Search Results

The IND Urinary Tract Infection (UTI) Test Strips are intended for qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infection in persons with signs and symptoms of urinary tract infection. Testing of urine is performed by urinating into a sample cup and briefly dipping the test strip into it. This test is intended for over-the-counter home use only.

Not Found

Here's an analysis of the provided FDA 510(k) summary, specifically looking for acceptance criteria and study details.

Crucial Note: The provided document is an FDA 510(k) clearance letter and an "Indications for Use" statement. It does not contain the detailed study report, acceptance criteria, or performance data itself. FDA clearance letters only state that the device has been found substantially equivalent to a predicate device. To get the information you're asking for, one would typically need access to the full 510(k) submission, which is not usually publicly available in this level of detail.

Therefore, many of your questions cannot be answered from the provided text. I will indicate where the information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The FDA clearance letter for K103037 for the "IND Urinary Tract Infection (UTI) Test Strips" does not detail the specific acceptance criteria or the reported device performance metrics (e.g., sensitivity, specificity) from the studies conducted. This information would typically be found in the full 510(k) submission's performance section.

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

• Sample size for test set: Not provided.
• Data Provenance (country of origin, retrospective/prospective): Not provided.

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

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

4. Adjudication Method for the Test Set

• Adjudication method: Not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: Unlikely, as this is a diagnostic test strip for over-the-counter home use, not an imaging device typically involving multiple human readers interpreting complex images. The device is intended for direct user interpretation. Therefore, a traditional MRMC study as commonly understood for AI in medical imaging would not be applicable or expected.
• Effect size of improvement with AI vs. without AI: Not applicable, as this is a standalone test strip, not an AI-assisted interpretation system for human readers.

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

• Standalone Performance: Yes, implicitly. As a chemical test strip, its performance is inherently "standalone" in that it provides a direct result (color change) based on chemical reactions, without an algorithmic interpretation layer in the same way an AI software would operate. The user directly observes the result. The studies would have evaluated the accuracy of these chemical reactions against a reference method.

7. The Type of Ground Truth Used

• Type of Ground Truth: While not explicitly stated in this document, for a UTI test strip detecting nitrite and leukocytes, the ground truth would almost certainly be established through laboratory-based microbiological urine culture (for confirming actual UTI presence and specific pathogens) and potentially microscopic analysis of urine sediment (for leukocyte presence).

8. The Sample Size for the Training Set

• Sample size for training set: Not provided. For a non-AI diagnostic strip, "training set" isn't a conventional term in the same way as for machine learning. Instead, product development and optimization might involve iterative testing, but this wouldn't typically be called a "training set" in the context of FDA submissions for such devices.

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

• Ground truth for training set: Not provided. As noted above, the concept of a "training set" with established ground truth is less directly applicable for this type of chemical diagnostic strip. Optimization and development would rely on comparison to established laboratory methods.

Ask a specific question about this device

The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "IND One Step Fecal Occult Blood Test." It primarily states that the device has been found substantially equivalent to a legally marketed predicate device.

Unfortunately, this document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

This type of information is typically found in the 510(k) submission itself, or in supplementary documents such as clinical study reports or performance verification reports, which are not included in this letter.

Therefore, I cannot provide the requested table and details based solely on the provided text. The document confirms the device's clearance but does not elaborate on the specific performance data or study methodology used to achieve that clearance.

Ask a specific question about this device

Urine Chemistry Analyzer UR-50 is for use with the IND Urinalysis Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity in urine. It can be used for testing in the clinical laboratory setting. For professional use only. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Urine Chemistry Analyzer UR-50. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the device to legally marketed predicate devices.
• Regulatory classifications and requirements.
• Contact information for further inquiries.
• The intended use of the device, as described in the "Indications for Use" section.

Therefore, I cannot fulfill your request for:

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

This information would typically be found in a separate submission document, such as the 510(k) summary or a detailed clinical study report, which is not part of the provided text.

Ask a specific question about this device

The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person.

For in vitro diagnostic use only.

As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method

Not Found

This looks like a 510(k) summary, but unfortunately, the provided document is a letter stating the FDA's decision regarding the device's substantial equivalence, along with the Indications for Use. It does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

Therefore, I cannot extract the requested information. The document primarily focuses on the regulatory approval process and the intended use of the device, rather than the specific performance data and study design.

To provide the requested details, I would need access to the actual 510(k) submission or a performance study report for the "One Step DOA-2, DOA-4 Multi-Panel Test" and its single-analyte counterparts.

Ask a specific question about this device

One Step HCG Pregnancy Test 2000 mIU / mL is a qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL designed to aid in the detection of pregnancy. This test device is intended for professional central laboratory use only.

Not Found

The provided text is a 510(k) premarket notification approval letter for a medical device called "One Step HCG Pregnancy Test 2000 mIU / mL." This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and does not contain the detailed study information needed to answer the specific questions about acceptance criteria and device performance as typically found in a clinical study report.

Therefore, I cannot provide a comprehensive answer to your request based on the given input. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Details on standalone algorithm performance.
7. Type of ground truth used (beyond implying a "determination of human chorionic gonadotropin (HCG) concentration").
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states the device is a "qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL to aid in the detection of pregnancy." This implies that the device's performance would be evaluated based on its accuracy (sensitivity and specificity) in detecting HCG at or above the 2000 mIU/mL threshold against a known reference method or clinical outcome, but the specific study details are not present.

