510(k) · Cleared

Cleared

Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog NO. DF 96A

K000459510(k) TraditionalCleared Apr 3, 200052-day reviewClass II21 CFR 862.3150

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

Dade Behring, Inc. · DIS Enzyme Immunoassay, Barbiturate

Cleared on Apr 3, 2000 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Apr 3, 2000
Review: 52 days
Class: Class II
Product code: DIS
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK000459 Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog NO.…Dade Behring, Inc. · 2000
Descendant · cites it directly · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK102045 Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · cites it directly1descendant
K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000459	Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog NO. DF 96A	Dade Behring, Inc.	2000	—
+1	K062128	The Dimension Vista Flex Reagent Cartridges / Kit Assays	Dade Behring, Inc.	2006	—
+2	K102045	Dimension Visa HBA1C, Model K3105A	Siemens Heatlhcare Diagnostics, Inc.	2011	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2011	1	0

FIG. 1 — Lineage of K000459, 2000–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062128	The Dimension Vista Flex Reagent Cartridges / Kit Assays	Dade Behring, Inc.	2006	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?

Of its descendants, K062128 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DIS devices

DIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIS

1in 2016

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIS

29in 2015

2007high 331 (2007) · low 29 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DIS

1in 2016

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DIS

1in 2018

2007high 1 (2007) · low 0 (2009)2025

MAUDE reports naming product code DIS, 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	3	331	0	1
2008	0	—	0	1
2009	0	—	0	0
2010	0	—	0	0
2011	2	—	1	0
2012	0	—	1	0
2013	0	—	0	0
2014	2	—	0	0
2015	3	29	0	0
2016	1	—	1	0
2017	0	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

https://510kreport.com/device/K000459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000459: Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog NO. DF 96A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000459

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026