Optilite IgM Kit
FDA 510(k) K191635 · The Binding Site Group , Ltd.
510(k) numberK191635
Submission
- Device name
- Optilite IgM Kit
- Applicant
- The Binding Site Group , Ltd.
Edgbaston, GB - Received
- June 19, 2019
- Decision date
- July 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)CFN · Special | Siemens Healthcare Diagnostics Products GmbH | 12/13/2023SE |
| K221114 | Immunoglobulin G (IgG)CFN · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 08/02/2023SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | The Binding Site Group , Ltd. | 08/19/2019SE |
| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 01/23/2019SE |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentCFN · Traditional | Beckman Coulter, Inc. | 01/09/2017SE |
| K150526 | Optilite IgG4 KitCFN · Traditional | The Binding Site Group , Ltd. | 05/30/2015SE |
| K142735 | The Optilite IgG3 kitCFN · Traditional | The Binding Site Group , Ltd. | 12/21/2014SE |
More from The Binding Site Group , Ltd.
| 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 |
| 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 |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite…DCN · Traditional | 02/28/2018SE |
Questions and answers
When was Optilite IgM Kit cleared by the FDA?
Optilite IgM Kit (K191635) received a 510(k) decision of Substantially Equivalent on July 15, 2019, 26 days after the submission was received.
What is the product code of K191635?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.