POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE

K121065 · Polymed Therapeutics, Inc. · DKZ · May 24, 2013 · Clinical Toxicology

Device Facts

• Record ID: K121065
• Device Name: POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
• Applicant: Polymed Therapeutics, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Polymed Therapeutics' Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Faster™ Divcard Drugs of Abuse Screen Device are rapid chromatographic. immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The cutoff concentrations and direct calibrator for these drugs are as follows: [Table of analytes: AMP 1000ng/mL, BZO 300ng/mL, COC 300ng/mL, THC 50ng/mL, MOR 2000ng/mL, PCP 25ng/mL, MDMA 500ng/mL]. For prescription use in central laboratories only. This assay provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

The Fastep™ Dipstick and Dipcard are lateral flow chromatographic immunoassays for rapid, qualitative detection of drugs of abuse in human urine. The device uses colloidal gold-based technology to detect specific drug analytes at defined cutoff concentrations. It is intended for use in central laboratories by professional staff. The operator applies a urine sample to the device; results are read visually within a 5-10 minute window. The device provides a preliminary screening result; positive results require confirmation via GC/MS or LC/MS. The output assists clinicians in identifying potential drug presence, supporting clinical decision-making when combined with professional judgment.

Clinical Evidence

Performance evaluated via blind-labeled clinical specimen correlation studies and blind-labeled spiked control studies. Metrics included accuracy, precision, specificity, and interference. Results demonstrated substantial equivalence to the ACON One Step DOA Screen Test panels and performance characteristics consistent with GC/MS and/or LC/MS methodology.

Technological Characteristics

Lateral flow immunochromatographic strip; colloidal gold-based. Materials include membrane with immobilized drug-protein conjugates and antibody-colloidal gold conjugate pads. Dimensions: single strip or multi-strip card. Storage: 2–30°C. Shelf life: 24 months. No electronic components; visually read.

Indications for Use

Indicated for the qualitative, simultaneous detection of one to seven drugs (AMP, BZO, COC, THC, MOR, PCP, MDMA) in human urine. Intended for prescription use in central laboratories only to provide preliminary analytical results.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• ACON One Step Drug Screen Tests (k011673, k012300, k010841, k022589, k011353, k011730, k003557)

Submission Summary (Full Text)

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

MAY 2 4 2013

The Assigned 510(k) number is: k121065

Date of Summary: May 15, 2013

Common Name: Drugs of Abuse Screening Device

#### Regulatory Information:

1. Regulation section: 21 CFR part 862 (PCP), 862.3870 (THC), 862.3250 (COC), 862.3640 (MOR), 862.3100 (AMP), 862.3170 (BZO), 862.3610 (MDMA), Drugs of Abuse 2. Classification: Class II 3. Product Codes: LDJ (THC), DIO (COC), LCM (PCP), DNK (MOR), DKZ (AMP), JXM (BZO), DJC (MDMA), Drugs of Abuse

4. Panel: Toxicology (91)

### Applicant and Initial Importer:

Polymed Therapeutics. Inc. 3040 Post Oak Blvd., Ste 1110 Huston, TX 77056 Tel.: [phone] Fax: [phone]

#### Contact Persons:

Primary Contact: J.J. Xia Correspondent for this Application Polymed Therapeutics. Inc. c/o LSI Consulting Inc 12828 Doe Lane Gaithersburg, MD 20878 Tel: [phone] Fax: [phone] [e-mail] Alternate Only: Terri Wallace Polymed Therapeutics, Inc 3040 Post Oak Blvd., Ste 1110 Houston, TX 77056 Tel.: [phone] Fax: [phone] [e-mail]

#### Identification / Product Name:

Polymed Therapeutics' Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Fastep™ Dipcard Drugs of Abuse Screen Device

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#### Description:

One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana, Cocaine, Phencyclidine, Morphine, Amphetamine, Benzodiazepines, and MDMA (Ecstasy) in human urine.

#### Intended Use:

The Polymed Therapeutics' Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Faster™ Divcard Drugs of Abuse Screen Device are rapid chromatographic. immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The cutoff concentrations and direct calibrator for these drugs are as follows:

| Analyte | Abbreviation | Direct Calibrator | Cutoff (ng/ml) |
|-----------------|--------------|-------------------------|----------------|
| Amphetamine | AMP | Amphetamine | 1000 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Morphine | MOR | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Ecstasy | MDMA | 3,4-Methylenediioxy-MET | 500 |

For prescription use in central laboratories only. This assay provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

#### Predicate Kit:

ACON One Step Drug Screen Tests are used as predicate device for Polymed Therapeutics' Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Faster™ Dipcard Drugs of Abuse Screen Device to compare their performance with the GC/MS and/or LC/MS confirmed clinical urine specimens.

