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.

Device 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.

AI/ML Overview

The provided document describes the Polymed Therapeutics' Fastep™ Dipstick and Dipcard Drugs of Abuse Screen Devices. Here's an analysis of the acceptance criteria and study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against its ability to detect specific drugs of abuse in human urine at defined cutoff concentrations. The performance is assessed by comparing its results to confirmed analytical methods (GC/MS and/or LC/MS) and a predicate device. While explicit "acceptance criteria" are not numerically stated in the provided text (e.g., "sensitivity must be >95%"), the reported performance indicates that it demonstrated "substantial equivalence" to the established confirmatory methods and predicate devices for all specified drugs. This "substantial equivalence" effectively serves as the acceptance criterion in the context of a 510(k) submission.

Analyte	Abbreviation	Cutoff (ng/ml)	Reported Device Performance (vs. GC/MS, LC/MS and Predicate)
Amphetamine	AMP	1000	Substantial equivalence demonstrated
Benzodiazepines	BZO	300	Substantial equivalence demonstrated
Cocaine	COC	300	Substantial equivalence demonstrated
Marijuana	THC	50	Substantial equivalence demonstrated
Morphine	MOR	2000	Substantial equivalence demonstrated
Phencyclidine	PCP	25	Substantial equivalence demonstrated
Ecstasy	MDMA	500	Substantial equivalence demonstrated

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "blind-labeled clinical specimen correlation study" and "blind-labeled spiked control studies." However, specific sample sizes for these test sets are not provided in the given text.

The data provenance is not explicitly stated. The term "clinical specimen" suggests human-derived samples, but their geographic origin (country) and whether they are retrospective or prospective are not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the test set was established by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are analytical laboratory methods, not human expert evaluations for establishing ground truth in this context. Therefore, no human experts were used in this specific manner for ground truth establishment.

4. Adjudication Method for the Test Set

Since the ground truth was established by instrumental analytical methods (GC/MS/LC/MS), there was no adjudication method involving human experts for the test set. The analytical results from GC/MS/LC/MS are considered definitive.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study in the document. This device is a rapid chromatographic immunoassay, not an AI-powered diagnostic imaging or interpretation tool that would typically involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is an immunoassay that provides a qualitative result. It is inherently a "standalone" device in that its performance is judged on its own ability to detect the drugs without human-in-the-loop interpretation beyond reading the visual result (which is a standard part of such tests). The studies described ("clinical specimen correlation study" and "spiked control studies") evaluate the performance of the device itself.

7. The Type of Ground Truth Used

The type of ground truth used was confirmed analytical results from Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are objective, gold- standard laboratory methods for drug detection and quantification.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. Immunoassays like this are typically developed and validated using a series of experiments (which could be considered part of a broader development/training phase), but the specific terminology of "training set" as used in machine learning is not applicable here. The presented studies seem to focus on the validation/test phase of the device.

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

As no explicit "training set" is mentioned in the machine learning sense, the method for establishing its ground truth is also not described. If we consider the broader development process, the ground truth for establishing the performance characteristics of the assay (e.g., setting cutoffs, ensuring specificity) would also rely on confirmed analytical methods like GC/MS and LC/MS.

Summary

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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:

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
Panel: Toxicology (91)

Applicant and Initial Importer:

Polymed Therapeutics. Inc. 3040 Post Oak Blvd., Ste 1110 Huston, TX 77056 Tel.: (713) 777-7088 Fax: (713) 777-7091

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: (301) 250-0831 Fax: (301) 916-6213 ixia@lsi-consulting.org Alternate Only: Terri Wallace Polymed Therapeutics, Inc 3040 Post Oak Blvd., Ste 1110 Houston, TX 77056 Tel.: (713) 777-7088 Fax: (713) 777-7091 terri@polymedt.com

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:

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' FastepDipstick Drugs of Abuse Screen Deviceand Polymed Therapeutics' FastepDipcard Drugs of Abuse Screen Device	Acon PredicateDevices
Intended Use	Qualitative detection of amphetamine,benzodiazepines, cocaine, THC,morphine, PCP,and MDMA	Same
Sample Type	Urine	Same
Methodology	Qualitative lateral flow chromatographicimmunoassay	Same
Assay Cutoffs(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 laboratoriesonly	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 (800) 638-2041 or (301) 796-7100 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:

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

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

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).