(64 days)
The Access Total βhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total βhCG assay is indicated for use with patients where an early detection of pregnancy status is desired.
The Access Total BhCG assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffer.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that "proves" the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in a quantitative or qualitative manner. Instead, the entire submission hinges on demonstrating "substantial equivalence" to a previously cleared device. Therefore, the "reported device performance" is framed in terms of this equivalence, rather than meeting predefined performance metrics.
However, based on the study performed, we can infer the implicit acceptance criterion was "good correlation" between plasma and serum samples.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| "Good correlation" between plasma and serum samples | "Study results demonstrate good correlation between the plasma and serum samples." |
| Substantial equivalence to predicate device (K980173) | "The Access Total BhCG assay is substantially equivalent to the previously cleared Access Total BhCG assay (K980173)." |
| Same methodology, product type, and quantitative results as predicate device | "Both assays utilize the same methodology, are the same product type, and are quantitative." |
| Including same components as predicate device | "The subject and predicate assays include the same components." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text states, "a method correlation study, using paired plasma and serum samples, was conducted." However, the exact number of paired samples is not provided.
- Data Provenance: The text does not specify the country of origin. The study was a "method correlation study," which implies it was conducted specifically to support this submission. It is prospective in the sense that the data was generated for the purpose of demonstrating equivalence, and likely involved fresh samples run on the new and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth in this submission. This type of device (quantitative immunoassay for hCG) typically relies on direct measurement and comparison with a reference method or predicate device, rather than expert interpretation of results. The "ground truth" here is the value obtained by the predicate device and the correlation between different sample types.
4. Adjudication Method for the Test Set
No adjudication method is described or implied. As mentioned above, the "ground truth" is based on direct measurement and comparison, not on expert consensus that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices where human readers (e.g., radiologists) are involved in assessing images or other complex data, often with and without AI assistance. This submission describes a quantitative in-vitro diagnostic (IVD) assay where the device provides a numerical result, not an interpretation requiring human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an IVD assay, not an algorithm in the typical sense of AI/ML. The "device performance" described for the Access Total BhCG assay is inherently what would be considered "standalone" clinical performance. It measures hCG levels directly. There is no human "in-the-loop" for the interpretation of the raw quantitative output of the assay, though a clinician would interpret the hCG level in the context of a patient's overall health.
7. The Type of Ground Truth Used
The ground truth used for this study is essentially analytical performance against a legally marketed predicate device (Access Total BhCG assay, K980173) and consistency across different sample matrices (serum vs. plasma). The "truth" for the new device is its ability to produce results that correlate well with the established method and to demonstrate similar performance characteristics.
8. The Sample Size for the Training Set
No training set is described. This context is for a traditional IVD assay, not an AI/ML-based device that would typically involve a distinct training (and validation/test) set. The "supporting data" section focuses on the test set (paired plasma and serum samples) for demonstrating equivalence.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for this specific device, this question is not applicable.
§ 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.