510(k) · Cleared
ClearedN Latex FLC kappa, N Latex FLC lambda
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics Products GmbH · DFH Kappa, Antigen, Antiserum, Control
Cleared on Mar 2, 2022 as substantially equivalent to K171742 (Siemens Healthcare Diagnostics Products GmbH, 2017) and 3 other predicates after a 212-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Mar 2, 2022
- Review
- 212 days
- Class
- Class II
- Product code
- DFH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K031016 (2003). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK031016 Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring…The Binding Site, Ltd. · 2003
- 1 generation backK171742 N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard…Siemens Healthcare Diagnostics Products GmbH · 2017
- This deviceK212379 N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031016 | Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring… | The Binding Site, Ltd. | 2003 | — |
| −1 | K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC… | Siemens Healthcare Diagnostics Products GmbH | 2017 | — |
| 0 (this device) | K212379 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
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 K253358 Diazyme Human Kappa (k) Free Light Chain…score 10.5 · 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? (4)
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 |
|---|---|---|---|
| * | K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1…Summary page 5…Name Code clearance N Latex Immunoglobulin Class II per DFH Immunology K171742 FLC kappa (light chain specific) 21CFR (82) K182098 immunological test… | 2017 |
| * | K182098 | N Latex FLC kappa assay, N Latex FLC lambda assaySummary page 5…N Latex Immunoglobulin Class II per DFH Immunology K171742 FLC kappa (light chain specific) 21CFR (82) K182098 immunological test 866.5550 K193047 system… | 2018 |
| * | K193047 | N Latex FLC kappa, N Latex FLC lambdaSummary page 5…LC kappa (light chain specific) 21CFR (82) K182098 immunological test 866.5550 K193047 system K201496 N Latex Immunoglobulin… | 2021 |
| * | K201496 | N Latex FLC kappa, N Latex FLC lambda Cleared while this submission was under review Summary page 5…claim to N Latex FLC kappa and lambda on the Atellica® CH Analyzer 3. Legally Marketed Unmodified / Predicate Devices Cleared for use on Siemens’ BN Systems under K201496 on October 29, 2021 as an aid in the monitoring of amyloidosis (AL) on the BN Systems. Trade Name Common/Usual… | 2021 |
| † | K190879 | N Latex FLC kappa, N Latex FLC lambda | 2019 |
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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K171742.
How does its category compare?
All DFH devicesDFH Kappa, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma. N Latex FL.C kappa and lambda assays are used: » as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer. » as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH…
Read the full statement (133 words)
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma. N Latex FL.C kappa and lambda assays are used:
» as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer.
» as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer.
* as an aid in the monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems.
» as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems and Atellica® CH Analyzer.
Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212379: N Latex FLC kappa, N Latex FLC lambda.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212379
Report an extraction error
Are you the manufacturer?
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