DIASTAT ANTI-RO (SS-A)— 510(k) K905194

Clearance details

Applicant

Shield Diagnostics, Ltd.

Product code

Code LKO

Device class

Class 2

Regulation

21 CFR 866.5100

Advisory panel

Immunology

Date received

1990-11-19

Decision date

1990-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Scotland, KN

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• Z-2919-2018 — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.Class III·Terminated·Euro Diagnostica AB·20161021

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K905194.