# K070200: TDM Control Set, Model Cat# 04521536

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 19, 2007 after 56 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
Longest line of descent: 1 generation back to K060429 (2006). 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)
- K060429: TDM Control Set, Roche Diagnostics Corp. (2006) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The TDM Control Set is intended for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers. Two assayed levels of serum barbiturates and three assayed levels of acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin are provided.

Source page: https://510kreport.com/device/K070200
Methodology: https://510kreport.com/methodology