POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
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)
Related Devices
- K061005 — ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS · Applied Dna Technologies, Inc. · Oct 4, 2006
- K012541 — MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET · Branan Medical Corp. · Sep 4, 2001
- K023489 — QUICKTOX MULTIPLE DRUG DIPCARD · Branan Medical Corp. · Dec 16, 2002
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k121065
B. Purpose for Submission:
New device
C. Measurand:
Amphetamine, Benzodiazepines, Cocaine, Marijuana, Morphine, Phencyclidine, MDMA (Ecstasy)
D. Type of Test:
Qualitative lateral flow chromatographic immunoassay
E. Applicant:
Polymed Therapeutics, Inc
F. Proprietary and Established Names:
Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics Fastep Dipcard Drugs of Abuse Screen Device
G. Regulatory Information:
| Product Code | Classification | Regulation section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 862.3100 | Toxicology (91) |
| JXM | | 862.3170 | |
| DIO | | 862.3250 | |
| LDJ | | 862.3870 | |
| DJC | | 862.3610 | |
| LCM | | unclassified | |
| DNK | | 862.3640 | |
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H. Intended Use:
1. Intended use(s):
Refer to Indications for Use
2. Indication(s) 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-Methylenedioxy-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.
3. Special conditions for use statement(s):
For prescription use in central laboratories only
4. Special instrument requirements:
Not applicable; this is a visually read single use device
I. Device Description:
The devices incorporate a one-step, colloidal gold based immunochromatographic strip for the rapid, qualitative detection of Marijuana, Cocaine, Phencyclidine, Morphine, Amphetamine, Benzodiazepines, and MDMA (Ecstasy) in human urine. The Dipstick device consists of a single strip, and the Dipcard device consists of one or more strips held by a card.
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J. Substantial Equivalence Information:
1. Predicate device name(s):
ACON One Step Drug Screen Tests
2. Predicate 510(k) number(s):
Amphetamine k011673
Benzodiazepine k012300
Cocaine k010841
THC k003557
Morphine 2000 k011353
PCP k011730
MDMA k022589
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Qualitative detection of amphetamine, benzodiazepines, cocaine, THC, morphine, PCP, and MDMA | Same |
| Sample Type | Urine | Same |
| Methodology | Qualitative lateral flow chromatographic immunoassay | Same |
| Cutoff (ng/mL) | Amphetamine 1000
Benzodiazepines 300
Cocaine 300
THC 50
Morphine 2000 2000
PCP 25
MDMA 500 | Same |
| Read Time Window | 5 – 10 minutes | Same |
| Storage | 2 – 30° C | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Users | Prescription use in central laboratories only | Point of care use |
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K. Standard/Guidance Document Referenced (if applicable):
None referenced.
L. Test Principle:
The Fastep Dipstick and Dipcard Drugs of Abuse Screen Devices are one-step immunoassays in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The single and multi-test device contains one or more than one test strips in the cassette or dip card. The drug-protein conjugates are pre-coated on the test band of the membrane and the drug antibody-colloidal gold conjugate pads are placed at one end of the membrane. In the absence of drugs in the urine, the solution of the colored antibody-colloidal gold conjugates move along with the sample solution upward chromatographically by capillary action across the membrane to the immobilized drug-protein conjugate zones on the test band region. The colored antibody-gold conjugates then attach to the drug-protein conjugates to form visible lines as the antibodies complex with the drug conjugates. Therefore, the formation of the visible precipitant in the test band occurs when the test urine is negative for the drug. When drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. When a sufficient concentration of the drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody (drug-protein conjugate)-colloidal gold conjugate to the drug-protein conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result. A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has performed properly.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision for each test format was evaluated in a study conducted with three operators collecting the data in three runs per day over 17 days. This resulted in a total of 51 results per operator per each concentration for each of the seven analytes. Results are summarized below:
