# K961462: Cedia Theophylline Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 27, 1996 after 71 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CEDIA® Theophylline Assay: BM/Hitachi 911: named in the summary without a submission number

## Most influential descendants
- K063705: Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol (2007), 0 descendants of its own

## Indications for use
The CEDIA Theophylline Assay is a homogeneous enzyme immunoassay for the in vitro assay of theophylline in human serum and plasma. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure proper therapy.

Source page: https://510kreport.com/device/K961462
Methodology: https://510kreport.com/methodology