# K013272: Acs: 180 and Advia Centaur Theophylline 2 Assay

- Pathway: 510(k) (Special)
- Applicant: Bayer Corp.
- Decided: Oct 25, 2001 after 24 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 K951169 (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)
- K951169: Ciba Corining Acs Theophylline Immunoassay, Ciba Corning Diagnostics Corp. (1995) Summary page 1.

## Indications for use
The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of theophylline in human serum and plasma for use on the automated analyzer marketed by Bayer Corporation. Theophylline (1,3-dimethylxanthine) is a potent bronchodilator and respiratory stimulant that is used for the treatment of asthma. Monitoring a patient's theophylline level is very important in reducing the risks of over- or under-medication resulting from the individual variability of theophylline absorption, metabolism and clearance and the narrow therapeutic index. The ACS and ADVIA Centaur Theophylline 2 immunoassays are used as an aid to monitor a patient's theophylline level. The ACS and ADVIA Centaur Theophylline 2 assays are an enhanced version of the current ACS Theophylline assay. The enhancements are aimed at providing a more versatile assay in the clinical laboratory.

Source page: https://510kreport.com/device/K013272
Methodology: https://510kreport.com/methodology