Optilite IgM CSF Kit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Optilite® IgM CSF Kit EUDAMED
- Device Name
- Optilite® IgM CSF Kit EUDAMED
- Model / Reference
- LK012.L.OPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051700018265 EUDAMED
- Basic UDI-DI
- 5051700LK012.L.OPTGA EUDAMED
- 510(k) Number
- K190686 FDA 510(k)
- FDA Product Code
- CFN FDA 510(k)
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5510 FDA 510(k)
- Regulation Number
- 866.5510 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
The Optilite IgM CSF Kit is an in vitro diagnostic reagent system classified as a nephelometric method for measuring immunoglobulins (specifically IgM). It is designed to quantify IgM concentrations in cerebrospinal fluid (CSF) samples through immunoturbidimetric analysis, utilizing sheep anti-human-IgM antibodies to form insoluble complexes for detection.
This kit is intended for use with the Binding Site Optilite analyser and is supplied as a single-use diagnostic reagent. It has received FDA 510(k) clearance under the Traditional pathway and is also compliant with the In Vitro Diagnostic Regulation (IVDR). The device is classified under product code CFN and falls under the Immunology specialty, adhering to regulatory standards for Class 2 medical devices.
Frequently asked questions
What types of samples is the Optilite IgM CSF Kit designed to analyze, and how does it work?
The Optilite IgM CSF Kit is specifically designed to measure IgM concentrations in cerebrospinal fluid (CSF) samples using an immunoturbidimetric (nephelometric) method. It forms insoluble complexes with IgM in the sample by binding to sheep anti-human-IgM antibodies, which are then detected through turbidity changes. This allows for precise quantification of IgM levels, aiding in immunology-related diagnostics.
Is this kit single-use, and if so, what does that mean for workflow efficiency?
Yes, the Optilite IgM CSF Kit is supplied as a single-use diagnostic reagent, meaning each kit is intended for one analysis only. This design ensures consistency in results by eliminating carryover contamination and reduces the need for reprocessing or validation between uses, streamlining workflow in clinical or research settings.
Which analyser is required to use this kit, and does it have any special handling requirements?
This kit is exclusively designed for use with the Binding Site Optilite analyser, a dedicated nephelometric system. While the analyser handles the turbidimetric detection, the kit itself does not require additional handling beyond standard in vitro diagnostic procedures—such as maintaining refrigerated storage (2–8°C) and avoiding freeze-thaw cycles—to preserve reagent integrity.
What regulatory pathways has this kit undergone, and how does that affect its use in clinical settings?
The Optilite IgM CSF Kit has received FDA 510(k) clearance under the Traditional pathway and complies with the In Vitro Diagnostic Regulation (IVDR). This means it meets U.S. and EU standards for safety, performance, and clinical accuracy, allowing its use in regulated clinical or diagnostic laboratories. The classification as a Class 2 device under product code CFN (Immunology) ensures it adheres to rigorous quality controls for immunology assays.
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: Optilite™ Analyser | Binding Site - Thermo Fisher Scientific, Optilite IgM CSF Kit (K190686) — FDA 510 (k) | Innolitics, K190686 - Optilite IgM CSF Kit | FDA 510 (k)
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 | K190686 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Binding Site Group Ltd
- FDA Applicant
- The Binding Site Group , Ltd.
Sources (2)
- FDA 510(k) K190686 24 fields · synced Sep 18, 2026
- EUDAMED 3ded4c45-b50c-4544-8a26-44a65b1376a0 61 fields · synced Jul 25, 2026