(82 days)
IND One Step hCG Urine Pregnancy Tests Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use.
Not Found
The provided text does not contain information about acceptance criteria or a study proving the device meets them. It is an FDA 510(k) clearance letter for the "IND One Step hCG Urine Pregnancy Test (Strip)", indicating that the device has been found substantially equivalent to legally marketed predicate devices.
The letter does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any test sets.
- Information regarding expert involvement, adjudication methods, or MRMC studies.
- A description of standalone algorithm performance.
- Sample size or ground truth methods for a training set.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. The document is solely an FDA clearance letter affirming substantial equivalence for marketing.
§ 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.