| | Concentration Tested | Operator1/Lot One | Operator 2/Lot Two | Operator 3/Lot Three |
| --- | --- | --- | --- | --- |
| | | Neg/Pos | Neg/Pos | Neg/Pos |
| AMP | -100% | 51/0 | 51/0 | 51/0 |
| Dipstick | -75% | 51/0 | 51/0 | 51/0 |
| Format | -50% | 51/0 | 51/0 | 51/0 |
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| | Concentration Tested | Operator1/Lot One | Operator 2/Lot Two | Operator 3/Lot Three |
| --- | --- | --- | --- | --- |
| | | Neg/Pos | Neg/Pos | Neg/Pos |
| | -25% | 40/11 | 43/8 | 41/10 |
| | Cutoff | 20/31 | 19/32 | 20/31 |
| | +25% | 11/40 | 11/40 | 9/42 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| BZO Dipstick Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 41/10 | 41/10 | 41/10 |
| | Cutoff | 20/31 | 17/34 | 18/33 |
| | +25% | 8/43 | 8/43 | 11/40 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| COC Dipstick Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 40/11 | 41/10 | 41/10 |
| | Cutoff | 21/30 | 19/32 | 20/31 |
| | +25% | 9/42 | 9/42 | 8/43 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| MOR Dipstick Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 39/12 | 42/9 | 40/11 |
| | Cutoff | 21/30 | 22/29 | 17/34 |
| | +25% | 9/42 | 8/43 | 11/40 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
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| PCP Dispstick Format | -100% | 51/0 | 51/0 | 51/0 |
| --- | --- | --- | --- | --- |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 41/10 | 39/12 | 42/9 |
| | Cutoff | 19/32 | 18/33 | 19/32 |
| | +25% | 11/40 | 11/40 | 11/40 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| THC Dipstick Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 40/11 | 39/12 | 42/9 |
| | Cutoff | 19/32 | 20/31 | 19/32 |
| | +25% | 8/43 | 6/45 | 8/43 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| MDMA Dipstick Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 41/10 | 41/10 | 41/10 |
| | Cutoff | 19/32 | 21/30 | 21/30 |
| | +25% | 8/43 | 5/46 | 9/42 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| AMP Dipcard Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 40/11 | 40/11 | 40/11 |
| | Cutoff | 19/32 | 20/30 | 18/33 |
| | +25% | 9/42 | 11/40 | 9/42 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
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| BZO
Dipcard
Format | -100% | 51/0 | 51/0 | 51/0 |
| --- | --- | --- | --- | --- |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 42/9 | 42/9 | 39/12 |
| | Cutoff | 20/31 | 20/31 | 21/30 |
| | +25% | 10/41 | 7/44 | 10/41 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| COC
Dipcard
Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 42/9 | 41/10 | 41/10 |
| | Cutoff | 18/33 | 19/32 | 19/32 |
| | +25% | 11/40 | 8/43 | 10/41 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| MOR
Dipcard
Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 41/10 | 42/9 | 42/9 |
| | Cutoff | 20/31 | 21/30 | 17/34 |
| | +25% | 10/41 | 10/41 | 11/40 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| PCP
Dipcard
Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 42/9 | 39/12 | 40/11 |
| | Cutoff | 20/31 | 20/31 | 20/31 |
| | +25% | 8/43 | 10/41 | 8/43 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
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| THC
Dipcard
Format | -100% | 51/0 | 51/0 | 51/0 |
| --- | --- | --- | --- | --- |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 41/10 | 40/11 | 42/9 |
| | Cutoff | 20/31 | 20/31 | 19/32 |
| | +25% | 8/43 | 10/41 | 8/43 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
| MDMA
Dipcard
Format | -100% | 51/0 | 51/0 | 51/0 |
| | -75% | 51/0 | 51/0 | 51/0 |
| | -50% | 51/0 | 51/0 | 51/0 |
| | -25% | 41/10 | 41/10 | 41/10 |
| | Cutoff | 20/31 | 18/33 | 19/32 |
| | +25% | 9/42 | 11/40 | 10/41 |
| | +50% | 0/51 | 0/51 | 0/51 |
| | +75% | 0/51 | 0/51 | 0/51 |
| | +100% | 0/51 | 0/51 | 0/51 |
b. Linearity/assay reportable range:
Not applicable. The assays produce qualitative results only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
These devices have internal process controls. A colored line appearing in the control region confirms sufficient sample volume and adequate membrane wicking. Users are informed that the test is invalid if a line fails to appear in the control region.
