(86 days)
The Contrast® II hCG Urine/Serum Test system is intended for the qualitative detection of human chorionic gonadotropin (hCG), a placental hormone, in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.
The Genzyme Diagnostics Contrast® II hCG Urine/Serum test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories. The Contrast® II Urine/Serum device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume AccuPipette® provided. The sample migrates through reaction pads where hCG. if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled monoclonal antibody-hCG complex is captured at a test line region containing immobilized monoclonal anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it). The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.
Here's an analysis of the Genzyme Contrast® II hCG Urine/Serum Test based on the provided text, focusing on the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Genzyme Contrast® II hCG Urine/Serum Test are implicitly tied to demonstrating substantial equivalence to the predicate device, the Quidel QuickVue® One-Step hCG Combo Test, particularly in analytical sensitivity and overall agreement.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Contrast® II hCG Urine/Serum Test) |
|---|---|---|
| Analytical Sensitivity | Urine: Equal to or better than predicate (20 mIU/mL) Serum: Equal to or better than predicate (10 mIU/mL) | Urine: 20 mIU/mL Serum: 10 mIU/mL |
| Overall Agreement | High agreement with predicate device (Quidel QuickVue® One-Step hCG Combo Test) for both positive and negative results. | In a study of 201 urine samples and 319 serum samples, the Contrast® II hCG Urine/Serum Test showed agreement with the currently marketed qualitative hCG assay (predicate) with the exception of two discrepant samples. One urine sample (2.6 mIU hCG/mL) and one serum sample (0 mIU hCG/mL) were positive by the predicate but negative by the Contrast® II. The quantitative assay re-testing supported the Contrast® II results for these two samples. This suggests high overall agreement, with the discrepancies being resolved in favor of the Contrast® II's accuracy. |
| Intended Use Equivalence | Qualitative detection of hCG in urine or serum for early pregnancy detection, usable in physicians' offices and clinical laboratories. | The device is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy, for use in physicians' offices and clinical laboratories. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- 201 urine samples
- 319 serum samples
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "samples," which implies they were collected for the study, but the precise nature of the collection is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set was not established by human experts in the traditional sense. The "ground truth" was determined by comparison to a legally marketed predicate device (Quidel QuickVue® One-Step hCG Combo Test) and, for discrepant samples, a quantitative reference assay (Diagnostics Products Coat-A-Count® hCG IRMA). Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically applied to image-based diagnostics or clinical diagnoses is not directly applicable here.
4. Adjudication Method for the Test Set
The adjudication method involved:
- Initial comparison to the predicate device.
- For discrepant samples (where the Contrast® II and predicate results differed), a third, quantitative assay (Diagnostics Products Coat-A-Count® hCG IRMA) was used to resolve the discrepancy. This can be viewed as a form of third-party arbitration/resolution using a more definitive method.
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 done. This device is an in-vitro diagnostic (IVD) based on an immunoassay, not an imaging device or a diagnostic requiring human interpretation of complex visual data. Therefore, the concept of "human readers" and improved performance with or without AI assistance is not relevant to this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance study effectively represents a standalone performance of the Contrast® II hCG Urine/Serum Test. The device itself is designed to provide a direct visual result (bands) without requiring complex human interpretation or an AI algorithm. The study assesses the device's ability to accurately detect hCG in samples on its own, compared to other established methods.
7. The Type of Ground Truth Used
The ground truth for the test set was established using a hierarchical approach:
- Predicate Device Comparison: Initial agreement was assessed against the Quidel QuickVue® One-Step hCG Combo Test.
- Quantitative Assay: For discrepant samples, the Diagnostics Products Coat-A-Count® hCG IRMA (a quantitative assay) served as the definitive ground truth, providing a more precise measurement of hCG levels.
8. The Sample Size for the Training Set
The document does not specify a training set size. IVD devices like this typically undergo extensive R&D and optimization during development, often using numerous samples for analytical characterization and calibration. However, the 510(k) summary focuses on the clinical performance study (test set) for demonstrating substantial equivalence, not the internal development process that might involve a "training set."
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" with ground truth establishment in the context of machine learning is not discussed, this question is not applicable to the provided information. The development of such an immunoassay relies on established biochemical principles and extensive internal validation, rather than a formal machine learning training paradigm with independently adjudicated ground truth for a "training set."
§ 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.