LP(A) Calibrators and Controls
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Biokit, S.a.
Identifiers
- 510(k) Number
- K132400 FDA 510(k)
- FDA Product Code
- JIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LP(A) Calibrators and Controls are secondary calibrators and controls designed for use in clinical chemistry assays. These devices provide reference standards and quality control materials to ensure the accuracy and reliability of laboratory measurements, particularly in automated chemistry analysers.
Supplied as single-use liquid reagents, these calibrators and controls are intended for use in clinical laboratory settings. They are regulated under the FDA 510(k) clearance process and comply with the In Vitro Diagnostic Regulation (IVDR). Each product is available in specific Can Male, Serial Number (S/N) configurations, with no MRI safety considerations noted. Storage conditions and shelf life are manufacturer-specified and must be adhered to for optimal performance.
Frequently asked questions
Are the LP(A) Calibrators and Controls designed for reuse in clinical laboratories, or are they single-use only?
The LP(A) Calibrators and Controls are explicitly supplied as single-use liquid reagents. This design ensures consistency and accuracy in clinical chemistry assays, as reuse could introduce contamination or variability in results. Always follow the manufacturer’s storage and usage guidelines to maintain optimal performance.
What types of automated chemistry analysers are these calibrators and controls intended to work with?
While the exact analyser compatibility isn’t detailed, the LP(A) Calibrators and Controls are secondary calibrators and controls specifically designed for clinical chemistry assays in automated chemistry analysers. Their purpose is to ensure accuracy and reliability across these systems, so they should be compatible with most standard analysers used in clinical laboratories for chemistry testing.
How should these calibrators and controls be stored, and what happens if storage conditions aren’t followed?
The LP(A) Calibrators and Controls require manufacturer-specified storage conditions, which must be strictly adhered to for optimal performance. Deviations from these conditions—such as improper temperature or exposure to light—could compromise stability, accuracy, or shelf life. Always refer to the accompanying documentation for precise storage instructions to avoid invalidating results.
Are there different sizes or models of LP(A) Calibrators and Controls, and if so, how are they distinguished?
Yes, the LP(A) Calibrators and Controls are available in specific configurations identified by Can Male and Serial Number (S/N). These distinctions likely correspond to different assay types, concentrations, or lot-specific formulations. The exact variations should be clarified in the product documentation or by contacting the manufacturer, as they ensure proper matching with laboratory workflows and analyser requirements.
What regulatory pathways have these calibrators and controls undergone, and what does that mean for their use in clinical settings?
The LP(A) Calibrators and Controls are regulated under the FDA 510(k) clearance process and comply with the In Vitro Diagnostic Regulation (IVDR). This means they have undergone evaluation to demonstrate substantial equivalence to predicate devices and meet safety and performance standards for use in clinical chemistry assays. Their regulatory status ensures they meet necessary quality and reliability criteria for laboratory 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.
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 | K132400 | Class II | Active |
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Manufacturer
- Manufacturer
- Biokit, S.a.
Sources (2)
- FDA 510(k) K132400 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026