# K113314: Precichek NS-101 Poct Professional Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hmd Biomedical, Inc.
- Decided: Nov 9, 2012 after 366 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
Longest line of descent: 2 generations back to K023279 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023194: Suresteppro/Surestepflexx Professional Blood Glucose Management System, Lifescan, Inc. (2002) Summary page 1.
- K032985: Glucoleader Enhance Self-Monitoring of Blood Glucose System, Hmd Biomedical, Inc. (2003) Summary page 2.

## Indications for use
The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by health care professionals in a clinical setting: The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The PRECICHEI( NS-1O1 POCT Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The PRECICHEK KP Blood Glucose Test Strip is for use with the PRECICHEK NS-1O1 POCT Professional Blood Glucose Meter to quantitatively measure glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K113314
Methodology: https://510kreport.com/methodology