510(k) · Cleared
Recalled · 2011Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF Calibrator
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 Jun 3, 1997 as substantially equivalent to K963048 (Beckman Instruments, Inc., 1996) after a 20-day review. Its family tree reaches back 2 generations to 1994. It has been recalled 2 times.
- Decided
- Jun 3, 1997
- Review
- 20 days
- Class
- Class II
- Product code
- DHR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942328 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK942328 N Latex RFBehring Diagnostics, Inc. · 1994
- 1 generation backK963048 Immage System Rheumatoid Factor (RF) ReagentBeckman Instruments, Inc. · 1996 · Recalled
- This deviceK971788 Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems…Beckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942328 | N Latex RF | Behring Diagnostics, Inc. | 1994 | — |
| −1 | K963048 | Immage System Rheumatoid Factor (RF) Reagent | Beckman Instruments, Inc. | 1996 | 2 |
| 0 (this device) | K971788 | Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF… | 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 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 |
|---|---|---|---|
| * | K963048 | Immage System Rheumatoid Factor (RF) Reagent Our OCR of the scanned summary read K963043, FDA’s number for Endospot (Corin USA). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “IMMAGE Immunochemistry System Rheumatoid Factor (RF) Reagent Test…”. | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2011 | Not classified | Z-1194-2012 | Nonconforming Material/Component | The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures. |
| Jun 21, 2010 | Not classified | Z-1743-2011 | Other | The recall was initiated because Beckman Coulter testing indicated that Rheumatoid Factor (RF) reagent lot M907325 will not remain stable to the labeled expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K963048.
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 SYNCHRON® Systems Rheumatoid Factor (RF) Reagent , in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma.
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/K971788 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971788: Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971788
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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