather than presenting a performance study against predefined acceptance criteria.

However, I can extract information related to the device's technical specifications and intended use, which inherently imply certain performance expectations for this type of immunoassay.

Here's an attempt to structure the available information, noting the limitations of the provided document:

Reported Device Performance and Implied Acceptance Criteria

For rapid immunoassay drug screening devices like the HomeCheck™ Multiple Drug Cup Test, the primary performance measure is its ability to accurately detect the presence or absence of specific drugs at predefined cutoff concentrations, compared to a gold standard (typically GC/MS). While explicit "acceptance criteria" against which a study directly proves performance are not detailed in this summary, the device's stated cutoffs and comparison to GC/MS as the confirmatory method imply accuracy expectations.

Note: The document focuses on demonstrating substantial equivalence to predicate devices and GC/MS, rather than presenting a dedicated clinical performance study with predefined acceptance criteria and a detailed statistical analysis against those criteria. The "Performance" section would typically contain this information, but it is absent here.

• Amphetamine: 1000 ng/ml
• Methamphetamine: 1000 ng/ml
• THC (Marijuana): 50 ng/ml
• Morphine: 2000 ng/ml
• Benzoylecgonine: 300 ng/ml
• Phencyclidine: 25 ng/ml
• Benzodiazepine (Oxazepam): 300 ng/ml
• Methadone: 300 ng/ml
• Oxycodone: 100 ng/ml
• Tricyclic Antidepressant (Nortriptyline HCl): 1000 ng/ml
• Barbiturates (Secobarbital): 300 ng/ml |
  | Correlation with Confirmatory Method: Preliminary positive results require confirmation by a more specific alternate chemical method. | "Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." (For TCA, HPLC is preferred). This implies the device provides preliminary results that are then validated by GC/MS/HPLC, but no concordance rates are provided in this document. |
  | Assay Time: Completion of test within a specified timeframe. | "5 minutes" assay time. |

Study Information (Based on interpretation of a 510(k) summary)

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

   • Sample Size: Not explicitly stated. The document refers to "summary" and "information provided," suggesting that underlying data was submitted, but the detailed results and sample sizes for performance evaluation are not included in this public summary.
   • Data Provenance: Not specified in this document. Given the submitter is from Tianjin, China, the data could originate from there or other locations. It's also not stated if the data was retrospective or prospective.

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

   • Not applicable in the typical sense for this device. The "ground truth" for drug detection in urine immunoassays is typically established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC), which are analytical gold standards, not by human experts interpreting results. The document states: "GC/MS is the preferred confirmatory method. HPLC is preferred confirmatory method for Tricyclic Antidepressant."

3. Adjudication method for the test set:

   • Not applicable. As noted above, the ground truth is established by analytical methods (GC/MS, HPLC), not by human adjudication of ambiguous cases. The device itself is visually read.

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

   • No MRMC study was done. This device is a rapid immunoassay test cup for drug screening. It does not involve AI or human readers for diagnostic interpretation in the way a medical imaging AI would. The test is visually read by the user (OTC home use) or a professional, and its result is a preliminary positive or negative, with GC/MS/HPLC for confirmation.

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

   • Yes, implicitly. This device is a standalone immunoassay. Its performance is evaluated on its ability to detect specific analytes at given cutoffs. It does not have a "human-in-the-loop" component in terms of interpretive aid. The user simply reads the visual lines. The underlying "algorithm" is the biochemical reaction of the immunoassay itself.

6. The type of ground truth used:

   • Analytical Gold Standard: Gas Chromatography/Mass Spectrometry (GC/MS) for most drugs, and High-Performance Liquid Chromatography (HPLC) for Tricyclic Antidepressant. This is considered the definitive method for confirming the presence and concentration of drugs/metabolites in urine.

7. The sample size for the training set:

   • Not applicable/Not provided. Immunoassay devices typically do not have a "training set" in the machine learning sense. Their design and performance are based on chemical specificity and sensitivity studies, often involving spiked samples and clinical samples, but this information is not detailed in the summary.

