BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30

• K Number: K981609
• Device Name: BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
• Manufacturer: DIAGNOSTIC CHEMICALS LTD.
• Date Cleared: 1998-06-03 ( 29 days)
• Product Code: CIG
• Regulation Number: 862.1110
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For the quantitative determination of in Bilirubin (Direct) in serum. For IN VITRO diagnostic use.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "Bilirubin-SL (Direct) Assay." It does not contain information about acceptance criteria, device performance, specific study details, or ground truth establishment. The letter confirms substantial equivalence to a predicate device and permits marketing, but it does not detail the technical performance data that led to this decision.

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

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.