# K052010: HBA1C Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Cone Bioproducts
- Decided: Oct 4, 2005 after 71 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 K040535 (2004). 1 ancestor in all.
2 later devices descend 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)
- K040535: Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron Systems, Cliniqa Corporation (2004) Summary page 1.

## Most influential descendants
- K121534: Cone-Trol Hemoglobin A1C Control Set (2012), 1 descendant of its own
- K162514: Multichem A1c (2016), 0 descendants of its own

## Indications for use
Hemoglobin Al c Linearity is intended for use as quality control material to demonstrate linearity throughout the reportable range of Hemoglobin AIc (IobAl c%) for Immunoassay and HPLC test methods using protocols established in individual laboratories.

Source page: https://510kreport.com/device/K052010
Methodology: https://510kreport.com/methodology