510(k) · Cleared
ClearedOlympus Igg Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Feb 11, 2008 as substantially equivalent to K951013 (Olympus America, Inc., 1995) and 1 other predicate after a 61-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Feb 11, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943997 (1994). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK943997 Behring Nephelometer IIBehring Diagnostics, Inc. · 1994
- 1 generation backK050113 Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
- This deviceK073490 Olympus Igg ReagentOlympus America, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK162208 DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK221114 Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G…Horiba Abx Sas · 2020
Most influential descendants
Showing 3 of 3 · See all- K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017 · cites it directly1descendant
- K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · 2 generations on0descendants
- K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943997 | Behring Nephelometer II | Behring Diagnostics, Inc. | 1994 | — |
| −1 | K050113 | Tina-Quant Igg Gen.2 | Roche Diagnostics Corp. | 2005 | — |
| 0 (this device) | K073490 | Olympus Igg Reagent | Olympus America, Inc. | 2008 | — |
| +1 | K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017 | — |
| +2 | K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023 | — |
| +1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K951013 | Olympus Igg Immunoturbidimetric ReagentSummary page 1…ontrol Serum/Plasma Olympus (OSR6145) IgG Reagent 3. Predicate device(s) Applications Submitted (K951013) CSF Application Roche Tina-Quant IgG GEN.2… | 1995 |
| * | K050113 | Tina-Quant Igg Gen.2Summary page 1…K951013) CSF Application Roche Tina-Quant IgG GEN.2 Submitted (K050113) 4. Device description In this Olympus procedure: * When a sample is mixed… | 2005 |
What descends from it? (3)
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)
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 14 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162208 (Beckman Coulter, Inc., 2017) has gone furthest, with 1 descendant of its own.
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. 2008, 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 OLYMPUS analyzers.
The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073490 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073490: Olympus Igg Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073490
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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