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

   • Not applicable/Not provided. If "training set" refers to samples used during the development and optimization of the immunoassay, their ground truth would also have been established using analytical methods like GC/MS or HPLC. However, details of such development-phase activities are not part of this 510(k) summary.

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Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels:

Test: Amphetamine, Calibrator: D-Amphetamine, Cutoff: 1000 ng/ml
Test: Methamphetamine, Calibrator: D-Methamphetamine, Cutoff: 1000 ng/ml
Test: Benzodiazepine, Calibrator: Oxazepam, Cutoff: 300 ng/ml
Test: Barbiturate, Calibrator: Secobarbital, Cutoff: 300 ng/ml
Test: Cocaine, Calibrator: Benzoylecgonine, Cutoff: 300 ng/ml
Test: Cannabinoids, Calibrator: 11-nor-delta9-THC-9 COOH, Cutoff: 50 ng/ml
Test: Opiates, Calibrator: Morphine, Cutoff: 2000 ng/ml
Test: Phencyclidine, Calibrator: Phencyclidine, Cutoff: 25 ng/ml
Test: Methadone, Calibrator: Methadone, Cutoff: 300 ng/ml
Test: Oxycodone, Calibrator: Oxycodone, Cutoff: 100 ng/ml
Test: Tricyclic Antidepressant, Calibrator: Nortriptyline, Cutoff: 1000 ng/ml
Test: Propoxyphene, Calibrator: Propoxyphene, Cutoff: 300 ng/ml

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Forsure One Step Dip & Read Drug Screen Test consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine, 1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine, 300 ng of Benzoylecognine , 25 ng/ml of Phencyclidine, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone , 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A PRELIMINARY POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided text, K061617, describes a 510(k) summary for the Forsure One Step Dip & Read Drug Screen Test. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, much of the requested information regarding acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for training sets is not available in the provided text.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device's ability to detect various drugs at specific cutoff concentrations. While it doesn't explicitly state "acceptance criteria" for a study, these cutoff concentrations define the required performance level for qualitative determination. The "reported device performance" is implicitly that the device does detect these drugs at or above these cutoffs, as demonstrated by its substantial equivalence claim.

Note: The reported device performance is inferred from the statement that the device is "safe and effective for its stated intended use" and "substantially equivalent" to predicate devices, which implies it meets these detection thresholds. No specific sensitivity/specificity, accuracy rates, or detailed concordance percentages are provided for each drug in this summary.

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. It is a submission from Tianjin New Bay Bioresearch Co., Ltd., China, but this does not confirm the origin of any test data.

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

• Number of Experts: Not applicable/not specified. The "ground truth" for drug detection is typically established using a reference chemical method, not human experts in this context.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The confirmation method mentioned is Gas Chromatography/mass spectrometry (GC/MS).

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

• Was an MRMC study done? No, an MRMC comparative effectiveness study is not relevant for this type of in-vitro diagnostic device that provides a visual "dip & read" result. The "read" aspect is direct observation of color bands, not interpretation that would require multiple human readers and comparison with AI assistance.

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

• Was a standalone study done? Yes, the device itself is a "standalone" test. It's an "algorithm only" in the sense that it relies on a chemical reaction to produce a visual result without requiring human interpretation for its primary function. The performance is intrinsically "standalone" as it's a test strip read visually by a single user. The described mechanism ("produces a magenta color band... no color band") indicates a direct chemical outcome.

7. Type of Ground Truth Used

• 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) is the preferred confirmatory method." This indicates that GC/MS is the gold standard used to establish the true presence or absence of drugs, serving as the ground truth.

8. Sample Size for the Training Set

• Sample Size: Not specified in the provided text. As this is an immunoassay device, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. Performance validation for such devices generally involves testing a range of known positive and negative samples, and samples spiked at or around the cutoff.

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

• How Ground Truth Was Established: As above, GC/MS would be the method for establishing the true concentration of drugs in samples used for any validation or "training-like" processes (e.g., cutoff calibration, cross-reactivity studies) for an immunoassay. However, the document does not detail specific "training set" procedures or how their ground truth was established.

