MINISTRIP/ SERUM AND URINE COMBO HCG TEST

• K Number: K974060
• Device Name: MINISTRIP/ SERUM AND URINE COMBO HCG TEST
• Manufacturer: INTERNATIONAL NEWTECH DEVELOPMENT, INC.
• Date Cleared: 1998-04-09 ( 164 days)
• Product Code: JHI
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for clinical lab used only.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Ministrip / Serum and Urine Combo HCG Test". This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on regulatory approval based on substantial equivalence, not on a detailed presentation of performance data or acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a scientific study report.

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.