510(k) Report

510(k) · Cleared

Cleared

Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439

K022707510(k) TraditionalCleared Aug 22, 20028-day reviewClass I21 CFR 862.3280

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

Bio-Rad · DIF Drug Mixture Control Materials

Cleared on Aug 22, 2002 after an 8-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 11 later devices descend from it.

Decided
Aug 22, 2002
Review
8 days
Class
Class I
Product code
DIF
Recalls
None
Predicates
1

11 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2006: 7 descendants cleared2007: 1 descendant cleared2010: 1 descendant cleared2004: 1 descendant cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK022707 Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E…Bio-Rad · 2002
  2. Descendant · cites it directly · 1 of its ownK062077 Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK143500 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015
  4. Descendant · cites it directly · 0 of its ownK093577 Liquichek Opiate ControlBio-Rad Laboratories · 2010
  5. Descendant · cites it directly · 0 of its ownK062165 Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS…Ortho-Clinical Diagnostics · 2007 · Recalled
  6. Descendant · cites it directly · 0 of its ownK063164 Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004: 12006: 72007: 12010: 12015: 1
2004high 7 (2006) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all
  • K062077Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly1descendant
  • K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…Immunalysis Corporation · 2015 · 2 generations on0descendants
  • K093577Liquichek Opiate ControlBio-Rad Laboratories · 2010 · cites it directly0descendants
  • K062165Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics · 2007 · cites it directly0descendants
  • K063164Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022707Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Bio-Rad2002—
+1K062077Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1…Ortho-Clinical Diagnostics, Inc.20065
+2K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine…Immunalysis Corporation2015—
+1K093577Liquichek Opiate ControlBio-Rad Laboratories2010—
+1K062165Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1…Ortho-Clinical Diagnostics20075
+1K063164Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and…Ortho-Clinical Diagnostics, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200670
200710
201010
201510
FIG. 1 — Lineage of K022707, 2002–2015Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DIF? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK991558Liquichek Urine Toxicology Control Levels S1 and S2
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…valence is Claimed Liquichekm Urine Toxicology Control Levels S1 and S2 Bio-Rad Laboratories Irvine, California Docket Numbers: K99 1558 4.0 Description of Device LiquichekTMUrine Toxicology Control Levels S I E and S2E is prepared from h…

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K062077Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics, Inc.20061
K093577Liquichek Opiate ControlBio-Rad Laboratories20100
K062165Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics20070
K063164Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat…Ortho-Clinical Diagnostics, Inc.20060
K062285Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc.20060
K062460Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance Verifiers I…Ortho-Clinical Diagnostics, Inc.20060
K062637Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I…Ortho-Clinical Diagnostics, Inc.20060
K062094Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat…Ortho-Clinical Diagnostics, Inc.20060
K062123Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc.20060
K042865Liquichek Urine Toxicology Control, (Levels S1S and S2S)Bio-Rad20040

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, K062077 (Ortho-Clinical Diagnostics, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DIF devices

DIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIF

1in 2016

2007: 12008: 22010: 12011: 12012: 32013: 22016: 1
2007high 3 (2012) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIF

35in 2012

2012: 35 days median
2007high 35 (2012)2026

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

Recalls per year · DIF

1in 2021

2011: 12013: 12017: 52021: 1
2007high 5 (2017) · low 0 (2007)2026

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

Adverse event reports per year · DIF

1in 2016

2011: 12012: 32016: 1
2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code DIF, 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
20071—00
20082—00
20090—00
20101—00
20111—11
201233503
20132—10
20140—00
20150—00
20161—01
20170—50
20180—00
20190—00
20200—00
20210—10
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

LiquichekTM Urine Toxicology Control Levels S1E and S2E is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

Indications for use as stated in the FDA summary.

More from Bio-Rad

322 FDA decisions under this applicant name. See the company

  • K171061MRSASelect IIBio-Rad · 20171 recall
  • K122187Vreselect Culture MediumBio-Rad · 2012
  • K103684Vreselect Culture MediumBio-Rad · 2011
  • K093678Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
  • K100589Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010

Recent decisions in DIF

The DIF category page

  • K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control…Biochemical Diagnostics, Inc. · 2016
  • K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc. · 2013
  • K132174Multichem WBTTechno-Path Manufacturing, Ltd. · 2013
  • K121122Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid ControlBiochemical Diagnostic, Inc. · 2012
  • K121143Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)Bio-Rad Laboratories · 2012

https://510kreport.com/device/K022707 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022707

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026