# K972495: Accumeter Theophylline Test

- Pathway: 510(k) (Traditional)
- Applicant: Chemtrak, Inc.
- Decided: Oct 10, 1997 after 99 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 K932127 (1993). 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)
- K932127: TDX/Tdxflx & Tdxflx Theophylline Monoclonal II, Abbott Laboratories (1993) Summary page 1.

## Indications for use
The AccuMeter® Theophylline Test is a rapid, noninstrumented enzyme immunochromatographic method for the in vitro quantitative measurement of theophylline concentrations in ambulatory patients using fingerstick whole blood, heparinized venous whole blood or serum. This test has not been validated for use with blood from neonates.

Source page: https://510kreport.com/device/K972495
Methodology: https://510kreport.com/methodology