510(k) · Cleared
Recalled · Class II · 2012Immage System Rheumatoid Factor (RF) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DHR System, Test, Rheumatoid Factor
Cleared on Nov 4, 1996 as substantially equivalent to K942328 (Behring Diagnostics, Inc., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 4, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- DHR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942328 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942328 N Latex RFBehring Diagnostics, Inc. · 1994
- This deviceK963048 Immage System Rheumatoid Factor (RF) ReagentBeckman Instruments, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK971602 Array Systems Rheumatoid Factor (Rfmpe) ReagentBeckman Instruments, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK971788 Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems…Beckman Instruments, Inc. · 1997 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942328 | N Latex RF | Behring Diagnostics, Inc. | 1994 | — |
| 0 (this device) | K963048 | Immage System Rheumatoid Factor (RF) Reagent | Beckman Instruments, Inc. | 1996 | — |
| +1 | K971602 | Array Systems Rheumatoid Factor (Rfmpe) Reagent | Beckman Instruments, Inc. | 1997 | — |
| +1 | K971788 | Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF… | Beckman Instruments, Inc. | 1997 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 DHR? 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 |
|---|---|---|---|
| * | K942328 | N Latex RFSummary page 1…matoid Factor (RF) Reagent 3.2 Classification Names Rheumatoid factor immunological test system(21 CFR 866.5775) Predicate Device(s): Behring Diagnostics N Latex RF, K942328 PEE—— Description: The IMMAGE Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on the IMMAGE Immunoch… | 1994 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Jan 27, 2012 | Class II | Z-0003-2013 | Nonconforming Material/Component | The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF… |
| May 31, 2011 | Not classified | Z-2887-2011 | Pending | The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHR
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · DHR
Too few DHR 510(k)s in any year since 2007 to give a median.
Recalls per year · DHR
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHR
2in 2025
MAUDE reports naming product code DHR, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 19 |
| 2011 | 1 | — | 3 | 400 |
| 2012 | 0 | — | 2 | 91 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 2 | 1 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
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/K963048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963048: Immage System Rheumatoid Factor (RF) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963048
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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