# K012430: Multi-Meter Glucose Calibration Verification Material, Model Rna GL3

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Aug 27, 2001 after 27 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: 1 generation back to K925479 (1993). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925479: Sugar Chex Linearity for the One Touch, Streck Laboratories, Inc. (1993) Summary page 1.
- K002540: Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems, Bionostics, Inc. (2000) Summary page 1.

## Most influential descendants
- K021624: Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4 (2002), 1 descendant of its own
- K081478: Rna Medical Glucose and B-Ketone Calibration Verification Controls (2008), 0 descendants of its own
- K032819: Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System (2003), 0 descendants of its own
- K021697: Glucose Control Solution for BD Latitude (2002), 0 descendants of its own
- K013147: Glucose Control Solution for Therasense Freestyle (2001), 0 descendants of its own

## Indications for use
Multi-Meter Glucose Calibration Verification Material assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems’ performance.

Source page: https://510kreport.com/device/K012430
Methodology: https://510kreport.com/methodology