Abx Pentra Amylase Cp +5 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Horiba Abx
Identifiers
- 510(k) Number
- K062180 FDA 510(k)
- FDA Product Code
- JFJ FDA 510(k)
- Models / Variants
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)
The ABX Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CP are catalytic reagents and controls for clinical chemistry analyzers, designed for quantitative enzymatic assays. These include amylase reagents, calibrators, and quality control materials for monitoring accuracy, precision, and system performance in biochemical testing.
Supplied as liquid reagents and controls, these products are intended for use with Horiba ABX clinical chemistry analyzers, specifically the ABX Pentra 400 platform. They comply with FDA 510(k) clearance and In Vitro Diagnostic Regulation (IVDR) requirements, with Class II designation under the FDA’s regulatory framework. The reagents and controls are non-sterile, single-use, and require proper storage as per manufacturer instructions to maintain stability and accuracy.
Frequently asked questions
What clinical chemistry analyzers are these reagents and controls designed to work with specifically?
These reagents and controls are designed exclusively for use with the Horiba ABX Pentra 400 clinical chemistry analyzer platform. They are not compatible with other analyzer systems.
Are these reagents and controls sterile, and can they be reused?
No, these reagents and controls are non-sterile and intended for single-use only. Reuse is not recommended or supported by the manufacturer to ensure accuracy and prevent contamination.
What types of tests do these products support, and what is their primary purpose?
These products include amylase catalytic reagents and quality control materials (Multical, N Control, P Control) for quantitative enzymatic assays in clinical chemistry. Their primary purpose is to monitor accuracy, precision, and system performance of biochemical testing on the ABX Pentra 400 platform.
How should these reagents and controls be stored to maintain stability and accuracy?
The manufacturer specifies that these products require proper storage as instructed to preserve stability and accuracy. While exact storage conditions (e.g., temperature, light exposure) are not detailed here, adherence to the provided guidelines is critical to prevent degradation and ensure reliable assay results.
What regulatory pathways have these products undergone, and what classification do they hold?
These products have undergone FDA 510(k) clearance and comply with the In Vitro Diagnostic Regulation (IVDR) in the EU. Under FDA classification, they are designated as Class II devices, indicating a moderate level of regulatory oversight for their intended use in clinical chemistry assays.
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, Abx Pentra Amylase Cp; Multical; N Control; P Control; Clean-chem Cp ..., ABX Pentra N MultiControl - Horiba, Horiba ABX Pentra Clean-Chem CP - Cleaning Solution - 30 mL - Pentra 4
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K062180 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx
Sources (2)
- FDA 510(k) K062180 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026