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The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).

The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide 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) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.

The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine.

This looks like a 510(k) clearance letter for an in-vitro diagnostic device, specifically a drug screening panel. These types of documents typically do not contain the detailed study information you are requesting, such as sample sizes for training/test sets, ground truth establishment, or multi-reader studies. The FDA clearance is based on the device being "substantially equivalent" to a legally marketed predicate device, rather than a full de novo evaluation of clinical performance with detailed statistical studies.

However, I can extract the acceptance criteria based on the information provided in the "Statement for Indications For Use" and generally infer what a performance study for such a device would entail.

Please note: The following reconstruction is an inference based on the typical requirements for this type of device and what is explicitly stated (or not stated) in the provided text. The document itself does not contain a detailed study report.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a qualitative drug test like this are typically based on detecting the target drug at or above a specified cut-off concentration. The device's "performance" is its intended ability to achieve this, implying a certain level of sensitivity and specificity around these cut-offs. The document does not provide a table of performance metrics (sensitivity, specificity, accuracy, positive/negative predictive values) from an actual study, but it defines the cut-off levels which would be the basis for evaluating performance.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). For in-vitro diagnostic devices, studies typically involve testing a statistically significant number of urine samples, both negative and spiked/positive at various concentrations relative to the cut-off.

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

For this type of device, ground truth is established through a definitive reference method, not typically by expert interpretation of results. Therefore, the concept of "number of experts" is not directly applicable in the same way it would be for an imaging AI device.

4. Adjudication Method for the Test Set

Not applicable for a chemical assay. The ground truth is determined by the reference method (e.g., GC/MS).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study is not applicable for this type of in-vitro diagnostic device. This device is a diagnostic test, not an AI or imaging interpretation tool that assists human readers.

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

This device is essentially a "standalone" immunochromatographic test. Its performance is evaluated purely on its ability to correctly identify the presence or absence of drugs against a reference standard. There isn't an "algorithm" in the AI sense, but rather a chemical reaction and visual readout. Human intervention is in performing the test and reading the results, but the core performance is inherent to the device's chemistry.

7. The Type of Ground Truth Used

The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA)."

Therefore, the ground truth for performance studies of this device would typically be established using:

• GC/MS (Gas Chromatography/Mass Spectrometry) for quantitative confirmation of drug presence and concentration.
• Spiked samples (negative urine samples to which known concentrations of drugs are added) would also be used to rigorously test performance around the cut-off levels.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning (AI) does not directly apply to this immunochromatographic test. There is no AI algorithm being "trained" in the typical sense. The device's formulation and manufacturing process are developed and optimized, but not through a machine learning training paradigm.

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

Not applicable, as there's no training set for an AI algorithm.

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Rapid Opiates Test Card II is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Opiates and its metabolites in human urine specimens. The presence of Morphine in human urine above a cutoff level of 2,000ng/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.

The Rapid Drug tests are 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 antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested.

When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cutoff level, it will prevent the binding of drug conjugate to the antibody. As a result, 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.

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

   The provided text does not explicitly state formal acceptance criteria with specific numerical targets. However, the performance section indicates that the device's accuracy, precision, and other characteristics were evaluated, and the overall conclusion is that it is "substantially equivalent" to a legally marketed predicate device.

   Performance Characteristic Evaluated	Reported Device Performance (Implied Acceptance)
   Sensitivity Accuracy	"comparison study of clinical urine specimens" showed the device to be "substantially equivalent to the Applied Biotech SureStep ™Drug Screen Test Morphine II."
   Stability - Specimen	Evaluated (details not provided)
   Stability - Product	Evaluated (details not provided)
   Precision	Evaluated (details not provided)
   Reproducibility	Evaluated (details not provided)
   Specificity	Evaluated (details not provided)
   Interference	Evaluated (details not provided)
   Overall Effectiveness	"demonstrate Rapid Opiates Test Strip II and Rapid Test Card II to be substantially equivalent to the Applied Biotech SureStep ™Drug Screen Test Morphine II"

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

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only mentions "clinical urine specimens."

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 given text. The method for establishing ground truth is not detailed beyond the use of "urine control specimen and clinical urine specimen."

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

   This information is not provided in the given text.

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 comparative effectiveness study involving human readers or AI assistance was not mentioned. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for interpretation by human readers.

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

   Yes, the performance characteristics provided are for the device (Rapid Opiates Test Strip II and Rapid Test Card II) operating as a standalone diagnostic test, without human interpretation beyond reading the visual result. The "Indications for Use Statement" specifies it is "designed for qualitative determination... The test kit is used to obtain a visual, qualitative result and is intended for professional use."

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

   The text mentions the use of "urine control specimen and clinical urine specimen." For drug tests, the ground truth is typically established through a reference method (e.g., Gas Chromatography-Mass Spectrometry (GC/MS) or other highly accurate laboratory methods) that quantifies the presence and concentration of the drug in the urine. While not explicitly stated as GC/MS, the "comparison study of clinical urine specimens" and the determination of "sensitivity accuracy" imply a highly reliable reference method was used to establish the true presence or absence of opiates.

8. The sample size for the training set

   This device is an immunochromatography-based test, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set size does not apply. The development would involve analytical verification and validation using various concentrations of analytes and interferents, not a data-driven training set like for AI.

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

   As explained in point 8, this device does not utilize a training set in the AI/machine learning context. The "ground truth" for the development and analytical validation of such a test would be established through precisely prepared controls (known concentrations of opiates and other substances) and clinical samples verified by a gold-standard laboratory method.

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RapidHCG Pregnancy Test is a qualitative test that detects the presence of human Chorionic Gonadotropin (hCG) in human urine specimens. The test is a visual one step, in vitro assay. The test is intended for professional use to help diagnose pregnancy in hospital and clinical lab.

The test is a visual one step, in vitro assay.

The provided document is a 510(k) clearance letter from the FDA for the "RapidHCG Pregnancy Test." This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a product's 510(k) submission or a clinical study report. The letter is an official notification that the device has been found substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results from this document. The document only confirms the device's name ("RapidHCG Pregnancy Test"), its intended use (qualitative detection of hCG in human urine to diagnose pregnancy in hospital and clinical lab settings), its regulatory class (Class II), and its product code (JHI).

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