# K031755: Accu-Chek Compact Test Strip

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 3, 2003 after 27 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.
15 later devices descend from it; 3 cite it directly.
0 of 16 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) current legally marketed version of the same device: named in the summary without a submission number

## Most influential descendants
- K040796: Accu-Chek GO System (2004), 12 descendants of its own
- K082169: Pro Glucose Test Strip (2008), 10 descendants of its own
- K100322: TD-4277 Blood Glucose Monitoring System, Model 4277 (2010), 6 descendants of its own
- K190579: TD-4183 Blood Glucose Monitoring System (2019), 1 descendant of its own
- K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 (2010), 1 descendant of its own

## Indications for use
The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact Meter. The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.

Source page: https://510kreport.com/device/K031755
Methodology: https://510kreport.com/methodology