(84 days)
Multi-Use Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. The test will be marketed for the retail or "over-the-counter" (OTC) market use.
Not Found
This looks like a 510(k) clearance letter for a medical device (Multi-Use Electronic Pregnancy Test). However, the document provided does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to a "premarket notification" but does not include the actual performance study details from that notification.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Training set sample size
- How ground truth for the training set was established
To provide this information, you would need to find the actual 510(k) submission summary or the detailed study report submitted by Mizuho USA, Inc. to the FDA, not just the clearance letter.
§ 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.