(34 days)
The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe counter home use.
The Bluetest® Pregnancy Test, also sold under the brandname RapidVue® Pregnancy Test, is a one-step immunossay intended for the qualitative detection of hCG in urine.
The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. If the sample contains hCG, a pink and blue plus sign (+) is visible in the large Result Window, along with a blue line in the small Control Window to indicate a positive result. If hCG is not present in the sample, a blue minus sign (-) is visible in the large Result Window, along with a blue line in the small Control Window, to indicate a negative result.
Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy in qualitative detection of hCG in urine | Demonstrated "substantial equivalence" to existing products. |
| Precision (Intra- and Inter-assay) | "Excellent intra- and inter-assay precision." |
| Lot-to-lot consistency during manufacturing | "Reproducibly manufacturable." |
| Freedom from interference by common substances | "Common drugs, chemicals, and biologicals were shown not to interfere." |
| Usability by lay users (home use) | "Consumer study showed lay users could read package insert, perform test, and obtain results similar to clinic personnel." |
| Similarity to other commercially available pregnancy tests | "Similar to other commercially distributed tests in terms of features and intended use." |
Note: The document does not explicitly state acceptance thresholds (e.g., >95% sensitivity), but rather describes categories of performance that were evaluated and found to be satisfactory. The primary outcome measure for the overall device seems to be "substantial equivalence" to already marketed devices.
Study Details
Below are the details of the studies as described in the provided text:
1. Sample size for the test set and data provenance:
* Sample Size: Not explicitly stated. The document mentions "urine samples obtained from women presenting for pregnancy testing" for the clinical study and a "consumer study" without specific numbers.
* Data Provenance:
* Clinical study: "multi-center clinical study." Implies prospective collection from women presenting for pregnancy testing. Country of origin not specified, but the manufacturer is based in the USA.
* Consumer study: Not specified, but likely from individuals in the intended home-use demographic.
2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not explicitly stated. For the clinical study, ground truth would likely be established by clinical personnel (e.g., doctors, nurses, or lab technicians) using a reference method, but this is not detailed. For the consumer study, "clinic personnel" are mentioned, suggesting a comparison to professional results.
3. Adjudication method for the test set:
* Not explicitly stated. The clinical study involved a "direct comparison of the test." The consumer study compared lay user results to those "obtained by clinic personnel," implying a form of comparison but not a formal adjudication process involving multiple expert readers to resolve discrepancies.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
* No. This device is a rapid immunoassay for qualitative detection of hCG, not an AI-assisted diagnostic device requiring interpretation by human readers. Therefore, an MRMC study with AI assistance is not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, effectively. The device itself is a standalone assay that produces a result (plus or minus sign). The consumer study evaluated this standalone device directly (albeit with untrained users).
6. The type of ground truth used:
* For the clinical study: Likely a reference laboratory method for hCG detection, or clinical diagnosis of pregnancy (e.g., confirmed by ultrasound or physician assessment). Not explicitly stated as "pathology" or "outcomes data."
* For the consumer study: The ground truth was established by "results obtained by clinic personnel," implying a comparison to professional interpretation of the device or a reference method used by the clinic.
7. The sample size for the training set:
* Not applicable. This is a traditional immunoassay, not a machine learning or AI-based device that would typically involve a separate "training set" for model development. The "training" here would refer to the manufacturing and design process.
8. How the ground truth for the training set was established:
* Not applicable, as there is no specific "training set" in the context of an immunoassay. The development and optimization of the assay would involve various experimental samples and reference materials, but these are not segmented into "training" and "test" sets in the AI sense.
§ 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.