CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k102203 B. Purpose for Submission: New Device C. Measurand: Amphetamine, Cocaine, Methamphetamine, Morphine (OPI 300), Phencyclidine, Marijuana D. Type of Test: Qualitative lateral flow chromatographic immunoassay E. Applicant: Chemtron Biotech, Inc. F. Proprietary and Established Names: Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | DKZ | Class II | 21 CFR §862.3100: Amphetamine Test System | Toxicology (91) | | DIO | Class II | 21 CFR §862.3250: Cocaine and Cocaine Metabolites Test System | Toxicology (91) | | DJC | Class II | 21 CFR §862.3610: Methamphetamine Test System | Toxicology (91) | | DNK | Class II | 21 CFR §862.3640: Morphine Test System | Toxicology (91) | | LCM | Class II | Unclassified, Enzyme immunoassay Phencyclidine | Toxicology (91) | | LDJ | Class II | 21 CFR §862.3870: Cannabinoids Test System | Toxicology (91) | {1} H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid chromatographic immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows: | Analyte Concentration | Abbreviation | Calibrator | Cutoff | | --- | --- | --- | --- | | Amphetamine | AMP | Amphetamine | 1000 ng/ml | | Cocaine | COC | Benzoylecgonine | 300 ng/ml | | Marijuana | THC | 11-nor-Δ⁹-THC9-COOH | 50 ng/ml | | Methamphetamine | MET | Methamphetamine | 1000 ng/ml | | Opiates | OPI/MOR | Morphine | 300 ng/ml | | Phencyclidine | PCP | Phencyclidine | 25 ng/ml | The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card are intended for qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic use and prescription use ONLY. It is not intended for point-of-care settings or over the counter use. 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 methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. 3. Special conditions for use statement(s): For prescription use only. Not for Point-of-Care use {2} 4. Special instrument requirements: Not applicable, as the devices are visually-read single-use devices. I. Device Description: Chemtrue® Single/Multi Drug Screen DOA test kits has two formats: cassette and dipstick. Each kit contains 25 or 50 devices and each device contains the reagent strip(s) housed in a separate strip channel in the plastic holder. These devices are used to obtain visual qualitative results for the following analytes: amphetamine, cocaine, methamphetamine, Opiates (morphine 300) Phencyclidine, and THC. Materials Required But Not Provided: Specimen collection container, timer, external urine controls J. Substantial Equivalence Information: 1. Predicate Device Name: ACON (INNOVACON) One Step Drug Screen Test 2. Predicate 510(k) Number(s): k020771 | SIMILARITIES | | | | | --- | --- | --- | --- | | Item | | Chemtrue® Device | Predicate Kit | | Intended Use/Indications for use | | Qualitative detection of drugs-of- abuse in urine for Professional, Prescription, In Vitro Diagnostic Use Only | Same | | Specimen | | Urine | Same | | Technological Characteristics and Principle | | One-Step lateral flow competitive Immunoassay | Same | | Device Design/ Performance | Positive result | 1 colored line | Same | | | Negative result | 2 colored lines | Same | | | Detection reagent | Colloidal gold | Same | | | Accuracy Assessment | Confirm with GC/MS reference method | Same | | Cut-off | Amphetamine 1000 ng/ml | Same | | | | | Methamphetamine 1000 ng/ml | Same | | | | Cocaine 300 ng/ml | Same | | | | Marijuana (THC) 50 ng/ml | Same | | | | Phencyclidine 25 ng/ml | Same | | | | Opiates(Morphine) 300 ng/ml | Same | | Safety and Precaution | | All urine specimens should be considered potentially