# K993031: Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 140 days
- Product code: DLZ (Enzyme Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913190 (1991). 1 ancestor in all.
1 later device descends 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)
- K913190: Emit (R) 2000 Phenobarbital Assay/Calibrators, Syva Co. (1991) Summary page 1.

## Most influential descendants
- K123271: Abbott Phenobarbital Assay (2013), 0 descendants of its own

## Recalls of this device
- Nov 16, 2012 · Class II · Z-1118-2013: Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the P
- Sep 26, 2006 · Not classified · Z-0454-2007: Erratic elevated results and or the inability to calibrate due to imprecision.

## Indications for use
The Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the following reasons (1-3): » Serum phenobarbital concentrations correlate better with concentration in the brain than does dosage once steady state is reached. « Patients taking the same dosage of phenobarbital show considerable variation in serum phenobarbital concentrations because of individual differences in absorption, metabolism, disease states, and compliance. Serum level monitoring helps physicians individualize dosage regimens. Methods historically used to monitor serum phenobarbital concentrations are gas-liquid chromatography, high-performance liquid chromatography, radlmmmunoassay, and immunoassay (1,2).

Source page: https://510kreport.com/device/K993031
Methodology: https://510kreport.com/methodology