510(k) · Cleared
ClearedSynchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX Systems Cali
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CZW Complement C3, Antigen, Antiserum, Control
Cleared on Aug 7, 2003 as substantially equivalent to K964842 (Beckman Instruments, Inc., 1997) and 2 other predicates after a 37-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Aug 7, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- CZW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K771603 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
- 1 generation backK964842 Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4…Beckman Instruments, Inc. · 1997
- This deviceK032035 Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems…Beckman Coulter, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771603 | Immochemistry System | Beckman Instruments, Inc. | 1977 | — |
| −1 | K964842 | Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent | Beckman Instruments, Inc. | 1997 | — |
| 0 (this device) | K032035 | Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement… | Beckman Coulter, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 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 CZW? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964842 | Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentSummary page 1…Number LX Systems c 3 Beckman IMMAGE Complement C3 Beckman K964842 and C4 Reagent and C4 Reagents Coulter I IL LXCALI Beckman… | 1997 |
| * | K771603 | Immochemistry SystemSummary page 1…librator 1 Beckman Coulter I K771603 K791341 I… | 1977 |
| * | K791341 | Human Alpha, Acid GlycoproteinSummary page 1…Coulter I K771603 K791341 I 11 *Beckman Coulter, Inc… | 1979 |
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?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 19.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K964842.
How does its category compare?
All CZW devicesCZW Complement C3, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CZW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CZW
Too few CZW 510(k)s in any year since 2007 to give a median.
Recalls per year · CZW
No recall names CZW since 2007.
Adverse event reports per year · CZW
2in 2024
MAUDE reports naming product code CZW, 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 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 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 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
C3 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry.
C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry.
The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032035: Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX Systems Cali.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032035
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