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Instant-View Marijuana (THC) Urine Test (Cassette) is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9, THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.

The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.

This test is a one-step lateral flow chromatographic immunoassay.

Here's an analysis of the provided text regarding the Alfa Scientific Designs, Inc. Instant-View™ Marijuana (THC) Urine Cassette Test, structured to address your specific questions:

The provided text focuses on the 510(k) submission for a diagnostic device. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on performance characteristics.

Acceptance Criteria and Device Performance Summary

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies the "acceptance criteria" through statements of achievement for substantial equivalence. Explicit criteria values are not provided as a separate list but rather as the achieved performance which was deemed acceptable.

Study Details

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

• Test Set Sample Size: The document does not explicitly state the total number of samples used in the accuracy evaluation. It mentions "results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory," suggesting multiple sites contributed data, but the specific number of cases tested is not provided.
• Data Provenance: The document does not specify the country of origin of the data. It indicates the data came from a "clinical laboratory" and "three physician's office laboratory," suggesting a prospective clinical evaluation, but it doesn't explicitly state "retrospective" or "prospective." Given that accuracy was evaluated, it's highly likely to be prospective.

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

The concept of "experts" and "ground truth" in the context of identifying THC in urine typically refers to a reference method, not individual human interpreters for diagnostic readings.

• The ground truth in this case is established by the predicate device (QuikStrip One Step Marijuana Test, manufactured by Syntron Bioresearch, Inc.) and a more specific alternate chemical method for confirmation.
• The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method."
• Therefore, the "experts" are the analytical instruments and validated methodologies of a clinical laboratory, not human readers assessing images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods like 2+1 or 3+1 typically apply to studies where multiple human readers independently interpret results and discrepancies need to be resolved. For a qualitative, competitive binding immunoassay like this, the "reading" is typically objective (presence/absence of a line) and compared against a reference method (GC/MS or the predicate device). Discrepancies would involve retesting or review by laboratory personnel following standard operating procedures, rather than an "adjudication committee."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a standalone in-vitro diagnostic assay for detecting a substance in urine, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers in the primary diagnostic step.

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

Yes, in essence, a "standalone" performance evaluation was conducted. The device itself (the cassette test) produces a result (presence or absence of a line) which is then interpreted by a healthcare professional. The performance metrics (correlation and agreement) are for the device's ability to accurately detect THC compared to a reference standard, independent of human interpretive variability beyond simply reading the lines according to instructions. The device essentially is the "algorithm" in this context.

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

The primary ground truth described for confirmation is Gas Chromatography/Mass Spectrophotometry (GC/MS), which is an analytical gold standard for substance identification and quantification. For the broader comparison, the predicate device's results served as a comparative ground truth.

8. The Sample Size for the Training Set

Not applicable. This is an immunoassay device, not a machine learning or AI model that requires a "training set." Its performance is based on the chemical and biological interactions built into the test strip.

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

Not applicable, as there is no "training set" for this type of device.

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Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, evcaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:

THC 11-nor-Δ9-9-carboxylic acid 50 ng/mL
OPI Morphine 300 ng/mL
COC Benzoylecgonine 300 ng/mL
AMP Amphetamine 1000 ng/mL
MET D-Methamphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL

Not Found

I am sorry, but the provided text does not contain information regarding rejection criteria or studies that prove the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a drug screening device, outlining the device's substantial equivalence to predicate devices and its intended use. It does not include performance data, study design details, or acceptance criteria tables.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the associated table, sample sizes, expert qualifications, or other study-specific details.

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Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:

Not Found

The provided FDA document (K991751) is a 510(k) clearance letter for the Status Cup™ drug testing device. It does not contain a detailed study report with acceptance criteria and performance data in the format requested. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices for the qualitative detection of multiple drugs in human urine.

However, based on the Indications For Use section (page 3), we can infer the implied acceptance criteria and the claimed device performance with respect to the detecting cut-off concentrations.

