# K962199: Quantex C3

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 25, 1996 after 110 days
- Product code: CZW (Complement C3, 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 K920007 (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)
- K920007: IL Test Complement 3, Instrumentation Laboratory CO (1992) Summary page 1.

## Indications for use
This product permts the quantitative in vitro diagnostic determination of Complement 3 in serum and plasma on the [Lab Clinical Chemistry System by turbidimetric immunoassay method. C3 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 C3.

Source page: https://510kreport.com/device/K962199
Methodology: https://510kreport.com/methodology