Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
FDA 510(k) K160819 · The Binding Site Group , Ltd.
510(k) numberK160819
Submission
- Device name
- Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
- Applicant
- The Binding Site Group , Ltd.
Edgbaston, GB - Received
- March 24, 2016
- Decision date
- June 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OPX – Immunoglobulin A Kappa Heavy & Light Chain Combined
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.
Other 510(k)s with product code OPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use…OPX · Traditional | The Binding Site Group , Ltd. | 11/06/2015SE |
| K140105 | Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for…OPX · Traditional | The Binding Site | 03/18/2014SE |
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| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | 01/23/2019SE |
| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | 10/12/2018SE |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH · Traditional | 08/23/2018SE |
Questions and answers
When was Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit cleared by the FDA?
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit (K160819) received a 510(k) decision of Substantially Equivalent on June 16, 2016, 84 days after the submission was received.
What is the product code of K160819?
The FDA product code is OPX – Immunoglobulin A Kappa Heavy & Light Chain Combined, a Class II (moderate risk) device regulated under 21 CFR 866.5510.