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The FIRST RESPONSE™ Early Result Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Important note regarding negative results:

Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.

All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

The FIRST RESPONSE™ Early Result Pregnancy Test is a test system for the detection of human chorionic gonadotropin (hCG) hormone. Specifically, it is a screening device intended for the early detection of pregnancy by the lay user through the qualitative detection of hCG in urine, in some cases as early as six (6) days before the day of the missed period. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing. Following the instructions for use provided with the device, the test is performed by placing the absorbent pad of the device into the urine stream for 5 seconds (or alternatively by fully immersing the absorbent pad for 5 seconds in a urine sample that was collected in a cup). The test result is displayed at the housing window for reading by the layer user after the elapse of 3 minutes. Two pink lines indicate that hCG has been detected (pregnant); one pink line indicates that no hCG has been detected (not pregnant).

Here's a breakdown of the acceptance criteria and study information for the FIRST RESPONSE™ Early Result Pregnancy Test, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for this device is "substantial equivalence" to the predicate device, specifically in its ability to detect pregnancy early (as early as 6 days before the missed period). The studies below collectively demonstrate this substantial equivalence.

Study Information

The document describes several studies conducted to demonstrate the substantial equivalence of the modified FIRST RESPONSE™ Early Result Pregnancy Test.

1. A laboratory study to demonstrate the accuracy of the 510(k)-subject device compared to the accuracy of the predicate device.

• Sample size for the test set: Not specified.
• Data provenance: Urine samples quantified for hCG levels from pregnant and non-pregnant women. Implied to be retrospective lab samples, potentially from a collection of known states. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not specified, but "urine samples quantified for hCG levels" implies a lab standard, not expert consensus for ground truth.
• Adjudication method: Not applicable, as ground truth is based on quantitative hCG levels.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No, this was a comparative accuracy study against a predicate device.
• Standalone (algorithm only) performance: Yes, this appears to be a standalone performance evaluation against quantifiable samples.
• Type of ground truth used: Quantitative hCG levels in urine samples.
• Sample size for the training set: Not applicable, this is a performance evaluation, not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

2. A laboratory study to determine the analytical sensitivity and cut-off of the 510(k)-subject device.

• Sample size for the test set: Not specified.
• Data provenance: Uses "hCG standards of known concentration." This implies controlled laboratory samples. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
• Type of ground truth used: Known concentrations of hCG standards.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

3. A consumer study to demonstrate the ability of lay users to obtain similar results around the established sensitivity and cutoff as laboratory professionals.

• Sample size for the test set: Not specified, but involves "lay users" and "laboratory professionals."
• Data provenance: Implied to be prospective, involving actual users performing the test. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Laboratory professionals are part of the comparison, so they establish a reference, but not necessarily a "ground truth" in the diagnostic sense beyond comparing performance. The inherent ground truth would still be the hCG levels of the samples being tested.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No, this is a comparison of performance between user groups.
• Standalone (algorithm only) performance: No, this study involves human-in-the-loop (lay users and professionals).
• Type of ground truth used: Implicitly, the hCG levels of the samples used. The "ground truth" here is less about the state of pregnancy and more about whether different user groups get the same test outcome on the same sample.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

4. A laboratory study to assess intra and inter lot precision of the 510(k)-subject device.

• Sample size for the test set: Not specified.
• Data provenance: Uses "hCG standards of known concentration." Implied controlled laboratory samples. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
• Type of ground truth used: Known concentrations of hCG standards.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

5. Laboratory studies to demonstrate that potential interfering substances and homologous hormones do not affect the performance.

• Sample size for the test set: Not specified.
• Data provenance: Controlled laboratory conditions with added interfering substances and homologous hormones. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
• Type of ground truth used: Expected negative or positive results in the presence of various substances based on known hCG levels in test samples.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

6. A laboratory study to demonstrate that no high dose hook effect is observed.

• Sample size for the test set: Not specified.
• Data provenance: Controlled laboratory conditions using "very high levels of intact hCG." Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
• Type of ground truth used: Known very high concentrations of hCG, with the expectation of a positive result.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

7. A laboratory study to determine the effect of high levels of hCG ßcf on device performance.

• Sample size for the test set: Not specified.
• Data provenance: Controlled laboratory conditions. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
• Type of ground truth used: Known hCG levels in the presence of high hCG ßcf.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

8. An early pregnancy detection study using urine samples from conceptive cycles.

• Sample size for the test set: Not specified.
• Data provenance: Urine samples from conceptive cycles. Implied prospective collection to track early pregnancy onset. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not specified, but "conceptive cycles" suggests tracking women attempting to conceive, with pregnancy confirmation likely through clinical methods (blood tests, ultrasound) as the ground truth.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: Yes, this evaluates the device's standalone ability to detect hCG early.
• Type of ground truth used: Confirmed pregnancy status from conceptive cycles, likely through clinical gold standards.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

9. A laboratory study to determine the performance with urine samples quantified for hCG from pre-, peri-, and post-menopausal women.

