510(k) · Cleared
ClearedDiazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories, Inc. · DFH Kappa, Antigen, Antiserum, Control
Cleared on Dec 19, 2025 as substantially equivalent to K211648 (Diazyme Laboratories, Inc., 2022) after an 80-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Dec 19, 2025
- Review
- 80 days
- Class
- Class II
- Product code
- DFH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K211648 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backK211648 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda…Diazyme Laboratories, Inc. · 2022
- This deviceK253358 Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda…Diazyme Laboratories, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light… | Diazyme Laboratories, Inc. | 2022 | — |
| 0 (this device) | K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free… | Diazyme Laboratories, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DFH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DFH device
- #1 K250549 Optilite® Freelite Mx Kappa Free Kit…score 9.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssaySummary page 8…s): Diazyme Human Kappa (κ) Free Light Chain Assay Diazyme Human Lambda (λ) Free Light Chain Assay B. Predicate 510(k) Number(s): K211648 C. Comparison with Predicate(s): Device & Predicate Device(s): K253358 (Subject Device) K211648 (… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All DFH devicesDFH Kappa, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DFH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFH
340in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DFH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFH
10in 2025
MAUDE reports naming product code DFH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 4 | 340 | 0 | 11 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Diazyme Human Kappa (κ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with…
Read the full statement (156 words)
The Diazyme Human Kappa (κ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253358 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253358: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253358
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026