# K011605: Emit 2000 Quinidine Assay, Model OSR4Q229

- Pathway: 510(k) (Special)
- Applicant: Syva Co., Dade Behring, Inc.
- Decided: Jun 12, 2001 after 19 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. The FDA summary names its predicate without a number.
- (no number) Emit® 2000 Quinidine Assay: named in the summary without a submission number

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2976-2026: 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

## Indications for use
The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

Source page: https://510kreport.com/device/K011605
Methodology: https://510kreport.com/methodology