510(k) · Cleared
ClearedInterlab Ife Test Using G 26 Ver. 2.0 Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grifols USA, LLC · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Cleared on Aug 24, 2012 as substantially equivalent to K103757 (Grifols, 2011) after a 218-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Aug 24, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K103757 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK103757 Immunofixation Electrophoresis Test Using Interlab G26 InstrumentGrifols · 2011
- This deviceK120169 Interlab Ife Test Using G 26 Ver. 2.0 InstrumentGrifols USA, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K103757 | Immunofixation Electrophoresis Test Using Interlab G26 Instrument | Grifols | 2011 | — |
| 0 (this device) | K120169 | Interlab Ife Test Using G 26 Ver. 2.0 Instrument | Grifols USA, LLC | 2012 | — |
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 |
|---|---|---|---|
| * | K103757 | Immunofixation Electrophoresis Test Using Interlab G26 InstrumentSummary page 3…J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) numbet(s): Immunofixation Electrophoresis Test using Interlab 626 instrument (k103757) 2. Comparison with Dredicate: Predicate G26 ver.1 G26 ver.… | 2011 |
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. 2012, 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 Immunofixation Electrophoresis (IFE) Test using Interlab G 26 v2.0 instrument is for the qualitative in vitro.diagnostic separation and identification of immunoglobulins (lgG, IgA and 1gM), and kappa and lambda chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.
The Interlab IFE kits 2, 4, and 6 samples per gel, are intended to be used with the automated Interlab G26 vi1.0 and v2.0 electrophoresis analyzers in conjunction with the Easy Mask antisera application device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120169: Interlab Ife Test Using G 26 Ver. 2.0 Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120169
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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