Here's an attempt to structure the information based on the prompt, drawing directly from the provided text and acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states the "detecting cut-off concentrations" for each substance. While not explicitly termed "acceptance criteria" in a typical study report, these are the thresholds the device is designed to meet for qualitative detection. The "reported device performance" is the claim that the device does detect at these concentrations.

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

• Sample size for test set: Not specified in the provided document.
• Data provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set:

• Not specified.

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:

• MRMC study: Not applicable. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.

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

• This device is an immunoassay cup. Its performance is inherently "standalone" in that it produces a result directly from a biochemical reaction. There is no separate "algorithm" performance beyond the cup's chemical reactivity.

7. The type of ground truth used:

• While not explicitly stated, for IVD drug screens, the ground truth for performance studies is typically established using confirmatory analytical methods (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS)) on urine samples spiked with known concentrations of the target analytes or using clinically characterized urine samples.

8. The sample size for the training set:

• Training set size: Not applicable/not specified. For an immunoassay, there isn't typically a "training set" in the machine learning sense. Performance is based on chemical design and validation studies.

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

• Ground truth establishment for training set: Not applicable, as there's no "training set" in the machine learning sense for this type of device.

Summary of Limitations:

The provided document is a 510(k) clearance letter, which confirms substantial equivalence. It does not include the detailed study reports or performance data that would typically contain the requested information about sample sizes, ground truth establishment, expert qualifications, or specific study methodologies. These details would be found within the premarket notification (510(k) submission) itself, which is not publicly available in this format.

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Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.

Not Found

This FDA 510(k) clearance letter does not contain the detailed study information needed to fully answer your request. This document is a regulatory communication indicating that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not typically include the specifics of the performance studies themselves, such as acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly mentions:

• Device Name: AccuSign® DOA8 (THC/OPI/COC/AMP/BZO/BAR/TCA/PCP)
• Indications for Use: Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples. This device is for "Professional Use" and "Prescription Use."

To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) submission document or a summary of its contents, which would detail the performance data.

From the provided text, I can only state that a substantial equivalence determination was made based on the provided information, implying that the device’s performance was deemed comparable to legally marketed predicate devices.

Therefore, I cannot fill out the requested table or provide specific details about the study, sample sizes, expert qualifications, or ground truth establishment based solely on the text provided. The document is a clearance letter, not a study report.

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Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.

AccuSign® DOA 8 (THC/OPI/COC/AMP/BZO/BAR/TCA/PCP) Rapid One-Step Drugs of Abuse Panel Test

The provided text is an FDA 510(k) clearance letter for the AccuSign® DOA 8 Rapid One-Step Drugs of Abuse Panel Test from September 28, 1998. It primarily focuses on regulatory approval and does not contain specific details about acceptance criteria, study design, or performance metrics in the format requested.

Therefore, I cannot extract the information to fulfill your request. The document is a clearance letter, not a device performance study report.

To provide the requested information, I would need a document such as:

• A summary of safety and effectiveness (SSE) for the 510(k) submission.
• A clinical study report.
• A detailed technical review from the FDA's evaluation.

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PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations:

THC Tetrahydrocannabinol 50 ng/mL
COC Cocaine (Benzoylecgonine) 300 ng/mL
OPS Opiates (Codeine/Morphine) 300 ng/mL
AMP Amphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL

This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale.

PROFILE-II provides only a preliminary analytical test result. 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine.

This document is a 510(k) clearance letter and an Indications for Use form for a rapid drug detection device called PROFILE-II. It does not contain the detailed study information regarding acceptance criteria and device performance that you requested.

The document states the device's indications for use: "PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine." It also lists the cut-off concentrations for each drug.

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets, data provenance, or details on prospective/retrospective studies.
• Information on the number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Results of standalone (algorithm-only) performance.
• The type of ground truth used (e.g., pathology, outcomes data, beyond the implied GC/MS confirmation).
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is typically found in the full 510(k) submission, specifically in the performance data sections, which are not included in this letter. The letter is primarily an FDA clearance notification.

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