# K103099: Precicontrol HBA1C Norm; Precicontrol HBA1C Path

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Dec 6, 2010 after 47 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls (2014), 4 descendants of its own
- K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (2017), 1 descendant of its own
- K200256: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (2021), 0 descendants of its own
- K173206: SEKURE HbA1c Assay (2018), 0 descendants of its own
- K140654: Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K103099
Methodology: https://510kreport.com/methodology