Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii
FDA 510(k) K140105 · The Binding Site
510(k) numberK140105
Submission
- Device name
- Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii
- Applicant
- The Binding Site
Birmingham, GB - Received
- January 15, 2014
- Decision date
- March 18, 2014
- 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 |
| 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 |
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| 510(k) | Device | Decision |
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| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | 01/24/2024SE |
| K132555 | Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitPCN · Traditional | 12/20/2013SE |
| K103824 | Human Iga Liquid Reagent Kit for Use on SPA PlusCFN · Traditional | 02/27/2012SE |
| K100455 | Spaplus AnalyzerDBI · Traditional | 09/03/2010SE |
| K090920 | Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)CFN · Traditional | 12/30/2009SE |
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | 12/28/2009SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | 05/06/2009SE |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerCFN · Traditional | 02/10/2009SE |
| K081827 | Human Iga Liquid Reagent Kit for Use on SpaplusCFN · Traditional | 12/19/2008SE |
| K081674 | Bindazyme Human Anti-Gliadin (MGP), Igg Eia Kit; Bindazyme Human Anti-Gliadin (MGP) Iga…MST · Traditional | 10/15/2008SE |
Questions and answers
When was Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii cleared by the FDA?
Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii (K140105) received a 510(k) decision of Substantially Equivalent on March 18, 2014, 62 days after the submission was received.
What is the product code of K140105?
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.