# K081389: Accu-Chek Compact Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Jul 15, 2008 after 57 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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.
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) ACCU-CHEK Compact Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K152493: POGO Automatic Blood Glucose Monitoring System (2016), 0 descendants of its own

## Indications for use
The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact or Compact Plus Meter. The Accu-Chek Compact and Compact Plus 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 and Compact Plus system are 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/K081389
Methodology: https://510kreport.com/methodology