DBEST HCG PANEL TEST KIT

• K Number: K061257
• Device Name: DBEST HCG PANEL TEST KIT
• Manufacturer: AMERITEK USA, INC.
• Date Cleared: 2007-05-04 ( 365 days)
• Product Code: JHI , LCX
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

dBest hCG Panel Test Kit is a simple one step immunochromatographic assay for rapid, semi-quantitative detection of hCG in urine with cutoffs of 25, 100, 500, 2,000 and 1.0,000 mlU/mL. The dBest hCG Panel Test Kits are for professional, physician's offices laboratory and OTC use, for the early detection of pregnancy.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "dBest hCG Panel Test Kits." It does not contain the detailed information required for a study report on acceptance criteria and device performance. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or study types (MRMC, standalone, etc.) from this document. This document is a regulatory approval, 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.