Labeling states that control materials are not supplied with this device; however it is good laboratory practice to confirm the test procedure and to verify proper test performance. Users should follow all applicable guidelines for testing QC materials.
Stability:
Accelerated and real-time studies have been conducted. Real-time studies are ongoing. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date:
When stored at 2–30 °C product is stable until the expiration date which is 24 months.
d. Detection limit:
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Analytical performance of the device around the cutoff is characterized in section a (precision/reproducibility) above.
# e. Analytical specificity:
Cross-reactivity was evaluated by spiking various concentrations of similarly structured drug compounds into drug-free urine. By analyzing various concentration of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the tables below:
| Amphetamine Drug Compound | Response equivalent to cutoff in ng/mL | % Cross- reactivity |
| --- | --- | --- |
| d-amphetamine | 1000 | 100 |
| l-amphetamine | >100,000 | <1 |
| d-methamphetamine | >100,000 | <1 |
| l-methamphetamine | >100,000 | <1 |
| 3,4-Methylenedioxyamphetamine (MDA) | 1250 | 80 |
| D,L 3,4-Methylenedioxymethamphetamine (MDMA) | >100,000 | <1 |
| 3,4- Methylenedioxyethylamphetamine(MDEA) | >100,000 | <1 |
| Phentermine | 1250 | 80 |
| Tyramine | >100,000 | <1 |
| Paramethoxyamphetamine (PMA) | 625 | 160 |
| Benzodiazepines Drug Compound | Response equivalent to cutoff in ng/mL | % Cross- reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100 |
| Alprazolam | 125 | 240 |
| Bromazepam | 625 | 48 |
| Chlordiazepoxide | 2500 | 12 |
| Clobazam | 63 | 476 |
| Clonazepam | 2500 | 12 |
| Clorazepate | 3330 | 9 |
| Desalkflurazepam | 250 | 120 |
| Diazepam | 250 | 120 |
| Estazolam | 5000 | 6 |
| Fentanyl | >100,000 | <0.3 |
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| Benzodiazepines
Drug Compound | Response equivalent to cutoff in ng/mL | % Cross-reactivity |
| --- | --- | --- |
| Flunitrazepam | 375 | 80 |
| Flurazepam | >100,000 | <0.3 |
| Lorazepam | 1250 | 24 |
| Lormetazepam | 1250 | 24 |
| Medazepam | >100,000 | <0.3 |
| Midazolam | >100,000 | <0.3 |
| Nitrazepam | >25,000 | <1.2 |
| Nordiazepam | 500 | 60 |
| Norchlordiazepoxide | 250 | 120 |
| Prazepam | >100,000 | <0.3 |
| Temazepam | 63 | 476 |
| Triazolam | 5000 | 6 |
| Cocaine
Drug Compound | Response equivalent to cutoff in ng/mL | % Cross-reactivity |
| --- | --- | --- |
| Benzoylecogonine | 300 | 100 |
| Cocaine | 1000 | 30 |
| Ecgonine | 100000 | <0.3 |
| Ecgonine Methyl Ester | >100,000 | <0.3 |
| THC
Drug Compound | Response equivalent to cutoff in ng/mL | % Cross-reactivity |
| --- | --- | --- |
| 11-Hydroxy-Δ⁹-Tetrahydrocannabinol | 50 | 100 |
| 11-Nor-Δ⁹-Tetrahydrocannabinol carboxylic acid | 50 | 100 |
| Δ⁸-Tetrahydrocannabinol | 15000 | 0.33 |
| Δ⁹-Tetrahydrocannabinol | 15000 | 0.33 |
| Cannabinol | 20000 | 0.25 |
| Cannabidiol | >100,000 | <0.05 |
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| Morphine Drug Compound | Response equivalent to cutoff in ng/mL | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 2,000 | 100 |
