(28 days)
Rx Only For in vitro diagnostic use only
The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal destruction of red blood cells, are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.
The ALKP test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Not Found
This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically for VITROS XT Chemistry Products TBIL-ALKP Slides. The provided text is a regulatory communication and does not contain the acceptance criteria or study details for the device's performance.
To answer your request, I would need access to the actual 510(k) summary, often referred to as a "510(k) Premarket Notification." This document typically includes the performance data, acceptance criteria, and study designs to demonstrate substantial equivalence to a predicate device.
The information you've provided only states:
- Device Name: VITROS XT Chemistry Products TBIL-ALKP Slides
- Intended Use: Quantitative measurement of total bilirubin (TBIL) and alkaline phosphatase (ALKP) in serum and plasma using VITROS XT 7600 Integrated Systems.
- Regulatory Class: Class II
- Product Code: CIG (Bilirubin (total or direct) test system), CJE (Alkaline phosphatase test system)
- Date of Clearance: April 26, 2019
Without the 510(k) summary or a similar technical document, I cannot extract the specific acceptance criteria, study details, sample sizes, or ground truth information you've requested.
Therefore, I cannot provide the requested table and study details based solely on the provided text.
§ 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.