510(k) · Cleared
Recalled · 2003Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb
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 Feb 1, 2000 as substantially equivalent to K963868 (Beckman Instruments, Inc., 1997) and 1 other predicate after a 105-day review. Its family tree reaches back 2 generations to 1977. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2000
- Review
- 105 days
- Class
- Class II
- Product code
- CFN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771603 (1977). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
- 1 generation backK963868 Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M…Beckman Instruments, Inc. · 1997 · Recalled
- This deviceK993547 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK130122 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK032014 N Latex IgmDade Behring, Inc. · 2003 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771603 | Immochemistry System | Beckman Instruments, Inc. | 1977 | — |
| −1 | K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) | Beckman Instruments, Inc. | 1997 | 2 |
| 0 (this device) | K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | — |
| +1 | K130122 | Beckman Coulter Immage Immunochemistry System Low Concentration… | Beckman Coulter, Inc. | 2014 | — |
| +1 | K032014 | N Latex Igm | Dade Behring, Inc. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)Summary page 1…tnc Immunoglobulins (G, A, M) (21 CFR §866.5510) i Devi 40 IMMAGE System Serum Predicate Manufacturer | Docket Number | IMMAGE System Low Concentration | IMMAGE Beckman K963868 Immunoglobulin M | Immunochemistry Instruments, (IGMLC) Reagent Systems Inc. Cerebrospinal Fluid | Immunogiobulin M Protein Cali… | 1997 |
| * | K823884 | Paragon Immunoelectrophoresis ReagentSummary page 1…s Inc. Cerebrospinal Fluid | Immunogiobulin M Protein Calibrator (IGM) Reagent CSF Predicate Manufacturer | Docket: Number Paragon® Beckman Immunofixation Instruments, K823884 Electrophoresis Reagent | Inc. 5.0 Description: The IMMAGE® Low Concentration Immunoglobulin M (IGMLC) Reagent and Cerebrospin… | 1983 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2003 | Not classified | Z-1146-04 | Other | Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid). |
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 19.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K130122 (Beckman Coulter, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K963868.
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.
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?
The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin M in serum and cerebrospinal fluid by rate nephelometry.
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/K993547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993547: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993547
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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