510(k) Report

510(k) · Cleared

Cleared

Cedia (TM) Phenobarbital Assay

K904413510(k) TraditionalCleared Nov 5, 199040-day reviewClass II21 CFR 862.3610

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

Microgenics Corp. · LAF Gas Chromatography, Methamphetamine

Cleared on Nov 5, 1990 after a 40-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 5, 1990
Review
40 days
Class
Class II
Product code
LAF
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK904413 Cedia (TM) Phenobarbital AssayMicrogenics Corp. · 1990
  2. Descendant · cites it directly · 1 of its ownK961659 Cedia Core TDM Multi-CalBoehringer Mannheim Corp. · 1996
  3. Descendant · 2 generations on · 0 of its ownK120936 Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS…Microgenics Corporation · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K961659Cedia Core TDM Multi-CalBoehringer Mannheim Corp. · 1996 · cites it directly1descendant
  • K120936Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…Microgenics Corporation · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904413Cedia (TM) Phenobarbital AssayMicrogenics Corp.1990—
+1K961659Cedia Core TDM Multi-CalBoehringer Mannheim Corp.1996—
+2K120936Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS…Microgenics Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
201210
FIG. 1 — Lineage of K904413, 1990–2012Source: 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 LAF? 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 LAF device

  1. #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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
K961659Cedia Core TDM Multi-CalBoehringer 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, K961659 (Boehringer Mannheim Corp., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LAF devices

LAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAF

2in 2021

2008: 22011: 42012: 22014: 22015: 32016: 12017: 12020: 12021: 2
2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LAF

43in 2015

2011: 345 days median2015: 43 days median
2007high 345 (2011) · low 43 (2015)2026

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

Recalls per year · LAF

No recall names LAF since 2007.

Adverse event reports per year · LAF

No MAUDE report names LAF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—00
20100—00
2011434500
20122—00
20130—00
20142—00
201534300
20161—00
20171—00
20180—00
20190—00
20201—00
20212—00
20220—00
20230—00
20240—00
20250—00
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 LAF

The LAF category page

  • K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021
  • K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group · 2020
  • K170222Rapid Tox Cup IIAmerican Bio Medica Corp. · 2017
  • K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016

https://510kreport.com/device/K904413 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904413: Cedia (TM) Phenobarbital Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904413

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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