510(k) Report

510(k) · Cleared

Cleared

Triage Tox Drug Screen Controls

K050037510(k) TraditionalCleared Mar 22, 200574-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

Biosite Incorporated · DIF Drug Mixture Control Materials

Cleared on Mar 22, 2005 as substantially equivalent to K012999 (Biosite Incorporated, 2001) and 3 other predicates after a 74-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.

Decided
Mar 22, 2005
Review
74 days
Class
Class I
Product code
DIF
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K903430 (1990). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1994: 1 other ancestor2006: 1 descendant clearedK903430 · Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 · Bio-Rad · 1990K981590 · Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con · Bio-Rad · 1998K012999 · Triage Tox Drug Screen Controls, Catalog #94001 · Biosite Incorporated · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K012999 · Triage Tox Drug Screen Controls, Catalog #94001 · Biosite Incorporated · 2001K981590 · Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con · Bio-Rad · 1998K903430 · Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 · Bio-Rad · 19900
  1. Root · 3 generations backK903430 Liquichek CK/LD Isoenzyme Control; Levels 1 and 2Bio-Rad · 1990
  2. 2 generations backK981590 Liquichek Urine Toxicology Control Level C1, Liquichek Urine…Bio-Rad · 1998
  3. 1 generation backK012999 Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001
  4. This deviceK050037 Triage Tox Drug Screen ControlsBiosite Incorporated · 2005
  5. Descendant · cites it directly · 0 of its ownK060788 Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model…Biosite Incorporated · 2006 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K060788Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K903430Liquichek CK/LD Isoenzyme Control; Levels 1 and 2Bio-Rad1990—
−2K981590Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology…Bio-Rad1998—
−1K012999Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated2001—
0 (this device)K050037Triage Tox Drug Screen ControlsBiosite Incorporated2005—
+1K060788Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated20062

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K050037, 1990–2006Source: 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), 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012999Triage Tox Drug Screen Controls, Catalog #94001
Summary page 1
…21 CFR 862:3280 Class I Product Code: DIF C. Predicate Devices Triage TOX Drug Screen Controls (K012999) BIO-RAD Liquicheck Urine Toxicology Controls (K981 590, K970666) Dade Behring Emit Calibrators/Controls (K9352…
Biosite Incorporated2001—
*K981590Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level…
Summary page 1
…Product Code: DIF C. Predicate Devices Triage TOX Drug Screen Controls (K012999) BIO-RAD Liquicheck Urine Toxicology Controls (K981 590, K970666) Dade Behring Emit Calibrators/Controls (K935230) 0. Device Description and Intended Use…
Bio-Rad1998—
*K970666Liquicheck Urine Toxicology Negative Control
Summary page 1
…Product Code: DIF C. Predicate Devices Triage TOX Drug Screen Controls (K012999) BIO-RAD Liquicheck Urine Toxicology Controls (K981 590, K970666) Dade Behring Emit Calibrators/Controls (K935230) 0. Device Description and Intended Use The Triag…
Bio-Rad1997—
*K935230Emit Iic Negative Control, Control I and II
Summary page 1
…Triage TOX Drug Screen Controls (K012999) BIO-RAD Liquicheck Urine Toxicology Controls (K981 590, K970666) Dade Behring Emit Calibrators/Controls (K935230) 0. Device Description and Intended Use The Triage TOX Drug Screen Controls are to be used with the Triage…
Syva Co.1994—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K060788Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated20060

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?

  • The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K060788 (Biosite Incorporated, 2006) has gone furthest, with 0 descendants 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?

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage MeterPlus to assist the laboratory in monitoring test performance.

Indications for use as stated in the FDA summary.

More from Biosite Incorporated

46 FDA decisions under this applicant name. See the company

  • K092987Inratio/INRATIO2 Test StripsBiosite Incorporated · 20106 Class I recalls
  • K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
  • K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
  • K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 20082 Class I recalls
  • K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 20075 recalls

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/K050037 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050037: Triage Tox Drug Screen Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050037

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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