(62 days)
The dBest One-Step hCG Serum/Urine Test is a immunoassay designed for the qualitative determination of the human chorionic gonadotropin (hCG) in serum/urine for the early detection of pregnancy. It is intended for professional and laboratory use.
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The provided text includes a 510(k) premarket notification letter from the FDA regarding "dBest One-Step hCG Serum/Urine Dipstick and Cassette Pregnancy Test Kits." However, it does not contain the specific acceptance criteria or the study details that prove the device meets those criteria.
The letter primarily concerns the substantial equivalence determination for the device, allowing it to be marketed. It does not elaborate on the performance data or the methods used to establish that performance.
Therefore, I cannot provide the requested information based on the input text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, the full 510(k) submission, or a study report for the 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.