SAS HCG-CHECK

• K Number: K991193
• Device Name: SAS HCG-CHECK
• Manufacturer: SA SCIENTIFIC, INC.
• Date Cleared: 1999-05-04 ( 26 days)
• Product Code: LCX
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

SASTM hCG-Check is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. This test is for over-the-counter home use.

Device Description

SAS™ hCG-Check is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the SAS™ hCG-Check device, which is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This document does not contain any information regarding specific acceptance criteria, study details, or performance data as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria using only the provided text. The document primarily focuses on regulatory approval, substantial equivalence, and general administrative information.

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.