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e.p.t Certainty® 1-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

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This document is a 510(k) premarket notification acceptance letter for the e.p.t Certainty® 1-Step Pregnancy Test. It does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for testing or training sets.

To get this information, you would typically need to refer to the substantial equivalence documentation submitted by Unipath Ltd. to the FDA, which is not provided in this excerpt.

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Clearblue Easy Digital Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

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The provided document is an FDA 510(k) clearance letter for the Clearblue Easy Digital Pregnancy Test. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement. The letter simply states that the device has been found substantially equivalent to a predicate device.

To answer your questions thoroughly, I would need access to the actual 510(k) submission (K060128) which would detail the studies conducted.

However, based on the limited information available in the clearance letter, I can infer some general characteristics of this type of device and the likely studies.

Here's how I can address your request, acknowledging the limitations of the provided text:

Clearblue Easy Digital Pregnancy Test (K060128)

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The specific acceptance criteria are not detailed in the provided FDA letter. For an hCG pregnancy test, common acceptance criteria typically involve:

  • Sensitivity: The lowest concentration of hCG the device can reliably detect (often expressed as mIU/mL).
  • Specificity: The ability to accurately detect hCG without false positives from interfering substances or other hormones.
  • Accuracy (Agreement): The percentage of agreement with a reference method or clinical outcome.
  • Readability/Interpretation: For a digital test, clearly displaying "Pregnant" or "Not Pregnant."
  • Early Detection Claim: If the device claims early detection, its performance at low hCG levels (corresponding to days before the expected period) is critical. The letter mentions "use from four days before the expected period," indicating this was a key performance claim.

• Reported Device Performance: The letter only states that the device was found "substantially equivalent" to predicate devices. It does not provide specific performance metrics (e.g., sensitivity, specificity percentages) from Unipath Limited's studies.

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

• Sample Size: Not specified in the provided document. For an in vitro diagnostic (IVD) device like a pregnancy test, clinical studies typically involve a few hundred urine samples (both positive and negative for pregnancy, often spiked with known hCG concentrations or collected from pregnant/non-pregnant women).
• Data Provenance: The manufacturing company, Unipath Limited, is located in the United Kingdom. It is highly probable that at least some, if not all, of the clinical data was collected from studies conducted in the UK or other European countries, given the company's location. The letter does not specify whether the data was retrospective or prospective. Most clinical validation studies for IVDs involve prospectively collected samples or a combination of prospective and banked retrospective samples.

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

• This is not applicable in the traditional sense for a pregnancy test. The "ground truth" for hCG levels is established through quantitative laboratory assays (e.g., enzyme immunoassays, chemiluminescent immunoassays) performed by qualified laboratory personnel, not typically by a panel of clinical "experts" reviewing images or patient cases. The interpretation of the quantitative results would be the "expert" step.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth for hCG levels is quantitative. There wouldn't be an adjudication process among experts for a positive/negative result, as the quantitative gold standard determines the truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study (MRMC) is generally conducted for diagnostic imaging devices where human readers interpret medical images (e.g., radiologists interpreting X-rays, mammograms). A pregnancy test is an in-vitro diagnostic device that directly detects a biomarker (hCG) in urine. There is no "human reader" component in the sense of interpreting complex visual data that is then compared to an AI algorithm.

6. Standalone (Algorithm Only) Performance Study

• Yes, implicitly. The Clearblue Easy Digital Pregnancy Test is a standalone device. Its performance is evaluated on its ability to detect hCG in urine samples and display a result ("Pregnant" or "Not Pregnant") directly to the user. There isn't an "AI algorithm" in the same way one would refer to it in medical imaging. The "algorithm" here refers to the biochemical reactions and the digital reader's interpretation of the signal produced by the test strip. The clinical studies conducted by Unipath would have assessed this standalone performance.

7. Type of Ground Truth Used

• For an hCG test, the primary ground truth would be:
  • Quantitative laboratory hCG values: Urine or serum samples with known, precisely measured concentrations of hCG (determined by a highly sensitive and specific laboratory reference method).
  • Clinical outcome: Confirmation of pregnancy via ultrasound or subsequent clinical follow-up for samples from pregnant and non-pregnant individuals.

8. Sample Size for the Training Set

• The document does not provide this information. For a diagnostic device, the "training set" would refer to samples used during the development and optimization phase of the test (e.g., optimizing antibody concentrations, reaction times, digital reader thresholds). This is typically an internal development process, and the sample size is not usually reported in the 510(k) summary, which focuses on validation studies.

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

• Similar to the validation set, the ground truth for training/development samples would be established using:
  • Quantitative hCG reference methods: Accurate laboratory assays to determine the precise hCG concentration in samples.
  • Known pregnancy status: Samples from women with confirmed pregnancies (of varying gestational ages) and confirmed non-pregnancies.
    This allows developers to fine-tune the test's sensitivity and specificity.

