# K050100: RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Feb 25, 2005 after 38 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 K831478 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021484: Hemoglobin A1C Control, Canterbury Scientific, Ltd. (2002) Summary page 1.

## Indications for use
RNAlc Control for Bayer DCA2000 and DCA2000+ Analyzers is intended to be used to monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+ Analyzers that measure HbAlc. 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/K050100
Methodology: https://510kreport.com/methodology