# K152013: QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 11, 2016 after 265 days
- Product code: LSW (Anti-Dna 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 K993727 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993727: Bindazyme Anti-Dsdna Eia Kit, The Binding Site, Ltd. (1999) Summary page 7.

## Most influential descendants
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own

## Indications for use
QUANTA Flash dsDNA is a chemiluminescent immunoassay for the quantitative determination of IgG anti-double stranded deoxyribonucleic acid (dsDNA) antibodies in human serum. The presence of anti-dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus. QUANTA Flash dsDNA Calibrators are intended for use with the QUANTA Flash dsDNA chemiluminescent immunoassay for the determination of IgG anti-dsDNA antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash dsDNA Controls are intended for use with the QUANTA Flash dsDNA chemiluminescent immunoassay for quality control in the determination of IgG anti-dsDNA antibodies in human serum.

Source page: https://510kreport.com/device/K152013
Methodology: https://510kreport.com/methodology