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The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below.

This assay provides only a preliminary test result. A more specific alternate 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 must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For Professional Use Only.

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the First Sign™ Drug of Abuse Urine Screening Tests:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device (qualitative drug screening) are typically based on strong agreement with a definitive, confirmatory method. While explicit percentage targets (e.g., "must achieve >95% positive agreement") aren't directly stated as "acceptance criteria" in the submission, the performance characteristics provided demonstrate successful achievement of high agreement rates relative to the gold standard.

Note on Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are implicitly met when the sponsor demonstrates substantial equivalence to predicate devices, which typically includes performance data that is comparable or superior to the predicate. High positive, negative, and overall agreement rates with a confirmatory method are standard for establishing performance for qualitative drug tests.

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

• Sample Size: The document does not explicitly state the total sample size (number of urine samples/patients) used for the test set for each drug. It provides percentages (e.g., 97.5% positive agreement), which are derived from a sample, but the raw numbers of positive and negative samples are not given.
• Data Provenance: The document does not specify the country of origin of the data. It mentions that WHPM, Inc. is in El Monte, CA, and WHPM, Bioresearch and Technology Co. Ltd. is in Beijing, China, and that product would be manufactured in both locations. However, where the clinical samples were collected is not stated. The study described is a "clinical evaluation," implying it was prospective or at least involved testing on clinical samples (as opposed to entirely in-silico or simulated data).

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

• Number of Experts: Not applicable. The ground truth was established by laboratory methods (GC/MS or HPLC), not human experts interpreting the results of the rapid test.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC), which are objective analytical methods, not subjective interpretations requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a rapid, chromatographic immunoassay, not an imaging or interpretive AI device where human readers are involved in the primary result generation. The test provides a direct positive/negative result, not an interpretation of complex data by a human.
• Effect Size of Human Readers with/without AI: Not applicable, as there's no AI component or human interpretation in the workflow described.

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

• Standalone Performance: Yes, the described performance results are for the device (the immunoassay) operating in a standalone capacity. The comparison is between the immunoassay result and the confirmatory laboratory method. There is no human interpretation or intervention in determining the First Sign test result itself (beyond reading the visible lines, which is standard for such tests).

7. The Type of Ground Truth Used

• Ground Truth Type: The ground truth was established using confirmatory analytical laboratory methods:
  • Gas Chromatography/Mass Spectrometry (GC/MS)
  • High-Performance Liquid Chromatography (HPLC)
    These are considered the gold standard for drug detection and quantification in urine.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a training set. This is typical for traditional immunoassay devices based on chemical reactions rather than machine learning algorithms. Immunoassays are "trained" during their development and optimization phases in the lab, but there isn't a distinct "training set" of patient data in the same way there would be for an AI algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no specific "training set" of patient data in the context of an immunoassay. The inherent "ground truth" for developing such a test is the known presence/absence and concentration of analytes in controlled laboratory samples used during R&D.

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First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:

First Sign™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

A lateral flow immunoassay for the detection of drugs of abuse.

The provided text describes the First Sign Drug of Abuse Screening Test, a lateral flow immunoassay for detecting drugs in urine.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets. However, the performance claim serves as the de facto acceptance criterion.

Note: The SAMHSA recommended levels are the cut-off thresholds for qualitative detection, meaning the device should detect the drugs at or above these concentrations. The ">97%" performance refers to the device's accuracy (likely a combination of sensitivity and specificity, though not explicitly broken down) when compared to both a legally marketed predicate device and GC/MS.

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

• Sample Size: 60 positive samples and 60 negative samples were tested against each drug. Since there are 7 drugs listed, the total number of tests performed would be (60 positive + 60 negative) * 7 drugs = 840 tests.
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be a retrospective comparison, as samples were collected and then tested against existing methods.

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" in the traditional sense of medical professionals interpreting results for the ground truth.
• The ground truth was established by Gas chromatography/mass spectrometry (GC/MS), which is described as the "preferred confirmatory method." GC/MS is a laboratory analytical technique, not an expert human interpretation.

4. Adjudication Method for the Test Set:

• There was no explicit adjudication method described by multiple human readers. The primary comparison was against a predicate device and GC/MS.

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 was not done. This device is a standalone immunoassay device, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

• Yes, a standalone study was performed. The "First Sign™ Drug of Abuse Screening Test" is a standalone device (a lateral flow immunoassay) that provides a preliminary qualitative result without human-in-the-loop interpretation being part of its core performance evaluation in this context. The results of the immunoassay are visually interpreted, but the study focuses on the device's ability to accurately detect the analytes compared to established methods.

7. The Type of Ground Truth Used:

• The primary ground truth used was Gas chromatography/mass spectrometry (GC/MS). This is considered an objective and highly accurate analytical method for confirming the presence and concentration of drugs of abuse.

8. The Sample Size for the Training Set:

• The document describes a performance evaluation, not a machine learning study involving a "training set." Therefore, there is no training set sample size mentioned. The immunoassay is a chemical/biological assay, not an algorithm that learns from data.

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

• As there was no training set, this question is not applicable.

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The Texas FIRST SIGH test is a 3 minute one step pregnancy test for the dectection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use.

Not Found

The provided document is a 510(k) premarket notification letter for a device called "FIRST SIGN II." This letter approves the device for marketing and mentions its intended use. However, it does not contain a study report or detailed performance data to describe specific acceptance criteria and how a study proved the device meets them.

The document only states the "Indications For Use" for the FIRST SIGN test: "a 3 minute one step pregnancy test for the detection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use."

Without a detailed study report, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information would typically be found in the 510(k) submission itself, which is not provided here.

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