BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027

• K Number: K991741
• Device Name: BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
• Manufacturer: BIOCHECK, INC.
• Date Cleared: 1999-07-22 ( 62 days)
• Product Code: JHI
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The BioCheck hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) in serum. This assay is to be used for the early detection of pregnancy in a clinical laboratory setting.

Device Description

BioCheck human Chorionic Gonadotropin Enzyme Immunoassay Test Kit (hCG-ELISA)

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the BioCheck human Chorionic Gonadotropin Enzyme Immunoassay Test Kit (hCG-ELISA). It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study information based on the given input. The letter primarily confirms that the device has been reviewed and found substantially equivalent to a legally marketed predicate device, allowing it to proceed to market under general controls and applicable special controls.

Regulation Number and Section

§ 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.