# K060570: Hemoglobin Alc Control

- Pathway: 510(k) (Traditional)
- Applicant: Compass Bioscience
- Decided: Apr 13, 2006 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MAS Diabetes Control: named in the summary without a submission number

## Indications for use
The Compass Bioscience Hemoglobin Alc Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure Hemoglobin Alc levels. It is intended to validate the measurement of Hemoglobin Alc in patient samples. Two levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

Source page: https://510kreport.com/device/K060570
Methodology: https://510kreport.com/methodology