510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Cocaine Metabolite Eia Test

K960187510(k) TraditionalCleared Apr 2, 199677-day reviewClass II21 CFR 862.3250Recalls 1

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

Diagnostic Reagents, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cleared on Apr 2, 1996 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it. It has been recalled once.

Decided
Apr 2, 1996
Review
77 days
Class
Class II
Product code
DIO
Recalls
1
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960187 Cocaine Metabolite Eia TestDiagnostic Reagents, Inc. · 1996
  2. Descendant · cites it directly · 4 of its ownK020763 Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit)…Lin-Zhi International, Inc. · 2002
  3. Descendant · cites it directly · 1 of its ownK181499 DRI Cocaine Metabolite AssayMicrogenics Corporation · 2018
  4. Descendant · 2 generations on · 1 of its ownK113139 Lzi Cocaine Metabolite Homogeneous Enzyme…Lin-Zhi International, Inc. · 2011
  5. Descendant · 2 generations on · 0 of its ownK213211 Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme…Carolina Liquid Chemistries Corp. · 2022
  6. Descendant · 2 generations on · 0 of its ownK211973 DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12011: 12018: 12020: 12021: 12022: 1
2002high 1 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 7 · See all
  • K020763Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit)Lin-Zhi International, Inc. · 2002 · cites it directly4descendants
  • K181499DRI Cocaine Metabolite AssayMicrogenics Corporation · 2018 · cites it directly1descendant
  • K113139Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,ControlsLin-Zhi International, Inc. · 2011 · 2 generations on1descendant
  • K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…Carolina Liquid Chemistries Corp. · 2022 · 2 generations on0descendants
  • K211973DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960187Cocaine Metabolite Eia TestDiagnostic Reagents, Inc.1996—
+1K020763Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031…Lin-Zhi International, Inc.2002—
+1K181499DRI Cocaine Metabolite AssayMicrogenics Corporation2018—
+2K113139Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,ControlsLin-Zhi International, Inc.2011—
+2K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay…Carolina Liquid Chemistries Corp.2022—
+2K211973DRI Cocaine Metabolite AssayMicrogenics Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
201110
201810
202010
202110
202210
FIG. 1 — Lineage of K960187, 1996–2022Source: 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 DIO? 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 DIO device

  1. #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K020763Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit)Lin-Zhi International, Inc.20024
K181499DRI Cocaine Metabolite AssayMicrogenics Corporation20181

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 23, 2013Class IIZ-2267-2013Under Investigation by firmSurveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020763 (Lin-Zhi International, Inc., 2002) has gone furthest, with 4 descendants of its own.

How does its category compare?

All DIO devices

DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIO

1in 2022

2009: 12011: 52012: 52013: 22014: 22015: 22016: 32017: 32018: 12020: 12021: 12022: 1
2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIO

267in 2017

2011: 65 days median2012: 139 days median2016: 88 days median2017: 267 days median
2007high 267 (2017) · low 65 (2011)2026

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

Recalls per year · DIO

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · DIO

1in 2023

2011: 42014: 12015: 72016: 92017: 162018: 122019: 222022: 12023: 1
2007high 22 (2019) · low 0 (2007)2025

MAUDE reports naming product code DIO, 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
20091—00
20100—00
201156504
2012513900
20132—10
20142—01
20152—07
201638809
20173267016
20181—012
20190—022
20201—00
20211—00
20221—01
20230—01
20240—00
20250—00
20260—0—

More from Diagnostic Reagents, Inc.

66 FDA decisions under this applicant name. See the company

  • K983268Modification of Tricyclic Serum Tox Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983812Napa Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983323Digoxin ImmunoassayDiagnostic Reagents, Inc. · 1998
  • K983280Vancomycin Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983159Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998

Recent decisions in DIO

The DIO category page

  • K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp. · 2022
  • K211973DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021
  • K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020
  • K181499DRI Cocaine Metabolite AssayMicrogenics Corporation · 2018
  • K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc. · 2017

https://510kreport.com/device/K960187 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960187: Cocaine Metabolite Eia Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960187

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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