(594 days)
Wondfo One Step HCG Urine/Serum Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotropin (HCG) in human serum or urine to aid in the early detection of pregnancy. It is intended for professional use only (Clinical Laboratory Use).
Immunochromatograph assay for hCG using a lateral flow, one step system for the qualitative detection of hCG in human urine/serum. Each assay uses a monoclonal antibody-dye congugate from mouse against β-HCG with gold chloride and fixed a-HCG antibody conjugate and anti-mouse IgG polyclonal antibody in membriance
Here's a breakdown of the acceptance criteria and study information for the Wondfo One Step HCG Urine/Serum Test, based on the provided documents:
Acceptance Criteria and Device Performance
The provided document does not explicitly state numerical acceptance criteria for performance metrics. Instead, it states that the device has "similar technological characteristics and performance to the predicate and are equivalent."
However, the efficacy of an HCG pregnancy test is typically evaluated by its sensitivity (ability to correctly identify positive samples) and specificity (ability to correctly identify negative samples). While the document doesn't provide specific thresholds, we can infer that the device's sensitivity and specificity should be comparable to or better than the predicate device (Acon Laboratories, Inc. HCG One Step Urine/Serum Pregnancy Test, K980736) to be considered equivalent.
Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not provided, the table below reflects what would typically be expected for such a device and the general statement of performance provided.
| Performance Metric | Acceptance Criteria (Inferred/Expected) | Reported Device Performance |
|---|---|---|
| Sensitivity | Comparable to predicate device | "Similar technological characteristics and performance to the predicate and are equivalent." |
| Specificity | Comparable to predicate device | "Similar technological characteristics and performance to the predicate and are equivalent." |
| Cross-Reactivity | Low/Minimal with LH, TSH, FSH | "aimed to be a HCG specific test by using a monoclonal antibody against highly purified β-HCG." |
Study Information
The provided document is a 510(k) summary, which typically summarizes the information submitted for regulatory clearance, rather than being the full study report itself. Therefore, detailed study methodology and data may be limited.
Here's what can be extracted and inferred:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document is a 510(k) summary and doesn't provide the raw study data or sample sizes for performance evaluations.
- Data Provenance: Not explicitly stated. Given the manufacturer is Guangzhou Wondfo Biotech Co., Ltd. (China) and the submission is to the FDA (USA), the data could be from studies conducted in China, the US, or a combination. The document does not specify.
- Retrospective or Prospective: Not explicitly stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. Since this is an in-vitro diagnostic (IVD) test for professional use, ground truth for HCG detection is typically established through reference laboratory methods or clinical diagnosis, rather than expert consensus on images or interpretations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not explicitly stated. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on subjective interpretations (e.g., radiology images). For an IVD like an HCG test, ground truth is established by objective laboratory methods, not by expert adjudication of interpretations.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test for HCG, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data. Therefore, this type of study is not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. This device is a standalone diagnostic test kit. Its performance (accuracy in detecting HCG) is evaluated based on its ability to correctly identify the presence or absence of HCG in a sample. There isn't an "algorithm" in the typical AI sense; it's a biochemical assay. The evaluation of such a device is inherently "standalone" in that it performs its function without a "human-in-the-loop" directly influencing its result, though a human interprets the visual result.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference laboratory methods for HCG detection and/or clinical diagnosis of pregnancy. For an HCG test, ground truth would be established by confirmed pregnancy (e.g., via quantitative HCG tests, ultrasound, clinical follow-up) or confirmed absence of pregnancy. The document highlights the use of a "monoclonal antibody against highly purified β-HCG," implying that the ground truth for specificity would involve testing against other related hormones (LH, TSH, FSH) at physiological concentrations to confirm no cross-reactivity.
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The sample size for the training set:
- Not applicable/Not explicitly stated. This is a biochemical immunoassay, not a machine learning or AI model that requires a "training set" in the computational sense. Development and optimization would involve R&D and quality control testing, but not a distinct "training set" for an algorithm.
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How the ground truth for the training set was established:
- Not applicable. As explained above, this device does not utilize a training set in the AI/ML context. Ground truth for development and validation (which is distinct from a "training set") would be established through known positive and negative samples, often spiked samples or clinically confirmed specimens, using established reference methods.
§ 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.