510(k) Report

510(k) · Cleared

Cleared

Modification to the Emit II Plus Cocaine Metabolite Assay

K011162510(k) SpecialCleared May 2, 200116-day reviewClass II21 CFR 862.3250

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

Syva Co., Dade Behring, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cleared on May 2, 2001 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 2, 2001
Review
16 days
Class
Class II
Product code
DIO
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK011162 Modification to the Emit II Plus Cocaine Metabolite AssaySyva Co., Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK020441 Emit II Plus Monoclonal Cocaine Metabolite AssayDade Behring, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K020441Emit II Plus Monoclonal Cocaine Metabolite AssayDade Behring, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011162Modification to the Emit II Plus Cocaine Metabolite AssaySyva Co., Dade Behring, Inc.2001—
+1K020441Emit II Plus Monoclonal Cocaine Metabolite AssayDade Behring, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K011162, 2001–2002Source: 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 3.0 · 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020441Emit II Plus Monoclonal Cocaine Metabolite AssayDade Behring, Inc.20020

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, K020441 (Dade Behring, Inc., 2002) has gone furthest, with 0 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 Syva Co., Dade Behring, Inc.

19 FDA decisions under this applicant name. See the company

  • K011920Emit 2000 Digoxin Assay, Model OSR4H229Syva Co., Dade Behring, Inc. · 2001
  • K011620Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229Syva Co., Dade Behring, Inc. · 2001
  • K011605Emit 2000 Quinidine Assay, Model OSR4Q229Syva Co., Dade Behring, Inc. · 20011 recall
  • K011300Emit II Plus Cannabinoid Assay, Model OSR9N229Syva Co., Dade Behring, Inc. · 2001
  • K011306Emit II Plus Benzodiazepine Assay, Model 0SR9F229Syva Co., Dade Behring, Inc. · 2001

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/K011162 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011162: Modification to the Emit II Plus Cocaine Metabolite Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011162

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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