# K853872: Emit Caffeine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jun 13, 1986 after 269 days
- Product code: KLS (Enzyme Immunoassay, Theophylline)
- Device class: 2
- Regulation: 21 CFR 862.3880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042520: Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and Iii (2004), 0 descendants of its own
- K042407: Emit Caffeine Assay (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K853872
Methodology: https://510kreport.com/methodology