510(k) · Cleared
ClearedImmunoglobulin G (IgG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Aug 2, 2023 as substantially equivalent to K162208 (Beckman Coulter, Inc., 2017) after a 474-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Aug 2, 2023
- Review
- 474 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943997 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK943997 Behring Nephelometer IIBehring Diagnostics, Inc. · 1994
- 3 generations backK050113 Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
- 2 generations backK073490 Olympus Igg ReagentOlympus America, Inc. · 2008
- 1 generation backK162208 DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017
- This deviceK221114 Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943997 | Behring Nephelometer II | Behring Diagnostics, Inc. | 1994 | — |
| −3 | K050113 | Tina-Quant Igg Gen.2 | Roche Diagnostics Corp. | 2005 | — |
| −2 | K073490 | Olympus Igg Reagent | Olympus America, Inc. | 2008 | — |
| −1 | K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017 | — |
| 0 (this device) | K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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
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 |
|---|---|---|---|
| * | K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentSummary page 4…mber: 21 CFR §866.5510 4.0 Predicate Device Candidate Predicate Manufacturer IgG Reagent IgG Reagent (K162208) Beckman Coulter, Inc. 5.0 Device Description The device consists of two reagents: R1 buffer (Tris buffer pH 7.2, p… | 2017 |
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 29 years and passes through 5 companies; a new generation was cleared every 8.9 years on median.
- None of the 5 ancestors has a recall.
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. 2023, 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?
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221114: Immunoglobulin G (IgG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221114
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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