K Number
K131069
Device Name
QUICKSCREEN AMPHETINE 500 TEST
Manufacturer
Date Cleared
2014-05-14

(392 days)

Product Code
Regulation Number
862.3100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuickScreen™ Amphetamine 500 Test Model 9058 (dip card): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. 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. QuickScreen™ Amphetamine 500 Test Model 9054 (cassette): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. 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. QuickScreen ™ Multi Drug Screening Test Model 9346T(dip card): The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinquish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. 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. QuickScreen™ Drug Cup Model 9346Z: The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. 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.
Device Description
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine. The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.
More Information

Not Found

No
The device description and performance studies indicate a standard immunoassay technology with visual interpretation, not involving AI or ML for analysis or result generation.

No.
This device is an in-vitro diagnostic test used for the detection of substances in urine, not for treating or preventing a disease or condition.

Yes

The "Intended Use / Indications for Use" explicitly states that the devices are "qualitative in-vitro diagnostic screen[s]".

No

The device description and performance studies clearly indicate that this is an in-vitro diagnostic test that relies on physical components (dip card, cassette, cup) and chemical reactions (immunoassay) to detect substances in urine. There is no mention of software being the primary or sole component of the device.

Yes, all of the described devices are IVDs (In Vitro Diagnostics).

Here's why:

  • Explicitly Stated: The intended use/indications for use for each device explicitly states that it is an "in-vitro diagnostic screen" or "in vitro diagnostic test".
  • Definition of IVD: An in vitro diagnostic product is a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. These products are intended for use in the collection, preparation, and examination of specimens taken from the human body.
  • Function: These devices are designed to detect the presence of substances (drugs or drug metabolites) in a specimen taken from the human body (urine) to provide information about the individual's health status (presence of drugs).
  • Intended Use: The intended use is for "prescription point of care use only," which aligns with the use of diagnostic tests in a healthcare setting.

Therefore, based on the provided text, these devices clearly fall under the definition of In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

QuickScreen Amphetamine 500 Test Model 9058 (dip card): The QuickScreen Amphetamine 500 Test Model 9058 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. 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 any drug of abuse test result, particularly when preliminary positive results are observed.

QuickScreen Amphetamine 500 Test Model 9054 (cassette): The QuickScreen Amphetamine 500 Test Model 9054 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific altemate 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.

QuickScreen™ Multi Drug Screening Test Model 9346T(dip card): The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxvoodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazenine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. Amphetamine (d amphetamine) 500 ng/m! Cocaine (benzoylecgonine) 150 ng/ml Methamphetamine (d methamphetamine) 500 ng/m1 Opiates (morphine) 300 ng/ml PCP (phencyclidine) 25 ng/ml Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines (Oxazepam) 200 ng/ml Methadone (Methadone) 300 ng/ml Oxycodone (Oxycodone) 100 ng/ml THC (Cannabinoids) 50 ng/ml 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.

QuickScreen™ Drug Cup Model 9346Z: The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. Amphetamine (d amphetamine) 500 ng/ml Cocaine (benzoylecgonine) 150 ng/ml Methamphetamine (d methamphetamine) 500 ng/ml Opiates (morphine) 300 ng/ml PCP (phencyclidine) 25 ng/ml Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines (Oxazepam) 200 ng/ml Methadone (Methadone) 300 ng/ml Oxycodone (Oxycodone) 100 ng/ml THC (Cannabinoids) 50 ng/ml 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.

Product codes (comma separated list FDA assigned to the subject device)

DKZ

Device Description

Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine. The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.