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The Inverness Medical TestPack + Plus Strep A with OBC Test is intended for the qualitative detection of Group A Streptococcal (Group A Strep) antigen in throat swab specimens from patients with suspected Group A Strep associated pharyngitis and for confirmation of presumptive Group A Strep colonies isolated on culture plates. The test is intended for Professional and Laboratory Use only.

Inverness Medical TestPack + Plus Strep A with OBC Strep A is an immunoassay employing sheep and rabbit polyclonal antibodies and gold colloid particles. The test device uses lateral flow technology; following antigen extraction, the test time is approximately 5 minutes. The Streptococcal Group A specific antigen is extracted from the throat swab using Reagent 1 (2.0 M Sodium Nitrite (& Xylenol Orange) and Reagent 2 (1.0 M Acetic Acid). Following this, Reagent 3 (1.0 M Tris Buffer) is added to neutralise the acid formed by Reagents 1 and 2. The mixture is then dropped into the sample well of the reaction disc from which it migrates through the membrane until it reaches the End of Assay (EOA) Window. As the specimen extract migrates through the membrane, it mobilises the antibody-coated colloid (colloid coated with Rabbit Anti-Strep A antibody). If Group A Streptococcal antigen is present in the specimen it will form a complex with the antibody-colloid. The antibody colloid complex migrates through the membrane and is then captured by the Group A Strep antibody (Sheep polyclonal antibody) in the result window, providing a visual indication of the presence of antigen. The test can be read when the 'End of Assay' (EOA) window has turned pink / red. A pink / red Plus Sign (+) appearing in the result window indicates the presence of the Group A Strep antigen. A Minus Sign (-) indicates no antigen was detected. The device also includes integral Control features.

Acceptance Criteria and Study Details for Inverness Medical TestPack + Plus Strep A with OBC

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for sensitivity and specificity. Instead, the study aimed to demonstrate "substantial equivalence" to established culture techniques and other commercially available products. The clinical performance data is presented below, representing the "reported device performance."

2. Sample Size and Data Provenance

The study was a "multi-centre study" conducted to evaluate clinical performance.

• Sample Size for Test Set: 1048 throat swab specimens.
• Data Provenance: The document does not explicitly state the country of origin. Given the submitter is from the United Kingdom, it's possible the study involved centers in the UK, but this is not confirmed. The study was "multi-centre," suggesting data from multiple locations.
• Retrospective or Prospective: Not explicitly stated, but the nature of a clinical performance study evaluating a diagnostic device typically implies prospective data collection from patients with suspected Group A Strep pharyngitis.

3. Number of Experts and their Qualifications for Ground Truth

• The ground truth was established by "established culture techniques." While it's implied that laboratory personnel with appropriate qualifications performed the culture methods and interpretations, the document does not specify the "number of experts" involved in establishing this ground truth, nor their specific "qualifications" beyond operating these established techniques.

4. Adjudication Method

Not applicable. The ground truth was based on culture results, which are objective laboratory findings, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly done to assess how much human readers improve with AI vs. without AI assistance.
• The document implies a physicians' office study was conducted to show that physician office personnel could correctly perform and interpret the results of the device (not an AI assistant). This is a study of user performance with the device, not an MRMC study comparing AI-assisted vs. unassisted human readings.

6. Standalone Performance Study

• Yes, a standalone study was done. The reported performance metrics (sensitivity, specificity, overall agreement) are for the device (algorithm only, in this context, the immunoassay device's output) without human interpretation added into the performance calculation, beyond reading the clear positive or negative result on the device.

7. Type of Ground Truth Used

• The primary ground truth used for the clinical performance evaluation was "established culture techniques" for Group A Strep.

8. Sample Size for the Training Set

• The document does not mention a training set or any details about it. This device is a lateral flow immunoassay that relies on chemical reactions and visual indicators, not a machine learning or AI algorithm that typically requires a large training dataset.

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

• Not applicable, as no training set for a machine learning model is mentioned or implied.

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e.p.t CertaintyTM Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from the first day of the expected period and thereafter, but can also be used from three days before the expected period.

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The provided text does not contain specific information about the acceptance criteria and the study that proves the device meets those criteria. It is a 510(k) clearance letter from the FDA for the 'e.p.t CertaintyTM Pregnancy Test'.

The document includes:

• Device Name: e.p.t CertaintyTM Pregnancy Test
• Regulation Number: 21 CFR 862.1155 (Human chorionic gonadotropin (HCG) test system)
• Regulatory Class: Class II
• Product Code: LCX
• Indications For Use: Over-the-counter urine hCG test for the detection of pregnancy, indicated for use from the first day of the expected period and thereafter, and also from three days before the expected period.
• 510(k) Number: K050750

However, it does not include:

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

To obtain this information, one would typically need to review the full 510(k) submission summary or associated clinical study reports, which are not provided in this document.

