510(k) · Cleared
ClearedImmage Immunochemistry System Alpha-1-Microglobulin (AI) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control
Cleared on Apr 21, 1997 as substantially equivalent to K933078 (Beckman Instruments, Inc., 1994) after a 125-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 21, 1997
- Review
- 125 days
- Class
- Class I
- Product code
- MGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933078 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK933078 Beckman Alpha-1-Microglobulin (A1M) ReagentBeckman Instruments, Inc. · 1994
- This deviceK965033 Immage Immunochemistry System Alpha-1-Microglobulin (AI) ReagentBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933078 | Beckman Alpha-1-Microglobulin (A1M) Reagent | Beckman Instruments, Inc. | 1994 | — |
| 0 (this device) | K965033 | Immage Immunochemistry System Alpha-1-Microglobulin (AI) Reagent | Beckman Instruments, Inc. | 1997 | — |
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 MGA? 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 |
|---|---|---|---|
| * | K933078 | Beckman Alpha-1-Microglobulin (A1M) ReagentSummary page 1…MAGE ™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent — 3.2 Classification Name Not classified 4.0 IMMAGE System Beckman Alpha-1- Beckman Instruments, | K933078 . " i lin A1M inc. Alpha-1-Microgiobutin | Microglobu (A1M) Reagent Reagent Beckman Instruments, Inc. twx: 910-592-1260 » tel… | 1994 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K933078.
How does its category compare?
All MGA devicesMGA Alpha-1 Microglobulin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGA
FDA has decided no MGA device since 2007.
Median 510(k) review, days · MGA
Too few MGA 510(k)s in any year since 2007 to give a median.
Recalls per year · MGA
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGA
No MAUDE report names MGA since 2007.
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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of of alpha-1-microglobulin 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/K965033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965033: Immage Immunochemistry System Alpha-1-Microglobulin (AI) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965033
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