# K052264: Quanta Lite CCP3 Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Nov 23, 2005 after 96 days
- Product code: NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp))
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143754: QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (2015), 0 descendants of its own
- K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform (2009), 0 descendants of its own

## Indications for use
The QUANTA LiteTM CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K052264
Methodology: https://510kreport.com/methodology