510(k) · Cleared
ClearedCapi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Cleared on Dec 21, 2016 as substantially equivalent to K130500 (Sebia, 2013) after a 160-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Dec 21, 2016
- Review
- 160 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960669 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK960669 Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, &…Morax · 1996
- 1 generation backK130500 Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control…Sebia · 2013
- This deviceK161928 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 1 of 1 · See all- K192095CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits | Morax | 1996 | — |
| −1 | K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2… | Sebia | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 CFF? 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 CFF device
- #1 K203184 HYDRASHIFT 2/4 isatuximabscore 2.3 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex…Summary page 6…= Predicate Device Name Predicate Device 510(k) number CAPILLARYS IMMUNOTYPING K130500 CAPILLARYS 2 / CAPILLARYS 2 FLEX- K130500 PIERCING IT / IF CONTROL… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | 2019 | 0 |
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 CFF devicesCFF Immunoelectrophoretic, Immunoglobulins, (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · CFF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CFF
Too few CFF 510(k)s in any year since 2007 to give a median.
Recalls per year · CFF
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFF
1in 2021
MAUDE reports naming product code CFF, 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 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically…
Read the full statement (275 words)
The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), 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 nm.
The electrophoregrams 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 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, CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA instruments and on SEBIA MINICAP 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 K20 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/K161928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161928: Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161928
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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