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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It doesn't typically contain detailed "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it presents performance data to show the new device performs similarly to the predicate device and is safe and effective for its intended use. The "acceptance criteria" can be inferred from the reported performance meeting the generally understood expectations for such devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that explicit formal acceptance criteria are not stated in the document, I will infer them based on the context of drug screening tests and the data presented. The primary acceptance criteria for a qualitative drug screening test revolve around its ability to accurately identify positive and negative samples relative to a confirmatory method, especially around the cutoff concentration.

Device: QuickScreen Drug Screening Test System (specifically for Amphetamine 500 ng/ml cutoff)

Performance Metric (Inferred Acceptance Criterion)	Reported Device Performance (Amphetamine 500 ng/ml)
Sensitivity / Precision (Qualitative Agreement around Cutoff): Accurately identify negative samples below cutoff. Accurately identify positive samples above cutoff.	Negative samples: All samples at 100.86 ng/ml, 211.2 ng/ml, 286.22 ng/ml tested negative (60/60 for multi-card, cassette, cup; 80/80 for dipcard at 100.86 ng/ml; 60/60 for dipcard at other concentrations). Positive samples: All samples at 583.3 ng/ml, 878 ng/ml, 1062 ng/ml, 1361 ng/ml tested positive (60/60 for all formats and concentrations).
Method Comparison (Clinical Sample Agreement with GC/MS): High concordance with GC/MS for both positive and negative samples, particularly near the cutoff. Minimize false positives and false negatives.	Overall Agreement: For samples above cutoff, the device correctly identified all as positive (22 samples in "Cutoff to +50%" and 20 in "High Positive" categories for all formats). For samples below cutoff, the device correctly identified all as negative (23 samples in "Negative: NO DRUG" and 19 in "Negative < -50% of cutoff" categories for all formats). Discordant Results: 4 samples (421.6 ng/ml, 440.2 ng/ml, 450.1 ng/ml, 454.6 ng/ml) with GC/MS values below the 500 ng/ml cutoff were reported as Positive by the device. These fall within the "Negative -50% to Cutoff" GC/MS range (250 ng/ml to 500 ng/ml). While technically "false positives" relative to the cutoff, these are expected for screening devices and are often described as "cross-cutoff" detections, indicating sensitivity. All these were within 50 ng/ml (~10%) of the cutoff concentration.
Cross-reactivity: Limited cross-reactivity with structurally related compounds at physiologically relevant concentrations. No significant interference from unrelated compounds.	Structurally Related: L-amphetamine: 5.0% cross-reactivity at 10,000 ng/ml. MDA: 50% cross-reactivity at 1000 ng/ml. MDMA: 0% cross-reactivity at 100,000 ng/ml. Unrelated Compounds: No interference observed up to 100 µg/ml.
Sample pH Effects: Performance should be stable across typical urine pH ranges.	No effect observed from pH 4.5 to 8.5 for samples at 250, 375, 625, and 750 ng/ml.
Specific Gravity Effects: Performance should be stable across typical urine specific gravity ranges.	No effect observed from 1.002 to 1.040 for samples at 250, 375, 625, and 750 ng/ml.