510(k) numbers for predicate devices are:

| Amphetamine | k011673 |
|----------------|---------|
| Benzodiazepine | k012300 |
| Cocaine | k010841 |
| MDMA | k022589 |
| Morphine 2000 | k011353 |
| PCP | k011730 |
| THC | k003557 |

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| Similarities | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Item | The Polymed Therapeutics' Fastep<br>Dipstick Drugs of Abuse Screen Device<br>and Polymed Therapeutics' Fastep<br>Dipcard Drugs of Abuse Screen Device | Acon Predicate<br>Devices |
| Intended Use | Qualitative detection of amphetamine,<br>benzodiazepines, cocaine, THC,<br>morphine, PCP,<br>and MDMA | Same |
| Sample Type | Urine | Same |
| Methodology | Qualitative lateral flow chromatographic<br>immunoassay | Same |
| Assay Cutoffs<br>(ng/mL) | Amphetamine 1000 | Same |
| | Benzodiazepines 300 | |
| | Cocaine 300 | |
| | THC 50 | |
| | Morphine 2000 | |
| | PCP 25 | |
| | MDMA 500 | |
| Read Time Window | 5 - 10 minutes | Same |
| Storage | 2 - 30° C | Same |
| Differences | | |
| Item | Device | Predicate |
| Intended Users | Prescription use in central laboratories<br>only | Point of care use |

#### Performance:

The product performance characteristics of Polymed Therapeutics' Faster™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Fastep™ Dipcard Drugs of Abuse Screen Device were evaluated in the blind-labeled clinical specimen correlation study and in the blind-labeled spiked control studies including accuracy, precision, specificity, and interference studies. Results of these studies demonstrate substantial equivalence between Polymed Therapeutics' Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Fastep™ Dipcard Drugs of Abuse Screen Device and performance characteristics of GC/MS and/or LC/MS methodology as well as ACON's One Step DOA Test Panels.

#### Conclusion:

Results of Accuracy, Precision, Specificity, and Interference studies demonstrate substantial equivalence between Polymed Therapeutics' Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Fastep™ Dipcard Drugs of Abuse Screen Device and the ACON One Step DOA Screen Test panels. Results also demonstrate that Polymed Therapeutics' Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics' Fastep™ Dipcard Drugs of Abuse Screen Device are safe and effective in detecting Amphetamine, Benzodiazepines, Cocaine, Marijuana, Morphine, Phencyclidine, and Ecstasy in human urine specimen, for prescription use in central laboratories.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

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

May 24, 2013

Polymed Therapeutics, Inc. C/O J.J. Xia LSI Consulting Inc. 12828 Doe Lane GAITHERSBURG MD 20878

Re: K121065

Trade/Device Name: Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device, Polymed Therapeutics Fastep Dipcard Drugs of Abuse Screen Device Regulation Number: 21 CFR 862.3100

Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, JXM, DIO, LDJ, DJC, LCM, DNK Dated: May 20, 2013 Received: May 23, 2013

Dear J.J. Xia:

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 to devices that have been reclassified in accordance with the provisions of the Federal Foond, 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, l'isting 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 (see above) into either class II (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 Part 801); medical device reporting (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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2— J.J. Xia

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Katherine Serrano

For:

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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# Indications for Use

#### 510(k) Number (if known): k121065

Device Name: Polymed Therapeutics Fastep™ Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics Fastep™ Dipcard Drugs of Abuse Screen Device

Indications for Use:

Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics Fastep Dipcard Drugs of Abuse Screen Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The cutoff concentrations and direct calibrator for these drugs are as follows:

| Analyte | Abbreviation | Direct Calibrator | Cutoff (ng/mL) |
|-----------------|--------------|-------------------------|----------------|
| Amphetamine | AMP | Amphetamine | 1000 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Morphine | MOR | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Ecstasy | MDMA | 3,4-Methylenediioxy-MET | 500 |

For prescription use in central laboratories only. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

# Yung W. @han -S

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k121065