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Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

The RapidBAR test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-barbiturate antibody between barbiturate-protein conjugate and free drug which may be present in the urine specimen being tested. When barbiturate is present in the urine specimen, it competes with barbiturate-protein conjugate for the limited amount of mouse anti-barbiturate MAb-colloidal gold conjugate. When the amount of barbiturate is equal or more than the cut-off, it will prevent the binding of barbiturateprotein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.

The provided document describes the 510(k) summary for the Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card. It states the intended use as qualitative determination of secobarbital in human urine specimens above a cutoff level of 300 ng/ml. The document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data in a comprehensive study report.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative format (e.g., minimum sensitivity, specificity thresholds). Instead, it lists various "Performance" studies conducted, implying that these studies were performed to demonstrate the device's acceptable performance and substantial equivalence.

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

• Sample Size: The document mentions that "Both urine control specimen and clinical urine specimen were tested," but it does not provide the specific sample size for either the control or clinical urine specimens used in the accuracy/comparison studies.
• Data Provenance: The country of origin of the data is not explicitly stated. Given the manufacturer's address in Burlingame, CA, U.S.A., and the FDA 510(k) submission, it is implied that the studies were conducted to meet U.S. regulatory standards, but the physical location of the data collection is not specified. The studies involved "clinical urine specimens," indicating they were likely retrospective or prospective collections from a clinical setting, but this detail is not explicitly stated.

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

This information is not provided in the document. For in-vitro diagnostic devices like this, ground truth for drug testing typically involves confirmatory methods.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device. The Rapid Barbiturate Test is a rapid immunochromatography test designed for a qualitative, visual result, primarily relying on the presence or absence of a colored band. It does not involve human readers interpreting complex images or data in a way that an MRMC study would assess. The "comparison study of clinical urine specimens" mentioned is a comparison of the device's results against a reference method (ground truth), not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for both the Rapid Barbiturate Test Strip and Test Card. The document lists "Sensitivity Accuracy (comparison study of clinical urine specimens)," "Precision," "Reproducibility," "Specificity," and "Interference" as studies performed. These studies evaluate the device's intrinsic performance characteristics.

7. Type of Ground Truth Used

The most common type of ground truth for urine drug screens is a more specific and sensitive chemical method, such as Gas Chromatography-Mass Spectrometry (GC/MS). While the document states, "A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result," it doesn't explicitly state that GC/MS was used as the ground truth for the comparison studies mentioned. However, this is the standard practice for validating such devices, and it is highly probable that a similar confirmatory method was employed for ground truth establishment.

8. Sample Size for the Training Set

This information is not provided in the document. Immunochromatographic assays like this are typically developed based on laboratory experiments and antibody-antigen binding characteristics, rather than "training" an algorithm on a large dataset in the way a machine learning model would be. Therefore, the concept of a "training set" in the context of an algorithm may not directly apply.

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

As noted above, the concept of a "training set" for this type of device is not directly applicable in the same way it would be for AI/ML algorithms. The ground truth for the underlying immunochemistry would be established through known concentrations of barbiturates and cross-reactants, and the selection of antibodies would be based on their empirically determined binding characteristics. The document does not provide details on this developmental process.

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Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.

The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.

This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.

The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.

This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

Rapid Methadone Test Strip is a dipstick device for detecting the presence or absence of the tested drug. The test strip is also used for the composition of Rapid Methadone Test Card. These test devices are manufactured with the same formulation and procedure except the test card consists a plastic housing containing one methadone test strip. There is no any functional design that may affect the test strip's performance in the test card.

A. Test Strip
Test strips that containing absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, are used to assemble Rapid Methadone Test Strip as shown below:

B. Test Card Format
The above test strip that contains an absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, is used to assemble the Test Card Device as shown below.

