FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD

K122752 · Branan Medical Corp. · JXN · Jan 30, 2013 · Clinical Toxicology

Device Facts

• Record ID: K122752
• Device Name: FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
• Applicant: Branan Medical Corp.
• Product Code: JXN · Clinical Toxicology
• Decision Date: Jan 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3700
• Device Class: Class 2

Indications for Use

The Fastect® II PPX Drug Screen Dipstick is lateral flow immunoassay in vitro diagnostic screen test for qualitative detection of propoxyphene at or above 300ng/ml in human urine. The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay in vitro diagnostic screen tests for the qualitative detection of cocaine (at or above 300ng/ml), opiates (at or above 300ng/ml), methamphetamine (at or above 500ng/ml), THC (at or above 50ng/ml), amphetamine (at or above 1000ng/ml), phencyclidine (at or above 25ng/ml), benzodiazepines (at or above 300ng/ml), barbiturates (at or above 300ng/ml), methadone (at or above 300ng/ml), tricyclic antidepressants (at or above 1000ng/ml), MDMA (at or above 500ng/ml), oxycodone (at or above 100ng/ml), buprenorphine (at or above 10ng/ml), or propoxyphene (at or above 300ng/ml) in human urine. It is for prescription point-of-care use and not intended for over-the-counter sale to non-professionals.

Device Story

Lateral flow immunoassay devices (dipsticks/dipcards) for qualitative drug screening in human urine. Principle: competitive immunoassay; immobilized drug conjugate competes with drug in urine for limited antibody binding sites. User dips device into urine sample; visual qualitative results appear on membrane strip. Includes internal procedural control band to validate test completion. Used in point-of-care settings by healthcare professionals. Provides preliminary results; positive findings require confirmatory testing via GC/MS or LC/MS. Assists clinicians in rapid drug screening; supports clinical decision-making when combined with professional judgment.

Clinical Evidence

Bench testing only. Precision studies conducted at three point-of-care sites using spiked urine samples at various concentrations relative to cutoff. Method comparison study evaluated 84 urine specimens against GC/MS reference method. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay. Uses mouse monoclonal antibodies against propoxyphene. Qualitative visual readout. No instrumentation required. Shelf life 24 months at 15-30°C. Analyte cutoff 300 ng/mL.

Indications for Use

Indicated for rapid, qualitative, in vitro diagnostic screening of propoxyphene and other specified drugs/metabolites in human urine at defined cutoff concentrations. Intended for prescription point-of-care use by professionals. Preliminary results require confirmation by GC/MS or LC/MS.

Regulatory Classification

Identification

A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A propoxyphene 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 MULTI-CLIN Drug Screen Test Device (k041685)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k122752

B. Purpose for Submission:
New device and addition of new analyte

C. Measurand:
Propoxyphene (PPX)

D. Type of Test:
Qualitative, immunochromatographic

E. Applicant:
Branan Medical Corporation

F. Proprietary and Established Names:
QuickTox® Drug Screen Dipcard
Fastect® II PPX Drug Screen Dipstick
Fastect® II Drug Screen Dipstick

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JXN | II | 862.3700 – Propoxyphene test system | 91-Toxicology |

H. Intended Use:

1. Intended use(s):
See indications for use below

2. Indication(s) for use:
The Fastect® II PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL.
The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are

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lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

| THC | 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
| --- | --- | --- |
| COC | Benzoylecgonine | 300 ng/ml |
| OPI | Morphine | 300 ng/ml |
| MET | Methamphetamine | 500 ng/ml |
| AMP | Amphetamine | 1000 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| BAR | Secobarbital | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 ng/ml |
| OXY | Oxycodone | 100 ng/ml |
| BUP | Buprenorphine | 10 ng/ml |
| PPX | Propoxyphene | 300 ng/ml |

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to non-professionals.

These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickTox® Drug Screen Dipcard, Fastect® II Drug Screen Dipstick or Fastect® II PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical Consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.

3. Special conditions for use statement(s):

These tests are for prescription point-of-care use only and not intended for over-the-counter use.

4. Special instrument requirements:

Not applicable

I. Device Description:

The Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene contain multiple drugs and drug metabolites in addition to Propoxyphene. Propoxyphene is added as a new analyte. The Fastect® II PPX Drug Screen Dipstick only contains the propoxyphene analyte. All dipstick and dipcard devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and all devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the

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drug present in urine for limited antibody binding sites.

