# K141328: Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Feb 12, 2015 after 267 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
Longest line of descent: 1 generation back to K962719 (1997). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962719: Hycor HY.Tec/Manual SS-a Auto-Antibody, Hycor Biomedical, Inc. (1997) Summary page 6.

## Most influential descendants
- K253817: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La (2026), 0 descendants of its own
- 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 Ro60 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro60 autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren’s Syndrome. QUANTA Flash Ro60 Calibrators are intended for use with the QUANTA Flash Ro60 Reagents for the determination of IgG anti-Ro60 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash Ro60 Controls are intended for use with the QUANTA Flash Ro60 reagents for quality control in the determination of IgG anti-Ro60 autoantibodies in human serum.

Source page: https://510kreport.com/device/K141328
Methodology: https://510kreport.com/methodology