# K070810: Architect I Theophylline Reagents and Calibrators (a-F)

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Jun 8, 2007 after 74 days
- Product code: LGS (Fluorescence Polarization 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 K953016 (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)
- K953016: Axsym Theophylline II, Abbott Laboratories (1995) Summary page 2.

## Indications for use
The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy. The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum or plasma.

Source page: https://510kreport.com/device/K070810
Methodology: https://510kreport.com/methodology