# K113614: Accu-Check Compact Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 12, 2013 after 434 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031755 (2003). 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)
- K031755: Accu-Chek Compact Test Strip, Roche Diagnostics Corp. (2003)

## Recalls of this device
- Apr 14, 2014 · Class II · Z-1616-2014: Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not descr

## Indications for use
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Source page: https://510kreport.com/device/K113614
Methodology: https://510kreport.com/methodology