# K973583: Ace Theophylline Reagent, Theo Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Nov 12, 1997 after 51 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 K952596 (1995). 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)
- K952596: Theophylline Enzyme Immunoassay, Diagnostic Reagents, Inc. (1995) Summary page 1.

## Indications for use
ACE® Theophylline Reagent is intended for the quantitative determination of theophylline in serum using the ACE® clinical chemistry analyzer. Theophylline is a methylxanthine derivative which is widely used in the treatment of asthma, obstructive lung disease and neonatal apnea. The primary therapeutic effect of theophylline is due to relaxation of bronchial smooth muscle; however, theophylline has a variety of other effects. These include stimulation of the central nervous system and medullary respiratory centers, decreased peripheral vascular resistance, cardiac stimulation, and diuresis. In combination with other clinical data, monitoring serum theophylline levels may provide the physician with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

Source page: https://510kreport.com/device/K973583
Methodology: https://510kreport.com/methodology