510(k) Report

510(k) · Cleared

Cleared

Dri Ecstasy Urine Calibrators

K012109510(k) TraditionalCleared Aug 27, 200152-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

Microgenics Corp. · DLJ Calibrators, Drug Specific

Cleared on Aug 27, 2001 as substantially equivalent to K983159 (Diagnostic Reagents, Inc., 1998) after a 52-day review. Its family tree reaches back 1 generation to 1998. 8 later devices descend from it.

Decided
Aug 27, 2001
Review
52 days
Class
Class II
Product code
DLJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K983159 (1998). 8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared2006: 3 descendants cleared2011: 2 descendants cleared2015: 1 descendant clearedK983159 · Drugs of Abuse Urine Calibrators and Controls · Diagnostic Reagents, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K983159 · Drugs of Abuse Urine Calibrators and Controls · Diagnostic Reagents, Inc. · 19980
  1. Root · 1 generation backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
  2. This deviceK012109 Dri Ecstasy Urine CalibratorsMicrogenics Corp. · 2001
  3. Descendant · cites it directly · 6 of its ownK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
  4. Descendant · 2 generations on · 2 of its ownK053337 Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006
  5. Descendant · 2 generations on · 1 of its ownK102779 Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy…Siemens Healthcare Diagnostics, Inc. · 2011 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
  7. Descendant · 3 generations on · 0 of its ownK150275 Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 32011: 22015: 1
2003high 3 (2006) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all
  • K043028Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005 · cites it directly6descendants
  • K053337Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006 · 2 generations on2descendants
  • K102779Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level…Siemens Healthcare Diagnostics, Inc. · 2011 · 2 generations on1descendant
  • K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · 3 generations on1descendant
  • K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine…Immunalysis Corporation · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983159Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc.1998—
0 (this device)K012109Dri Ecstasy Urine CalibratorsMicrogenics Corp.2001—
+1K043028Emit II Plus Ecstasy AssayDade Behring, Inc.2005—
+2K053337Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc.2006—
+2K102779Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/…Siemens Healthcare Diagnostics, Inc.20112
+3K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.2006—
+3K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200630
201120
201510
FIG. 1 — Lineage of K012109, 1998–2015Source: 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), 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 DLJ? 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K983159Drugs of Abuse Urine Calibrators and Controls
Summary page 1
…(91) DRI Ecstasy Unnc Cahbrators are substantxally oqmvalent to DRI Multl—Drug Calibrators (Microgenics Corporation, Fremont, CA), cleared under premarket notification K983159 ion | DRI Ecstasy Urine Calibrators are human urine-based and ready to use. They are prepared by spiking negative urine matrix w…
Diagnostic Reagents, Inc.1998—

Also cleared against K983159: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K043028Emit II Plus Ecstasy AssayDade Behring, Inc.20056
K033094Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit)Lin-Zhi International, Inc.20030

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 no recall.
  • Of its descendants, K043028 (Dade Behring, Inc., 2005) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K983159.

How does its category compare?

All DLJ devices

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

FDA decisions per year · DLJ

1in 2013

2008: 12009: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DLJ

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

Recalls per year · DLJ

2in 2011

2010: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DLJ

3in 2025

2011: 62012: 52013: 12017: 12018: 22020: 12022: 12024: 12025: 3
2007high 6 (2011) · low 0 (2007)2025

MAUDE reports naming product code DLJ, 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
20081—00
20091—00
20100—10
20110—26
20120—05
20131—01
20140—00
20150—00
20160—00
20170—01
20180—02
20190—00
20200—01
20210—00
20220—01
20230—00
20240—01
20250—03
20260—0—

What is it indicated for?

The DRI® Ecstasy Urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K983159

3 other devices cite the same predicate.

  • K051088Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 20053 recalls
  • K023316Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
  • K020769Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002

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 DLJ

The DLJ category page

  • K132090Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2Randox Laboratories, Ltd. · 2013
  • K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009
  • K082030Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc. · 2008
  • K062182Dimension Vista System Ecstasy Calibrator, Model KC520Dade Behring, Inc. · 2006
  • K062199Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)Dade Behring, Inc. · 2006

https://510kreport.com/device/K012109 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012109: Dri Ecstasy Urine Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012109

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026