Coagulation Control, Level II
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K870686 FDA 510(k)
- FDA Product Code
- JPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Coagulation Control, Level II is a System, Multipurpose for In Vitro Coagulation Studies, designed as a reference standard for monitoring coagulation assays. It provides calibrated controls to ensure accuracy and precision in laboratory testing of blood coagulation parameters, such as prothrombin time (PT) and activated partial thromboplastin time (APTT).
This device is intended for in vitro diagnostic use in clinical hematology laboratories. Supplied as a sterile, single-use reagent, it is classified under FDA regulation 21 CFR 864.5425 and cleared via a Traditional 510(k) pathway (K870686) as substantially equivalent to a predicate device. Storage conditions and expiration dates are specified on the packaging, and it must be handled in accordance with standard laboratory practices for in vitro diagnostics.
Frequently asked questions
What is the primary purpose of the Coagulation Control, Level II, and how does it support laboratory testing?
The Coagulation Control, Level II is designed as a reference standard for monitoring coagulation assays in clinical hematology laboratories. It provides calibrated controls to verify the accuracy and precision of tests measuring blood coagulation parameters like prothrombin time (PT) and activated partial thromboplastin time (APTT). By ensuring consistent results, it helps maintain reliable diagnostic performance for patient care.
Is this device intended for single-use or repeated use, and what are the handling requirements?
This device is sterile and intended for single-use only, as specified in its design. It must be handled according to standard laboratory practices for in vitro diagnostics to preserve sterility and accuracy. Discard after one use to avoid contamination or degradation of results.
How do I determine if a lot of this product is still valid for use, and what storage conditions are recommended?
The expiration date is clearly marked on the packaging, and you must adhere to it to ensure reliability. Storage conditions are also specified on the packaging—follow those instructions closely, as improper storage (e.g., temperature fluctuations or light exposure) could compromise the reagent’s stability and performance.
What regulatory pathway was used for clearance, and which advisory committee was involved in its review?
The Coagulation Control, Level II was cleared via a Traditional 510(k) pathway (K870686) and is classified under 21 CFR 864.5425. Its review was conducted by the Hematology (HE) Advisory Committee, which evaluates devices intended for coagulation studies. The clearance confirms it is substantially equivalent to a predicate device.
Are there multiple sizes or models of this device, and how can I identify the correct one for my lab’s needs?
While the device is marketed as a Level II Coagulation Control, the OpenFDA registration lists multiple FEI numbers (e.g., 3015222335, 3010653929), which may correspond to different lot codes or packaging variants. However, the core functionality remains identical—all versions are calibrated controls for PT/APTT assays. Verify the label or packaging for the specific lot number and expiration date to ensure compatibility with your lab’s testing systems.
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: COAGULATION CONTROL, LEVEL II (K870686) — FDA 510(k) | Innolitics, 510(k) K870686 — COAGULATION CONTROL, LEVEL II - RegDataLab, Coagulation Control, Level Ii - Beudamed, COAGULATION CONTROL, LEVEL II 510 (k) K870686 - FDA.report, PDF K870686 - Coagulation Control, Level Ii
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K870686 | Class II | Active |
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Manufacturer
- Manufacturer
- U.s. Diagnostics Inc.
- FDA Applicant
- U. S. Diagnostics, Inc.
Sources (1)
- FDA 510(k) K870686 24 fields · synced Sep 19, 2026