alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DI…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182474 FDA 510(k)
- FDA Product Code
- JFJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1070 FDA 510(k)
- Regulation Number
- 862.1070 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device comprises a series of catalytic assay methods for measuring alpha-amylase (direct, EPS, and pancreatic) and bilirubin (direct and total) in human serum, plasma, or urine. It falls under the classification of catalytic methods for amylase and is designed for diagnostic use in clinical chemistry settings to support the assessment of pancreatic and hepatic function, as well as hemolytic and metabolic disorders.
The assays are supplied as in vitro diagnostic reagents, intended for single-use in laboratory environments. They are classified as Class II devices under FDA regulations (510(k) clearance K182474) and comply with the EU In Vitro Diagnostic Device Directive (IVDD). Sterility and performance are validated for clinical chemistry applications, with no MRI safety considerations. Storage and handling follow standard laboratory protocols for reagent stability.
Frequently asked questions
What clinical conditions can these assays help diagnose or monitor using alpha-amylase and bilirubin measurements?
These assays measure alpha-amylase (direct, EPS, and pancreatic) and bilirubin (direct and total) in human serum, plasma, or urine to support the assessment of pancreatic function, hepatic (liver) disorders, and metabolic or hemolytic conditions. Elevated alpha-amylase levels may indicate pancreatitis or other pancreatic issues, while bilirubin assays help evaluate liver function, bile duct obstruction, or hemolytic anemia.
Are these reagents intended for reuse, or are they designed for single-use only?
The reagents are explicitly labeled for single-use only in laboratory environments. They are supplied as in vitro diagnostic reagents with validated sterility and performance for clinical chemistry applications, ensuring each batch is used once per test to maintain accuracy and safety.
How should these assays be stored, and what are the key handling requirements?
Storage and handling follow standard laboratory protocols for reagent stability. While exact conditions (e.g., temperature) aren’t specified in the data, typical in vitro diagnostic reagents require protection from light, moisture, and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage guidelines to preserve assay performance.
What regulatory pathways have these assays undergone, and which agencies have approved them?
These assays are cleared by the FDA under a 510(k) submission (K182474) as substantially equivalent to a predicate device, classified as Class II under FDA regulations. They also comply with the EU In Vitro Diagnostic Device Directive (IVDD), ensuring adherence to both U.S. and European regulatory standards for clinical chemistry diagnostics.
Are these assays compatible with MRI environments, or are there any safety concerns?
The data explicitly states there are no MRI safety considerations for these assays. Since they are laboratory reagents (not implanted or active devices), they pose no risk in MRI environments, but standard laboratory safety protocols should still be followed during handling and storage.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC ..., K182474 FDA 510 (k) - alpha-AMYLASE DIRECT | Biosystems S.A., PDF K182474 - alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE ..., Alpha-amylase Direct, Alpha-amylase Eps, Alpha-amylase Pancreatic ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182474 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
Sources (2)
- FDA 510(k) K182474 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026