HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

• K Number: K041728
• Device Name: HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
• Manufacturer: IMMUNOSTICS, INC.
• Date Cleared: 2004-08-11 ( 47 days)
• Product Code: JHI
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The Immuno / hCG Detector™ - Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

The Immuno / hCG Detector Stix is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

The Immuno / hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

Device Description

Not Found

AI/ML Overview

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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.