510(k) · Cleared

Cleared

Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical, Models 04590856 190, 04500873 190

K090939510(k) TraditionalCleared Jun 18, 200976-day reviewClass II21 CFR 862.3200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostics · DKB Calibrators, Drug Mixture

Cleared on Jun 18, 2009 as substantially equivalent to K031775 (Roche Diagnostics Corp., 2003) and 2 other predicates after a 76-day review. Its family tree reaches back 3 generations to 2006.

Decided: Jun 18, 2009
Review: 76 days
Class: Class II
Product code: DKB
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K060429 (2006). 6 ancestors in all, the oldest K951595 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK060429 TDM Control SetRoche Diagnostics Corp. · 2006
2 generations backK070200 TDM Control Set, Model Cat# 04521536Roche Diagnostics Corp. · 2007
1 generation backK080183 Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control…Roche Diagnostics Corp. · 2008
This deviceK090939 Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control…Roche Diagnostics · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K060429	TDM Control Set	Roche Diagnostics Corp.	2006	—
−2	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	—
0 (this device)	K090939	Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat…	Roche Diagnostics	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2003	2	0

FIG. 1 — Lineage of K090939, 2006–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DKB? 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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K031775	Preciset Dat Plus I Calibrators	Roche Diagnostics Corp.	2003	—
*	K033306	Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators Summary page 2 …brators · Preciset DAT Plus I Calibrators (K03'1775) * Preciset DAT Plus IIand Cfas DAT Qualitative Plus Calibrators (K033306) Control Set DAT Clinical We claim substantial equivalence to the currently marketed Roche…	Roche Diagnostics Corp.	2003	—
*	K080183	Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000… Summary page 2 …ntial equivalence to the currently marketed Roche controls: * Control Set DAT I, Control Set DAT II, Control Set DAT III, (K080183) Page 2 of 6 Confidential…	Roche Diagnostics Corp.	2008	—

Also cleared against K031775: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
1 of the 6 ancestors has a recall of any class.
1 other device also cites its predicate K031775.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DKB

2in 2014

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKB

Too few DKB 510(k)s in any year since 2007 to give a median.

Recalls per year · DKB

2in 2022

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DKB

1in 2017

2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code DKB, 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	0	—	0	0
2008	0	—	0	0
2009	2	—	3	0
2010	0	—	0	0
2011	2	—	2	1
2012	1	—	1	4
2013	0	—	0	0
2014	2	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	2	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The C.f.a.s. DAT Qualitative Plus Clinical calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Control Set DAT Clinical is for use as an assayed control in the Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090939 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090939: Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical, Models 04590856 190, 04500873 190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090939

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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