510(k) Report

510(k) · Cleared

Cleared

Emit II Plus Ethyl Alcohol Assay, Model OSR9K229

K010960510(k) SpecialCleared Apr 26, 200127-day reviewClass II21 CFR 862.3040

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. · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Cleared on Apr 26, 2001 after a 27-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
Apr 26, 2001
Review
27 days
Class
Class II
Product code
DIC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 2 descendants cleared200020052010201520202025
  1. This deviceK010960 Emit II Plus Ethyl Alcohol Assay, Model OSR9K229Syva Co., Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK071811 Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc. · 2007 · Recalled
  3. Descendant · cites it directly · 0 of its ownK070853 Dimension Vista Etoh Flex Reagent Cartridge, Model K5022Dade Behring, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K071811Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc. · 2007 · cites it directly0descendants
  • K070853Dimension Vista Etoh Flex Reagent Cartridge, Model K5022Dade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010960Emit II Plus Ethyl Alcohol Assay, Model OSR9K229Syva Co., Dade Behring, Inc.2001—
+1K071811Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc.20071
+1K070853Dimension Vista Etoh Flex Reagent Cartridge, Model K5022Dade Behring, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
FIG. 1 — Lineage of K010960, 2001–2007Source: 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 DIC? 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 DIC device

  1. #1 K250609 Sober Self-Testscore 10.3 · 2 generations · no Class I recall
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)

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

NumberDeviceApplicantDecidedDescendants
K071811Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc.20070
K070853Dimension Vista Etoh Flex Reagent Cartridge, Model K5022Dade Behring, Inc.20070

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, K071811 (Dade Behring, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DIC devices

DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIC

1in 2025

2007: 22010: 22011: 22012: 12013: 12018: 12025: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIC

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

Recalls per year · DIC

1in 2025

2010: 12025: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DIC

3in 2025

2009: 12010: 12011: 12020: 12025: 3
2007high 3 (2025) · low 0 (2007)2025

MAUDE reports naming product code DIC, 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
20072—00
20080—00
20090—01
20102—11
20112—01
20121—00
20131—00
20140—00
20150—00
20160—00
20170—00
20181—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20251—13
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 DIC

The DIC category page

  • K250609Sober Self-TestSober Ip, LLC · 2025
  • K181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation · 2018
  • K121247Alco-ScreenChematics, Inc. · 2013
  • K121256Alco-Screen 02Chematics, Inc. · 2012
  • K111005Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialMedica Corp. · 2011

https://510kreport.com/device/K010960 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010960: Emit II Plus Ethyl Alcohol Assay, Model OSR9K229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010960

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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