# K021960: Precision Point of Care Blood Glucose Test Strip with True Measure Technology

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 16, 2002 after 63 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: 1 generation back to K980731 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980731: Accu-Chek Comfort Curve Test Strips, Boehringer Mannheim Corp. (1998) Summary page 1.

## Most influential descendants
- K070984: The Precision / Optium Point of Care Blood Glucose Test Strips (2007), 0 descendants of its own

## Indications for use
The PrecisionlOptium Point of Care Blood Glucose Test Strip with True Measure TechnoIogy is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-gIucose) in fresh neonatal venous, merial and fmgertip capillary whoIe blood. The test strip is indicated for use by health care professionals in health care fmilities. The test strip is to be used for monitoring diabetes mellitus. This strip may be used with the Precision Xtra and Optium meters.

Source page: https://510kreport.com/device/K021960
Methodology: https://510kreport.com/methodology