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The UniMark® Home Pregnancy Test Device is intended for the qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy.

UniMark® Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin (hCG) in urine. It is intended for consumer use at home.

It is indicated for use in the early detection of pregnancy.

The UniMark® Home Pregnancy Test Device is a colored solid-phase Chromatographic Immunoassay (CIA) for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is a home use, rapid, visual, one step pregnancy screening test.

Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone synthesized by the placenta and released in blood and urine soon after the implantation of a fertilized ovum in the chorionic tissue. HCG is the principal signal and specific marker of the pregnancy. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies conjugated to colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat anti-hCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates the presence of an hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.

Here's an analysis of the provided text regarding the UniMark® Home Pregnancy Test Device, structured to address your specific questions:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-Clinical (Accuracy): 364 urine specimens (189 positive, 175 negative).
  • Provenance: Not explicitly stated, but likely laboratory-based. Retrospective.
• Consumer Study: 100 home users, and for each user, 4 spiked urine fractions (0, 20, 30, 1000 mIU/ml hCG) were tested. This means 400 total individual tests performed by home users.
  • Provenance: Central New Jersey and New York City, prospective (performed by home users in a test setting).

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

• Non-Clinical (Accuracy): The ground truth was established by a "commercially available quantitative visual hCG test." The number and qualifications of experts using this test are not specified, but it's implied to be a standard laboratory method.
• Consumer Study: The "organizer or lab assistant" observed and verified user test results. The "lab technician of Biotech Atlantic" subsequently tested the coded controls with the professional (predicate) test. The number and specific qualifications of these individuals are not provided beyond their roles.

4. Adjudication Method for the Test Set

• Non-Clinical (Accuracy): No explicit adjudication method is mentioned beyond the comparison to a "commercially available quantitative visual hCG test."
• Consumer Study: For the home user tests, the "user test results were observed and verified by the organizer or lab assistant to verify correct interpretation of positive or negative." For the internal verification, "the lab technician of Biotech Atlantic subsequently tested the set of coded controls in the back-kit from each home user with the professional (predicate) test." This implies a form of expert verification against a reference method, but not a multi-reader consensus adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described for this device. The consumer study involved multiple users, but it was to assess user interpretation against a control, not to compare human readers with and without AI assistance or to quantify an effect size of AI improvement.

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

Yes, the non-clinical tests (Sensitivity, Accuracy, Specificity, Interference) represent standalone performance of the device without human interpretation (other than the initial reading in a lab setting). The "Accuracy" study compared the UniMark® hCG test (likely read by lab personnel) with another quantitative visual hCG test.

7. The Type of Ground Truth Used

• Non-Clinical (Sensitivity, Accuracy, Specificity, Interference): The ground truth was established against known concentrations of hCG (for sensitivity and spiked samples for accuracy) and other hormones/substances (for specificity and interference). For accuracy, a "commercially available quantitative visual hCG test" served as the reference standard.
• Consumer Study: The ground truth was established by a lab technician using the professional (predicate) UniMark® hCG Pregnancy Test Device on spiked urine samples (0, 20, 30, and 1000 mIU/ml hCG).

8. The Sample Size for the Training Set

The document does not explicitly describe a training set or a machine learning algorithm for this device. This is a chemical immunoassay, not an AI/ML-based device. Therefore, the concept of a "training set" in the context of AI development is not applicable here.

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

As explained above, there is no mention of a training set as this is not an AI/ML device.

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UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.

It is indicated for use in the early detection of pregnancy.

UniMark® hCG Combo Pregnancy Test is a chromatographic immunoassay (CIA) for qualitative detection of elevated levels of hCG in serum and urine specimens for the early pregnancy diagnosis. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies coated on colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat antihCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negtive result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.

Here's an analysis of the provided text regarding the UniMark® hCG Combo Pregnancy Test, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's performance in terms of sensitivity, accuracy (correlation), and specificity. It also mentions interference testing. However, explicit numerical acceptance criteria (e.g., "sensitivity must be >95%") are not directly stated within the provided text. Instead, the performance is evaluated by comparison to other legally marketed devices.

Note: The application states the UniMark® hCG Combo Pregnancy Test "performs as well as the legally marketed device to which equivalence is claimed, the UniMark® hCG Pregnancy Test when tested with urine specimens." and "as well as a legally marketed combo device when tested with both serum and urine specimens." This establishes the acceptance criteria implicitly as non-inferiority or equivalence to these predicate devices. The specific numerical thresholds for "as well as" are not provided in this summary.

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

• Sample Size: The document does not explicitly state the sample size used for the test set in the performance studies.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective.

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

• This information is not provided in the given text. As a simple immunoassay device, the "ground truth" (presence or absence of hCG) would typically be established by a different, often more sensitive, laboratory method rather than expert interpretation of results.

4. Adjudication Method for the Test Set

• This information is not provided in the given text.

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

• No, an MRMC comparative effectiveness study was not conducted or described. This type of study typically applies to imaging or diagnostic interpretation tasks where human readers interpret data, often with and without AI assistance. The UniMark® hCG Combo Pregnancy Test is a rapid, qualitative immunoassay designed for direct visual interpretation.

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

• This device is a standalone test in the sense that it provides a qualitative result (positive/negative band) without requiring human interpretation of complex data or an accompanying algorithm. The "algorithm" is the biochemical reaction itself that produces the visible band. The performance studies described are inherently of the standalone device, as it's a point-of-care type test.