Ask a specific question about this device

FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.

One Step FSH Menopausal Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the "One Step FSH Menopausal Test":

A. Acceptance Criteria and Reported Device Performance

The acceptance criteria for diagnostic tests often involve measures like sensitivity, specificity, and accuracy, especially when comparing to a reference method or clinical endpoint. While the specific numerical acceptance criteria established by the manufacturer are not explicitly detailed in this FDA letter (which typically focuses on substantial equivalence), the provided data implies a performance standard for "positive agreement" and "negative agreement" in comparison to a predicate device or clinical reference.

Note: The FDA 510(k) summary usually provides the specific acceptance criteria. This document indicates the device is "substantially equivalent," meaning its performance is comparable to a legally marketed predicate device, implicitly meeting accepted performance standards for its intended use.

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

The provided document does not explicitly state the specific sample size used for the test set in a clinical study to validate these performance metrics. The agreement percentages (Positive Agreement, Negative Agreement, Overall Agreement) are listed, but the accompanying sample sizes for "Professional Use" and "Lay Use" are not present in this excerpt.

• Data Provenance: Not specified in this document. It does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not available in the provided document. For an FSH Menopausal Test, the "ground truth" for elevated FSH levels would likely be established by a laboratory assay (e.g., ELISA) for quantitative FSH levels, interpreted by a qualified medical professional (e.g., endocrinologist, gynecologist). The document doesn't detail the involvement of experts in establishing the ground truth or their qualifications.

D. Adjudication Method for the Test Set

This information is not available in the provided document. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging or subjective interpretation studies. For a diagnostic test like this, the ground truth is usually established by a reference method (e.g., quantitative laboratory FSH measurement), making multi-reader adjudication less relevant in the same way.

E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates how AI assistance impacts human reader performance, is not applicable to a single-use, qualitative in-vitro diagnostic test like the One Step FSH Menopausal Test. This device is not an AI-assisted interpretation tool.

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

Yes, in essence. This device inherently operates as a "standalone" test. The "performance" figures provided (Positive Agreement, Negative Agreement, Overall Agreement) reflect the device's ability to accurately detect FSH in urine samples, without human intervention in the detection process itself. The "Lay Use" section specifically evaluates its performance when interpreted by non-professionals, which is a key aspect of its standalone functionality for over-the-counter use.

G. The Type of Ground Truth Used

The ground truth used for performance evaluation is indicated by "Clinical Reference" and "Negative Reference" / "Positive Reference." This strongly suggests that the device's results were compared against an established clinical reference method for FSH levels (likely a quantitative laboratory assay) to determine true positive and true negative cases.

H. The Sample Size for the Training Set

This information is not available in the provided document. For a traditional in-vitro diagnostic test, there isn't a "training set" in the machine learning sense. The device's components (antibodies, reagents) are developed and optimized through research and development, but the sample sizes involved in that development process are distinct from the clinical validation (test set) discussed above.

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

Not applicable in the machine learning sense. The "ground truth" for the development of such a test would involve confirming the specificity and sensitivity of the antibodies and reagents against known concentrations of FSH, using established laboratory standards and methods. This is part of the product development and quality control process, rather than a "training set" in AI/ML terminology.

Ask a specific question about this device

IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a pregnancy test device. It does not contain the detailed study information or acceptance criteria that would allow me to answer your request with all the specified points.

The document primarily focuses on the regulatory clearance of the device (IND One Step hCG Pregnancy Test - Cassette Format) and its substantial equivalence to a predicate device. It briefly mentions the "Indications for Use" but does not delve into the performance studies or the specific acceptance criteria used to validate the device.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text.

To answer your request, you would need a document that includes performance study summaries, such as:

• Clinical Study Report: This would detail the methodology, sample sizes, ground truth establishment, expert qualifications, and results.
• Validation Report: Similar to a clinical study report, focusing on the technical validation of the device's performance characteristics.
• Predicate Device Performance Data: Sometimes, the 510(k) summary might compare the new device's intended performance to a predicate device, but it still often lacks the granular detail of specific acceptance criteria.

Without such a document, I am unable to fill in the table or address points 1-9 of your request.

Ask a specific question about this device

One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.

Urine RCG (Cassette Format) One Step Test Kit

While the provided documents confirm FDA clearance for the Urine HCG (Cassette Format) One Step Test Kit and describe its intended use, they do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

Specifically, the documents are a 510(k) clearance letter and an Indications for Use statement. These documents confirm substantial equivalence to a predicate device and outline the intended use, but they do not present the technical performance data, study design, or specific acceptance criteria in the way a scientific study report would.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details based solely on the provided text.

However, based on what is typically expected for an in vitro diagnostic device like a pregnancy test and what might be inferred from such a regulatory submission, here's a general idea of what that information would look like if it were present:

Hypothetical Acceptance Criteria and Study Information (Based on typical IVDD requirements, NOT the provided document)

Since the provided document is an FDA clearance letter and an "Indications For Use" statement, it does not contain the detailed technical performance study information you are asking for. However, for a device like a pregnancy test, the following information would typically be part of the submission that led to this clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device