# K011528: Emit 2000 Phenobarbital Assay, Model OSR4D229

- Pathway: 510(k) (Special)
- Applicant: Syva Co.
- Decided: Jun 6, 2001 after 20 days
- Product code: DLZ (Enzyme Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: 3 (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
- Aug 30, 2013 · Class II · Z-0181-2014: Imprecision with certain lots
- Dec 10, 2012 · Class II · Z-0664-2013: Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) Sy
- Jul 30, 2012 · Class II · Z-0030-2013: Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an applic

Source page: https://510kreport.com/device/K011528
Methodology: https://510kreport.com/methodology