hazardous and handled in the same manner as infectious agent. | Same | {3} | Read time | | 5 minutes | | Same | | --- | --- | --- | --- | --- | | Storage | | 2 – 30 °C (36 – 86°F) | | Same | | DIFFERENCES | | | | | | Item | Chemtrue® Device | | Predicate Kit | | | Pre-treatment for urine specimen | Does not require pre-treatment for urine specimen. | | Urine specimen needs to be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing. | | | Time Frame of Result Stabilization | Do not read after 8 minutes. | | Results remain stable for up to 4 hours after test initiation. | | ## K. Standard/Guidance Document Referenced (if applicable): None were referenced. ## L. Test Principle: Chemtron Biotech’s Chemtrue® Single/Multi Drug Screen tests are a one-step lateral flow immunoassay containing a conjugate pad with colloidal gold conjugate with anti-drug antibodies, a nitrocellulose membrane with a test line (T) and a control line (C). The T line is coated with drug antigen bound to bovine protein and the C line is coated with goat anti-rabbit IgG antibodies. The test is a competitive binding immunoassay in which drugs and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. When a sufficient amount of sample is applied the sample migrates through the test device by capillary action. If the concentration of drug is below the cutoff level, the anti-drug antibodies in the colloidal gold particles will bind to the drug antigens coated in the test zone producing a band which indicates a negative result. If the drug concentration is at the cutoff level or higher no band will form in the test zone indicating a preliminary positive. A band should form in the control region regardless of the presence of drug or drug metabolite in the sample. ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: #### a. Precision/Reproducibility: The precision study was conducted by three operators. Three different lots were tested for all 6 analytes performed for 10 devices/lot at each control level of Negative, -50%, -25%, cut-off, +25%, and +50% of the cut-off. The study was conducted in non-consecutive 10 days using GC/MS confirmed commercial urine controls. The controls were blinded according to a random table and then evenly distributed to three operators. Each device was tested and interpreted by the same operator. The total of ten days run data were grouped into three sets: 3-day, 3-day, and 4 day. Summaries are presented in {4} the following tables: Chemtrue® Drug Screen Dip Card Test: | AMP 1000 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 8 | 0 | 13 | 0 | 9 | 0 | 30 | | -50% cutoff | 30 | 0 | 12 | 0 | 5 | 0 | 13 | 0 | 30 | | -25% cutoff | 30 | 1 | 11 | 0 | 10 | 0 | 8 | 1 | 29 | | Cutoff | 30 | 4 | 2 | 3 | 7 | 7 | 7 | 14 | 16 | | +25% cutoff | 30 | 7 | 0 | 8 | 1 | 13 | 1 | 28 | 2 | | +50% cutoff | 30 | 9 | 0 | 7 | 0 | 14 | 0 | 30 | 0 | Chemtrue® Drug Screen Cassette Test: | AMP 1000 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 11 | 0 | 6 | 0 | 13 | 0 | 30 | | -50% cutoff | 30 | 0 | 6 | 0 | 9 | 0 | 15 | 0 | 30 | | -25% cutoff | 30 | 0 | 9 | 0 | 9 | 0 | 12 | 0 | 30 | | Cutoff | 30 | 2 | 8 | 3 | 4 | 7 | 6 | 12 | 18 | | +25% cutoff | 30 | 8 | 0 | 14 | 0 | 7 | 1 | 29 | 1 | | +50% cutoff | 30 | 10 | 0 | 9 | 0 | 11 | 0 | 30 | 0 | Chemtrue® Drug Screen Dip Card Test: | COC 300 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 10 | 0 | 9 | 0 | 11 | 0 | 30 | | -50% cutoff | 30 | 0 | 11 | 0 | 8 | 0 | 11 | 0 | 30 | | -25% cutoff | 30 | 0 | 10 | 0 | 7 | 0 | 13 | 0 | 30 | | Cutoff | 30 | 4 | 6 | 4 | 4 | 4 | 8 | 12 | 18 | | +25% cutoff | 30 | 3 | 0 | 13 | 1 | 10 | 