510(k) Report

510(k) · Cleared

Cleared

Emit II Plus Opiate Assay, Model OSR9B229

K011289510(k) SpecialCleared May 15, 200118-day reviewClass II21 CFR 862.3650

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. · DJG Enzyme Immunoassay, Opiates

Cleared on May 15, 2001 after an 18-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 15, 2001
Review
18 days
Class
Class II
Product code
DJG
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared200020052010201520202025
  1. This deviceK011289 Emit II Plus Opiate Assay, Model OSR9B229Syva Co., Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK062460 Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K062460Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and 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)K011289Emit II Plus Opiate Assay, Model OSR9B229Syva Co., Dade Behring, Inc.2001—
+1K062460Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance…Ortho-Clinical Diagnostics, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K011289, 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.

Planning a device in DJG? 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 DJG device

  1. #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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? (1)

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

NumberDeviceApplicantDecidedDescendants
K062460Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and 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, K062460 (Ortho-Clinical Diagnostics, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DJG devices

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

FDA decisions per year · DJG

3in 2025

2007: 22008: 22009: 22010: 62011: 62012: 52013: 52014: 92015: 122016: 22017: 42018: 52019: 32020: 52021: 32022: 22023: 102024: 52025: 32026 (partial year): 3
2007high 12 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJG

31in 2025

2010: 187 days median2011: 233 days median2012: 95 days median2013: 60 days median2014: 62 days median2015: 141 days median2017: 101 days median2018: 134 days median2019: 235 days median2020: 30 days median2021: 422 days median2023: 140 days median2024: 150 days median2025: 31 days median2026 (partial year): 157 days median
2007high 422 (2021) · low 30 (2020)2026

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

Recalls per year · DJG

2in 2025

2011: 12019: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · DJG

1in 2025

2011: 42012: 12013: 42015: 32016: 22017: 12018: 12021: 22022: 12024: 32025: 1
2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJG, 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
20082—00
20092—00
2010618700
2011623314
201259501
201356004
201496200
20151214103
20162—02
2017410101
2018513401
2019323510
202053000
2021342202
20222—01
20231014000
2024515003
202533121
202631570—

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 DJG

The DJG category page

  • K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
  • K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
  • K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc. · 2026
  • K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025
  • K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen®…Healgen Scientific,, LLC · 2025

https://510kreport.com/device/K011289 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011289: Emit II Plus Opiate Assay, Model OSR9B229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011289

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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