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Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine 25 ng/ml of Phencyclidine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the "Forsure One Step Multiple (Up to Six) Drug Screen Test Card":

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics. However, the implicit acceptance criteria are that the device is "substantially equivalent" to predicate devices (Monitect Multiple Drug Screen MOR2000/MET/THC/COC/PCP and GC/MS) for the qualitative determination of specific drugs at defined cut-off concentrations in human urine. The "reported device performance" is the claim of substantial equivalence.

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

The provided document does not report specific sample sizes for a test set used to evaluate the Forsure One Step Multiple Drug Screen Test Card. It describes the device and claims substantial equivalence to predicate devices and GC/MS, implying that performance data was collected to justify this claim, but the details of such a study (sample size, data provenance like country of origin, retrospective/prospective) are not included in this summary.

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

The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The ground truth for confirming results is stated to be Gas Chromatography/Mass Spectrometry (GC/MS).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. This type of device relies on a chemical "ground truth" (GC/MS) rather than expert consensus adjudication.

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

This question is not applicable to the described device. The Forsure One Step Multiple Drug Screen Test Card is a qualitative immunoassay device, not an AI-assisted diagnostic tool for which MRMC comparative effectiveness studies with human readers would typically be conducted. There is no mention of AI or human-in-the-loop assistance.

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

This question is not applicable in the context of an immunoassay test with visual interpretation. The device's performance is inherently standalone in the sense that the test strip itself produces the result (presence/absence of a line), which is then visually interpreted. There is no complex algorithm involved in 'standalone' performance as understood in AI-driven diagnostics.

7. The Type of Ground Truth Used

The primary ground truth explicitly mentioned for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate analytical method used to identify and quantify substances in a sample, making it a robust reference standard for drug testing.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. As an immunoassay device, it does not involve machine learning or AI that would typically require a "training set" in the computational sense. The device's components and assays are developed based on chemical and biological principles, not statistical training data.

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

Since there is no "training set" in the context of machine learning, this question is not applicable. The underlying scientific principles and calibration of the immunoassay are established through chemical and biological validation, rather than a data-driven training process with established ground truth.

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The Forsure One Step Single or Multiple (X) Drug Screen Strip of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene Test device are a Chromatographic immunoassay for qualitative determination of the presence of Amphetamine at a cutoff concentration of 1000 ng/ml, Methamphetamine at a cutoff concentration of 1000 ng/ml, THC at a cutoff concentration of 50 ng/ml, Morphine at a cutoff concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml . Phencyclidine at a cutoff concentration of 25 ng/ml, Benzodiazepine at cutoff concentration of 300 ng/ml, Methadone at cutoff concentration of 300 ng/ml, Oxycodone at cutoff concentration of 100 ng/ml, Tricyclic Antidepressant at cutoff concentration of 1000 ng/ml, Barbiturates at cutoff concentration of 300 ng/ml, and Propoxyphene at cutoff concentration of 300 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine, Phencyclidine, Benzodiazepine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method.

New Bay Forsure Rapid One Step Single and Multiple(X) Abuse Drug Screen Test Cup Device consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine , 25 ng/ml of Phencyclidine, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone, 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided text describes a medical device, the Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup Device, but does not include a study or data proving it meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested details cannot be extracted from the provided input.

Here's a breakdown of what can be inferred and what is missing:

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

The document does not explicitly state "acceptance criteria" or present a table of device performance against such criteria. It lists cutoff concentrations for various drugs, which serve as a de facto performance threshold for the qualitative detection. However, it does not provide sensitivity, specificity, accuracy, or other performance metrics.

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 filing is a 510(k) summary focused on substantial equivalence to existing devices, not a detailed report of clinical study results.

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. The ground truth is established using a Gas Chromatography/Mass Spectrometry (GC/MS) system, which is a laboratory method, not human expert consensus.

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

This information is not applicable/not provided. The ground truth is established by GC/MS, not human interpretation requiring adjudication.

