510(k) · Cleared
ClearedTDM Control Set, Model Cat# 04521536
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Mar 19, 2007 as substantially equivalent to K060429 (Roche Diagnostics Corp., 2006) after a 56-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Mar 19, 2007
- Review
- 56 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060429 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK060429 TDM Control SetRoche Diagnostics Corp. · 2006
- This deviceK070200 TDM Control Set, Model Cat# 04521536Roche Diagnostics Corp. · 2007
- Descendant · cites it directly · 1 of its ownK080183 Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control…Roche Diagnostics Corp. · 2008
- Descendant · 2 generations on · 0 of its ownK090939 Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control…Roche Diagnostics · 2009
Most influential descendants
Showing 2 of 2 · See all- K080183Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000…Roche Diagnostics Corp. · 2008 · cites it directly1descendant
- K090939Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…Roche Diagnostics · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060429 | TDM Control Set | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K070200 | TDM Control Set, Model Cat# 04521536 | Roche Diagnostics Corp. | 2007 | — |
| +1 | K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set… | Roche Diagnostics Corp. | 2008 | — |
| +2 | K090939 | Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat… | Roche Diagnostics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060429 | TDM Control SetSummary page 1…trols, all kinds (assayed and unassayed) 3) Predicate We claim substantial equivalence to the currently marketed TDM Control Set devices (K060429). 4) Device The TDM Control Set contains liquid controls based on human serum with Description added therapeutic dr… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000… | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K080183 (Roche Diagnostics Corp., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070200: TDM Control Set, Model Cat# 04521536.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070200
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026