510(k) · Cleared
Recalled · Class II · 2018C3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CZW Complement C3, Antigen, Antiserum, Control
Cleared on Nov 4, 1998 as substantially equivalent to K964298 (Crestat Diagnostics, Inc., 1997) after a 35-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Nov 4, 1998
- Review
- 35 days
- Class
- Class II
- Product code
- CZW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964298 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964298 N-Assay Tia Multi V-NLCrestat Diagnostics, Inc. · 1997
- This deviceK983441 C3Abbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964298 | N-Assay Tia Multi V-NL | Crestat Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K983441 | C3 | Abbott Laboratories | 1998 | — |
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? (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 |
|---|---|---|---|
| * | K964298 | N-Assay Tia Multi V-NLSummary page 2…C3 510(k) Section II September 29, 1998 Page 1 C3 Viiwp 0000011 Substantial Equivalence: The C3 assay is substantially equivalent to the K-ASSAY® C3 (K964298/S3) on the Hitachi® 717 Analyzer. Both assays yield similar Performance Characteristics. Similarities: « Both assays are in vi… | 1997 |
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 |
|---|---|---|---|---|
| May 16, 2018 | Class II | Z-1987-2019 | Under Investigation by firm | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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?
The C3 assay is used for the quantitation of C3 in human serum or plasma.
Complement is a group of serum proteins which destroy infectious agents.
Measurements of these proteins aids in the diagnosis of immunologic disorders,
especially those associated with deficiencies of complement components.
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/K983441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983441: C3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983441
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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