# K070585: Accu-Chek Performa System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 25, 2007 after 85 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 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 Aviva System: named in the summary without a submission number

## Most influential descendants
- K140210: Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720 (2014), 4 descendants of its own
- K141351: Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring System (2015), 3 descendants of its own
- K173638: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus (2018), 2 descendants of its own
- K231192: RIGHTEST Blood Glucose Monitoring System Max Tel (2024), 1 descendant of its own
- K171785: WowGoHealth Blood Glucose Monitoring System (2017), 1 descendant of its own

## Recalls of this device
- Jun 10, 2009 · Not classified · Z-2006-2009: There may be a significant negative bias when testing neonate samples.
- Jun 10, 2009 · Not classified · Z-2005-2009: There may be a significant negative bias when testing neonate samples.

## Indications for use
The ACCU-CHEK® Performa system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.

Source page: https://510kreport.com/device/K070585
Methodology: https://510kreport.com/methodology