# K162514: Multichem A1c

- Pathway: 510(k) (Abbreviated)
- Applicant: Technopath Manufacturing
- Decided: Oct 26, 2016 after 48 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: 3 generations back to K040535 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121534: Cone-Trol Hemoglobin A1C Control Set, Cone Bioproducts (2012) Summary page 4.

## Indications for use
Multichem Alc control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analyte, HbAlc, as listed in the package insert

Source page: https://510kreport.com/device/K162514
Methodology: https://510kreport.com/methodology