# K141210: Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B Controls

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jan 29, 2015 after 265 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 K922832 (1992). 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)
- K922832: Quanta Lite SS-B Elisa, Inova Diagnostics, Inc. (1992) 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

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

Source page: https://510kreport.com/device/K141210
Methodology: https://510kreport.com/methodology