# K922913: Emit 2000 Quindine Assay Quididine Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Aug 24, 1992 after 68 days
- Product code: LBZ (Enzyme Immunoassay, Quinidine)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2975-2026: Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patien

Source page: https://510kreport.com/device/K922913
Methodology: https://510kreport.com/methodology