2. Sample Size and Data Provenance for the Test Set

Sensitivity/Precision Study (around cutoff):
- Sample Size:
  - Negative samples (various sub-cutoff concentrations): 60 samples per concentration per format (multi-card, cassette, cup) and 80 for one concentration on dipcard. Totaling: (3 formats * 3 concentrations * 60 samples) + (1 format * 1 concentration * 80 samples) = 540 + 80 = 620 samples for negative range.
  - Positive samples (various supra-cutoff concentrations): 60 samples per concentration per format. Totaling: (4 formats * 4 concentrations * 60 samples) = 960 samples for positive range.
  - Overall, a significant number of samples were tested multiple times.
- Data Provenance: The study used "standard drug solutions diluted in drug free urine." This suggests controlled laboratory samples, not clinical patient samples. The testing was performed at 3 sites by 2 technicians and repeated over a period of 20 days, indicating internal company studies. The document does not specify countries of origin, but given the manufacturer's location (San Diego, California), it's highly probable it's US-based. It is a prospective study as samples were created and tested for performance evaluation.
Method Comparison Study (clinical samples):
- Sample Size: 106 unaltered clinical samples.
- Data Provenance: "clinical samples" which implies human urine samples. Since it was conducted for a 510(k) submission in the US, it's likely US-based, although not explicitly stated. The samples were "blinded and sufficiently randomized," indicating a prospective collection and testing for this specific study.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Sensitivity/Precision Study: For this study, the "ground truth" was established by the known concentrations of the standard drug solutions prepared in drug-free urine. No human experts were required to establish this ground truth, as it was based on precise laboratory preparation.
Method Comparison Study: The ground truth for the 106 clinical samples was established by GC/MS (Gas Chromatography/Mass Spectrometry) testing. GC/MS is described as "the preferred confirmatory method" and is considered the gold standard for drug confirmation in toxicology. This is an analytical method, not determined by human experts in the typical sense (e.g., radiologists). While technicians operate GC/MS, their role is to perform the assay and interpret the machine's output, not to make a subjective expert judgment about the presence of a drug.

4. Adjudication Method for the Test Set

Sensitivity/Precision Study: There was no adjudication method described. The "ground truth" was the known concentration of the samples. The device's qualitative result (positive/negative) was compared directly to this known concentration relative to the 500 ng/ml cutoff.
Method Comparison Study: The ground truth for the clinical samples was GC/MS testing. There was no adjudication process described beyond comparing the device's qualitative result to the quantitative GC/MS result relative to the 500 ng/ml cutoff. Discordant results were simply listed and not subject to further expert panel review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) rapid test system, not an imaging device typically used by human readers for diagnosis that would benefit from an MRMC study. The "readers" here are laboratory technicians or healthcare professionals at the point of care who visually interpret a color change, not clinical experts evaluating complex data. The performance focuses on the device's accuracy against a gold standard (GC/MS), not on comparing human interpretation with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies presented are representative of standalone performance of the algorithm (the immunoassay). The device (dip card, cassette, cup) directly provides a qualitative result based on its internal chemical reactions, which is then visually read. This is the "algorithm only" performance for such a device, as there isn't a separate algorithmic component that then feeds into human interpretation in a complex way. The results presented directly reflect the device's ability to classify samples as positive or negative. The phrase "typical operators" refers to people performing the test according to instructions; their involvement is in test execution and simple visual interpretation, not complex diagnostic decision-making that would constitute "human-in-the-loop" performance in the sense of advanced AI systems.

7. Type of Ground Truth Used

Sensitivity/Precision Study: The ground truth was based on known, precisely prepared concentrations of Amphetamine in drug-free urine. This is a form of analytical truth or definitive sample preparation.
Method Comparison Study: The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) results, which is considered the gold standard confirmatory method for drug detection in urine. This is an analytical truth based on a highly accurate laboratory technique.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay, not a machine learning or AI-driven system that undergoes a separate training phase with data. Its "training" involves the development and optimization of the chemical reagents and test strip design. Therefore, the concept of a separate "training set sample size" as found in AI/ML development is not applicable here. The data presented are for performance evaluation and validation.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a "training set" and its associated ground truth is not applicable to this type of immunoassay device. The scientific and engineering principles of immunoassay development guide its design, rather than data-driven machine learning training.

