# K021624: Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Jul 12, 2002 after 57 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: 2 generations back to K925479 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012430: Multi-Meter Glucose Calibration Verification Material, Model Rna GL3, Bionostics, Inc. (2001) 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
- K081478: Rna Medical Glucose and B-Ketone Calibration Verification Controls (2008), 0 descendants of its own

## Indications for use
RNA GL4 Glucose Calibration Verification Control 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/K021624
Methodology: https://510kreport.com/methodology