Format: Integrated Cup/Dip Card/Cassette
Methodology: Lateral flow Immunoassay
Qualitative: YES
Antibodies: Monoclonal / Polyclonal
Analyte's detected: 10
Cutoffs (ng/ml): AMP 500, Cocaine: 150, THC: 50, Opiates: 300, PCP: 25, MET: 500, BZD: 200, Barb: 200, MTD: 300, OXY 100
Incubation: 10 minutes
Control: Control Line
Features: Test Expired Indicator

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription point of care use only.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Performance of the QuickScreen Drug Screening Test System around the cutoff for amphetamine was evaluated by testing standard drug solutions diluted in drug free urine at 3 sites by 2 technicians in card, cup and cassette formats for a period of 20 days.
METHOD COMPARISON - The performance of the QuickScreen Drug Screening Test System was evaluated at three locations by typical operators at each site. Operators tested 106 unaltered clinical samples. These samples were blinded and sufficiently randomized. Results were compared to GC/MS testing.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance of the QuickScreen Drug Screening Test System around the cutoff for amphetamine was evaluated by testing standard drug solutions diluted in drug free urine at 3 sites by 2 technicians in card, cup and cassette formats for a period of 20 days.

METHOD COMPARISON - The performance of the QuickScreen Drug Screening Test System was evaluated at three locations by typical operators at each site. Operators tested 106 unaltered clinical samples. These samples were blinded and sufficiently randomized. Results were compared to GC/MS testing.

Other technical performance tests included:
Assay Cross-reactivity: Tested d-amphetamine (500 ng/ml, N/A % Crossreactivity), L-amphetamine (10,000 ng/ml, 5.0 % Crossreactivity), Methylenedioxyamphetamine (MDA) (1000 ng/ml, 50 % Crossreactivity), Methylenedioxymethamphetamine (MDMA) (100,000 ng/ml, 0 % Crossreactivity).
Assay Interference: Not observed from structurally un-related compounds up to concentrations of 100 µg/ml.
Effect of Sample pH: Samples with amphetamine concentrations of 250, 375, 625 and 750 ng/ml were tested in pH ranges of 4.5 to 8.5. No effect was observed.
Specific Gravity Effects: Samples with amphetamine concentrations of 250, 375, 625 and 750 ng/ml were tested In specific gravity ranges of 1.002 to 1.040. No effect was observed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

SENSITIVITY / PRECISION - Summary of all sites (for Amphetamine 500 ng/ml cutoff):
Negative concentration: 60 Negative readings, 0 Positive readings across Multi-card, Cassette, Cup, Dipcard.
100.86 concentration: 60 Negative readings, 0 Positive readings across Multi-card, Cassette, Cup; 80 Negative readings, 0 Positive readings in Dipcard.
211.2 concentration: 60 Negative readings, 0 Positive readings across Multi-card, Cassette, Cup, Dipcard.
286.22 concentration: 60 Negative readings, 0 Positive readings across Multi-card, Cassette, Cup, Dipcard.
583.3 concentration: 0 Negative readings, 60 Positive readings across Multi-card, Cassette, Cup, Dipcard.
878 concentration: 0 Negative readings, 60 Positive readings across Multi-card, Cassette, Cup, Dipcard.
1062 concentration: 0 Negative readings, 60 Positive readings across Multi-card, Cassette, Cup, Dipcard.
1361 concentration: 0 Negative readings, 60 Positive readings across Multi-card, Cassette, Cup, Dipcard.

METHOD COMPARISON results (for Dip, Cassette, Cup, Multi drug dip):
Candidate Device Result (+): 0 Negative (NO DRUG), 0 Negative (

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

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KC13/069

MAY 1 4 2014 Page 1 of 6

510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

Manufacturer & Submitter:

Contact:

Phamatech Inc. 10151 Barnes Canyon Road San Diego, California 92121, USA Carl A. Mongiovi Vice President Telephone 858 643 5555 Fax 858 635 5843

Date Prepared 5/08/2014

QuickScreen Drug Screening Test System Proprietary Name:

Common Name: Drug of Abuse Rapid Test System

Description: Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine

Classification Names:

The applicant test system regulatory classification is Class II, Classification Panel is Clinical Toxicology (91). Requlatory information applicable to this test system is provided below:

21 CFR 862.3100 Amphetamine test system Product Code: DKZ

Predicate Device: QuikStrip OneStep Amphetamine Test - Syntron Bioresearch Predicate 510(k) #: K971218

Intended Use:

QuickScreen™ Amphetamine 500 Test Model 9058 (dip card)

The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only.

