510(k) · Cleared

Cleared

Preciset Dat Plus I Calibrators

K031775510(k) AbbreviatedCleared Aug 5, 200356-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 Corp. · DKB Calibrators, Drug Mixture

Cleared on Aug 5, 2003 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) after a 56-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided: Aug 5, 2003
Review: 56 days
Class: Class II
Product code: DKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951595 (1995). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
This deviceK031775 Preciset Dat Plus I CalibratorsRoche Diagnostics Corp. · 2003
Descendant · cites it directly · 0 of its ownK090939 Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control…Roche Diagnostics · 2009
Descendant · cites it directly · 0 of its ownK060645 Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative…Roche Diagnostics Corp. · 2006

Most influential descendants

Showing 2 of 2 · See all

K090939Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…Roche Diagnostics · 2009 · cites it directly0descendants
K060645Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsRoche Diagnostics Corp. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951595	Roche Cobas Integra Analyzer, Reagent Cassettes	Roche Diagnostic Systems, Inc.	1995	7
0 (this device)	K031775	Preciset Dat Plus I Calibrators	Roche Diagnostics Corp.	2003	—
+1	K090939	Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat…	Roche Diagnostics	2009	—
+1	K060645	Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus…	Roche Diagnostics Corp.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0

FIG. 1 — Lineage of K031775, 1995–2009Source: 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? (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	Applicant	Decided	Recalls
*	K951595	Roche Cobas Integra Analyzer, Reagent Cassettes Summary page 1 …We claim substantial equivalence to the currently marketed Roche calibrators: devices Abuscreen OnLine Preciset DAT I Calibrators, cleared in 5 1O(k) K95 1595 (formerly Abuscreen OnLine Calibration Pack).…	Roche Diagnostic Systems, Inc.	1995	7

Also cleared against K951595: 31 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090939	Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…	Roche Diagnostics	2009	0
K060645	Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators	Roche Diagnostics Corp.	2006	0

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 a recall.
Of its descendants, K090939 (Roche Diagnostics, 2009) has gone furthest, with 0 descendants of its own.
31 other devices also cite its predicate K951595.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031775 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031775: Preciset Dat Plus I Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031775

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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