Phosphoplastin RL
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Phosphoplastin RL EUDAMEDFDA UDI
- Generic Name
- Prothrombin time (PT) IVD, reagent FDA UDI
- Device Name
- Phosphoplastin RL EUDAMEDPT reagent 10 x 5 ml FDA UDIPT reagent 10 x 10 ml FDA UDI
- Model / Reference
- 11-305 EUDAMEDFDA UDI11-310 EUDAMEDFDA UDI
- Description
- PT reagent 10 x 5 ml FDA UDIPT reagent 10 x 10 ml FDA UDI
Identifiers
- Catalog Number
- 11-305 FDA UDI11-310 FDA UDI
- Primary DI / UDI-DI
- 10859394006023 EUDAMEDFDA UDI10859394006030 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10859394006030 EUDAMEDB-10859394006023 EUDAMED
- 510(k) Number
- FDA Product Code
- GJS FDA 510(k)FDA UDI
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
- GMDN Term
- Prothrombin time (PT) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.7750 FDA 510(k)
- Regulation Number
- 864.7750 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
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
Phosphoplastin RL is a liquid thromboplastin reagent used in the one-stage prothrombin time (PT) test, a critical in vitro diagnostic assay for assessing coagulation function. It is designed for extrinsic factor assays and therapeutic monitoring of anticoagulant drugs such as Warfarin, enabling clinicians to evaluate coagulopathies and monitor hemostasis.
The device is supplied as a liquid reagent intended for single-use in clinical coagulation laboratories. It is classified as a Class II medical device under FDA regulations (864.7750) and has received both FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization. Storage and handling conditions are not specified in the provided data, but standard laboratory practices for sensitive reagents should be followed.
Frequently asked questions
What clinical applications is Phosphoplastin RL primarily used for in a laboratory setting?
Phosphoplastin RL is specifically designed for the one-stage prothrombin time (PT) test, which evaluates coagulation function by measuring the time it takes for blood to clot. It is used for extrinsic factor assays and therapeutic monitoring of anticoagulant drugs like Warfarin, helping clinicians assess coagulopathies and monitor hemostasis.
Is Phosphoplastin RL intended for single-use or repeated use in a clinical setting?
Phosphoplastin RL is supplied as a liquid reagent explicitly intended for single-use in clinical coagulation laboratories. This ensures consistency and reliability in test results, as reuse could compromise sterility and accuracy.
What regulatory pathways has Phosphoplastin RL undergone, and what does that mean for its use?
Phosphoplastin RL has received both FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, confirming it meets regulatory standards for safety and performance. The device is classified as a Class II medical device under FDA regulations (864.7750), indicating it has undergone rigorous review by the Hematology (HE) advisory committee.
How is Phosphoplastin RL supplied, and what should be considered when handling it?
Phosphoplastin RL is supplied as a liquid reagent, intended for use in clinical coagulation laboratories. While specific storage conditions aren’t detailed, standard laboratory practices for sensitive reagents—such as protecting from light, contamination, and extreme temperatures—should be followed to maintain its integrity and ensure accurate test results.
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: Phosphoplastin RL - r² Diagnostics, Home - r² Diagnostics, PHOSPHOPLASTIN RL (K040296) — FDA 510 (k) | Innolitics
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 | K040296 | Class II | Active |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (5)
- FDA 510(k) K040296 24 fields · synced Sep 18, 2026
- FDA UDI 83071d2c-a7ad-44b9-9898-0c8e7f296da1 35 fields · synced May 29, 2026
- FDA UDI 34333a9d-95bc-4750-82b4-9fbc5ee2fe4c 35 fields · synced May 30, 2026
- EUDAMED 1afcea3d-ff86-4154-8e08-4abfe8ede3f6 61 fields · synced Jun 20, 2026
- EUDAMED bc1f6d97-994d-4579-99eb-8aae44b8b0a7 61 fields · synced Jul 10, 2026