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LupoTek KCT

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K090105

by R2 Diagnostics, Inc.

Identifiers

510(k) Number
K090105 FDA 510(k)
FDA Product Code
GGW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7925 FDA 510(k)
Regulation Number
864.7925 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LupoTek KCT is a kaolin-activated partial thromboplastin reagent without phospholipid, classified as an in vitro diagnostic device for coagulation screening. It functions as a qualitative assay designed to detect circulating lupus-like anticoagulants in citrated human plasma, aiding hematological evaluations in professional laboratory settings.

This reagent is intended for use in automated coagulometers and is supplied as a liquid reagent. It is classified under FDA 510(k) clearance (K090105) and IVDD (In Vitro Diagnostic Device Directive) regulations, adhering to medical specialty standards in hematology. The device is non-sterile, single-use, and requires proper storage as specified in manufacturer guidelines.

Frequently asked questions

What is the LupoTek KCT used for in a clinical setting?

The LupoTek KCT is an in vitro diagnostic reagent designed specifically for detecting circulating lupus-like anticoagulants in citrated human plasma. It aids hematologists in coagulation screening by functioning as a qualitative assay, helping identify abnormalities that may mimic lupus anticoagulants during laboratory evaluations.

How is the LupoTek KCT supplied, and is it reusable?

The LupoTek KCT is supplied as a liquid reagent, intended for single-use only. Since it is non-sterile and designed for one-time use in automated coagulometers, it should not be reused to maintain accuracy and prevent contamination.

What type of equipment is required to use the LupoTek KCT, and does it need special handling?

The LupoTek KCT is formulated for use exclusively in automated coagulometers, which are specialized laboratory instruments for coagulation testing. As a non-sterile, single-use reagent, it requires adherence to manufacturer guidelines for storage and handling to ensure proper performance.

Are there specific storage instructions for the LupoTek KCT, and why are they important?

While the exact storage instructions are detailed in the manufacturer’s guidelines, proper storage is critical for maintaining the reagent’s stability and accuracy. Since it is a liquid reagent, exposure to extreme temperatures or improper conditions could compromise its effectiveness in detecting lupus-like anticoagulants.

What regulatory pathways does the LupoTek KCT follow, and how does this affect its use?

The LupoTek KCT has received FDA 510(k) clearance (K090105) and complies with the In Vitro Diagnostic Device Directive (IVDD). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device and meets EU regulatory standards for hematology reagents, ensuring its suitability for clinical use in coagulation screening.

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: LupoTek KCT - r² Diagnostics, Home - r² Diagnostics, LUPOTEK KCT 510 (k) K090105 - FDA.report, PDF REVIEW MEMORANDUM - Food and Drug Administration

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
R2 Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K090105 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026