510(k) · Cleared
ClearedMinicap Immunotyping, Model: 2300
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 Apr 14, 2009 after a 238-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Apr 14, 2009
- Review
- 238 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK082388 Minicap Immunotyping, Model: 2300Sebia · 2009
- Descendant · cites it directly · 0 of its ownK143483 MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGSebia · 2015
Most influential descendants
Showing 1 of 1 · See all- K143483MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGSebia · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082388 | Minicap Immunotyping, Model: 2300 | Sebia | 2009 | — |
| +1 | K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | Sebia | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | 2015 | 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?
- Of its descendants, K143483 (Sebia, 2015) has gone furthest, with 0 descendants of its own.
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. 2009, 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 MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP System, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The MINICAP performs all procedural sequences automatically to obtain a protein profile for qualitative…
Read the full statement (138 words)
The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of
monoclonal proteins (immunotyping) in human serum with the MINICAP System, SEBIA, for capillary
electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for
proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The MINICAP 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 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
suspected monoclonal proteins.
For In Vitro Diagnostic Use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082388: Minicap Immunotyping, Model: 2300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082388
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