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The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.

Here's an analysis of the acceptance criteria and study details for the Assure Tech hCG Pregnancy Serum/Urine Combo Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its "precision/reproducibility/cut-off value" and "method comparison" studies. The goal is to perform accurately around the established cut-off values and show strong agreement with a predicate device.

Study Details

1. Sample Size and Data Provenance:

   • Test Set (Precision/Reproducibility): For each format (Serum Strip, Serum Cassette, Urine Strip, Urine Cassette), 150 replicates were used for each hCG concentration level (10 replicates per site x 3 sites x 5 days for each of 3 lots = 450 total data points per concentration level for each format). Total tests: 10 concentrations per serum format, 10 for urine strip, 10 for urine cassette. This would be a massive number, but the table combines the three lots and three operators. So for each concentration, 150 total tests (3 sites x 50 tests per site). This means for Serum Strip, 150 tests at 0 mIU/mL, 150 tests at 4 mIU/mL, and so on.
     • Provenance: This data was generated in vitro by spiking negative serum/urine specimens with hCG. The origin of the negative serum/urine is not specified (e.g., country) but is likely lab-obtained.
   • Test Set (Method Comparison): 120 urine samples and 120 serum samples were collected.
     • Provenance: The samples were collected prospectively from 120 women (ages 18-49, about half pregnant and in early stages < 5 weeks) from three testing sites. The country of origin is not explicitly stated, but the submitter is in Hangzhou, China, and the regulatory consultant is in Maryland, USA. It's common for such studies to be multi-site, and given the FDA submission, the data would ideally meet international standards.
   • Training Set: The document does not describe a training set as this is an immunoassay, not a machine learning algorithm.

2. Number of Experts and Qualifications (Test Set Ground Truth):

   • For the precision study, results were interpreted by "three different operators." Their qualifications are not specified beyond being "operators."
   • For the method comparison study, samples were tested by "six different health professionals." Their specific qualifications (e.g., type of professional, experience level) are not detailed.
   • The primary "ground truth" for these studies is the known concentration of spiked hCG for precision, and the result from the predicate device for method comparison.

3. Adjudication Method (Test Set):

   • The document does not explicitly describe an adjudication method for conflicting results if they occurred during the precision or method comparison studies. For the precision study, it shows the aggregate positive/negative counts. For the method comparison, it reports 100% agreement, suggesting no need for adjudication for the final results presented.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study in the typical sense (where human readers interpret cases with and without AI assistance to measure improvement) was not done. This device is a diagnostic test kit (immunoassay), not an AI algorithm assisting human interpretation of complex data (like radiology images). The "comparison studies" section refers to comparing the new device's results to a predicate device, and the "operators" or "health professionals" are performing the test and reading the visual result, not interpreting complex cases.

5. Standalone Performance:

   • Yes, the performance presented for the "Analytical Performance" (precision, stability, specificity, interference) and "Comparison Studies" represents the standalone performance of the Assure Tech hCG Pregnancy Serum/Urine Combo Test. It is an algorithm-only (test kit only) without a human-in-the-loop interaction beyond performing the test and visually reading the results.

6. Type of Ground Truth Used:

   • Precision/Reproducibility: The ground truth was based on known spiked concentrations of hCG (traceable to the 4th WHO international Standard).
   • Method Comparison: The ground truth was established by comparison to a legally marketed predicate device (QuickVue+ One-Step hCG Combo test, K973858), implying the predicate device's results serve as the reference. Additionally, the samples were collected from "pregnant" and "non-pregnant" women, suggesting clinical status (outcomes data regarding pregnancy) was also a factor in sample selection.

7. Sample Size for the Training Set:

   • Not applicable. This is an immunoassay kit, not a machine learning model, so there is no "training set."

8. How Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set.

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