510(k) · Cleared
ClearedCAPI 3 Immunotyping, Capillarys 3 Tera
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 Nov 1, 2019 as substantially equivalent to K130500 (Sebia, 2013) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Nov 1, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960669 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK960669 Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, &…Morax · 1996
- 2 generations backK130500 Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control…Sebia · 2013
- 1 generation backK161928 Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016
- This deviceK192095 CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits | Morax | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (2)
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 5…nation CAPI 3 IMMUNOTYPING using the CAPILLARYS 3 TERA, K161928. The predicate device used in this submission is Sebia’s CAPILLARYS IMMUNOTYPING using the CAPILLARYS 2, K130500 1. DEVICE DESCRIPTION The capillary electrophoresis provides complete automation with fast separation and good resolution.… | 2013 |
| * | K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSummary page 5…mission is to support the additional of new matrix (Urine) to Sebia’s previously cleared reagent/ instrument combination CAPI 3 IMMUNOTYPING using the CAPILLARYS 3 TERA, K161928. The predicate device used in this submission is Sebia’s CAPILLARYS IMMUNOTYPING using the CAPILLARYS 2, K130500 1. DEVICE… | 2016 |
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 23 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K130500.
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. 2019, 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 urine and 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…
Read the full statement (155 words)
The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal
proteins (immunotyping) in human urine and 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 urine or 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.
For In Vitro Diagnostic Use.
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/K192095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192095: CAPI 3 Immunotyping, Capillarys 3 Tera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192095
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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