# K993029: Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 140 days
- Product code: KLS (Enzyme Immunoassay, Theophylline)
- Device class: 2
- Regulation: 21 CFR 862.3880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913123 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913123: Emit (R) 2000 Theophylline Assay/Calibrators, Syva Co. (1991) Summary page 1.

## Indications for use
The Abbott Aeroset® Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma on the Abbott Aeroset® analyzer (K980367). The physiological effects of the antiasthmatic drug theophylline correlate better with the drug’s concentration in serum than with dosage. Since serious toxic effects of theophylline are related to the serum concentration and are not always preceded by minor adverse symptoms, serum theophylline monitoring helps to avoid serious toxicity(1-5). When theophylline is used to treat acute symptoms, monitoring serum concentrations allows the physician to adjust the dosage regimen to compensate for interpatient variations in the theophylline elimination rate (1). The chronic treatment of asthma and other bronchospastic diseases also requires individualization of the theophylline dosage to maintain serum concentrations within the therapeutic range (2,3). A theophylline dosage generally can be maintained without further monitoring for six months in rapidly growing children and for twelve months in other patients. Changes in concurrent drug therapy, variations in drug elimination, or the appearance of side effects, uncontrolled symptoms, or altered drug clearance signal the need for measuring the serum theophylline concentration (1,3). Methods historically used to monitor serum theophylline concentrations include gas-liquid chromatography, high-performance liquid chromatography, and immunoassay (1,5,6).

Source page: https://510kreport.com/device/K993029
Methodology: https://510kreport.com/methodology