# K050961: RNA1C Control for Nycocard HBA1C

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: May 13, 2005 after 25 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 K992921 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992921: Primus Liquid Control for GHB/Alc Level I and Level II, Primus Corp. (1999) Summary page 1.

## Indications for use
RNAIc Control for NycoCard HbAlc is intended to be used to monitor and evaluate the analytical performance of the Axis-Shield NycoCard HbAlc reader for the measurement of glycosylated hemoglobin. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of controls allow performance monitoring within the clinically important range.

Source page: https://510kreport.com/device/K050961
Methodology: https://510kreport.com/methodology