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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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

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

• Sample Size: Typically, hundreds to thousands of urine samples would be used for a comprehensive clinical study. For a general pregnancy test, this might involve:
  • Positive samples: 100-200 confirmed pregnant urine samples (various stages of pregnancy).
  • Negative samples: 200-500 confirmed non-pregnant urine samples.
  • Spiked samples: A range of hCG concentrations (e.g., 0, 10, 25, 50, 100, 500,000 mIU/mL) to assess sensitivity, linearity, and hook effect.
• Data Provenance: Likely a combination of:
  • Prospective collection: From clinical sites within Canada (where the manufacturer is located) and potentially the US.
  • Retrospective collection: Archived samples with known hCG status, potentially from various countries if adequately characterized.

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

• Ground Truth Determination: For clinical samples, the ground truth for hCG status is typically established by:
  • Confirmation with a highly sensitive and quantitative reference laboratory method: Such as a validated immunoassay (e.g., chemiluminescent immunoassay) performed at a College of American Pathologists (CAP) accredited laboratory.
  • Clinical confirmation: Including follow-up with patient medical records for pregnancy confirmation (e.g., ultrasound, continued elevated hCG levels over time).
• "Experts": While individual "experts" don't typically "read" the ground truth for every sample, the ground truth is overseen by:
  • Board-certified Clinical Pathologists or Clinical Biochemists: Supervising the reference laboratory testing. (e.g., Clinical Biochemist with 10+ years of experience, similar to Dr. David Lee's qualifications).
  • Clinical Obstetricians/Gynecologists: Providing clinical correlation for patient outcomes.

4. Adjudication Method for the Test Set

• Not applicable in the typical sense for a quantitative ground truth. Adjudication (e.g., 2+1) is more common when human readers are involved in interpreting images or subjective results.
• For a quantitative ground truth (like a reference immunoassay), the result itself is the "adjudicated" truth, usually with established cut-off values. Discrepancies between the investigational device and the reference method would be resolved by re-testing (e.g., re-running both tests on an aliquot, using a third confirmatory method).

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

• Highly Unlikely for this device. This is a standalone diagnostic kit with a visual, qualitative result (a line appearing or not appearing). There are no "human readers" interpreting complex images or data that AI would assist with in this context. MRMC studies are typical for imaging AI, not for a simple in vitro diagnostic test like a pregnancy strip.

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

• Yes, this is a standalone device. The performance claimed (sensitivity, specificity, accuracy) is inherently the "standalone" performance of the test kit itself, without a human interpretation component that could be "assisted" or compared to. The user simply observes the line/no line.

7. The Type of Ground Truth Used

• Reference Laboratory Assay + Clinical Outcomes: The primary ground truth would be established by a highly sensitive and quantitative laboratory hCG assay, combined with clinical correlation like ultrasound confirmation or longitudinal hCG observation to confirm pregnancy status.

8. The Sample Size for the Training Set

• Not applicable in the traditional "AI training set" sense. This device is a biochemical assay (lateral flow immunoassay), not an AI algorithm that undergoes machine learning training. The "training" for such a device involves iterative development and optimization of the reagents and strip components. The "test set" described above serves as the validation for the final product.

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

• Not applicable. See point 8. The "ground truth" during development involves ensuring the assay correctly detects hCG at specific concentrations and does not cross-react with other substances, which is done through laboratory experiments using purified hCG and known interferents, not through a "training set" of patient data in the AI sense.

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