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

This is not applicable. The device is an immunoassay test cup for drug screening, which is visually read. There is no AI component or human reader interpretation in the context of an MRMC study described. The document states "None, Visual read single use" under instrumentation.

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

The device is a standalone immunoassay test that provides a visual reading. The performance described would inherently be "standalone" in that it produces a result without human interpretation of complex data. However, the document does not detail specific performance studies, only cut-off concentrations.

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

The ground truth used for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS). 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) is the preferred confirmatory method."

8. The sample size for the training set

This information is not provided. The document describes an immunoassay device, not an algorithm that would typically have a "training set" in the machine learning sense. If the question implicitly refers to samples used during the development or validation of the immunoassay, that data is not included.

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

This information is not provided. As above, the concept of a "training set" is not directly applicable in the context of the provided information about this immunoassay device.

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The Glucose Pilot Blood Glucose monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from a finger stick, for the lay-user. It is also intended for the professional use, which include fresh capillary whole blood. It is intended for use outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The Glucose Pilot Glucose monitoring System consists of a hand-held blood glucose meter, test strips, lancing device, lancets, and two levels of control solution. The test strip has a lot - specific calibration information and the meter reads automatically. The meter is turned on by inserting the strip, the user supplies the capillary blood or control solution, the meter makes an audible tone and starts the assay, which completes in five seconds. The meter's software converts the results read off the test strip into a plasma glucose concentration and displays the value on the meter's display. The provided instructions and illustrations explaining that the blood drop will be pulled into the strip sample entry by capillary action. Results are stored in the meter's memory for tracking purposes.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the device study:

Important Note: The provided document is a 510(k) summary for a blood glucose monitoring system. These typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics against defined acceptance criteria in the same way a novel high-risk device might. Consequently, some of the requested information (especially regarding expert adjudication, MRMC studies, explicit acceptance criteria with pre-defined ground truth for this specific device's performance claims) is not explicitly stated in this type of document. I will extract what is available and highlight where information is absent due to the nature of the submission.

Acceptance Criteria and Device Performance

The document doesn't explicitly list a table of acceptance criteria with corresponding device performance metrics in the format you requested for a complex diagnostic device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Ultra One Touch Glucose Monitoring System). The "acceptance criteria" in this context are implicitly that the new device performs similarly or equivalently to the predicate device across various characteristics and specifications.

However, based on the Comparison to Predicate Device(s) table, we can infer performance specifications that the new device aims to meet or match.

1. Table of Acceptance Criteria and the Reported Device Performance

Since explicit "acceptance criteria" are not given, I will present the key performance specifications listed for the new device as its "reported device performance" and the corresponding values from the predicate device as an indication of the expected or "accepted" range for similar devices.

Study Details

The document mentions "The information provided in this pre-market notification demonstrates that Glucose Plot [Pilot] Monitoring System is substantially equivalent to Ultra One Touch Blood Glucose Monitoring System. Substantial Equivalence was established through comparison of intended use and physical properties to the commercialized predicate devices. The information supplied in this pro-marketing notification provides reasonable assurance that the Glucose Pilot Blood Glucose Monitoring System is safe and effective for its stated intended use."

This indicates that the "study" demonstrating equivalence primarily involved analytical and performance testing to show the new device meets the same specifications and analytical performance characteristics as the predicate device. Details of a formal "clinical study" in the sense of a large-scale patient trial with statistical comparison of diagnostic accuracy against a gold standard are not provided in this summary.

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

• Sample size used for the test set: Not explicitly stated in this 510(k) summary. For glucose meters, accuracy studies typically involve a certain number of subjects across different glucose ranges.
• Data provenance: Not explicitly stated. For a 510(k) submission from a Chinese manufacturer, the testing could be done in China (country of origin for manufacturing) or potentially through contract labs elsewhere. The submission itself is dated from China with a US contact. It's safe to assume it's retrospective analytical performance data.

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 510(k) summary. For blood glucose meters, the "ground truth" for comparative studies is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert consensus on diagnostic images.

