510(k) · Cleared
Recalled · Class II · 2024Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DEW Igg, Antigen, Antiserum, Control
Cleared on Feb 10, 1997 as substantially equivalent to K771603 (Beckman Instruments, Inc., 1977) after a 137-day review. Its family tree reaches back 1 generation to 1977. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 10, 1997
- Review
- 137 days
- Class
- Class II
- Product code
- DEW
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K771603 (1977). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
- This deviceK963868 Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M…Beckman Instruments, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK993549 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK993547 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 0 of its ownK183151 Optilite IgA CSF KitThe Binding Site Group, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK130122 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK060130 Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc. · 2006
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K993549Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…Beckman Coulter, Inc. · 2000 · cites it directly3descendants
- K993547Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc)…Beckman Coulter, Inc. · 2000 · cites it directly2descendants
- K183151Optilite IgA CSF KitThe Binding Site Group, Ltd. · 2019 · 2 generations on0descendants
- K130122Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman…Beckman Coulter, Inc. · 2014 · 2 generations on0descendants
- K060130Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771603 | Immochemistry System | Beckman Instruments, Inc. | 1977 | — |
| 0 (this device) | K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) | Beckman Instruments, Inc. | 1997 | — |
| +1 | K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | — |
| +1 | K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | 1 |
| +2 | K183151 | Optilite IgA CSF Kit | The Binding Site Group, Ltd. | 2019 | — |
| +2 | K130122 | Beckman Coulter Immage Immunochemistry System Low Concentration… | Beckman Coulter, Inc. | 2014 | — |
| +2 | K060130 | Immage Systems Low Concentration Immunoglobulin a Reagent | Beckman Coulter, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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 DEW? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K771803 | FDA’s K771803 is Aca Phosphorus Calibrator Our OCR of the scanned summary read K771803, FDA’s number for Aca Phosphorus Calibrator (E.I. Dupont DE Nemours & Co., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Immunoglobulin G Reagent”. Kept off the family tree. Summary page 1…tem (21 CFR §866.5510) Immunoglobulin M Test System (21 CFR §866.5510) Immunoglobulin G Immunochemistry Beckman Instruments, (IGG) Reagent Systems Inc. immunoglobulin G K771803 Reagent | in A Immunochemistry mmuuoglobu in 3ystems (IGA) Reagent immunoglobulin A peckman Instruments. | k771608 Reagent ) Immu… | 1977 |
| Kept off the family tree | K771608 | FDA’s K771608 is A-Gent Triglycerides Our OCR of the scanned summary read K771608, FDA’s number for A-Gent Triglycerides (Abbott Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “Immunoglobulin A Reagent”. Kept off the family tree. Summary page 1…struments, (IGG) Reagent Systems Inc. immunoglobulin G K771803 Reagent | in A Immunochemistry mmuuoglobu in 3ystems (IGA) Reagent immunoglobulin A peckman Instruments. | k771608 Reagent ) Immunochemistry i Systems Beckman Instru Immunoglobulin M Immunoglobulin M Inc n Instruments, (IGM) Reagent Reagent - K… | 1977 |
| * | K771603 | Immochemistry SystemSummary page 1…globulin A peckman Instruments. | k771608 Reagent ) Immunochemistry i Systems Beckman Instru Immunoglobulin M Immunoglobulin M Inc n Instruments, (IGM) Reagent Reagent - K771603 Becliman Instruments, Inc. twx: 910-592-1260 o telex: 06-78413 Beckman Instruments, Inc., Section 510(k) Notifi… | 1977 |
What descends from it? (7)
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 |
|---|---|---|---|---|
| Jul 31, 2024 | Class II | Z-0118-2025 | Employee error | Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU |
| Jun 6, 2003 | Not classified | Z-1150-04 | Other | low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DEW devicesDEW Igg, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DEW
FDA has decided no DEW device since 2007.
Median 510(k) review, days · DEW
Too few DEW 510(k)s in any year since 2007 to give a median.
Recalls per year · DEW
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEW
4in 2024
MAUDE reports naming product code DEW, 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 | 4 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 1 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry. The IMMAGE immunochemistry System immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative…
Read the full statement (102 words)
The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.
The IMMAGE immunochemistry System immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.
The IMMAGE immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin M 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/K963868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963868: Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963868
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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