(256 days)
The y.b.t. Pregnancy Test is an immunochromatographic assay for the qualitative determination of HCG in human urine. The test is intended for use as an aid in the early detection of pregnancy.
The test is available in two formats: strip and cassette.Both of them are intended for prescription use. Both of them have the same memebrane format, reagents and flow characteristics. Devices are packaged one device per pouch with 1 devices per kit.
The y.b.t. Pregnancy Test Strip and Cassette are immuno-chromatographic assays intended for the qualitative determination of hCG in human urine as an aid in early pregnancy detection.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" for overall performance in a formal table; however, the Method Comparison and Precision sections demonstrate performance against expected outcomes, which serve as de facto acceptance criteria for this type of diagnostic device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | Detect hCG at 25 mIU/ml and higher. | Confirmed with hCG standards (25, 50, 2500, and 500,000 mlU/ml) in urine calibrated against the WHO Third I.S. |
| Specificity | No interference from menopausal urine samples. | All 20 menopausal urine samples tested negative. |
| No interference from various common substances. | No interference from 16 specified substances at given concentrations when added to urine samples containing 0 mlU/ml and 25 mlU/ml hCG. | |
| No cross-reactivity with related glycoprotein hormones. | No interference from Luteinizing hormone, Follicle stimulating hormone, and Thyroid stimulating hormone at specified concentrations. | |
| Accuracy (Method Comparison) | 100% agreement with routine diagnostic method for positive and negative samples. | Positive agreement: 100% (60/60) |
| Negative agreement (Specificity): 100% (60/60) | ||
| Intra-assay Precision | 100% correct results across replicates for 0, 25, and 250 mIU/ml hCG. | Eleven replicate assays performed with 0, 25, and 250 mIU/ml hCG specimens yielded 100% correct negative and positive results. |
| Inter-assay Precision | 100% correct results across different assays, lots, and times for 0, 25, and 250 mIU/ml hCG. | The same three specimens (0, 25, 250 mIU/ml hCG) analyzed in eleven independent assays with y.b.t. hCG Cards from three different lots over two months yielded 100% expected negative and positive results. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Specificity (Menopausal urine): 20 samples
- Method Comparison: 120 patient urine specimens (60 positive, 60 negative)
- Precision (Intra-assay & Inter-assay): For each test: 3 specimens (0, 25, 250 mIU/ml hCG)
- Data Provenance: The document does not explicitly state the country of origin for the patient urine specimens. The "Method Comparison" study was performed "at two certified hospital," but the location of these hospitals is not specified. The studies appear to be prospective for the experiments involving spiked samples and controlled conditions (specificity, precision). For the method comparison, it refers to "patient urine specimens confirmed with routine diagnostic method," suggesting these were retrospective or collected for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of experts to establish ground truth for the test set.
- For the "Method Comparison," ground truth was established by "routine diagnostic method" performed by the "two certified hospital," implying diagnosis by healthcare professionals using established laboratory practices. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set
- No specific adjudication method (like 2+1, 3+1, etc.) is described. The "Method Comparison" states that patient urine specimens were "confirmed with routine diagnostic method," suggesting a single, established diagnostic report served as the ground truth against which the y.b.t. pregnancy test results were compared.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test, not an imaging AI; therefore, human reader improvement with or without AI assistance is not applicable in this context. The comparator is the "routine diagnostic method" for confirming hCG.
6. Standalone (Algorithm Only) Performance
- This device is an IVD test, not a software algorithm. Its performance is inherent to the physical test strip/cassette and its chemical reactions, which are read directly for results. Therefore, the reported performance metrics (sensitivity, specificity, precision, method comparison) represent its standalone performance as a diagnostic device. There is no human-in-the-loop component in its fundamental operation or result interpretation that would distinguish "algorithm only" from "human-in-the-loop," as the human reading is an essential part of using the device.
7. Type of Ground Truth Used
- Sensitivity: Calibrated hCG standards (WHO Third I.S.).
- Specificity: Known negative menopausal urine samples, and urine samples spiked with known substances/hormones.
- Method Comparison: "Routine diagnostic method" from two certified hospitals, which would typically involve laboratory-based quantitative hCG assays or other established qualitative pregnancy tests.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" or "validation set" in the context of machine learning or AI algorithm development. This device is a biochemical immunoassay. Its development would involve R&D and optimization, but not typically "training" in the AI sense.
9. How Ground Truth for the Training Set Was Established
- As the device is an immunoassay and not an AI algorithm, the concept of a "training set" and establishing ground truth for it in the AI context does not directly apply. The development of such devices involves extensive laboratory testing and optimization using characterized samples and reagents to ensure the assay performs as intended.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.