510(k) · Cleared
ClearedBeckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr
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. 3 later devices descend from it.
- Decided
- Feb 1, 2000
- Review
- 105 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771603 (1977). 3 ancestors in all. 3 later devices descend from it, 3 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 deviceK993549 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK183151 Optilite IgA CSF KitThe Binding Site Group, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK060130 Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK024038 N Latex IgaDade Behring, Inc. · 2003
Most influential descendants
Showing 3 of 3 · 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) | K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | — |
| +1 | K183151 | Optilite IgA CSF Kit | The Binding Site Group, Ltd. | 2019 | — |
| +1 | K060130 | Immage Systems Low Concentration Immunoglobulin a Reagent | Beckman Coulter, Inc. | 2006 | — |
| +1 | K024038 | N Latex Iga | Dade Behring, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2019 | 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…ice(s): ~ IMMAGE System Serum Predicate ‘Manufacturer | Docket Number J IMMAGE System Low MM it —] Concentration mmunochemistry Immunoglobulin A (IGALC) System . Beckman K963868 Reagent Immunoglobulin A Instruments, | ~€ag (IGA) Reagent Inc. Cerebrospinal Fluid Protein Calibrator 'CSF Predicate | Manufactu… | 1997 |
| * | K952309 | N Latex IgaSummary page 1…ent Immunoglobulin A Instruments, | ~€ag (IGA) Reagent Inc. Cerebrospinal Fluid Protein Calibrator 'CSF Predicate | Manufacturer | Docket Ni N Latex IgA Reagents Behring K952309 Diagnostics, Inc* *Westwood, MA 02090 5.0 Description: The IMMAGE® Low Concentration Immunogiobulin A (IGALC) Reagent and Cerebro… | 1995 |
What descends from it? (3)
3 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)
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 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, K183151 (The Binding Site Group, Ltd., 2019) 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 A (IGALC) 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 A 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/K993549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993549: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993549
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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