# K182474: alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

- Pathway: 510(k) (Traditional)
- Applicant: Biosystems S.A.
- Decided: May 2, 2019 after 234 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic a-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

Source page: https://510kreport.com/device/K182474
Methodology: https://510kreport.com/methodology