# K913123: Emit (R) 2000 Theophylline Assay/Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Sep 19, 1991 after 66 days
- Product code: KLS (Enzyme Immunoassay, Theophylline)
- Device class: 2
- Regulation: 21 CFR 862.3880
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K993029: Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89 (2000), 0 descendants of its own

## Recalls of this device
- Nov 27, 2017 · Class II · Z-1946-2018: Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
- Jun 17, 2016 · Class II · Z-2298-2016: Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reag
- Jun 17, 2016 · Class II · Z-2299-2016: Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reag

Source page: https://510kreport.com/device/K913123
Methodology: https://510kreport.com/methodology