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The Microdiagnostics, Inc. D&V The Microdiagnostics, Inc. Distincts the metabolit The Microdiagnostics, Inc. barge of detects the metabolites is an immunoassay that quartiallery oceates and Phencyclidine of Amphecamine, Gocaine, Massystems in human urine at the SAMHSA cutoff levels. This test is intended for professional use only.

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The provided text describes a 510(k) premarket notification for a "Multi-Test Strip" device for detecting drugs of abuse in human urine. However, it does not contain any information regarding acceptance criteria, study results, sample sizes (for test or training sets), expert qualifications, ground truth methods, or MRMC studies.

The document is a letter from the FDA to Microdiagnostics, Inc., confirming the substantial equivalence of their device to legally marketed predicate devices. It lists the device's indications for use and regulatory classifications but does not detail the internal validation studies performed by the manufacturer to establish performance.

Therefore, I cannot provide the requested information based on the input text.

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The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is an immunoassay that qualitatively detects the major Phencyclidine metabolites in urine at the SAMHSA cutoff level of 25 ng/m1. The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is intended for use by clinical toxicology labratories, physician offices, drug abuse clinics and law enforcement agencies only.

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I am unable to answer this question. The provided text is a 510(k) clearance letter from the FDA, which confirms that a device (MICRO-STRIP FOR PHENCYCLIDINE METABOLITES) is substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information about the acceptance criteria, study details, performance data, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for the device. It merely states that the device is cleared for marketing based on its substantial equivalence to a predicate.

Therefore, I cannot extract the requested information from the provided text.

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The MICRO-STRIP FOR MARIJUANA METABOLITES is an immunoassay that qualitatively detects the major Marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/m1. The MICRO-STRIP FOR MARIJUANA METABOLITES is Intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics and law enforcement agencies only.

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This is a 510(k) premarket notification for "MICRO-STRIP FOR MARIJUANA METABOLITES", an immunoassay for qualitatively detecting major marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/ml. The document explicitly states that the device is intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics, and law enforcement agencies. This FDA letter approves the device, meaning it was found substantially equivalent to a predicate device. Often, 510(k) summaries, not the approval letter itself, contain detailed study information. The provided text is an approval letter, not the full submission. Therefore, much of the requested detailed study information is not available in the provided text.

However, based on the nature of the device (an immunoassay detecting a specific metabolite at a cutoff level), we can infer certain aspects of the acceptance criteria and study design, even if the explicit details are missing.

Here's an attempt to answer the questions based on the available information and general knowledge of such devices, highlighting what is directly stated, inferred, or not present.

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA letter does not include a table of acceptance criteria or specific reported device performance metrics. Such information would typically be found in the 510(k) summary or the full submission, not in the FDA's approval letter.

However, for a qualitative immunoassay like this, the primary performance metrics would likely revolve around:

• Sensitivity: The ability of the test to correctly identify samples containing marijuana metabolites at or above the 50 ng/ml cutoff.
• Specificity: The ability of the test to correctly identify samples not containing marijuana metabolites above the 50 ng/ml cutoff, or to not react with interfering substances.
• Cutoff Performance: Accurate classification of samples around the 50 ng/ml threshold.
• Reproducibility/Precision: Consistency of results when tested multiple times.
• Cross-reactivity: Assessment against various prescription and over-the-counter drugs, as well as structurally similar compounds, to ensure no false positives.

Inferred Acceptance Criteria (Typical for such devices):

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The Microdiagnostics, Inc. Micro-Strip for Cocaine Metabolites is intended to qualitatively detect the metabolites of cocaine in urine at the SAMHSA/NIDA cutoff limit of 300 ng/ml.

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The provided FDA document (K981388) is a 510(k) clearance letter for the "Micro-Strip for Cocaine Metabolites" device. This document primarily focuses on regulatory approval and does not contain specific details about acceptance criteria, device performance studies, or the methodologies typically associated with evaluating AI/ML-based devices.

The device described is a rapid, qualitative immunoassay for detecting cocaine metabolites in urine, which is a chemical assay, not an AI/ML algorithm. Therefore, many of the requested criteria (e.g., sample size for AI test set, expert qualifications for ground truth, MRMC studies, training set details) are not applicable to this type of device and are not present in the provided text.

However, I can interpret the available information to address the relevant aspects as best as possible for a traditional diagnostic device.

Here's an analysis based on the provided text:

Device Name: Micro-Strip for Cocaine Metabolites

Intended Use: To qualitatively detect the metabolites of cocaine in urine at the SAMHSA/NIDA cutoff limit of 300 ng/ml.

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, the document doesn't explicitly state "acceptance criteria" as a separate section with numerical goals for sensitivity, specificity, etc., nor does it provide a detailed "reported device performance" table as one might expect for a modern clinical study. However, the intended use defines a key performance characteristic. The device must accurately detect cocaine metabolites at a specific cutoff.

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

This information is not provided in the FDA clearance letter. For traditional diagnostic assays, performance is typically evaluated using a panel of urine samples (both positive and negative) that have been confirmed by a reference method (e.g., GC/MS). The exact number of samples, their origin, or whether they were retrospective or prospective are not mentioned in this document.

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

This is not applicable and not provided. For a chemical assay like this, ground truth is established by a definitive analytical method (e.g., Gas Chromatography-Mass Spectrometry (GC/MS)), not by human expert opinion or interpretation in the way AI models are evaluated.

4. Adjudication method for the test set

This is not applicable and not provided. As ground truth is established by a definitive analytical method, there would be no need for expert 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. This device is a rapid diagnostic strip, not an AI-assisted diagnostic tool requiring human interpretation and an MRMC study.

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

This is not applicable. This device is a standalone chemical assay, not an algorithm. Its performance is inherent to the chemical reactions on the strip.

7. The type of ground truth used

While not explicitly stated in this letter, for qualitative drug screening assays, the ground truth is typically established by a definitive analytical method, most commonly Gas Chromatography-Mass Spectrometry (GC/MS). GC/MS provides quantitative and highly specific confirmation of the presence and concentration of drug metabolites.

8. The sample size for the training set

This is not applicable and not provided. This is a chemical assay, not an AI/ML model, so there is no "training set" in the computational sense. The development of the assay involves optimizing reagents and conditions, but not "training data" in the AI context.

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

This is not applicable. As there is no training set for an AI/ML algorithm, this question does not apply.

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The Microdiagnostics, Inc. Micro-Strip for Amphetamine Metabolites is intended to qualitatively detect the metabolites of Amphetamine and Amphetamine-like drugs in urine.

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I am sorry, but the provided text is a government document (FDA approval letter) and does not contain the specific information needed to answer your request regarding acceptance criteria and a study proving device performance. The document confirms that the "Micro-Strip for Amphetamine Metabolites" device is substantially equivalent to legally marketed predicate devices, but it does not detail the performance study, acceptance criteria, or other requested metrics.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness study.
6. Information on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Microdiagnostics, Inc. Micro-Strip for Opiate Metabolites is intended to qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine.

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The provided document is an FDA 510(k) clearance letter for the "Micro-Strip for Opiate Metabolites" device. It does not contain information about acceptance criteria, device performance studies, or the specifics of such studies. Therefore, I cannot generate the requested table and answer the questions based on the given text.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It outlines regulatory classifications, contact information for further inquiries, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

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