510(k) · Cleared
ClearedMINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
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 Jan 8, 2015 as substantially equivalent to K082388 (Sebia, 2009) after a 31-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Jan 8, 2015
- Review
- 31 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082388 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK082388 Minicap Immunotyping, Model: 2300Sebia · 2009
- This deviceK143483 MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGSebia · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082388 | Minicap Immunotyping, Model: 2300 | Sebia | 2009 | — |
| 0 (this device) | K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | Sebia | 2015 | — |
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 |
|---|---|---|---|
| * | K082388 | Minicap Immunotyping, Model: 2300Summary page 4…otification of the modification to our MINICAP IMMUNUNOTYPING procedure. The MINICAP IMMUNOTYPING reagent kit was originally cleared for use with the MINICAP instrument, k082388 April 14, 2009. This modification includes a new instrument family member, MINICAP FLEX-PIERCING. Modifications to the test syst… | 2009 |
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?
- Its one ancestor has no recall.
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. 2015, 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 and the MINICAP FLEX-PIERCING instruments, 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 and MINICAP FLEX-PIERCING instruments perform all…
Read the full statement (145 words)
The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of
monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP
FLEX-PIERCING instruments, 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 and MINICAP FLEX-PIERCING instruments perform 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 suspected 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/K143483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143483: MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143483
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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