# K983356: C4

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 4, 1998 after 41 days
- Product code: DBI (Complement C4, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964297 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964297: N-Assay Tia C4 Test Kit, Crestat Diagnostics, Inc. (1997) Summary page 1.

## Recalls of this device
- May 16, 2018 · Class II · Z-1992-2019: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K983356
Methodology: https://510kreport.com/methodology