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

• This information is not applicable/provided as the ground truth for blood glucose measurements is generally established by a laboratory reference instrument, not by human expert adjudication in the context of image 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

• This information is not applicable/provided. The device is a Blood Glucose Monitoring System, which is an in vitro diagnostic device for quantitative measurement, not an AI-powered diagnostic imaging system requiring human reader performance analysis.

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

• Yes, implicitly. The "standalone" performance for a blood glucose meter refers to its analytical accuracy and precision in measuring glucose concentrations, independent of human interpretation of a complex output. The specifications (measurement range, test time, sample volume, etc.) are characteristics of the device itself.

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

• For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer, hexokinase method, or similar highly accurate laboratory method) on plasma or whole blood samples. This document does not explicitly state the specific reference method used, but it would be a standard part of analytical performance testing.

8. The sample size for the training set

• This information is not applicable/provided in the context of this traditional electrochemical biosensor device. Blood glucose meters are not typically "trained" using machine learning algorithms in the same way an AI-driven image analysis system would be. Their performance is based on the chemical and electrochemical properties of the test strips and the meter's calibration algorithms.

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

• This information is not applicable/provided for the reasons stated in point 8.

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For Sure One Step Buprenorphine Test Card is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

For Sure Buprenorphine Rapid Test Card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate in whilel the arag of aring membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibodysample from and ages free drug in the specimen forming an antibody-antigen complex. conjugate onlike to the from bilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 will of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen unor color band in the control area. There is no meaning attributed to color produces only one other line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's a breakdown of the acceptance criteria and study information for the "For Sure Buprenorphine Rapid Test Card" based on the provided text:

Important Note: The provided document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed study report with all the specific performance metrics and methodologies that would typically be found in a full scientific publication or comprehensive regulatory submission. Therefore, some requested information (like specific sample sizes for test and training sets, number and qualifications of experts, and MRMC study details) is not explicitly stated in this document.

Acceptance Criteria and Reported Device Performance

The document implies acceptance criteria based on the comparison to the predicate device and the intended use. The primary performance metric mentioned is the device's ability to qualitatively determine the presence of buprenorphine at a specific cutoff concentration.

Study Details

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

   • Sample Size (Test Set): Not explicitly stated in the provided text.
   • Data Provenance: Not explicitly stated. The submission is from Tianjin New Bay Bioresearch Co., Ltd. in China, but the origin of the urine samples used for testing is not detailed. It is also not specified if the data was retrospective or prospective.

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

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: Not explicitly stated. However, the preferred confirmatory method for ground truth is Gas Chromatography/Mass Spectrometry (GC/MS), which would typically be performed and interpreted by qualified laboratory personnel (e.g., toxicologists, chemists).

3. Adjudication method for the test set:

   • Adjudication Method: Not explicitly stated. The document refers to GC/MS as the preferred confirmatory method, implying this is the gold standard for ground truth, rather than an adjudication among human readers for the device itself.

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

   • MRMC Study: No. This device is a rapid, visual immunoassay test card, not an AI-powered diagnostic system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not applicable.

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

   • Standalone Performance: Yes, in the sense that the test card itself provides a visual result (presence or absence of a line) without needing a human to interpret complex data from an algorithm. The reading is visual: "A NEGATIVE specimen produces two distinct color bands... A POSITIVE specimen produces only one color band in the control area." This is the "algorithm only" performance for this type of device.

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

   • Type of Ground Truth: Gas chromatography /mass spectrometry (GC/MS) is explicitly stated as the preferred confirmatory method for obtaining confirmed analytical results. This serves as the gold standard ground truth.

7. The sample size for the training set:

   • Sample Size (Training Set): Not explicitly stated. This document primarily focuses on the substantial equivalence study for regulatory clearance, not the development process of the immunoassay itself.

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

   • Ground Truth (Training Set): Not explicitly stated. Again, the document focuses on regulatory clearance. However, it's highly probable that similar laboratory methods, likely GC/MS, would have been used during the development and optimization (training) phase of the immunoassay to establish its performance characteristics against known samples.

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