Human Kappa and Lambda Free Kitfor Use on the SPA Plus Analyser
FDA 510(k) K120056 · The Binding Site Group , Ltd.
510(k) numberK120056
Submission
- Device name
- Human Kappa and Lambda Free Kitfor Use on the SPA Plus Analyser
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- January 9, 2012
- Decision date
- April 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFH – Kappa, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | Diazyme Laboratories, Inc. | 12/19/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | The Binding Site Group , Ltd. | 05/23/2025SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 02/23/2024SE |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | The Binding Site, Ltd. | 01/24/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 11/18/2022SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 08/04/2022SE |
| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 10/29/2021SE |
| K193047 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 07/14/2021SE |
More from Siemens Healthcare Diagnostics Products GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserSGG · Traditional | 10/17/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | 05/23/2025SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | 08/19/2019SE |
| K191635 | Optilite IgM KitCFN · Special | 07/15/2019SE |
| 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 Human Kappa and Lambda Free Kitfor Use on the SPA Plus Analyser cleared by the FDA?
Human Kappa and Lambda Free Kitfor Use on the SPA Plus Analyser (K120056) received a 510(k) decision of Substantially Equivalent on April 1, 2013, 448 days after the submission was received.
What is the product code of K120056?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.