The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Propoxyphene in human urine at a cutoff concentration of 300 ng/ml. These tests can be performed without the use of any additional instruments.

A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

ACON MULTI-CLIN Drug Screen Test Device

2. Predicate K number(s):

k041685

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Feature | Candidate Devices
(QuickTox® Drug Screen Dipcard, Fastect® II PPX Drug Screen Dipstick and Fastect® II Drug Screen Dipstick) | Predicate Device
(ACON® multi-CLIN™ Drug Screen Test Device k041685) |
| Intended Use | Screening Device | Same |
| Matrix | Human Urine | Same |
| Test Principle | Competitive immunoassay | Same |
| Analytes | Propoxyphene | Same |
| Cut-Off | 300 ng/ml | Same |
| Sample Volume | 10 ml | Same |
| Target User Population | For professional point of care | Same |
| Shelf Life | 24 Months | Same |
| Testing Method | Lateral Flow Immunoassay | Same |
| Antibody/Antigen | Mouse monoclonal antibody PPX antigen | Same |

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| Differences | | |
| --- | --- | --- |
| Feature | Candidate Devices
(QuickTox® Drug Screen Dipcard and Fastect® II Drug Screen Dipstick) | Predicate Device
(ACON® multi-CLIN™ Drug Screen Test Device k041685) |
| Test Strip | Single Drug/Multi-Drug | Multi-Drug |
| Product Design | Dip method | Dip method and drop method |
| Storage | Sealed pouch at 15-30°C | Sealed pouch at 2-30°C |
| Reading Time | 5-30 minutes | 5-8 hours |
| Internal Procedural Controls | Negative control line | Positive and negative control lines |

K. Standard/Guidance Document Referenced (if applicable):

None were referenced

L. Test Principle:

The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene are based on the principle of highly specific immunochemical reactions between antigens and antibodies. All dipstick and dipcard devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision studies were performed over ten days at three point-of-care sites using drug-free normal urine spiked with drug standards to the following concentrations: cutoff, $\pm 25\%$, $\pm 50\%$, $\pm 75\%$ and $\pm 100\%$ of the cutoff. A total of 30 samples were tested at cutoff, $\pm 25\%$, $\pm 50\%$, $\pm 75\%$ and $\div 100\%$ cutoff levels, respectively. A total of 60 samples were tested at negative (zero) level. Sample concentrations were confirmed by GC/MS. The intended users performed the testing by following the instructions for use.

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PPX measured by QuickTox® Drug Screen Dipcard

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 |
| -75% | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| -50% | 10 | 0 | 10 | 0 | 9 | 1 | 29 | 1 |
| -25% | 9 | 1 | 8 | 2 | 9 | 1 | 26 | 4 |
| Cutoff | 4 | 6 | 3 | 7 | 7 | 3 | 14 | 16 |
| +25% | 2 | 8 | 0 | 10 | 3 | 7 | 5 | 25 |
| +50% | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| +75% | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| +100% | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |

PPX measured by Fastect® II Drug Screen Dipsticks

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 |
| -75% | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| -50% | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| -25% | 9 | 1 | 8 | 2 | 8 | 2 | 25 | 5 |
| Cutoff | 6 | 4 | 1 | 9 | 7 | 3 | 14 | 16 |
| +25% | 2 | 8 | 1 | 9 | 2 | 8 | 5 | 25 |
| +50% | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| +75% | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| +100% | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |

b. Linearity/assay reportable range:

Not applicable, the devices are intended for qualitative use.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of the drug or its metabolites. The appearance of the control band during testing indicates that the test has completed and the test is valid.

Device Stability:

Accelerated studies have been conducted for one lot of Fastect® II Drug Screen Dipsticks and two lots of QuickTox® Drug Screen Dipcard kits. The manufacturer claims that when stored at room temperature (15 - 30 °C), the product is stable for 24 months. Real time studies have been conducted to support a shelf life of 24 months at room temperature. Stability protocols and acceptance criteria were reviewed and considered acceptable.

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Sample Storage and Stability:

Urine specimens may be refrigerated at 2-8°C for up to two days.

d. Detection limit:

Not applicable, this is a qualitative assay.

e. Analytical specificity:

Analytical specificity was established by spiking structurally related compounds into negative human urine. The lowest amount of compounds required to produce a positive response in Fastect® II Drug Screen Dipsticks and QuickTox® Drug Screen Dipcard and their corresponding % cross reactivity are displayed below.

| Compound | Concentration | % cross reactivity |
| --- | --- | --- |
| Propoxyphene | 300 ng/mL | 100% |
| Norpropoxyphene | 500 ng/mL | 60% |

Potential interference from structurally unrelated and endogenous compounds was tested by spiking the potentially interfering compound into ±50% of cutoff urine controls at a concentration of 100,000 ng/mL. No negative or positive interference was observed for the following compounds except furosemide in this study.