| Acetylcodeine | 1,563 | 128 |
| Buprenorphine | 25,000 | 8 |
| Codeine | 500 | 400 |
| Diacetyl Morphin (Heroin) | 1,250 | 160 |
| Dihydrocodeine | 1,563 | 128 |
| Ethylmorphine | 800 | 250 |
| Nalorphine Hydrochloride | >100,000 | <2 |
| Hydromorphone | 25,000 | 8 |
| Hydrocodone | 50,000 | 4 |
| Oxymorphone | >10,000 | <20 |
| Oxycodone | >20,000 | <10 |
| Merperidine | >100,000 | <2 |
| 6-Monoacetylmorphine | 1250 | 160 |
| Morphine-3-glucuronid | 12,500 | 16 |
| Rifampicine | >100,000 | <2 |
| Thebaine | 50,000 | 4 |
| PCP Drug Compound | Response equivalent to cutoff in ng/mL | % Cross-reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100 |
| Hydrocodone | 12500 | 0.2 |
| Hydromorphone | 6250 | 0.4 |
| 4-hydroxyphencyclidine | 75 | 33 |
| MDMA Drug Compound | Response equivalent to cutoff in ng/mL | % Cross-reactivity |
| --- | --- | --- |
| D,L 3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100 |
| d-amphetamine | >100,000 | <0.5 |
| l-amphetamine | >100,000 | <0.5 |
| d-methamphetamine | >100,000 | <0.5 |
| l-methamphetamine | >100,000 | <0.5 |
| 3,4-Methylenedioxyethylamphetamine(MDEA) | 156 | 320 |
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The following structurally unrelated compounds were evaluated at $+50\%$ and $-50\%$ of the cutoff for each analyte, and did not cause any negative or positive interference when tested at the concentrations listed below.
| Compound | Concentration (μg/mL) |
| --- | --- |
| Acetaminophen | 100 |
| Acetone | 200 |
| Albumin | 50,000 |
| Amitriptyline | 100 |
| Ampicillin | 100 |
| Aspartame | 100 |
| Aspirin | 100 |
| Benzocaine | 100 |
| Bilirubin | 150 |
| Caffeine | 100 |
| Chloroquine | 100 |
| Chlorpheniramine | 100 |
| Creatine | 100 |
| Dextromethorphan | 100 |
| Dextrorphan tartrate | 100 |
| 4-Dimethylaminoantiyrine | 100 |
| Dopamine | 100 |
| (+/-)-Ephedrine | 100 |
| (-)-Ephedrine | 100 |
| Erythromycin | 100 |
| Ethanol | 1000 |
| Furosemide | 100 |
| Glucose | 1200 |
| Guaiacol Glyceryl Ether | 100 |
| Hemoglobin | 200,000 |
| Ibuprofen | 100 |
| Imipramine | 100 |
| Isoproterenol | 100 |
| Lidocaine | 100 |
| Methadone | 100 |
| Methadone 2,4-dioxane | 100 |
| Methadone 2,4-dioxane | 100 |
| Methadone 2,4-dioxane | 100 |
| Methadone 2,4,5-trimethylpheniramine | 100 |
| Methadone 2,4,5-trimethylpheniramine | 100 |
| Methadone 2,4,5-trimethylpheniramine | 100 |
| Methadone 2,4,5-trimethylpheniramine | 100 |
| Methadone 2,4,5-trimethylphen | 100 |
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| Compound | Concentration (μg/mL) |
| --- | --- |
| (+)-Naproxen | 100 |
| Oxalic Acid | 100 |
| Penicillin-G | 100 |
| Pheniramine | 100 |
| Phenothiazine | 100 |
| b-Phenylethyl-amine | 100 |
| Procaine | 100 |
| Protonix | 100 |
| Pseudoephedrine | 100 |
| Ranitidine | 100 |
| Quinidine | 100 |
| Sertraline | 100 |
| Tyramine | 100 |
| Vitamin C (Ascorbic Acid) | 100 |
Evaluation of specific gravity and pH on test results:
To evaluate the effect of pH value on the test results, urine controls at 0%, 75%, 125% and 300% of the cutoff value were used. Each control level was adjusted by either NaOH or HCl solution to pH levels at 3.0, 5.0, 6.5, 7.5, and 8.5. Each test sample was tested in duplicate.
