510(k) Report

510(k) · Cleared

Cleared

Cannabinoid Urine Controls

K932113510(k) TraditionalCleared Jun 29, 199357-day reviewClass I21 CFR 862.1660

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

Diagnostic Reagents, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Jun 29, 1993 after a 57-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.

Decided
Jun 29, 1993
Review
57 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared1997: 1 descendant cleared2011: 1 descendant cleared2015: 2 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK932113 Cannabinoid Urine ControlsDiagnostic Reagents, Inc. · 1993
  2. Descendant · cites it directly · 5 of its ownK021449 Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK110239 Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2011
  4. Descendant · 3 generations on · 2 of its ownK141320 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid…Lin-Zhi International, Inc. · 2015
  5. Descendant · 4 generations on · 1 of its ownK223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC · 2023
  6. Descendant · 5 generations on · 0 of its ownK252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate…Healgen Scientific,, LLC · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12011: 12015: 22023: 12026: 1
1997high 2 (2015) · low 0 (1998)2026

Most influential descendants

Showing 5 of 7 · See all
  • K021449Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002 · cites it directly5descendants
  • K110239Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, ControlLin-Zhi International, Inc. · 2011 · 2 generations on4descendants
  • K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…Lin-Zhi International, Inc. · 2015 · 3 generations on2descendants
  • K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC · 2023 · 4 generations on1descendant
  • K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932113Cannabinoid Urine ControlsDiagnostic Reagents, Inc.1993—
+1K021449Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.20021
+2K110239Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, ControlLin-Zhi International, Inc.2011—
+3K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids…Lin-Zhi International, Inc.2015—
+4K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test…Healgen Scientific,, LLC2023—
+5K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
201110
201520
202310
202610
FIG. 1 — Lineage of K932113, 1993–2026Source: 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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 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
K021449Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.20025
K971210Synchron Systems 10 NG/ML & 40 NG/ML THC Urine ControlsBeckman Instruments, Inc.19970

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, K021449 (Lin-Zhi International, Inc., 2002) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
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

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The JJX category page

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https://510kreport.com/device/K932113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932113: Cannabinoid Urine Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932113

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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