(68 days)
ACON™ One Step Pregnancy Test Strip (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. This test is for professional use.
ACON™ One Step Pregnancy Test Strip (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by immersing the test strip in the urine sample and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Test Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.
The provided text describes the ACON™ One Step Pregnancy Test Strip (Urine) and its clinical evaluation for market clearance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets (e.g., "sensitivity must be >95%"). Instead, the study aims for 100% concordance with a legally marketed predicate device, and a claimed detection limit of 25 mIU/ml hCG. The reported performance is based on direct comparison to this predicate.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Concordance | 100% | 100% |
| hCG Detection Limit | 25 mIU/ml | 25 mIU/ml and greater |
| Cross-Reactivity | None with hLH, hFSH, hTSH | None observed |
2. Sample Size and Data Provenance for the Test Set
- Sample Size (Test Set): 150 urine specimens.
- Data Provenance: The text states "A multi-center clinical evaluation was conducted." This suggests prospective data collection. The country of origin is not specified, but the submission is to the US FDA, implying testing relevant to US regulatory standards. The data itself is from "urine specimens."
3. Number of Experts and Qualifications for Ground Truth
The study does not describe the use of human experts to establish ground truth for individual cases in the same way one might for diagnostic imaging. Instead, the ground truth for the clinical evaluation is based on the results of a "commercially available urine membrane test" (a predicate device). Therefore, the "experts" here would implicitly be the validated performance of that predicate device.
4. Adjudication Method for the Test Set
Not applicable. The study directly compares the ACON™ device to a predicate device; there is no mention of a separate adjudication process involving multiple human readers for conflict resolution.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a new in vitro diagnostic (IVD) device compared to an existing IVD, not on how human readers' performance improves with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the study describes the standalone performance of the ACON™ One Step Pregnancy Test Strip (Urine). The results are based solely on the device's ability to detect hCG in urine without human interpretation or intervention beyond the standard test procedure (immersing the strip and observing lines).
7. Type of Ground Truth Used
The primary ground truth used for the clinical evaluation was the result from another commercially available urine membrane test (a predicate device).
Additionally, for the analytical performance characteristics (detection limit and cross-reactivity):
- Detection Limit: Standardized to the World Health Organization Third International Standard, implying a reference standard.
- Cross-Reactivity: Evaluated by adding known concentrations of hLH, hFSH, and hTSH to negative and positive serum and urine specimens, indicating controlled laboratory experiments with defined ground truths.
8. Sample Size for the Training Set
Not applicable. This is an immunoassay device, not a machine learning model, so there is no "training set" in the conventional sense. The device's mechanism is based on specific antibody-antigen reactions, not on learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The device's design and manufacturing are based on established biochemical principles for detecting hCG.
§ 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.