# K962295: Precision Qid Blood Glucose Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Medisense, Inc.
- Decided: Jul 26, 1996 after 71 days
- Product code: CGA (Glucose Oxidase, 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: 1 generation back to K945887 (1995). 2 ancestors in all.
61 later devices descend from it; 4 cite it directly.
3 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945887: Precision Q I D Blood Glucose Test Strips, Medisense, Inc. (1995) Summary page 1.
- K951887: Advantage Test Strips, Boehringer Mannheim Corp. (1995) Summary page 1.

## Most influential descendants
- K963676: Precision G Blood Glucose Testing System (1997), 60 descendants of its own
- K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip (1997), 59 descendants of its own
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST (1999), 40 descendants of its own
- K052980: Liberty Glucose Control, Model 2120031 (2005), 19 descendants of its own
- K040814: Modification to Precision Xtra Advanced Diabetes Management System (2004), 16 descendants of its own

## Indications for use
The Precision QID Blood Glucose Test Strips are intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.

Source page: https://510kreport.com/device/K962295
Methodology: https://510kreport.com/methodology