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Clearblue® Plus 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 (5 days before the missed period).

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This FDA 510(k) clearance letter for the Clearblue Plus Pregnancy Test does not contain the detailed scientific study information requested. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing the specifics of performance studies, acceptance criteria, or ground truth establishment.

Therefore, most of the requested information cannot be extracted from the provided text.

However, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

• This information is not present in the provided document. The 510(k) summary (which is a separate document typically submitted with the 510(k) application) would contain this.

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

• This information is not present in the provided document.

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

• This information is not present in the provided document.

4. Adjudication method for the test set:

• This information is not present in the provided document.

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 a pregnancy test, not an AI-assisted diagnostic device for image interpretation. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.

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

• This is a pregnancy test; the "algorithm" is the biochemical reaction and visual interpretation. Standalone "algorithm only" performance, in the AI sense, is not applicable and not described. The device's performance is inherently "standalone" in its function as a qualitative diagnostic test.

7. The type of ground truth used:

• This information is not present in the provided document. For a pregnancy test, ground truth would typically be established by laboratory methods for hCG concentration (e.g., quantitative serum hCG).

8. The sample size for the training set:

• This information is not present in the provided document. "Training set" as understood in machine learning contexts is not applicable here.

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

• This information is not present in the provided document. "Training set" and its ground truth establishment are not applicable in the context of this regulatory clearance document for a pregnancy test.

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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.

Not Found

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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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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CLEARBLUE EASY DIGITAL PREGNANCY TEST is an over-thecounter qualitative 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) summary for the CLEARBLUE EASY DIGITAL PREGNANCY TEST. It primarily covers the regulatory determination of substantial equivalence and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the format requested.

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

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CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of preguancy. The test has a sensitivity of 50mIU/ml hCG in urine, and is indicated for use from four days before the first day of the missed 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 or performance data for an AI/ML device. Therefore, I cannot extract the requested information. The letter confirms substantial equivalence to a predicate device and states the indications for use, but does not contain performance study details typically associated with AI/ML device evaluations.

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CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mlU/ml hCG in urine, and is indicated for use from four days before the expected missed period.

Not Found

The provided text is a 510(k) premarket notification approval letter for the Clear Blue Easy™ Early Result Pregnancy Test. It acknowledges the device's substantial equivalence to previously marketed predicate devices. However, this document does not contain the details required to answer your specific questions about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on regulatory approval based on substantial equivalence and general controls, rather than on a detailed scientific study report.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need access to the actual 510(k) submission document (K013372) which would outline the performance data and testing conducted by Unilever United States, Inc.

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Ask a specific question about this device