510(k) Report

510(k) · Cleared

Cleared

Dri Cotinine Eia Assay

K030649510(k) TraditionalCleared May 22, 200383-day reviewClass I21 CFR 862.3220

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

Microgenics Corp. · MRS Test System, Nicotine, Cotinine, Metabolites

Cleared on May 22, 2003 as substantially equivalent to K972481 (OraSure Technologies, Inc., 1997) after an 83-day review. Its family tree reaches back 1 generation to 1997.

Decided
May 22, 2003
Review
83 days
Class
Class I
Product code
MRS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K972481 (1997). No later device cites it as a predicate yet.

K972481 · Auto-Lyte Cotinine Eia · OraSure Technologies, Inc. · 199719961998200020022004
K972481 · Auto-Lyte Cotinine Eia · OraSure Technologies, Inc. · 19970
  1. Root · 1 generation backK972481 Auto-Lyte Cotinine EiaOraSure Technologies, Inc. · 1997
  2. This deviceK030649 Dri Cotinine Eia AssayMicrogenics Corp. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972481Auto-Lyte Cotinine EiaOraSure Technologies, Inc.1997—
0 (this device)K030649Dri Cotinine Eia AssayMicrogenics Corp.2003—
FIG. 1 — Lineage of K030649, 1997–2003Source: 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.

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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? (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
*K972481Auto-Lyte Cotinine Eia
Our reading of the summary gave K072481, FDA’s number for Jet Port Plus HP Catheter System (Pfm Medical, Inc.), decided Mar 7, 2008, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OTI AUTO-LYTE Cotinine EIA Assay”.
OraSure Technologies, Inc.1997—

Also cleared against K972481: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 2 other devices also cite its predicate K972481.

How does its category compare?

All MRS devices

MRS Test System, Nicotine, Cotinine, Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRS

FDA has decided no MRS device since 2007.

Median 510(k) review, days · MRS

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

Recalls per year · MRS

No recall names MRS since 2007.

Adverse event reports per year · MRS

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code MRS, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The DRI@ Cotinine Enzyme Immunoassay is intended for the Qualitative and Semi-Quantitative determination of Cotinine in human urine at a cutoff level of 500 ng/mL. This assay is intended for in vitro diagnostic use only. The assay is intended as an aid in the detection of cotinine after use or exposure to tobacco products.

Indications for use as stated in the FDA summary.

Also cleared against K972481

2 other devices cite the same predicate.

  • K062565Status DS Nicotine, Accusign Nicotine, Biosign NicotinePrinceton BioMeditech Corp. · 2007
  • K021944Cozart Eia Cotinine Urine KitCozart Bioscience, Ltd. · 2003

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 MRS

The MRS category page

  • K021688NicalertNymox Pharmaceutical Corporation · 2002
  • K963733Niccheck IDynagen, Inc. · 1996

https://510kreport.com/device/K030649 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030649: Dri Cotinine Eia Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030649

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026