Ristocetin Cofactor Assay Kit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K945414 FDA 510(k)
- FDA Product Code
- GGP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7290 FDA 510(k)
- Regulation Number
- 864.7290 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ristocetin Cofactor Assay Kit is a diagnostic in vitro device used for the quantitative determination of Factor VIII Ristocetin Cofactor (FVIII:C) activity in citrated plasma. It falls under the classification of a qualitative and quantitative factor deficiency test, specifically for von Willebrand Factor (vWF) assessment in hematological diagnostics.
This kit is supplied as a reagent set containing lyophilized components, including ristocetin (7.5 mg/vial), lyophilized human platelets (6 mL), normal and deficient von Willebrand reference plasmas, and Tris Buffered Saline (12 mL). Designed for single-use, it requires no sterilization beyond its pre-packaged state and is intended for use in clinical laboratory settings. The device holds FDA 510(k) clearance (K945414) and IVDR compliance, adhering to regulatory standards for hematology diagnostics.
Frequently asked questions
What clinical condition is this assay kit primarily used to evaluate in patients?
This kit is designed for the quantitative measurement of Factor VIII Ristocetin Cofactor (FVIII:C) activity in citrated plasma, which helps assess von Willebrand Factor (vWF) levels. It is particularly useful in diagnosing and monitoring von Willebrand disease, a bleeding disorder caused by deficiencies in vWF or its activity.
How is the Ristocetin Cofactor Assay Kit supplied, and is it intended for single-use?
The kit is supplied as a reagent set containing lyophilized components, including ristocetin, lyophilized human platelets, reference plasmas (normal and deficient), and Tris Buffered Saline. It is explicitly labeled for single-use only, meaning each kit is intended for one test procedure and should not be reused or restocked.
Does this kit require any special handling or sterilization before use?
No additional sterilization is required beyond its pre-packaged state. The kit is designed for clinical laboratory use and is provided in a sterile, ready-to-use format, ensuring no extra preparation is needed before performing the assay.
What regulatory pathways has this device undergone, and which committees were involved?
The kit holds FDA 510(k) clearance (K945414) under the Traditional pathway, determined by the Hematology (HE) Advisory Committee as substantially equivalent to a predicate device. It also complies with the In Vitro Diagnostic Regulation (IVDR) standards, ensuring its suitability for quantitative and qualitative factor deficiency testing in hematology.
Are there multiple sizes or models of this assay kit, or is it available in a single configuration?
The data provided does not specify multiple sizes or models; the kit is described as a single reagent set configuration. It includes fixed components like ristocetin (7.5 mg/vial), lyophilized platelets (6 mL), and reference plasmas, implying a standardized format for consistent testing.
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: Chrono Log Corporation Ristocetin Cofactor Assay, P/N 299 Ristocetin CoFactor Assay Kit (von Willebrand Factor Assay), RISTOCETIN COFACTOR ASSAY KIT (K945414) — FDA 510(k) | Innolitics, CHRONO-LOG® Platelet Function Reagents - Avant Medical
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 | K945414 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chrono-Log Corp
- FDA Applicant
- Chrono-Log Corp.
Sources (2)
- FDA 510(k) K945414 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026