510(k) · Cleared
ClearedVitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · CZW Complement C3, Antigen, Antiserum, Control
Cleared on Oct 19, 2004 as substantially equivalent to K964842 (Beckman Instruments, Inc., 1997) and 2 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Oct 19, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- CZW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K771603 (1977). 7 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 deviceK042494 Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20…Ortho-Clinical Diagnostics · 2004
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) | K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein… | Ortho-Clinical Diagnostics | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 7…lement C3 Reagent assayed on the Beckman IMMAGE® Immunochemistry System (predicate device #1) which was cleared by the FDA (K964842) for LVD use. Continued on next… | 1997 |
| * | K860894 | Behring Nephelometer SystemSummary page 8…Human Complement C4 assayed on the Dade Behring BN " ProSpec Nephelometer (predicate device #2) which was cleared by the FDA (K860894) for IVD use. The relationship between the VITROS C4 assay and the predicate device,… | 1986 |
| * | K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Summary page 10…substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K041720) for IVD use. Table 3 Table 3 lists the similarities and differences of the device characteristics between the… | 2004 |
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 27 years and passes through 2 companies; a new generation was cleared every 19.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 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?
For in vitro diagnostic use only. VITROS Chemistry Products C3 Reagent is used to quantitatively measure complement C3 (C3) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the…
Read the full statement (222 words)
For in vitro diagnostic use only. VITROS Chemistry Products C3 Reagent is used to quantitatively measure complement C3 (C3) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.
For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products C4 Reagent is used to quantitatively measure complement C4 (C4) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.
For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems.
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/K042494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042494: Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042494
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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