# K913190: Emit (R) 2000 Phenobarbital Assay/Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Aug 26, 1991 after 39 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.
2 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993031: Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54 (2000), 1 descendant of its own
- K123271: Abbott Phenobarbital Assay (2013), 0 descendants of its own

## 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/K913190
Methodology: https://510kreport.com/methodology