Summary

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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

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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)

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

QuickScreen™ Drug Cup Model 9346Z

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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

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™ OneStepAmphetamine 500 Test	QuickScreen™Drug Screening Test System
510(k) #	K971218	K131069
Format	Dip Card	Integrated Cup/Dip Card/Cassette
Intended Use	Detection ofdrugs of abuse	Detection ofdrugs of abuse
Specimen	Urine	Urine

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Methodology	Lateral flow Immunoassay	Lateral flow Immunoassay
Qualitative	YES	YES
Antibodies	Monoclonal / Polyclonal	Monoclonal / Polyclonal
Analyte'sdetected	1	10
Cutoffs(ng/ml)	AMP 500	AMP 500Cocaine: 150THC: 50Opiates: 300PCP: 25MET: 500BZD: 200Barb: 200MTD: 300OXY 100
Incubation	5 minutes	10 minutes
Control	Control Line	Control Line
Features	Test Expired Indicator	Test Expired Indicator
End User	Point of Care Use	Point 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-card		Cassette		Cup		Dipcard
	Neg	Pos	Neg	Pos	Neg	Pos	Neg	Pos
Negative	60	0	60	()	60	0	60	0
100.86	60	0	60	()	60	0	80	0
211.2	60	O	60	()	60	0	60	0
286.22	60	O	60	0	60	0	60	0

SENSITIVITY / PRECISION - Summary of all sites

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Cutoff	50	22	22	22
583.3	60	60	60	60
878	60	60	60	60
1062	60	60	60	60
1361	60	60	60	60

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.

CandidateDevice Result		Negative:NO DRUG	Negative<-50%of cutoff	Negative-50% toCutoff	PositiveCutoff to+50%	HighPositive
Dip	+	0	0	4	22	20
	-	23	19	18	0	0
Cassette	+	0	0	4	22	20
	-	23	19	18	0	0
Cup	+	0	0	4	22	20
	-	23	19	18	0	0
Multi drug dip	+	0	0	4	22	20
	-	23	19	18	0	0

Discordant Results

Sample ID	QuickScreenTest Result	GC/MS Test Result
18	Positive	421.6
	Positive	440.2
12	Positive	450.1
73	Positive	454.6

Other technical performance tests include:

Assay Cross-reactivity:

The following cross reactivity by structurally related compounds was observed:

Substance	Concentration (ng/ml)	% Crossreactivity
d-amphetamine	500	N/A
L-amphetamine	10,000	5.0
Methylenedioxyamphetamine (MDA)	1000	50
Methylenedioxymethamphetamine(MDMA)	100,000	0

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of any and any and the comments of the contribution and the first and the first and the first and the first and the first and the first and the first and the first and the fiA- Adv. alle. Bulle 40. 4. 11-41. 481..HIS NO LE MILLE LEA LE RE RE SEMELER BERESERVE	10 Ph Ph. Ph.	contract for the conside commend and controlled and the color of the color of the collection of the color of the collection of the collection of the color of the collection o

Assay Interference from structurally un-related compounds was not observed 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 by sample pH within these ranges.

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 by sample specific gravity within these ranges.

For the reasons mentioned above, it may be concluded that Phamatech's Conclusion: QuickScreen Drug Test system is substantially equivalent to the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. The symbol on the right resembles a stylized human figure with outstretched arms, possibly representing care and protection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

May 14, 2014

PHAMATECH INC. CARL MONGIOVI VICE PRESIDENT 10151 BARNES CANYON RD SAN DIEGO CA 92121

Re: K131069

Trade/Device Name: Quickscreen™ Amphetamine 500 Test Model 9054 (cassette) Quickscreen™ Multi Drug Screening Test Model 9346T Quickscreen™ Drug Cun Model 9346Z

Quickscreen™ Amphetamine 500 Test Model 9058 (dip card) Regulation Number: 21 CFR 862.3100

Regulation Name: Amphetamine test system

Regulatory Class: 11 Product Code: DKZ Dated: April 10, 2014 Received: April 10, 2014

Dear Mr. Carl Mongiovi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (sec above) into either class 11 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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Page 2-Mr. Carl Mongiovi

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.

Sincerely yours.

Courtney H. Lias -S

Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131069

Device Name

QuickScreen Amphetamine 500 Model 9058 (dip card) QuickScreen Ampletamine 500 Test Model 9054 (cassette) QuickScreen Multi Drug Screening Test Model 9346T (dip card) QuickScreen Multi Drug Cup Model 9346Z

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

Indications for Use (Describe)

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.

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

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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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

se Johnson-lyl

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Regulation Number and Section

§ 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).