510(k) · Cleared
ClearedBeckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Jan 7, 2014 as substantially equivalent to K993547 (Beckman Coulter, Inc., 2000) after a 355-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Jan 7, 2014
- Review
- 355 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771603 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
- 2 generations backK963868 Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M…Beckman Instruments, Inc. · 1997 · Recalled
- 1 generation backK993547 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000 · Recalled
- This deviceK130122 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771603 | Immochemistry System | Beckman Instruments, Inc. | 1977 | — |
| −2 | K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) | Beckman Instruments, Inc. | 1997 | 2 |
| −1 | K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | 1 |
| 0 (this device) | K130122 | Beckman Coulter Immage Immunochemistry System Low Concentration… | Beckman Coulter, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 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 CFN? 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 CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc)…Summary page 4…0.53% 3.28% Conclusion: As summarized, the modification to the IMMAGE IGMLC Reagent is substantially equivalent to the originally cleared product (K993547). Substantial equivalence has been demonstrated through performance to verify that the device functions as intended and that desi… | 2000 |
| * | — | Beckman Coulter Cerebrospinal Fluid Protein Calibrator (CSF CAL) Named without a submission number | |
| † | K962294 | Immage Immunochemistry System | 1996 |
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 37 years and passes through 2 companies; a new generation was cleared every 13.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K993547.
How does its category compare?
All CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, 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 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IMMAGE Immunochemistry Systems IGMLC Reagent when used in conjunction with IMMAGE Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Immunoglobulin M (IGMLC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.
CSF Cal (Cerebrospinal Fluid Protein Calibrator), when used in conjunction with Beckman Coulter Low Concentration Immunoglobulin A (IGALC) and Low Concentration Immunoglobulin M (IGMLC) reagents is intended for use on Immage for the calibration of these reagents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130122: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130122
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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