To evaluate the effect of specific gravity, urine controls at +/-25% and +/-50% of the cut-off values were spiked or diluted to obtain specific gravities in the following four ranges: 1.000 – 1.015, 1.016 – 1.025, 1.026 – 1.03, and > 1.03. Each test sample was tested in duplicate.
The testing results demonstrate that the pH and specific gravity ranges tested do not affect results around each analyte cut-off.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, above.
2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies for each test format were performed in house by trained operators. Samples were blinded and randomized before being given to the operators. The percent agreement with GC-MS ranged from a low of 85% to a high of 100%. Results are summarized below:
{13}
Amphetamine Multi-Strip Dip (MSD) (Dipcard) and Single Strip (SS) (Dipstick)
| | | Drug-Free Urine | < -50% of the cutoff | -50% of the cutoff to the cutoff | Cutoff to +50% of the cutoff | > +50% of the cutoff |
| --- | --- | --- | --- | --- | --- | --- |
| MSD | positive | 0 | 0 | 2 | 4 | 49 |
| | negative | 35 | 0 | 8 | 2 | 0 |
| SS | positive | 0 | 0 | 3 | 5 | 49 |
| | negative | 35 | 0 | 7 | 1 | 0 |
Agreement among negatives: 94%
Agreement among positives: 97%
Discordant Results - Amphetamine
| PolyMed Dipcard Result | PolyMed Dipstick Result | GC-MS Concentration (ng/mL) | Cutoff (ng/mL) |
| --- | --- | --- | --- |
| POS | POS | 813 | 1000 |
| | POS | 839 | |
| POS | POS | 861 | |
| NEG | | 1124 | |
| NEG | NEG | 1205 | |
Benzodiazepines Multi-Strip Dip (MSD) (DipCard) and Single Strip (SS) (Dipstick)
| | | Drug-Free Urine | < -50% of the cutoff | -50% of the cutoff to the cutoff | Cutoff to +50% of the cutoff | > +50% of the cutoff |
| --- | --- | --- | --- | --- | --- | --- |
| MSD | positive | 0 | 0 | 0 | 2 | 38 |
| | negative | 35 | 0 | 5 | 2 | 0 |
| SS | positive | 0 | 0 | 0 | 2 | 38 |
| | negative | 35 | 0 | 5 | 2 | 0 |
Agreement among negatives: 100%
Agreement among positives: 95%
Discordant Results - Benzodiazepines
| PolyMed Dipcard Result | PolyMed Dipstick Result | GC-MS Concentration (ng/mL) | Cutoff (ng/mL) |
| --- | --- | --- | --- |
| NEG | NEG | 367 | 300 |
| NEG | NEG | 384 | |
{14}
15
Cocaine Multi-Strip Dip (MSD) (Dipcard) and Single Strip (SS) (Dipstick)
| | | Drug-Free Urine | < -50% of the cutoff | -50% of the cutoff to the cutoff | Cutoff to +50% of the cutoff | > +50% of the cutoff |
| --- | --- | --- | --- | --- | --- | --- |
| MSD | positive | 0 | 0 | 6 | 7 | 35 |
| | negative | 35 | 0 | 7 | 0 | 0 |
| SS | positive | 0 | 0 | 8 | 7 | 35 |
| | negative | 35 | 0 | 5 | 0 | 0 |
Agreement among negatives: 85%
Agreement among positives: 100%
Discordant Results - Cocaine
| PolyMed Dipcard Result | PolyMed Dipstick Result | GC-MS Concentration (ng/mL) | Cutoff (ng/mL) |
| --- | --- | --- | --- |
| POS | POS | 171 | 300 |
| POS | POS | 178 | |
| POS | POS | 194 | |
| POS | POS | 214 | |
| | POS | 229 | |
| | POS | 231 | |
| POS | POS | 239 | |
| POS | POS | 248 | |