7. The Type of Ground Truth Used

• The ground truth for hCG pregnancy tests typically involves quantitative laboratory assays (e.g., quantitative serum hCG tests) or clinical confirmation of pregnancy (e.g., ultrasound). The document states performance studies were done "in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test." (K013194, Section G). This implies the predicate device served as a reference, or the results were compared against an established "true" state of hCG presence/absence determined by a gold standard (likely a combination of clinical diagnosis and a highly sensitive laboratory method). The document does not explicitly detail the exact method used to establish the "true" hCG status for each sample.

8. The Sample Size for the Training Set

• This device is a biochemical immunoassay, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" of data to learn patterns. Therefore, the concept of a "training set" and its size is not applicable to this device. Its performance is based on the chemical formulation and manufacturing precision, which are validated through performance studies.

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

• As explained above regarding the training set, this question is not applicable to this type of medical device.

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The UniMark™ Midstream Pregnancy Test Stick is intended for the qualitative measurement of human chorionic gonadotropin (hCG) in urine as a home use screening test for pregnancy.

The UniMark™ Midstream Pregnancy Test Stick is a home use, rapid, visual, one step screening test for pregnancy. UniMark™ is a colored solid-phase immunoassay for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is based on a two-site sandwich immunometric assay which utilizes a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG with a high degree of sensitivity. UniMark™ contains a strip with a sample pad and a membrane area. The former contains mouse anti-hCG monoclonal antibody conjugated with colloid gold. The latter is coated with goat anti-mouse IgG at the control zone and goat anti-hCG antibody at the test zone. During the test, the urine is sucked up through sample pad by capillary action, and hCG in the urine sample binds to the gold conjugate, moving chromatographically toward the membrane. The immobilized goat anti-hCG antibody at the test zone catches the resulting complexes, forming an antibody-hCG-gold conjugate complex. The appearance of a purple band in the test window resulted from the complex shows a positive result, which indicates presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the urine sample. The appearing of a purple band in the control window demonstrates proper performance and validity of the reactive reagent.

Here's an analysis of the provided text regarding the UniMark™ Midstream Pregnancy Test Stick, structured to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Performance Breakdown:

Non-Clinical Tests:

• Sensitivity:
  • 0 mIU/ml hCG: 100% negative (3 lots tested)
  • 20 mIU/ml hCG: 95% negative, 5% positive (3 lots tested) - Note: This indicates some border-line detection at 20 mIU/ml, but full positive detection is at 25 mIU/ml.
  • 25 mIU/ml hCG: 100% positive (3 lots tested)
  • 50 mIU/ml hCG: 100% positive (3 lots tested)
  • 100 mIU/ml hCG: 100% positive (3 lots tested)
• Specificity (Interference Studies):
  • hLH: No interference observed at 10, 100, 200 mIU/ml hLH. The device remained positive when 25 mIU/ml hCG was added to these hLH concentrations.
  • hFSH: No interference observed at 1000 mIU/ml hFSH. The device remained positive when 25 mIU/ml hCG was added.
  • hTSH: No interference observed at 1000 uIU/ml hTSH. The device remained positive when 25 mIU/ml hCG was added.

Clinical Tests:

• Correlation with CIDA Professional Test (Reference Standard): 100% correlation with UniMark™ home user results.
  • UniMark™ Positive / CIDA Positive: 119 cases
  • UniMark™ Negative / CIDA Negative: 27 cases
  • Total cases: 146

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

• Sample Size (Clinical Test Set): 146 home users.
• Data Provenance: Prospective, from a women's center in southern New Jersey, USA.

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

• Number of Experts: At least two for the clinical portion:
  • "The user test results were observed and verified by the lab assistant (to verify correct interpretation of positive or negative)."
  • The "CIDA professional test results" imply a professional lab test was used as the ground truth, likely interpreted by qualified lab personnel, though their specific qualifications are not detailed beyond "professional test."
• Qualifications of Experts: The text states "lab assistant" and "CIDA professional test results." Specific qualifications (e.g., years of experience, certification) are not provided for either.

4. Adjudication Method for the Test Set

• Clinical Test Set: The text indicates that the home user's interpretations were "observed and verified by the lab assistant." This suggests a form of 1:1 verification, where the lab assistant confirmed the user's reading. The "CIDA professional test" was then used as the definitive ground truth against which both the home user's interpretation and the lab assistant's verification would presumably align or be compared. It implies a direct comparison rather than a formal voting/adjudication process like 2+1 or 3+1 among multiple human readers of the device itself.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a standalone home-use test, and the study evaluated its performance against a professional lab test, not the improvement of human readers with AI assistance.

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

• Standalone Performance: Yes, the entire study effectively evaluates the standalone performance of the UniMark™ device itself. Both the non-clinical (sensitivity, specificity) and clinical (correlation with CIDA) tests assess the device's ability to accurately detect hCG without human interpretive intervention beyond observing the colored bands. The "home user" aspect tests the device usability and interpretability by a layperson, but the underlying performance is that of the device.

7. The Type of Ground Truth Used

• Clinical Test Set: The primary ground truth for the clinical study was the CIDA professional test results. This represents a laboratory reference standard.
• Non-Clinical Test Set: The ground truth for sensitivity and specificity was known concentrations of hCG, hLH, hFSH, and hTSH (prepared according to WHO standards).

8. The Sample Size for the Training Set

• The document describes performance data for the UniMark™ device, which is a chemical/immunological test kit. It does not employ an AI algorithm or machine learning model, and therefore, there is no training set in the context of AI development. The device relies on pre-determined biochemical reactions.

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

• As stated in point 8, there is no training set for this type of device.

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