# K980731: Accu-Chek Comfort Curve Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: May 22, 1998 after 86 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 3 cite it directly.
3 of 53 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) Accu-Chek® Advantage H™ Test Strip: named in the summary without a submission number

## Most influential descendants
- K982002: Accu-Chek Comfort Curve Test Strip (1998), 49 descendants of its own
- K992684: Freestyle Blood Glucose Monitoring System (2000), 33 descendants of its own
- K012014: Modification to Blood Glucose Monitoring System (2001), 23 descendants of its own
- K020866: Freestyle Tracker Diabetes Management System (2002), 22 descendants of its own
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005 (2003), 18 descendants of its own

## Indications for use
The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete systems are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.

Source page: https://510kreport.com/device/K980731
Methodology: https://510kreport.com/methodology