510(k) Report

510(k) · Cleared

Cleared

Cedia Dau Benzodiazepine Assay (Modification)

K954626510(k) TraditionalCleared Nov 27, 199555-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

Microgenics Corp. · JXM Enzyme Immunoassay, Benzodiazepine

Cleared on Nov 27, 1995 after a 55-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
Nov 27, 1995
Review
55 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 1996: 1 descendant cleared2019: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954626 Cedia Dau Benzodiazepine Assay (Modification)Microgenics Corp. · 1995
  2. Descendant · cites it directly · 1 of its ownK962734 Cedia Dau Benzodiazepine AssayBoehringer Mannheim Corp. · 1996
  3. Descendant · 2 generations on · 0 of its ownK190968 CEDIA Benzodiazepine AssayMicrogenics Corporation · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K962734Cedia Dau Benzodiazepine AssayBoehringer Mannheim Corp. · 1996 · cites it directly1descendant
  • K190968CEDIA Benzodiazepine AssayMicrogenics Corporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954626Cedia Dau Benzodiazepine Assay (Modification)Microgenics Corp.1995—
+1K962734Cedia Dau Benzodiazepine AssayBoehringer Mannheim Corp.1996—
+2K190968CEDIA Benzodiazepine AssayMicrogenics Corporation2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
201910
FIG. 1 — Lineage of K954626, 1995–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
K962734Cedia Dau Benzodiazepine AssayBoehringer Mannheim Corp.19961

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, K962734 (Boehringer Mannheim Corp., 1996) 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 Microgenics Corp.

107 FDA decisions under this applicant name. See the company

  • K122766Thermo Scientific QMS Everolimus AssayMicrogenics Corp. · 20131 recall
  • K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp. · 20132 recalls
  • K123271Abbott Phenobarbital AssayMicrogenics Corp. · 2013
  • K110616Thermo Scientific Mas Omni-Immune, Mas Omni Immune ProMicrogenics Corp. · 20113 recalls
  • K101745Thermo Scientific Cedia Amphetamine Oft AssayMicrogenics Corp. · 2011

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/K954626 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954626: Cedia Dau Benzodiazepine Assay (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954626

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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