# K141655: Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Mar 5, 2015 after 258 days
- Product code: OBE (Anti-Ss-A 52 Autoantibodies)
- 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
Longest line of descent: 1 generation back to K063565 (2007). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063565: Quanta Lite SS-a 52 Elisa, Inova Diagnostics, Inc. (2007) Summary page 6.

## Most influential descendants
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own
- K210902: EliA Ro52, EliA Ro60 (2022), 0 descendants of its own

## Indications for use
QUANTA Flash Ro52 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of anti-Ro52 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus, Sjögren’s Syndrome, Systemic Sclerosis, Idiopathic Inflammatory Myopathies. QUANTA Flash Ro52 Controls are intended for use with the QUANTA Flash Ro52 Reagents for quality control in the determination of IgG anti-Ro52 autoantibodies in human serum. QUANTA Flash Ro52 Calibrators are intended for use with the QUANTA Flash Ro52 Reagents for the determination of IgG anti-Ro52 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

Source page: https://510kreport.com/device/K141655
Methodology: https://510kreport.com/methodology