Diastat Total Anti-Cardiolipin, Model FCAR 100T
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020156 FDA 510(k)
- FDA Product Code
- MID FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Diastat Total Anti-Cardiolipin, Model FCAR 100T is an ELISA-based in vitro diagnostic test classified as a System, Test, Anticardiolipin Immunological. It is designed to detect IgG, IgM, and IgA autoantibodies against cardiolipin in human serum or plasma samples, aiding in the immunological assessment of antiphospholipid syndrome and related conditions.
This device is supplied as a single-use reagent kit for laboratory use in immunology settings. It operates via enzyme-linked immunosorbent assay (ELISA) principles, where patient samples are incubated in wells coated with cardiolipin. The test is authorized under FDA 510(k) clearance (K020156) and falls under regulation 866.5660, with a classification of Class II. Storage and handling follow standard in vitro diagnostic protocols.
Frequently asked questions
What is the Diastat Total Anti-Cardiolipin FCAR 100T used for?
The Diastat Total Anti-Cardiolipin FCAR 100T is an ELISA-based in vitro diagnostic test designed to detect IgG, IgM, and IgA autoantibodies against cardiolipin in human serum or plasma samples. This aids in the immunological assessment of antiphospholipid syndrome and related autoimmune conditions, helping clinicians evaluate potential thrombotic risks or connective tissue disorders.
How is the Diastat Total Anti-Cardiolipin FCAR 100T supplied, and is it single-use?
The Diastat Total Anti-Cardiolipin FCAR 100T is supplied as a single-use reagent kit, intended for laboratory use in immunology settings. Each kit is designed for one-time use per test, ensuring sterility and consistency in results without cross-contamination risks. This aligns with standard in vitro diagnostic protocols for ELISA-based assays.
What storage and handling requirements apply to this test kit?
The Diastat Total Anti-Cardiolipin FCAR 100T follows standard in vitro diagnostic storage and handling protocols. It should be stored under controlled conditions to maintain reagent integrity, typically at 2–8°C (refrigerated) and protected from light. Always refer to the included instructions for specific storage durations and any thawing or preparation steps before use.
Is this test authorized for clinical use in the U.S., and how?
Yes, the Diastat Total Anti-Cardiolipin FCAR 100T is authorized for clinical use in the U.S. under FDA 510(k) clearance (K020156). This clearance confirms that the device is substantially equivalent to a legally marketed predicate device, meeting regulatory requirements for safety and effectiveness as an immunological test for detecting antiphospholipid antibodies.
What regulatory classification does this device hold, and where is it manufactured?
The Diastat Total Anti-Cardiolipin FCAR 100T is classified as a Class II medical device under FDA regulation 866.5660, indicating moderate regulatory oversight due to its role in diagnosing autoimmune conditions. It is manufactured by Axis-Shield Diagnostics, Ltd., located at The Technology Park, Luna Pl., Dundee, Scotland (DD2 1XA).
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: Diastat Total Anti-cardiolipin, Model Fcar 100t, DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T… - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020156 | Class II | Active |
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Manufacturer
- Manufacturer
- Axis-Shield Diagnostics, Ltd.
Sources (1)
- FDA 510(k) K020156 24 fields · synced Oct 1, 2026