The provided submission describes a medical device, the Rapid Methadone Test Strip and Rapid Methadone Test Card, which are immunochromatography-based one-step in vitro tests for the qualitative determination of methadone in human urine specimens above a cutoff level of 300 ng/ml.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria for accuracy, sensitivity, or specificity in the way it might for a diagnostic imaging device. Instead, it states that the devices demonstrate performance characteristics that are "substantially equivalent" to a predicate device, the Applied Biotech SureStep™ Drug Screen Test Methadone. This implies that the acceptance criteria are met if the new device's performance aligns with or is comparable to that of the predicate device.

However, based on the general understanding of drug screening tests, the primary performance metrics are Sensitivity (ability to correctly identify positive samples) and Specificity (ability to correctly identify negative samples). The document mentions "Sensitivity Accuracy" and "Specificity" in the list of studies performed.

Since specific quantitative acceptance criteria are not provided in the document, we will infer the reported device performance based on the claim of substantial equivalence to the predicate. To fully understand the acceptance criteria and corresponding performance, one would typically need access to the predicate device's performance data or a more detailed study report.

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

The submission states: "Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Methadone Test Strip and Rapid Methadone Test Card."

• Sample Size: The specific number of "clinical urine specimens" or "urine control specimens" used for the test set is not provided in the given text.
• Data Provenance: The provenance is "clinical urine specimen," implying human samples. The country of origin is not specified. The samples are likely retrospective as they are referred to as "clinical urine specimens" that were "tested," which typically refers to samples collected prior to the study for evaluation.

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

The submission states: "A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result." This indicates that Gas Chromatography/Mass Spectrometry (GC/MS) is the reference method for confirming methadone presence.

• Number of Experts: The document does not specify the number of experts.
• Qualifications of Experts: The document does not explicitly state the qualifications of individuals performing the GC/MS analysis. However, GC/MS is a laboratory-based method typically performed by trained laboratory technicians or chemists with expertise in analytical chemistry and toxicology. It's not a visually interpreted test like radiology, so "experts" in the typical sense of a clinician making a diagnosis from an image are not directly applicable here for ground truth establishment.

4. Adjudication Method for the Test Set

The adjudication method relies on a "more specific chemical method, such as GC/MS," for confirmation.

• Adjudication Method: GC/MS (or similar confirmatory chemical method) is used as the gold standard for ground truth. This is a definitive analytical process and doesn't typically involve human "adjudication" in the same way as, for example, multiple radiologists reviewing an image. Therefore, a 2+1 or 3+1 method is not applicable here. The GC/MS result is considered the definitive truth.

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

• Was an MRMC study done? No. The device is an in-vitro diagnostic test strip/card, not an imaging AI device that assists human readers. Its output is a qualitative visual result (presence/absence of a colored band), not an interpretation for a human reader to improve upon.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable as it's not an AI assistance tool for human interpretation.

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

• Was a standalone study done? Yes, effectively. The "Rapid Methadone Test Strip" and "Rapid Methadone Test Card" are themselves standalone devices. They produce a qualitative result (presence or absence of a colored band) that is then read by a user. The performance studies listed (Sensitivity Accuracy, Specificity, Precision, Reproducibility, etc.) are evaluating the device's inherent ability to detect methadone in urine, independent of "human-in-the-loop" assistance for interpretation, beyond simply reading the test result. The "algorithm" here is the immunochromatographic reaction itself.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for confirming methadone presence is established by a "more specific chemical method, such as GC/MS." This falls under laboratory-based analytical confirmation / definitive analytical truth.

8. Sample Size for the Training Set

The document does not explicitly mention a training set for the device. Given that this is an immunochromatographic test, the "training" for such a device typically refers to the development and optimization of the reagents (antibodies, conjugates, etc.) and manufacturing processes, rather than a data-driven machine learning algorithm that requires a distinct training dataset.

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

As no explicit training set is mentioned in the context of machine learning, this question is not applicable. The ground truth for developing and optimizing the assay components would have been established through controlled experiments and analytical methods, similar to how the final test set's ground truth is established (e.g., using known concentrations of methadone or GC/MS on samples).

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