(183 days)
The Bilichek™ Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The Bilichek™ provides a numerical measurement of predicted bilirubin count in mo/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromotography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose Bilichek™ test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.
The Bilichek™ Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer.
The provided document is limited to a 510(k) clearance letter for the Bilichek™ Non-Invasive Bilirubin Analyzer, and an "Indications for Use" statement. It does not contain information regarding detailed acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them from the given text.
The document only states:
- Trade Name: Bilichek™, Non-Invasive Bilirubin Analyzer
- Regulatory Class: II
- Intended Use: "as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight."
- Performance Claim: "The Bilichek™ provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromatography (HPLC)."
To provide the requested information, a more comprehensive submission, such as the full 510(k) submission or a detailed clinical study report, would be necessary.
§ 862.1113 Bilirubin (total and unbound) in the neonate test system.
(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.