510(k) · Cleared
ClearedCapillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · CEF Electrophoretic, Protein Fractionation
Cleared on Jul 26, 2013 as substantially equivalent to K960669 (Morax, 1996) and 4 other predicates after a 150-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Jul 26, 2013
- Review
- 150 days
- Class
- Class I
- Product code
- CEF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K960669 (1996). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960669 Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, &…Morax · 1996
- This deviceK130500 Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control…Sebia · 2013
- Descendant · cites it directly · 1 of its ownK161928 Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016
- Descendant · cites it directly · 0 of its ownK192095 CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits | Morax | 1996 | — |
| 0 (this device) | K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2… | Sebia | 2013 | — |
| +1 | K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control | Sebia | 2016 | — |
| +1 | K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 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 CEF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF KitsSummary page 3…Table of Predicate Devices Predicate Devices 510K Sample Type Clearance date HYDRAGEL IF kits K960669 Serum July 12, 1996 CAPILLARYS IMMUNOTYPING K042939 Serum June 27, 20… | 1996 |
| * | K042939 | Capillary's Immunotyping (PN 2100)Summary page 2…ted in the product package insert included with each kit in Section Ill (labeling). The Sebia CAPILLARYS IMMUNO TYPING reagent kit was cleared in prior 510K submission, K042939 using serum samples and K(082085 using urine samples. Electrophoresis is a process for the identification of monoclonal proteins… | 2005 |
| * | K082085 | Capillarys Immunotyping, Model 2100Summary page 2…device CAPILLARYS 2 instrument with serum and urine samples. The reagents CAPILLARYS IMMUNOTYPING were previously cleared in submissions K042939 and K082085. B. This submission also includes supporting data for the IT / IF Con trol with the device CAPILLARYS 2 instrument, u… | 2009 |
| * | K101863 | IT/IF ControlSummary page 2…T / IF Con trol with the device CAPILLARYS 2 instrument, using the CAPILLARYS IMMUNOTYPING reagents. The IT/IF control was cleared in prior 510K submissions, K101863. The results of the IT/IF control using the CAPILLARYS 2 instrument with the CAPILLARYS IMMUNOTYPING - procedure was compar… | 2011 |
| * | K002799 | Paragon Cze 2000 Capillary Electrophoresis System and Buffer-100Summary page 2…ontrol using the CAPILLARYS 2 instrument with the CAPILLARYS IMMUNOTYPING - procedure was compared to the Beckman Paragon CZE 2000 IFE/s Control which was cleared, K002799 C. This submission will demonstrate the CAPILLARYS IMMUNO TYPING with the CAPILLARYS 2 instrument compared to the CA… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All CEF devicesCEF Electrophoretic, Protein Fractionation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CEF
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CEF
Too few CEF 510(k)s in any year since 2007 to give a median.
Recalls per year · CEF
No recall names CEF since 2007.
Adverse event reports per year · CEF
1in 2015
MAUDE reports naming product code CEF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAPILLARYS IMMUNOTYPING kit is designed far the detection and the characterization of monoclonal proteins (immunotyping) in human wine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The CAI'ILLARYS, CAIPILLARYS 2 and the…
Read the full statement (279 words)
The CAPILLARYS IMMUNOTYPING kit is designed far the detection and the characterization of monoclonal proteins (immunotyping) in human wine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAI'ILLARYS, CAIPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig 0), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively..
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 n.
The electruphoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.
The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods:
-Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2 and CAFILLARYS 2 FLEX PIERCING instruments and on SEBIA MINCAP instrument.
- Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K(20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT/If control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130500: Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130500
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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