# K123880: Quanta Flash Centromere

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Feb 7, 2014 after 417 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own

## Indications for use
QUANTA Flash Centromere is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-centromere protein B autoantibodies in human serum. 'Me presence of anti-centromere protein B autoantibodies is used as an aid in the diagnosis Systemic Sclerosis, in conjunction with clinical finding and other laboratory tests. QUANTA Flash Centromnere Calibrators are intended for use with the QUANTA Flash Centroniere Reagents for the determination of lgG axti-Centromere autoantibodies in human serumn. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values. QUANTA Flash Centromere Controls are intended for use with the QUANTA Flash Centromere Reagents for quality control in the determination of lgG anti-centromere protein B autoantibodies in human serum.

Source page: https://510kreport.com/device/K123880
Methodology: https://510kreport.com/methodology