# K962198: Quantex C4

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 26, 1996 after 111 days
- Product code: DBI (Complement C4, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920010 (1992). 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)
- K920010: IL Test Complement 4, Instrumentation Laboratory CO (1992) Summary page 1.

## Indications for use
This product permits the quantitative in vitro diagnostic determination of Complement 4 in serum and plasma on the [Lab Clinical Chemistry System by turbidimetric immunoassay method. C4 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C4.

Source page: https://510kreport.com/device/K962198
Methodology: https://510kreport.com/methodology