# K081478: Rna Medical Glucose and B-Ketone Calibration Verification Controls

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Oct 6, 2008 after 132 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945887 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021624: Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4, Bionostics, Inc. (2002) Summary page 1.
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST, Medisense, Inc. (1999) Summary page 1.

## Indications for use
RNA Medical® Brand Glucose and f3-Ketone Calibration Verification Controls are assayed materials for confirming the calibration and linearity of glucose and 3-ketone at the upper and lower limits of the reportable range and at three (3) points within the range. This product is for use with the Precision Xceed Pro Blood Glucose and j3-ketone Monitoring System, which uses Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood j-Ketone Test Strips. It is not for use with the Precision PCx System or the i-STAr I Analyzer, which use Precision PCx Test Strips, Precision PCx Plus Test Strips, or i-STAT 1 glucose cartridges. RNA Medical Glucose and 3-Ketone Calibration Verification Controls is intended for use by healthcare professionals.

Source page: https://510kreport.com/device/K081478
Methodology: https://510kreport.com/methodology