(283 days)
StatusFirst™ hCG Serum/Urine test is in vitro diagnostic use for a qualitative detection of Human Chorionic Gonadotropin(hCG) in serum or urine for the detection of pregnancy.
Reflectance photometer for the measurement of concentration of analyte in various assays manufactured by PBM. The concentration is measured by density of light reflectance.
Reflectance photometer for a reading of test signal instead of visual reading in various qualitative assays manufactured by PBM.
StatusFirst™ hCG Serum/Urine is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in serum or urine. The device is used with DXpress™ Reader.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria. Therefore, the "acceptance criteria" here refer to the performance of the predicate device, which the new device aims to match or exceed.
| Feature/Metric | Acceptance Criteria (Predicate Device K993065: Icon 25 hCG) | Reported Device Performance (StatusFirst™ hCG Serum/Urine) |
|---|---|---|
| Detection Method | Immunochromatographic assay | Immunochromatographic assay |
| Qualitative Test | Yes | Yes |
| Detection Limit | 25 mIU/mL hCG in serum or urine | 25 mIU/mL hCG in serum or urine |
| Agreement with Predicate | N/A (Predicate performance itself) | 93% agreement (when 116 specimens compared for urine or serum) |
| Result Reading Method | Visual | DXpress Reader |
| Result Read Time (Urine) | 3 min | 5 min |
| Result Read Time (Serum) | 5 min | 5 min |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 116 specimens (for both urine and serum combined, or 116 for urine and 116 for serum separately - the wording "when 116 specimens were compared for urine test or for serum test" is slightly ambiguous but implies a significant sample size for comparison).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the context of an FDA submission for a "StatusFirst™ hCG Serum/Urine" device suggests human clinical samples were used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The comparison is made against a legally marketed predicate device (Icon 25 hCG), implying the predicate's results served as a comparative "ground truth" or reference, rather than independent expert adjudication.
4. Adjudication Method for the Test Set
This information is not provided. The study compares the results of the StatusFirst™ hCG Serum/Urine device with the Icon 25 hCG test. The predicate device's readings served as the reference point. The document notes that "disagreements were shown in the borderline samples," where "StatusFirst™ hCG Serum/Urine read the borderline samples as borderline level, whereas predicate device read most of borderline samples as positive," indicating a direct comparison rather than an adjudication process involving multiple third-party experts.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or described. The device, DXpress™ Reader, is a reader for the hCG test strips, providing an objective reading instead of a visual reading by a human. The comparison is between an automated reading (DXpress Reader) and a visual reading (Icon 25 hCG), not an AI assisting human readers.
6. Standalone Performance
Yes, a standalone performance study was done. The 93% agreement reported is the direct performance of the StatusFirst™ hCG Serum/Urine device (read by the DXpress Reader) when compared against the predicate device. This is the device's performance without human-in-the-loop decision making, as the DXpress Reader automates the result interpretation.
7. Type of Ground Truth Used
The "ground truth" used for comparison was the results obtained from a legally marketed predicate device, the Icon 25 hCG test. This is an existing device comparison rather than an independent gold standard like pathology or clinical outcomes.
8. Sample Size for the Training Set
This information is not provided in the document. The document describes a performance evaluation of the final product, not the development or training of the device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Given that the document describes the performance of a medical device rather than a machine learning algorithm, the concept of a "training set" and "ground truth for the training set" in the context of AI is not explicitly relevant or discussed here. The device is an immunochromatographic assay read by a reflectance photometer, which implies established chemical/biological principles rather than a machine learning model trained on data.
§ 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.