# K993636: Mdi SS-a Test

- Pathway: 510(k) (Traditional)
- Applicant: Micro Detect, Inc.
- Decided: Jan 10, 2000 after 75 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The MDI SS-A Test is a semi-quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto-antibodies against human SS-A in human serum. The test is intended as an aid in the diagnosis of rtheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

Source page: https://510kreport.com/device/K993636
Methodology: https://510kreport.com/methodology