510(k) Report

510(k) · Cleared

Cleared

Quickscreen Cocaine 150 Screening Test

K103295510(k) TraditionalCleared Feb 1, 2012450-day reviewClass II21 CFR 862.3250

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

Phamatech, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cleared on Feb 1, 2012 as substantially equivalent to K070009 (Phamatech, Inc., 2007) after a 450-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.

Decided
Feb 1, 2012
Review
450 days
Class
Class II
Product code
DIO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K070009 (2007). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK070009 · AT Home Drug Test Models, 9308T and 9308X · Phamatech, Inc. · 200720052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K070009 · AT Home Drug Test Models, 9308T and 9308X · Phamatech, Inc. · 20070
  1. Root · 1 generation backK070009 AT Home Drug Test Models, 9308T and 9308XPhamatech, Inc. · 2007
  2. This deviceK103295 Quickscreen Cocaine 150 Screening TestPhamatech, Inc. · 2012
  3. Descendant · cites it directly · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
  4. Descendant · 2 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
  5. Descendant · 3 generations on · 0 of its ownK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026

Most influential descendants

Showing 3 of 3 · See all
  • K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · cites it directly2descendants
  • K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 2 generations on1descendant
  • K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070009AT Home Drug Test Models, 9308T and 9308XPhamatech, Inc.2007—
0 (this device)K103295Quickscreen Cocaine 150 Screening TestPhamatech, Inc.2012—
+1K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug…Chemtron Biotech, Inc.2016—
+2K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.2023—
+3K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202310
202610
FIG. 1 — Lineage of K103295, 2007–2026Source: 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), 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 DIO? 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 DIO device

  1. #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 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? (2)

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
*K070009AT Home Drug Test Models, 9308T and 9308X
Summary page 2
…At Home Test QuickkcreenTMl ________ Model 9308T & 9308Z Drug Screening Test System 510(k)# K070009 K103295 Format Integrated Cup! Dip Card Integrated Cup/Dip Card/Cassette Use…
Phamatech, Inc.2007—
*—Phamatech QuickScreen Pro Multi Drug Screening Test
Named without a submission number
—

Also cleared against K070009: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc.20162

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?

  • Its one ancestor has no recall.
  • Of its descendants, K153192 (Chemtron Biotech, Inc., 2016) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K070009.

How does its category compare?

All DIO devices

DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · DIO

1in 2022

2009: 12011: 52012: 52013: 22014: 22015: 22016: 32017: 32018: 12020: 12021: 12022: 1
2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIO

267in 2017

2011: 65 days median2012: 139 days median2016: 88 days median2017: 267 days median
2007high 267 (2017) · low 65 (2011)2026

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

Recalls per year · DIO

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · DIO

1in 2023

2011: 42014: 12015: 72016: 92017: 162018: 122019: 222022: 12023: 1
2007high 22 (2019) · low 0 (2007)2025

MAUDE reports naming product code DIO, 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—00
20091—00
20100—00
201156504
2012513900
20132—10
20142—01
20152—07
201638809
20173267016
20181—012
20190—022
20201—00
20211—00
20221—01
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 nglml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical…

Read the full statement (341 words)

The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 nglml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confimatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone, oxycodone and TUG in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone, oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

This test provides only a preliminary test result. A more specific alternate testing meteod must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (OC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Indications for use as stated in the FDA summary.

Also cleared against K070009

1 other device cites the same predicate.

  • K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc. · 2018

More from Phamatech, Inc.

15 FDA decisions under this applicant name. See the company

  • K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc. · 2018
  • K131069Quickscreen Amphetine 500 TestPhamatech, Inc. · 2014
  • K070009AT Home Drug Test Models, 9308T and 9308XPhamatech, Inc. · 2007
  • K070098Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening Test, Model 9317T; Cup…Phamatech, Inc. · 2007
  • K043599Moments Menopause Check, Model 9113Phamatech, Inc. · 2005

Recent decisions in DIO

The DIO category page

  • K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp. · 2022
  • K211973DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021
  • K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020
  • K181499DRI Cocaine Metabolite AssayMicrogenics Corporation · 2018
  • K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc. · 2017

https://510kreport.com/device/K103295 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103295: Quickscreen Cocaine 150 Screening Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103295

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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