Abx Pentra Albumin Cp, Abx Pentra Micro-Albumin Cp, Abx Pentra Total Protein Cp…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Horiba Abx
Identity
- Trade Name
- ABX PENTRA ALBUMIN CP EUDAMEDFDA UDI
- Generic Name
- Albumin IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra Albumin CP EUDAMED
- Model / Reference
- A11A01664 EUDAMED1220001664 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005187 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03610230005187 EUDAMED
- 510(k) Number
- FDA Product Code
- CIX FDA 510(k)FDA UDI
- EMDN Code
- W01010201 ALBUMIN (CC) EUDAMED
- GMDN Term
- Albumin IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 862.1035 FDA 510(k)
- Regulation Number
- 862.1035 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The ABX Pentra Albumin CP, ABX Pentra Micro-Albumin CP, ABX Pentra Total Protein CP, and ABX Pentra Multical are in vitro diagnostic reagents classified under the Bromcresol Green Dye-Binding, Albumin category. These devices are designed for automated measurement of albumin, micro-albumin, total protein, and related biochemical parameters in serum or plasma samples using a clinical chemistry analyzer.
These reagents are supplied as liquid formulations for use with the ABX Pentra 400 analyzer, adhering to the In Vitro Diagnostic Device Directive (IVDD) and receiving FDA 510(k) clearance under the Clinical Chemistry advisory committee. Each reagent is intended for single-use, with specified volumes (e.g., 99 mL for Albumin CP) and no sterility requirements stated. Compliance with CE marking and FDA 510(k) clearance ensures regulatory alignment for clinical chemistry applications.
Frequently asked questions
What clinical chemistry parameters can these reagents measure, and how are they used in a lab setting?
The ABX Pentra reagents measure albumin, micro-albumin, total protein, and related biochemical parameters in serum or plasma samples. They are designed exclusively for automated analysis on the ABX Pentra 400 clinical chemistry analyzer. These measurements help assess liver function, nutritional status, and kidney health, particularly for conditions like nephropathy or malnutrition, by quantifying protein levels in patient samples.
Are these reagents single-use, and if so, what volume is provided per kit?
Yes, these reagents are intended for single-use only. For example, the ABX Pentra Albumin CP is supplied in a 99 mL liquid formulation, ensuring each vial is used once per measurement cycle. This design minimizes contamination risk and aligns with best practices for in vitro diagnostics.
What regulatory pathways have these reagents undergone, and how does that affect their use in clinical settings?
The ABX Pentra reagents received FDA 510(k) clearance under the Clinical Chemistry advisory committee, demonstrating they meet U.S. regulatory standards for safety and effectiveness. They also comply with the In Vitro Diagnostic Device Directive (IVDD) for European markets, ensuring compliance with both FDA and CE marking requirements. This dual approval allows seamless integration into labs worldwide.
Do these reagents require sterile handling, and what storage conditions should be followed?
The product description does not specify sterility requirements, so these reagents are not classified as sterile. However, standard laboratory practices for in vitro diagnostics—such as protecting from contamination and following manufacturer guidelines—should be observed. Storage conditions are not detailed, but liquid reagents typically require refrigeration (2–8°C) and protection from light until use.
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: ABX Pentra 400 Reagents - HORIBA, A91A00591E_ABX Pentra Albumin CP, Horiba Medical / Documentation Data Base - toolkits.horiba-abx.com
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 | K060434 | Class II | Active |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (3)
- FDA 510(k) K060434 24 fields · synced Oct 6, 2026
- FDA UDI 4d3ed72f-e77c-4a94-b63f-c79686b399d6 33 fields · synced May 29, 2026
- EUDAMED 9e77f38a-a2d5-4cdf-85fa-fb4c6c5d591e 61 fields · synced Jul 30, 2026