Optilite IgM Kit NK012.OPT.A
Optilite IgM Kit NK012.OPT.A is a Class II device made by The Binding Site Group, cleared under FDA 510(k) K191635 on 15 Jul 2019 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05051700017565), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) | NumberK191635 | Date15 Jul 2019 | StatusActive |
| United States | GUDID listing | Number05051700017565 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05051700017565
- FDA 510(k) database K191635
- FDA 510(k) database K082129
Across registries
- FDA 510(k) K191635 decided 15 Jul 2019 Active
- FDA GUDID UDI-DI 05051700017565 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-1327-2020
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
-
- Terminated Z-0604-2019
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
-
- Terminated Z-0477-2019
After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.
Timeline
- Cleared FDA 510(k) K082129
- Listed FDA GUDID 05051700017565
- Recall initiated FDA recalls Z-0477-2019
- Recall initiated FDA recalls Z-0604-2019
- Cleared FDA 510(k) K191635
- Recall initiated FDA recalls Z-1327-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optilite IgM Kit
- Generic name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
- Model / reference
- NK012.OPT.A
- Primary DI / UDI-DI
- 05051700017565
- FDA product code
- CFN
- GMDN term
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5510
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry.