# K121534: Cone-Trol Hemoglobin A1C Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Cone Bioproducts
- Decided: Jun 20, 2012 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: 2 generations back to K040535 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052010: HBA1C Linearity Set, Cone Bioproducts (2005) Summary page 1.

## Most influential descendants
- K162514: Multichem A1c (2016), 0 descendants of its own

## Indications for use
CONE-TROL Hemoglobin Aic Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin Aic determination methods.

Source page: https://510kreport.com/device/K121534
Methodology: https://510kreport.com/methodology