Diazyme DZ-Lite Total beta-hCG Test System

• K Number: K163418
• Device Name: Diazyme DZ-Lite Total beta-hCG Test System
• Manufacturer: Diazyme Laboratories
• Date Cleared: 2017-08-18 ( 255 days)
• Product Code: DHA
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

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AI/ML Overview

I apologize, but the provided text from the FDA letter (K163418 regarding the Diazyme DZ-Lite Total BhCG Test System) describes the regulatory approval of a medical diagnostic device, specifically a human chorionic gonadotropin (HCG) test system.

This type of document does not contain the detailed acceptance criteria and study data for an AI-powered medical device. The information requested in your prompt (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are specific to the development and validation of AI/ML-based diagnostic tools, particularly those involving image analysis or complex algorithmic interpretations.

The FDA letter focuses on the substantial equivalence of the Diazyme BhCG test system to existing predicate devices under 21 CFR 862.1155, which is a different regulatory pathway and does not involve AI/ML performance evaluation as described in your prompt.

Therefore, I cannot extract the requested information from the provided text because it is not present.

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.