510(k) · Cleared
Recalled · Class II · 2018C4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DBI Complement C4, Antigen, Antiserum, Control
Cleared on Nov 4, 1998 as substantially equivalent to K964297 (Crestat Diagnostics, Inc., 1997) after a 41-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Nov 4, 1998
- Review
- 41 days
- Class
- Class II
- Product code
- DBI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964297 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964297 N-Assay Tia C4 Test KitCrestat Diagnostics, Inc. · 1997
- This deviceK983356 C4Abbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964297 | N-Assay Tia C4 Test Kit | Crestat Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K983356 | C4 | 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 DBI? 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 |
|---|---|---|---|
| * | K964297 | N-Assay Tia C4 Test KitSummary page 1…ity at 604 nm, which correlates with the concentration of C4 in the sample. Substantial Equivalence: The C4 assay is substantially equivalent to the K-ASSAY C4 assay (K964297/S3) on the Hitachi® 717 Analyzer. C4 510(k) Section II September 23, 1998 Page 1 00000314 Both assays yield sim… | 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-1992-2019 | 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 DBI devicesDBI Complement C4, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBI
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DBI
Too few DBI 510(k)s in any year since 2007 to give a median.
Recalls per year · DBI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBI
1in 2024
MAUDE reports naming product code DBI, 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 | 0 | — | 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 | 0 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The C4 assay is used for the quantitation of C4 in human serum or plasma.
Complement is a group of serum proteins which destroy infectious agents.
Measurement 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/K983356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983356: C4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983356
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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