(42 days)
Perfecta Pregnancy Test is a pregnancy test intended for home use.
Perfecta Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
The provided text describes a 510(k) summary for the "Perfecta™ Pregnancy Test" by Wyntek Diagnostics Inc. While it outlines the product's intended use, description, and claims of substantial equivalence, it does not contain specific information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot fulfill your request for the detailed table and study information based on the input provided. The text lacks:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used for test or training sets.
- Training set sample size or how its ground truth was established.
The document primarily focuses on regulatory submission details like contact information, product name, intended use, and substantial equivalence claims, without delving into the specifics of performance validation studies.
§ 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.