510(k) Report

510(k) · Cleared

Cleared

Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog NO. DF 92A

K000458510(k) TraditionalCleared Apr 17, 200066-day reviewClass II21 CFR 862.3170

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

Dade Behring, Inc. · JXM Enzyme Immunoassay, Benzodiazepine

Cleared on Apr 17, 2000 after a 66-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 17, 2000
Review
66 days
Class
Class II
Product code
JXM
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2011: 1 descendant cleared200020052010201520202025
  1. This deviceK000458 Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog…Dade Behring, Inc. · 2000
  2. Descendant · cites it directly · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
  3. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000458Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog NO. DF 92ADade Behring, Inc.2000—
+1K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.2006—
+2K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.20113

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201110
FIG. 1 — Lineage of K000458, 2000–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in JXM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JXM device

  1. #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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.

NumberDeviceApplicantDecidedDescendants
K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.20061

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 JXM devices

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

FDA decisions per year · JXM

1in 2024

2010: 12011: 12012: 12015: 22016: 22017: 22018: 12019: 12022: 12024: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXM

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

Recalls per year · JXM

79in 2015

2015: 79
2007high 79 (2015) · low 0 (2007)2026

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

Adverse event reports per year · JXM

6in 2025

2008: 32009: 12010: 32011: 32012: 12013: 32014: 32015: 52016: 22017: 42018: 42019: 32021: 12023: 52024: 62025: 6
2007high 6 (2024) · low 0 (2007)2025

MAUDE reports naming product code JXM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—03
20090—01
20101—03
20111—03
20121—01
20130—03
20140—03
20152—795
20162—02
20172—04
20181—04
20191—03
20200—00
20210—01
20221—00
20230—05
20241—06
20250—06
20260—0—

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in JXM

The JXM category page

  • K243498Alinity c Benzodiazepines Reagent KitMicrogenics Corporation · 2024
  • K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics · 2022
  • K190968CEDIA Benzodiazepine AssayMicrogenics Corporation · 2019
  • K173963DRI Benzodiazepine AssayMicrogenics Corporation · 2018
  • K163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics Corporation · 2017

https://510kreport.com/device/K000458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000458: Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog NO. DF 92A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000458

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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