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For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma.

Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.

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This is a 510(k) clearance letter for a device called "Total Bilirubin L3K, Model 295-10 and 295-30," which is an in vitro diagnostic (IVD) test system. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Device Name: Total Bilirubin L3K, Model 295-10 and 295-30
• Regulation Number/Name: 21 CFR Sec. 862.1110, Bilirubin (total or direct) test system
• Regulatory Class: Class II
• Product Code: CIG
• Submission Date: December 5, 2008 (Received December 8, 2008)
• Clearance Date: December 16, 2008
• Manufacturer: Genzyme Diagnostics P.E.I. Inc.
• Intended Use: For the in vitro quantitative measurement of Total Bilirubin in serum and plasma, used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases, and disorders involving the metabolism of bilirubin.

To answer your specific questions, I would need access to the actual 510(k) submission document (K082210) itself, which would detail the performance data, acceptance criteria, and study methodologies used to demonstrate substantial equivalence. This clearance letter is merely the FDA's decision based on that submission.

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