# K122923: Quanta Flash ENA7

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: May 7, 2013 after 225 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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
QUANTA Flash ENA7 is a chemiluminescent immunoassay for the qualitative screening of IgG autoantibodies to Sm, RNP, Ro6O (SS-A), RoS2/TRIM2i, SS-B3 (La), Scl-70 (topoisomerase 1) and Jo-i in human serum. The presence of these autoantilbodies is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), pofymyositis (PM), dlermatomyositis (DM), siogren's syndrome (SjS) and mixed connective tissue disease (MaTD) in conjunction with clinical findings and other laboratory tests. QUANTA Flash. ENA7 Calibrators are intended for use with the QUANTA Flash ENA7 Reagents for the determination of IgO autoantibodies to Sm, RNP, Ro6O (SS-A), Ro52/TRIM21, S5-B3 (La), Scl-70 (topoisomerase 1)and Jo-i in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values. QUANTA Flash ENA7 Controls are intended for use with the QUANTA Flash ENA7 Reagents for quality control in the determination of lgG autoantibodies to Sm, RNP, Ro6O (55-A), Ro52/TRIM21, 55-83 (La), Scl-70 (topoisomerase 1)and Jo-i in human serum.

Source page: https://510kreport.com/device/K122923
Methodology: https://510kreport.com/methodology