510(k) · Cleared
ClearedCapillary's Immunotyping (PN 2100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia, Inc. · DFH Kappa, Antigen, Antiserum, Control
Cleared on Jun 27, 2005 after a 245-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 27, 2005
- Review
- 245 days
- Class
- Class II
- Product code
- DFH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK042939 Capillary's Immunotyping (PN 2100)Sebia, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK130500 Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control…Sebia · 2013
- Descendant · 2 generations on · 1 of its ownK161928 Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016
- Descendant · 2 generations on · 0 of its ownK192095 CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019
Most influential descendants
Showing 3 of 3 · See all- K130500Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex…Sebia · 2013 · cites it directly2descendants
- K161928Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016 · 2 generations on1descendant
- K192095CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042939 | Capillary's Immunotyping (PN 2100) | Sebia, Inc. | 2005 | — |
| +1 | K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2… | Sebia | 2013 | — |
| +2 | K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control | Sebia | 2016 | — |
| +2 | K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex… | 2013 | 2 |
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?
- Of its descendants, K130500 (Sebia, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DFH devicesDFH Kappa, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 or CAPILLARYS 1,1-112 + kits designed for serum proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The CAPILLARYS system performs all procedural sequences automatically to…
Read the full statement (176 words)
The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 or CAPILLARYS 1,1-112 + kits designed for serum proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS system performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each sample is mixed with individual antisera that are specific against gamma (IgG), alpha (IgA) and mu (IgM) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains.
The proteins fractions, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually by comparing the profile of the untreated sample with the individual profiles treated with the respective antisera. Monoclonal immunoglobulins are thus detected and identified.
Identification of Monoclonal immunoglobulins is essential for the classification of monoclonal gammopathies by the class and type of involved immunoglobulins.
"For In Vitro Diagnostic Use."
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042939 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042939: Capillary's Immunotyping (PN 2100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042939
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