# K060768: Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Apr 21, 2006 after 30 days
- Product code: JIN (Nitroprusside, Ketones (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1435
- 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: 6 generations back to K945887 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST, Medisense, Inc. (1999) Summary page 1.
- K040814: Modification to Precision Xtra Advanced Diabetes Management System, Abbott Laboratories (2004) Summary page 1.

## Recalls of this device
- Nov 14, 2019 · Class II · Z-1558-2020: Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple

## Indications for use
The Precision Xtra / Optium Blood β-Ketone Test Strips are intended to quantitatively measure blood β-Ketone (Beta-Hydroxybutyrate) in fresh capillary whole blood from the fingertip. The test strips are for use outside the body (in vitro diagnostic use) and are for self-testing or healthcare professional use. Healthcare professionals may also use venous whole blood samples, provided the samples are used within 30 minutes of collection. The test strip is to be used for ketone concentrations in persons with diabetes and other conditions.

Source page: https://510kreport.com/device/K060768
Methodology: https://510kreport.com/methodology