# K020414: Quanta Lite CCP Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 29, 2002 after 81 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The QUANTA Lite™ CCP IgG ELISA is a semi-quantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP (Cyclic Citrullinated Peptide) antibodies in patient sera. The presence of these antibadies, 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/K020414
Methodology: https://510kreport.com/methodology