Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
FDA 510(k) K220001 · Diazyme Laboratories, Inc.
510(k) numberK220001
Submission
- Device name
- Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- Applicant
- Diazyme Laboratories, Inc.
Poway, CA, US - Received
- January 4, 2022
- Decision date
- August 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K190879 | N Latex FLC kappa, N Latex FLC lambdaDFH · Special | Siemens Healthcare Diagnostics Products GmbH | 05/03/2019SE |
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|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | 06/16/2026SE |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M… · Traditional | 04/24/2026SE |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | 12/19/2025SE |
| K243462 | Diazyme Colorimetric Lithium AssayNDW · Traditional | 08/01/2025SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 09/08/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | 12/13/2021SE |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 ActivityNOE · Special | 08/06/2021SE |
| K180209 | Diazyme 1,5-AG AssayNOZ · Traditional | 10/04/2018SE |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDFH · Special | 06/26/2018SE |
| K180074 | Diazyme Lipoprotein (a) AssayDFC · Traditional | 03/22/2018SE |
Questions and answers
When was Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay cleared by the FDA?
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K220001) received a 510(k) decision of Substantially Equivalent on August 4, 2022, 212 days after the submission was received.
What is the product code of K220001?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.