510(k) Report

510(k) · Cleared

Cleared

Emit II Plus Methadone Assay, Model OSRE229

K010962510(k) SpecialCleared Apr 26, 200127-day reviewClass II21 CFR 862.3620

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. · DJR Enzyme Immunoassay, Methadone

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. 1 later device descends from it.

Decided
Apr 26, 2001
Review
27 days
Class
Class II
Product code
DJR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared200020052010201520202025
  1. This deviceK010962 Emit II Plus Methadone Assay, Model OSRE229Syva Co., Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK062637 Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat…Ortho-Clinical Diagnostics, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K062637Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010962Emit II Plus Methadone Assay, Model OSRE229Syva Co., Dade Behring, Inc.2001—
+1K062637Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance…Ortho-Clinical Diagnostics, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K010962, 2001–2006Source: 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.

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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?

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
K062637Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I…Ortho-Clinical Diagnostics, Inc.20060

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, K062637 (Ortho-Clinical Diagnostics, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DJR devices

DJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DJR

1in 2019

2009: 12010: 32013: 12015: 32016: 12017: 12018: 12019: 1
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJR

59in 2015

2010: 469 days median2015: 59 days median
2007high 469 (2010) · low 59 (2015)2026

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

Recalls per year · DJR

1in 2010

2008: 22009: 12010: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DJR

1in 2025

2010: 32011: 62012: 12014: 22015: 22016: 12025: 1
2007high 6 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJR, 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—20
20091—10
2010346913
20110—06
20120—01
20131—00
20140—02
201535902
20161—01
20171—00
20181—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
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 DJR

The DJR category page

  • K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc. · 2019
  • K182779ARK EDDP AssayArk Diagnostics, Inc. · 2018
  • K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc. · 2017
  • K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA…W.H.P.M., Inc. · 2016
  • K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests…Assure Tech. Co., Ltd. · 2015

https://510kreport.com/device/K010962 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010962: Emit II Plus Methadone Assay, Model OSRE229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010962

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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