Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
FDA 510(k) K151759 · The Binding Site Group , Ltd.
510(k) numberK151759
Submission
- Device name
- Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
- Applicant
- The Binding Site Group , Ltd.
Edgbaston, GB - Received
- June 29, 2015
- Decision date
- November 6, 2015
- 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 |
|---|---|---|---|
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda KitOPX · Traditional | The Binding Site Group , Ltd. | 06/16/2016SE |
| 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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| 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 Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS cleared by the FDA?
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS (K151759) received a 510(k) decision of Substantially Equivalent on November 6, 2015, 130 days after the submission was received.
What is the product code of K151759?
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.