Acetaminophen (4-Acetamidophenol; APAP; N-Acetyl-p-aminophenol), Acetone, Acetylsalicylic acid (Aspirin), Albumin, Amoxapine, Amoxicillin, Ampicillin, l-Ascorbic Acid (Vitamin C), Aspartame, Atropine, Benzocaine (Ethyl p-Aminobenzoate), Bilirubin, d-Brompheniramine, Caffeine, Chloroquine, d,l-Chlorpheniramine, Chlorpromazine, l-Cotinine, Creatine, Creatinine, Cyclobenzaprine, Desipramine, Dextromethorphan, 4-Dimethylaminoantipyrine, Diphenhydramine, Dopamine (3-Hydroxytyramine), Doxylamine, l-Ephedrine, d,l-Ephedrine, l-Epinephrine, Erythromycin, Ethanol, 2-Ethylidene-1,5-Dimethyl-1-3,3-Diphenylpyrrolidone, Furosemide*, Gentisic acid, Glucose, Guaiacol, Glyceryl Ether, Hemoglobin, Hippuric acid, Hydrochlorothizide, Hydrocodone, Hydromorphone, Ibuprofen, Lidocaine, Methaqualone, Methoxyphenamine, Methylphenidate, Methadone, Nalidixic acid, Naloxone, d-Naproxen, Niacinamide, Norethindrone, Oxalic acid, Oxolinic acid, Papaverine, Penicillin-G (Benzylpenicillin), Pentazocine, Perphenazine, Pheniramine, Phenothiazine (Thiodiphenylamine), Phenylephrine, β-Phenylethylamine, Procaine, Promethazine, Quinidine, Ranitidine, Riboflavin, Salicylic acid, Serotonin, Sodium Chloride, Sulfamethazine, Sulindac, Thiamine, Trimethobenzamide, Thioridazine, Trifluoperazine, Trimipramine Maleate, Tryptamine, d,l-Tryptophan, Tyramine, d,l-Tyrosine, Uric Acid, Verapamil, Zomepirac.

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Possible false negative result for PPX may be observed for Furosemide at $\geq 60,000\ \mathrm{ng/mL}$

The effects of pH and specific gravity of the specimen on the performance of QuickTox® Drug Screen Dipcard and Fastect® II Drug Screen Dipstick test kits at $\pm 50\%$ of the cutoff levels were also tested. The results demonstrated no interference to results with pH range of 4.5-8.5 and specific gravity range of 1.005 to 1.030.

f. Assay cut-off:

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, M.1.a, above.

2. Comparison studies:

a. Method comparison with predicate device:

A total of 84 urine specimens were evaluated with the QuickTox® Drug Screen Dipcard and Fastect® II Drug Screen Dipsticks devices. Of these 84 urine specimens, 42 were negative urine samples with 5 of them between cut-off and $-50\%$ cut-off levels. 42 were positive urine samples with 7 of them between cut-off and $+50\%$ cut-off levels. Both the QuickTox® Drug Screen Dipcard and Fastect® II Drug Screen Dipstick devices were compared against the values obtained through GC/MS analysis. The results are presented in the table below:

| Candidate Device | Candidate Device Results | Clinical Urine Cut-off (CO) Concentrations | | | |
| --- | --- | --- | --- | --- | --- |
| | | -100% to <-50% | ≥ -50% to < CO | ≥CO to <+50% | ≥ +50% |
| QuickTox® Drug Screen Dipcard | Positive | 0 | 2 | 5 | 35 |
| | Negative | 37 | 3 | 2 | 0 |
| Fastect® II Drug Screen Dipsticks | Positive | 0 | 2 | 7 | 35 |
| | Negative | 37 | 3 | 0 | 0 |

b. Matrix comparison:

Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

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b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

The sponsor performed an optimal read time evaluation by testing 5 levels of urine controls in 20 replicates per level using both dip stick and dip card devices. The test results supported a reading time of 5 to 60 minutes. The sponsor chose a more conservative reading time of 5 to 30 minutes in their product inserts.

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

Not applicable.

N. Proposed Labeling:

The labeling is sufficient and does satisfy the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and does support a substantial equivalence decision.