SAS VALUE HCG

• K Number: K020438
• Device Name: SAS VALUE HCG
• Manufacturer: SA SCIENTIFIC, INC.
• Date Cleared: 2002-03-08 ( 25 days)
• Product Code: JHI
• Regulation Number: 862.1155
• Type: Abbreviated
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

SASTM Value hCG is a visual test for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine.to aid in the early detection of pregnancy. The test is for professional use.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is an FDA 510(k) clearance letter for the "SASTM Value hCG" device, stating its substantial equivalence to a legally marketed predicate device. It defines the device's indications for use (qualitative detection of human chorionic gonadotropin in serum or urine to aid in early pregnancy detection for professional use). However, it does not include performance data or study details.

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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.