Plasmacon N, Plasmacon L-1, Plasmacon L-2
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PlasmaCon L1 EUDAMEDFDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- PlasmaCon L1 EUDAMEDAbnormal Control L-1 10 x 1 ml FDA UDI
- Model / Reference
- 31-201 EUDAMEDFDA UDI
- Description
- Abnormal Control L-1 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 31-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006078 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10859394006078 EUDAMED
- 510(k) Number
- FDA Product Code
- GGC FDA 510(k)FDA UDIGIZ FDA UDI
- EMDN Code
- W0103020702 CONTROL PLASMA FOR HAEMOSTASIS EUDAMED
- GMDN Term
- Multiple coagulation factor IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)FDA UDI
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Hematology 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
Yes
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 Plasmacon N, Plasmacon L-1, and Plasmacon L-2 are plasma controls designed for hematology testing. These devices are intended to simulate abnormal plasma samples, providing reference standards for evaluating laboratory instruments and procedures in blood analysis.
Supplied as sterile, single-use controls, these devices are classified as Class II medical devices under FDA regulations and comply with the In Vitro Diagnostic Device Directive (IVDD). They are used in clinical laboratories for quality assurance and calibration of hematology analyzers, ensuring accurate diagnostic results. Storage requirements and specific sizes are detailed in the accompanying documentation.
Frequently asked questions
What are the Plasmacon N, L-1, and L-2 devices used for in a clinical lab setting?
These devices are designed as plasma controls to simulate abnormal plasma samples, serving as reference standards for quality assurance and calibration of hematology analyzers. They help ensure the accuracy and reliability of blood analysis results in clinical laboratories.
Are the Plasmacon controls single-use or reusable, and how should they be stored?
The Plasmacon controls are supplied as sterile, single-use devices. Storage instructions are provided in the accompanying documentation, but generally, they should be kept in a clean, dry environment away from direct sunlight and extreme temperatures to maintain their integrity.
What regulatory pathways have these plasma controls undergone, and what class do they fall under?
The Plasmacon N, L-1, and L-2 controls are classified as Class II medical devices under FDA regulations. They have undergone a traditional 510(k) clearance process, with the decision described as substantially equivalent to a predicate device, and they also comply with the In Vitro Diagnostic Device Directive (IVDD).
How do I determine which size or model (N, L-1, or L-2) is appropriate for my hematology analyzer?
The Plasmacon N, L-1, and L-2 models are designed to simulate different abnormal plasma conditions, but the specific choice depends on your lab’s testing requirements and the analyzer’s calibration needs. The accompanying documentation likely includes guidance on compatibility, and consulting your analyzer’s manufacturer or R2 Diagnostics for detailed recommendations is advised.
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
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 | K062306 | Class II | Active |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (3)
- FDA 510(k) K062306 24 fields · synced Sep 18, 2026
- FDA UDI 0ed75792-54a1-4409-8bc8-3bbf8a1268e9 35 fields · synced May 30, 2026
- EUDAMED 79a1fb17-098f-4118-a17d-d5f2c48b9955 61 fields · synced Jul 8, 2026