510(k) · Cleared
ClearedYumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx Sas · CZP Iga, Antigen, Antiserum, Control
Cleared on Jun 26, 2020 as substantially equivalent to K073489 (Olympus America, Inc., 2008) and 2 other predicates after a 190-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 26, 2020
- Review
- 190 days
- Class
- Class II
- Product code
- CZP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K943997 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK943997 Behring Nephelometer IIBehring Diagnostics, Inc. · 1994
- 2 generations backK050113 Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
- 1 generation backK073490 Olympus Igg ReagentOlympus America, Inc. · 2008
- This deviceK193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G…Horiba Abx Sas · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943997 | Behring Nephelometer II | Behring Diagnostics, Inc. | 1994 | — |
| −2 | K050113 | Tina-Quant Igg Gen.2 | Roche Diagnostics Corp. | 2005 | — |
| −1 | K073490 | Olympus Igg Reagent | Olympus America, Inc. | 2008 | — |
| 0 (this device) | K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200… | Horiba Abx Sas | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 2008 | 2 | 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 CZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K073489 | Olympus Iga ReagentSummary page 7…number Olympus IgA reagent K073489 Yumizen C1200 (OSR6X171) BECKMAN COULTER Immunoglobulin A… | 2008 |
| * | K073490 | Olympus Igg ReagentSummary page 7…Immunoglobulin A Olympus IgG reagent Yumizen C1200 (OSR6X172) BECKMAN COULTER K073490 Immunoglobulin G Olympus IgM reagent Yumizen C1200 (OSR6X173)… | 2008 |
| * | K073487 | Olympus Igm ReagentSummary page 7…Immunoglobulin G Olympus IgM reagent Yumizen C1200 (OSR6X173) BECKMAN COULTER K073487 Immunoglobulin M The following tables show the similarities and differences and demonstrates substantial equivalence between t… | 2008 |
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 26 years and passes through 4 companies; a new generation was cleared every 10.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All CZP devicesCZP Iga, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · CZP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CZP
Too few CZP 510(k)s in any year since 2007 to give a median.
Recalls per year · CZP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CZP
1in 2025
MAUDE reports naming product code CZP, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Yumizen C 1200 Immunoglobulin A reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin A (IgA) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.This test should be used in conjunction with other laboratory and clinical findings. Yumizen C1200…
Read the full statement (188 words)
Yumizen C 1200 Immunoglobulin A reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin A (IgA) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.This test should be used in conjunction with other laboratory and clinical findings.
Yumizen C1200 Immunoglobulin G reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin G (IgG) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.This test should be used in conjunction with other laboratory and clinical findings.
Yumizen Cl200Immunoglobulin M reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin M (IgM) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
This test should be used in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193525: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193525
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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