# K984479: Liquichek Anti-SM Control, Eia, Model 208

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 22, 1998 after 6 days
- Product code: LKP (Anti-Sm 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 K954723 (1995). 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)
- K954723: Enzyme Immunoassay Ana Screening Test Kit, Helix Diagnostics, Inc. (1995). Our OCR of the scanned summary read K854723, FDA’s number for SKD Electrochemical System (Ecs) (Smithkline Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit”.

## Most influential descendants
- K024219: Liquichek Anti-SM Control, Positive, Catalog #115 (2003), 0 descendants of its own

## Indications for use
Liquichek Anti-Sm Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Smith (Sm) autoantibodies.

Source page: https://510kreport.com/device/K984479
Methodology: https://510kreport.com/methodology