# K133741: ACCU-CHEK Performa Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 29, 2014 after 263 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: 3 generations back to K010362 (2001). 6 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K121679: Accu-Chek Inform II Blood Glucose Monitoring System, Roche Diagnostics (2012) Summary page 4.

## Most influential descendants
- K170079: Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System (2017), 2 descendants of its own
- K182046: Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System (2018), 0 descendants of its own
- K182047: Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System (2018), 0 descendants of its own

## Recalls of this device
- Jul 28, 2021 · Class II · Z-2352-2021: Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentiall

## Indications for use
The ACCU-CHEK Performa Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from the fingertips. The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid in monitoring the effectiveness of glucose control. This system should only be used with single-use, auto-disabling lancing devices. The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use. The ACCU-CHEK Performa test strips are for use with the ACCU-CHEK Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.

Source page: https://510kreport.com/device/K133741
Methodology: https://510kreport.com/methodology