510(k) · Cleared
ClearedImage-Immunochemistry System Urine Immunoglobulin
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 Mar 6, 1997 as substantially equivalent to K951635 (Beckman Instruments, Inc., 1995) after a 155-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Mar 6, 1997
- Review
- 155 days
- Class
- Class II
- Product code
- DEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951635 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951635 Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine…Beckman Instruments, Inc. · 1995
- This deviceK963974 Image-Immunochemistry System Urine ImmunoglobulinBeckman Instruments, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
Most influential descendants
Showing 2 of 2 · See all- K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · cites it directly1descendant
- K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951635 | Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein… | Beckman Instruments, Inc. | 1995 | — |
| 0 (this device) | K963974 | Image-Immunochemistry System Urine Immunoglobulin | Beckman Instruments, Inc. | 1997 | — |
| +1 | K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control… | Siemens Healthcare Diagnostics | 2009 | 2 |
| +2 | K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K951635 | Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator…Summary page 1…Immunoglobulins A, G, M, D, and E immunological test system (21 CFR § 866.5510) 40 Predicate Device(s): Beckman Immunogiobulin G (IGG) Test System (Urine application) K951635 50 Description: The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in conjunction with Beckman's Urine Pro… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC | 2009 | 1 |
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?
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 Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of Immunoglobulin G in urine 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/K963974 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963974: Image-Immunochemistry System Urine Immunoglobulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963974
Report an extraction error
Are you the manufacturer?
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