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Fact plus® One-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

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The provided text is a 510(k) clearance letter for the "Fact plus® One-Step Pregnancy Test." It grants clearance for marketing but does not contain detailed information about the acceptance criteria, study design, or performance metrics beyond the general intended use. Therefore, I cannot extract the requested information from this document.

To answer your questions, I would need access to the actual 510(k) submission document or a summary of the clinical studies conducted for this device. The provided text is a regulatory approval, not a scientific study report.

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Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. The test is indicated for use from three days before the expected period.

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Here's an analysis of the provided text regarding the Clearblue Easy Easy Read Pregnancy Test, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided FDA clearance letter focuses on establishing substantial equivalence to a predicate device for marketing purposes. It does not detail the specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) that Unipath Ltd. used in their internal validation studies, nor the detailed results of those studies. The letter only confirms that the FDA reviewed the 510(k) and found the device substantially equivalent.

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The manufacturer is Unipath Ltd. based in the United Kingdom, so the studies could have been conducted there or elsewhere. The document does not indicate if the data was retrospective or prospective.

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

• Number of Experts: Not specified in the provided document.
• Qualifications of Experts: Not specified in the provided document.

4. Adjudication Method for the Test Set

• Not specified in the provided document. This type of detail is typically found in the full 510(k) submission, not the FDA clearance letter.

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

• Not Applicable: This device is an in-vitro diagnostic (IVD) pregnancy test, not an imaging device requiring human reader interpretation in the same way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study as typically understood for AI in radiology, for example, would not be relevant. The "human readers" for this device are the users interpreting the visual result (lines/symbols).

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

• Yes, implicitly: As an over-the-counter pregnancy test, the device is designed to be used by individuals without expert human intervention beyond interpreting the visual result. The "algorithm" in a qualitative test like this would be the chemical reaction leading to a visible line, and its performance is evaluated in a standalone manner (i.e., does the test correctly detect hCG in a sample). The 510(k) submission would have included data demonstrating the test's ability to accurately detect hCG levels.

7. The Type of Ground Truth Used

• Implicitly, clinical reference methods and/or known hCG concentrations: For a pregnancy test, ground truth would typically be established by:
  • Quantitative hCG measurements: Using highly accurate laboratory-based assays to determine the true hCG concentration in urine samples.
  • Clinical outcomes: Confirming pregnancy through other diagnostic methods (e.g., ultrasound, follow-up blood tests) to correlate with the test results.
  • Known hCG-spiked samples: Testing samples with precisely known concentrations of hCG to assess sensitivity and specificity at various levels.

8. The Sample Size for the Training Set

• Not specified in the provided document. This information would be part of the full 510(k) submission. For chemical-based IVDs, the concept of a "training set" in the machine learning sense is not directly applicable. Instead, there would be development and optimization phases where various reagents and designs are tested, and then validation studies on larger, independent sets.

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

• Not specified in the provided document. Similar to point 8, the "training set" concept is different here. However, for the development and optimization of such a test, the ground truth would involve precisely prepared samples with known hCG concentrations and potentially clinical samples with confirmed pregnancy status obtained through reference laboratory methods.

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Clearblue Easy Earliest Results Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

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This document is a 510(k) clearance letter from the FDA for a pregnancy test, not a study describing acceptance criteria and performance of a device with AI. Therefore, I cannot extract the requested information.

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e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and onwards.

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This document is a 510(k) premarket notification approval letter for the e.p.t.® Pregnancy Test. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, the letter itself does not contain the acceptance criteria or the study details that prove the device meets those criteria.

To answer your request, one would typically need to refer to the original 510(k) submission document (K040329) or related technical documentation, which is not provided in the given text. The provided text only states the "Indications for Use" and the FDA's concurrence with the marketing of the device.

Therefore, I cannot provide the requested information based solely on the text provided. The acceptance criteria, study details, sample sizes, expert qualifications, etc., would be found in the detailed submission to the FDA, not in the summary approval letter.

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e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and may be used before the expected period.

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The provided text is related to an FDA 510(k) clearance for the e.p.t. Pregnancy Test. While it details the regulatory aspects and intended use, it does not contain the specific information required to complete the table and answer the study-related questions.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which means specific performance data for the e.p.t. Pregnancy Test, beyond its intended use, is not detailed in this clearance letter. Such data would typically be found in the 510(k) summary or the full submission, which is not provided here.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details from the given text.

The only information that can be gleaned is:

• Device Name: e.p.t.® Pregnancy Test
• Intended Use: Over-the-counter urine hCG test for the detection of pregnancy. Indicated for use from the first day of a missed period and also for detection of pregnancy before the expected period.
• Regulatory Class: Class II
• Product Code: LCX
• Market Type: Over-The-Counter Use

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EPT Certainty™ Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.

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The provided text is a 510(k) clearance letter from the FDA for a pregnancy test. It does not contain information about the acceptance criteria, device performance, or details of a study that proves the device meets specific criteria. It only states the device's indications for use and sensitivity. Therefore, I cannot extract the requested information from the provided text.

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