LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40

• K Number: K041927
• Device Name: LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
• Manufacturer: DIAGNOSTIC CHEMICALS LTD.
• Date Cleared: 2004-11-23 ( 127 days)
• Product Code: MRR
• Regulation Number: 862.1475
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the "LDL-ADVANCE Assay, Cat. No. 279-20, 279-40". This document is a regulatory approval and does not contain the detailed study information or acceptance criteria typical for a device performance evaluation. It primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.

Specifically, the document states:

• Device Name: LDL-ADVANCE Assay, Cat. No. 279-20, 279-40
• Indications for Use: "For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases."

Without a separate clinical or performance study report, it's impossible to answer the specific questions about acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.