# K060429: TDM Control Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 15, 2006 after 22 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070200: TDM Control Set, Model Cat# 04521536 (2007), 2 descendants of its own
- K080183: Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000 and Control Set Amphetamine 500 (2008), 1 descendant of its own
- K090939: Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical, Models 04590856 190, 04500873 190 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K060429
Methodology: https://510kreport.com/methodology