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

1

judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

QuickScreen™ Amphetamine 500 Test Model 9054 (cassette)

The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only.

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 iudgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

QuickScreen ™ Multi Drug Screening Test Model 9346T(dip card)

The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinquish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only.

Amphetamine (d amphetamine) 500 ng/ml Cocaine (benzovlecgonine) 150 ng/ml Methamphetamine (d methamphetamine) 500 ng/ml Opiates (morphine) 300 ng/ml PCP (phencyclidine) 25 ng/ml Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines (Oxazepam) 200 ng/ml Methadone (Methadone) 300 ng/ml Oxycodone (Oxvcodone) 100 ng/ml THC (Cannabinoids) 50 ng/ml

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.

QuickScreen™ Drug Cup Model 9346Z

2

The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only.

Amphetamine (d amphetamine) 500 ng/ml Cocaine (benzovlecgonine) 150 ng/ml Methamphetamine (d methamphetamine) 500 ng/ml Opiates (morphine) 300 ng/ml PCP (phencvclidine) 25 ng/ml Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines (Oxazepam) 200 ng/ml Methadone (Methadone) 300 ng/ml Oxycodone (Oxycodone) 100 na/ml THC (Cannabinoids) 50 ng/ml

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.

Similarities and differences to predicate device:

The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech QuickScreen At Home Drug Test and the Phamatech QuickScreen Pro Multi Drug Screening Test. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.

| | QuikStrip™ OneStep
Amphetamine 500 Test | QuickScreen™
Drug Screening Test System |
|-----------------|--------------------------------------------|--------------------------------------------|
| 510(k) # | K971218 | K131069 |
| Format | Dip Card | Integrated Cup/Dip Card/Cassette |
| Intended Use | Detection of
drugs of abuse | Detection of
drugs of abuse |
| Specimen | Urine | Urine |

3

MethodologyLateral flow ImmunoassayLateral flow Immunoassay
QualitativeYESYES
AntibodiesMonoclonal / PolyclonalMonoclonal / Polyclonal
Analyte's
detected110
Cutoffs
(ng/ml)AMP 500AMP 500
Cocaine: 150
THC: 50
Opiates: 300
PCP: 25
MET: 500
BZD: 200
Barb: 200
MTD: 300
OXY 100
Incubation5 minutes10 minutes
ControlControl LineControl Line
FeaturesTest Expired IndicatorTest Expired Indicator
End UserPoint of Care UsePoint of Care Use

The QuickScreen Drug Testing System of this current 510(k) is similar to the version cleared in K103295. except for a change in amphetamine cutoff concentration. The cutoff concentration for amphetamine in K103295 was 1000 ng/ml. The cutoff concentration for amphetamine in this current 510(k) is 500 ng/ml. New performance studies for this current 510(k) were only conducted to support a 500ng/ml cutoff concentration for amphetamines. See K103295 for performance of all other analytes: barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites.

The following laboratory performance studies were performed to determine substantial equivalence of the QuickScreen Drug Screening Test system to the predicate:

Performance of the QuickScreen Drug Screening Test System around the cutoff for amphetamine was evaluated by testing standard drug solutions diluted in drug free urine at 3 sites by 2 technicians in card, cup and cassette formats for a period of 20 days. The results are summarized below.

Conc.Multi-cardCassetteCupDipcard
NegPosNegPosNegPosNegPos
Negative60060()600600
100.8660060()600800
211.260O60()600600
286.2260O600600600

SENSITIVITY / PRECISION - Summary of all sites

4

Cutoff1050382238223822
583.3060060060060
878060060060060
1062060060060060
1361060060060060

METHOD COMPARISON - The performance of the QuickScreen Drug Screening Test System was evaluated at three locations by typical operators at each site. Operators tested 106 unaltered clinical samples. These samples were blinded and sufficiently randomized. Results were compared to GC/MS testing. Those results are presented below.

| Candidate
Device Result | | Negative:
NO DRUG | Negative
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