(62 days)
The intended use of both assays is the qualitative determination of human chorionic gonadotropin in serum or urine.
While both assays utilize a plus/minus indicator, the ABBOTT TestPack Plus hCG COMBO with OBC assay incorporates additional On Board Controls: POS CTL ( ) and NEG CTL (X).
Here's an analysis of the provided text regarding the ABBOTT TestPack® Plus™ hCG COMBO with OBC® device, focusing on acceptance criteria and the supporting study:
The provided 510(k) summary is for a medical device modification, specifically adding On Board Controls (OBC®) to an existing device (ABBOTT TestPack® Plus™ hCG COMBO). Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to the predicate device, not necessarily establishing a new clinical utility or diagnostic accuracy from scratch against a true ground truth.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence submission, the primary "acceptance criterion" is high concordance with the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 100% Concordance with Predicate for Serum Specimens | 100% Concordance for Serum Specimens |
| 100% Concordance with Predicate for Urine Specimens | 100% Concordance for Urine Specimens |
Note: The document also states that both assays measure hCG levels of 25 mIU/mL or greater, implying this is a functional equivalence criterion that was met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- 1085 serum specimens
- 934 urine specimens
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in this context. The "ground truth" for this study is the result obtained from the predicate device (ABBOTT TestPack® Plus™ hCG COMBO). The study aims to show that the new device yields the same results as the predicate, not to establish a new diagnostic truth against an independent "expert consensus" or "pathology."
4. Adjudication Method for the Test Set
Not applicable. The study design is not described as requiring adjudication by experts. It's a direct comparison of results between the new device and the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is comparing the performance of a modified device against its predicate, not evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device (hCG test) is a standalone diagnostic, the study itself is an equivalence study comparing two standalone devices. It's not an "algorithm-only" study in the context of AI/software as a medical device. The performance reported (concordance) is the standalone performance of the new device relative to the predicate.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence study is the results obtained from the predicate device (ABBOTT TestPack® Plus™ hCG COMBO). The goal was to demonstrate that the new device (with OBC) yields identical results.
8. The Sample Size for the Training Set
Not applicable. This device is a biochemical assay, not an AI/ML algorithm that requires a "training set" in the computational sense. The "study" mentioned uses patient specimens to test the device's performance, not to train it.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device and study.
Summary of the Study:
The study performed was a concordance analysis to demonstrate substantial equivalence. It involved testing 1085 serum specimens and 934 urine specimens with both the new device (ABBOTT TestPack® Plus™ hCG COMBO with OBC®) and the predicate device (ABBOTT TestPack® Plus™ hCG COMBO). The results showed 100% concordance between the two assays for both serum and urine specimens. This high concordance, along with the consistent claim that both assays measure hCG levels of 25 mIU/mL or greater, was deemed sufficient to establish substantial equivalence.
§ 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.