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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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