THC Multi-Strip Dip (MSD) (Dipcard) and Single Strip (SS) (Dipstick)
| | | Drug-Free Urine | < -50% of the cutoff | -50% of the cutoff to the cutoff | Cutoff to +50% of the cutoff | > +50% of the cutoff |
| --- | --- | --- | --- | --- | --- | --- |
| MSD | positive | 0 | 0 | 4 | 6 | 39 |
| | negative | 35 | 0 | 8 | 0 | 0 |
| SS | positive | 0 | 0 | 2 | 5 | 39 |
| | negative | 35 | 0 | 10 | 1 | 0 |
Agreement among negatives: 94%
Agreement among positives: 99%
Discordant Results - THC
| PolyMed Dipcard Result | PolyMed Dipstick Result | GC-MS Concentration (ng/mL) | Cutoff (ng/mL) |
| --- | --- | --- | --- |
| POS | | 25 | 50 |
| POS | POS | 26 | |
| POS | POS | 27 | |
| POS | | 30 | |
| | NEG | 70 | |
{15}
Morphine Multi-Strip Dip (MSD) (Dipcard) and Single Strip (SS) (Dipstick)
| | | Drug-Free Urine | < -50% of the cutoff | -50% of the cutoff to the cutoff | Cutoff to +50% of the cutoff | > +50% of the cutoff |
| --- | --- | --- | --- | --- | --- | --- |
| MSD | positive | 0 | 0 | 0 | 4 | 41 |
| | negative | 35 | 0 | 7 | 0 | 0 |
| SS | positive | 0 | 0 | 0 | 4 | 41 |
| | negative | 35 | 0 | 7 | 0 | 0 |
Agreement among negatives: 100%
Agreement among positives: 100%
Phencyclidine Multi-Strip Dip (MSD) (Dipcard) and Single Strip (SS) (Dipstick)
| | | Drug-Free Urine | < -50% of the cutoff | -50% of the cutoff to the cutoff | Cutoff to +50% of the cutoff | > +50% of the cutoff |
| --- | --- | --- | --- | --- | --- | --- |
| MSD | positive | 0 | 0 | 3 | 5 | 45 |
| | negative | 39 | 0 | 6 | 0 | 0 |
| SS | positive | 0 | 0 | 3 | 5 | 45 |
| | negative | 39 | 0 | 6 | 0 | 0 |
Agreement among negatives: 94%
Agreement among positives: 100%
Discordant Results - Phencyclidine
| PolyMed Dipcard Result | PolyMed Dipstick Result | GC-MS Concentration (ng/mL) | Cutoff (ng/mL) |
| --- | --- | --- | --- |
| POS | POS | 15 | 25 |
| POS | POS | 21 | |
| POS | POS | 21.5 | |
MDMA Multi-Strip Dip (MSD) (Dipcard) and Single Strip (SS) (Dipstick)
| | | Drug-Free Urine | < -50% of the cutoff | -50% of the cutoff to the cutoff | Cutoff to +50% of the cutoff | > +50% of the cutoff |
| --- | --- | --- | --- | --- | --- | --- |
| MSD | positive | 0 | 0 | 0 | 3 | 39 |
| | negative | 35 | 1 | 4 | 1 | 0 |
| SS | positive | 0 | 0 | 0 | 3 | 39 |
| | negative | 35 | 1 | 4 | 1 | 0 |
Agreement among negatives: 100%
Agreement among positives: 98%
{16}
Discordant Results - MDMA
| PolyMed Dipcard Result | PolyMed Dipstick Result | GC-MS Concentration (ng/mL) | Cutoff (ng/mL) |
| --- | --- | --- | --- |
| NEG | NEG | 677 | 500 |
b. Matrix comparison:
Not applicable. Urine is the only matrix that may be used with this device.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
The sponsor performed a reading time study to validate the recommended read time. The protocol and acceptance criteria were described and found to be acceptable. The labeling instructs users that negative results may be read as early as 3 minutes after sample is added. Positive results may be read from 5 - 10 minutes.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
