(46 days)
The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. For Laboratory Professional Use Only.
The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is a lateral flow immunoassay intended for the detection of human Chorionic Gonadotropin (hCG) in urine or serum.
Here's a breakdown of the acceptance criteria and study information for the WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 100% agreement | 100% agreement |
Note: The acceptance criterion is inherently defined by the reported device performance in this summary – the goal was 100% agreement with the predicate device, and the device achieved it.
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "A method comparison study" and "100% agreement was observed," but does not specify the number of samples (urine or serum) used in this comparison.
- Data Provenance: Not explicitly stated. The document implies an internal study comparing the WH Accu Test™ to a predicate device, but does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not explicitly stated.
- Qualifications of experts: The testing was "done by a person who routinely performs pregnancy tests." Specific qualifications (e.g., years of experience, specific role) are not provided beyond this general statement.
4. Adjudication method for the test set:
- Not applicable/Not explicitly stated. The study involved a direct comparison to a predicate device rather than human adjudication of a novel test result against an existing gold standard.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a point-of-care, in-vitro diagnostic device, not an AI-assisted diagnostic tool for imaging or interpretation that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is inherently a "standalone" test in the sense that the test itself generates the result (color band). The "person who routinely performs pregnancy tests" is likely involved in correctly performing the test and visually interpreting the color bands as per the instructions, rather than providing an independent diagnostic opinion that the device then supports or contradicts. Therefore, no separate "algorithm only" study distinct from the described method comparison was performed or is relevant to this type of device.
7. The type of ground truth used:
- The ground truth was established by comparison to a predicate device: the Acon Laboratories hCG One Step Pregnancy Test (Urine/Serum) [510(k) number: K993065]. The predicate device's results were considered the "truth" against which the new device's performance was measured.
8. The sample size for the training set:
- Not applicable/Not stated. This type of immunoassay device does not typically involve a "training set" in the context of machine learning. The term "training set" usually refers to data used to train an algorithm. For this device, performance is based on its chemical and biological reactions, not a trained algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" for this type of device.
§ 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.