• Sample size for the test set: Not specified.
• Data provenance: Urine samples from pre-, peri-, and post-menopausal women, quantified for hCG. Implied retrospective lab samples. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not specified, but "urine samples quantified for hCG" implies a lab standard for ground truth.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: Yes, this is a standalone performance evaluation against quantifiable samples.
• Type of ground truth used: Quantitative hCG levels and menopausal status.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

10. A consumer self-use study to determine the ability of the consumers to perform the test and interpret the results correctly.

• Sample size for the test set: Not specified, but involves "consumers."
• Data provenance: Implied prospective, involving actual consumers performing the test. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not specified. Ground truth for correct interpretation would likely involve comparing consumer interpretation to an objective standard (e.g., a lab professional's read of the same test, or the known hCG status of the sample).
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
• Standalone (algorithm only) performance: No, this study involves human-in-the-loop (consumers).
• Type of ground truth used: The actual result shown on the strip and whether the consumer's interpretation matches it. The underlying ground truth of pregnancy for the samples would also be relevant.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of missing information:

• Specific sample sizes for most of the test sets.
• Country of origin for the data.
• Specific qualifications and number of experts for establishing ground truth, especially for the "conceptive cycles" study and the consumer interpretation study.
• Detailed methodology for ground truth establishment beyond "quantified hCG levels" or "conceptive cycles."
• Any training set information, as these are primarily performance evaluation studies for a diagnostic device, not a machine learning algorithm.

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The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period). This test is only intended for individual use at home. It is not intended for use in a healthcare setting.

The FIRST RESPONSE® Early Result Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a screening device intended for early detection of pregnancy by the lay user for the qualitative measurement of hCG in urine as early as six (6) days before the day of the missed period. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing. Following the instructions for use provided with the device, the test is performed by placing the absorbent collection tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds. The test result is read in the housing window after the elapse of 3 minutes. Two pink lines indicate hCG has been detected (pregnant); one pink line indicates no hCG has been detected (not pregnant).

The provided document describes the FIRST RESPONSE® Early Result Pregnancy Test, an at-home pregnancy test that detects human chorionic gonadotropin (hCG) in urine. The key focus of the submission is a modification to the device to achieve increased analytical and clinical sensitivity, allowing for earlier detection of pregnancy (6 days before the missed period, compared to 5 days for the predicate device).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, the primary acceptance criterion inferred from the submission is the ability of the device to detect hCG as early as 6 days before the missed period both analytically and when interpreted by consumers. The reported device performance is that it achieves this increased sensitivity and consumers can accurately read and interpret the results at this earlier time point.

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

The document mentions a "consumer study" and "professional testing" to verify device performance. However, it does not specify the sample size used for the test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective data collection, as it's a study designed to verify the performance of the modified device with "early pregnancy urines."

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

The document states, "A consumer study confirmed professional testing and verified the device performance characteristics..." This implies that "professional testing" established a ground truth against which consumer results were compared. However, the number of experts and their specific qualifications (e.g., medical professionals, lab technicians, etc.) are not provided.

4. Adjudication Method for the Test Set

The document mentions "professional testing" and a "consumer study," indicating a comparison. However, the specific adjudication method (e.g., 2+1, 3+1, none) for the test set is not described. It can be inferred that the professional testing results served as a reference or a form of adjudicated truth for the consumer study, but the methodology of this adjucation is absent.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. The study described focuses on consumer interpretation of the device's results, not a comparison of human readers' performance with and without AI assistance. The device itself is an in-vitro diagnostic test, not an AI-powered diagnostic tool requiring human-in-the-loop analysis.

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

The device is an at-home pregnancy test, meaning the "algorithm" (the immunochemical reactions on the strip) performs standalone, and the consumer then interprets the visual result (one or two lines). The "consumer study" specifically evaluates the human interpretation aspect. Therefore, a standalone performance of the immunochemical test (the core of the "algorithm") is implicitly what "professional testing" would assess, and the consumer study then assesses the human interpretation of that standalone output. The document does not explicitly present data from an "algorithm only" study in isolation from any human interpretation, but the entire device functions in a standalone manner before human interpretation.

7. The Type of Ground Truth Used

The ground truth for the "consumer study" was established through "professional testing" using "early pregnancy urines." This implies that the presence and concentration of hCG in these urine samples were independently verified and quantified by professional laboratory methods, serving as the objective ground truth for pregnancy status.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The description indicates a modification to an existing device (predicate device) and subsequent verification studies (professional testing and a consumer study) for the modified device. There is no indication of a machine learning model being trained, which would typically require a training set.

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

As no training set is mentioned in the context of a machine learning model, this information is not applicable and not provided. The studies described are for verification of the modified device's performance.

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