# K253817: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostics Systems Limited
- Decided: Aug 21, 2026 after 266 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: 2 generations back to K922832 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962054: Orgentec Anti-SS-a (RO) Elisa, American Laboratory Products Co., Ltd. (1996) Summary page 6.
- K141328: Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls, Inova Diagnostics, Inc. (2015) Summary page 14.
- K141210: Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B Controls, Inova Diagnostics, Inc. (2015) Summary page 22.

## Indications for use
The IDS SS-A/Ro test is an automated in vitro diagnostic device intended for the semi-quantitative determination of SS-A/Ro (52 kDa and 60 kDa) IgG autoantibodies in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome (SjS), and Systemic Sclerosis (SSc). The IDS SS-A/Ro 60 kDa test is an automated in vitro diagnostic device intended for the semi-quantitative determination of SS-A/Ro 60 kDa IgG antibodies in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE), and Sjögren’s Syndrome (SjS). The IDS SS-B/La test is an automated in vitro diagnostic device intended for the semi-quantitative determination of the SS-B/La IgG autoantibodies in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the in the diagnosis of Systemic Lupus Erythematosus (SLE), and Sjögren’s Syndrome (SjS).

Source page: https://510kreport.com/device/K253817
Methodology: https://510kreport.com/methodology