3 | 26 | 4 | | +50% cutoff | 30 | 10 | 0 | 8 | 0 | 12 | 0 | 30 | 0 | Chemtrue® Drug Screen Cassette Test: | COC 300 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 8 | 0 | 10 | 0 | 12 | 0 | 30 | | -50% cutoff | 30 | 0 | 9 | 0 | 9 | 0 | 12 | 0 | 30 | | -25% cutoff | 30 | 0 | 10 | 0 | 9 | 0 | 11 | 0 | 30 | | Cutoff | 30 | 5 | 4 | 2 | 5 | 7 | 7 | 14 | 16 | | +25% cutoff | 30 | 7 | 1 | 6 | 0 | 13 | 3 | 26 | 4 | | +50% cutoff | 30 | 10 | 0 | 13 | 0 | 7 | 0 | 30 | 0 | {5} Chemtrue® Drug Screen Dip Card Test: | MET 1000 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 8 | 0 | 11 | 0 | 11 | 0 | 30 | | -50% cutoff | 30 | 0 | 11 | 0 | 8 | 0 | 11 | 0 | 30 | | -25% cutoff | 30 | 0 | 10 | 1 | 9 | 0 | 10 | 1 | 29 | | Cutoff | 30 | 6 | 6 | 3 | 4 | 4 | 7 | 13 | 17 | | +25% cutoff | 30 | 6 | 0 | 7 | 0 | 16 | 1 | 29 | 1 | | +50% cutoff | 30 | 7 | 0 | 11 | 0 | 12 | 0 | 30 | 0 | Chemtrue® Drug Screen Cassette Test: | MET 1000 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 11 | 0 | 10 | 0 | 9 | 0 | 30 | | -50% cutoff | 30 | 0 | 5 | 0 | 14 | 0 | 11 | 0 | 30 | | -25% cutoff | 30 | 0 | 13 | 0 | 5 | 1 | 11 | 1 | 29 | | Cutoff | 30 | 7 | 7 | 0 | 3 | 8 | 5 | 15 | 15 | | +25% cutoff | 30 | 8 | 1 | 8 | 1 | 12 | 0 | 28 | 2 | | +50% cutoff | 30 | 2 | 0 | 13 | 0 | 15 | 0 | 30 | 0 | Chemtrue® Drug Screen Dip Card Test: | OPI/MOR 300 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 11 | 0 | 7 | 0 | 12 | 0 | 30 | | -50% cutoff | 30 | 0 | 12 | 0 | 11 | 0 | 7 | 0 | 30 | | -25% cutoff | 30 | 0 | 4 | 0 | 8 | 1 | 17 | 1 | 29 | | Cutoff | 30 | 5 | 6 | 3 | 2 | 7 | 7 | 15 | 15 | | +25% cutoff | 30 | 7 | 1 | 11 | 0 | 10 | 1 | 28 | 2 | | +50% cutoff | 30 | 8 | 0 | 12 | 0 | 10 | 0 | 30 | 0 | Chemtrue® Drug Screen Cassette Test: | OPI/MOR 300 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 9 | 0 | 9 | 0 | 12 | 0 | 30 | | -50% cutoff | 30 | 0 | 8 | 0 | 10 | 0 | 12 | 0 | 30 | | -25% cutoff | 30 | 0 | 11 | 0 | 8 | 0 | 11 | 0 | 30 | | Cutoff | 30 | 4 | 4 | 1 | 6 | 9 | 6 | 14 | 16 | | +25% cutoff | 30 | 9 | 0 | 10 | 0 | 10 | 1 | 29 | 1 | | +50% cutoff | 30 | 9 | 0 | 10 | 0 | 11 | 0 | 30 | 0 | {6} Chemtrue® Drug Screen Dip Card Test: | PCP 25 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 8 | 0 | 9 | 0 | 13 | 0 | 30 | | -50% cutoff | 30 | 0 | 13 | 0 | 7 | 0 | 10 | 0 | 30 | | -25% cutoff | 30 | 0 | 9 | 0 | 10 | 0 | 11 | 0 | 30 | | Cutoff | 30 | 4 | 7 | 7 | 4 | 3 | 5 | 14 | 16 | | +25% cutoff | 30 | 8 | 1 | 7 | 0 | 14 | 0 | 29 | 1 | | +50% cutoff | 30 | 4 | 0 | 10 | 0 | 16 | 0 | 30 | 0 | Chemtrue® Drug Screen Cassette Test: | PCP 25 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 9 | 0 | 8 | 0 | 13 | 0 | 30 | | -50% cutoff | 30 | 0 | 10 | 0 | 6 | 0 | 14 | 0 | 30 | | -25% cutoff | 30 | 0 | 7 | 1 | 12 | 0 | 10 | 1 | 29 | | Cutoff | 30 | 7 | 4 | 3 | 6 | 4 | 6 | 14 | 16 | | +25% cutoff | 30 | 9 | 1 | 7 | 0 | 13 | 0 | 29 | 1 | | +50% cutoff | 30 | 7 | 0 | 11 | 0 | 12 | 0 | 30 | 0 | Chemtrue® Drug Screen Dip Card Test: | THC 50 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 3 | 0 | 10 | 0 | 17 | 0 | 30 | | -50% cutoff | 30 | 0 | 7 | 0 | 12 | 0 | 11 | 0 | 30 | | -25% cutoff | 30 | 0 | 9 | 0 | 6 | 0 | 15 | 0 | 30 | | Cutoff | 30 | 3 | 7 | 4 | 2 | 5 | 9 | 12 | 18 | | +25% cutoff | 30 | 13 | 1 | 12 | 1 | 2 | 1 | 27 | 3 | | +50% cutoff | 30 | 11 | 0 | 7 | 0 | 12 | 0 | 30 | 0 | Chemtrue® Drug Screen Cassette Test: | THC 50 | No. tested | 3-day | | 3-day | | 4-day | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Control Level | | + | - | + | - | + | - | + | - | | Negative | 30 | 0 | 9 | 0 | 10 | 0 | 11 | 0 | 30 | | -50% cutoff | 30 | 0 | 9 | 0 | 7 | 0 | 14 | 0 | 30 | | -25% cutoff | 30 | 0 | 9 | 0 | 9 | 0 | 12 | 0 | 30 | | Cutoff | 30 | 4 | 7 | 6 | 5 | 3 | 5 | 13 | 17 | | +25% cutoff | 30 | 7 | 0 | 7 | 1 | 13 | 2 | 27 | 3 | | +50% cutoff | 30 | 9 | 0 | 9 | 0 | 12 | 0 | 30 | 0 | b. Linearity/assay reportable range: Not applicable, the assay is intended for qualitative use. {7} c. Traceability, Stability, Expected values (controls, calibrators, or methods): This device has 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. Control standards 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. d. Detection limit: Analytical performance of the device around the cutoff is described in Section f. (Assay cut-off) below. e. Analytical specificity: A prescreen test was conducted by diluting all structurally related compounds with the negative urine pool to give a final concentration of 0.1 mg/ml and tested in 2 duplicates with test devices. For all compounds which give positive test results were retested with a 1 to 10 serially diluted solution (10μg/ml, 1μg/ml, 0.1μg/ml, etc.) to find out a rough cutoff range. The serially diluted samples were tested until the operator observes a negative result. The following compounds were tested for cross-reactivity in the drug strip: The following compounds were found to produce positive results when tested at levels greater than the concentrations (ng/ml) listed below: Amphetamine | Compounds | Concentration (ng/mL) | | --- | --- | | d-amphetamine | 1000 | | d-methamphetamine | >10000 | | l-methamphetamine | >10000 | | MDMA | >10000 | | Ephedrine | >10000 | | Pseudoephedrine | >10000 | | d,l-amphetamine | 2500 | | l-amphetamine | 100000 | | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 3000 | | Phentermine | 5000 | {8} Cocaine | Compound | Concentration (ng/mL) | | --- | --- | | Benzoylecgonine | 300 | | Cocaine | 1000 | | Cocaethylene | 20000 | Methamphetamine | Compound | Concentration (ng/mL) | | --- | --- | | d-methamphetamine | 1000 | | d,l-methamphetamine | 5000 | | d-amphetamine | >10000 | | l-amphetamine | >10000 | | Ephedrine | >10000 | | Phenylephrine | >10000 | | Pseudoephedrine | >10000 | | (+/-)-3,4-Methylenedioxymethamphetamine (d,l MDMA) | 5000 | | d,l-MDEA (Methylenedioxyethylamphetamine) | 100000 | | d,l-MDA (3,4-Methylenedioxyamphetamine) | 100000 | Opiates | Compound | Concentration (ng/mL) | | --- | --- | | Morphine | 300 | | Codeine | 300 | | Diacetyl morphine (Heroine) | 1000 | | Hydrocodone | 50000 | | Hydromorphone | 5000 | | Oxycodone | 50000 | | 6-acetlmorphine | 500 | | Procaine | 20000 | | Thebaine | 2000 | | Oxymorphone | 19000 | PCP | Compounds | Concentration (ng/mL) | | --- | --- | | Phencyclidine | 25 | | Pheniramine | 30000 | | Morpholine | >10000 | THC | Compounds | Concentration (ng/mL) | | --- | --- | | 11-nor-Δ9-THC-9-COOH | 50 | | 11-nor-Δ8-THC-9-COOH | 30 | 9 {9} 10 | Δ9-Tetrahydrocannabinol | 12000 | | --- | --- | | Cannabidiol | >10000 | | Cannabinol | >10000 | Interference Studies: Interference studies were performed using the dip card and cassette tests using urine controls at +/-25% and +/-50% of each analyte cut-off concentration. Potential interferences to the Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests were evaluated by adding various drugs, drug metabolites, and other compounds (structurally unrelated and endogenous compounds) that are commonly found in the urine which may interfere with testing results. All potential interferents were tested at concentrations of 100 µg/mL. Any false positive or negative results using the +/-25% cut-off urine analyte concentrations were then retested at +/-50% of the cut-off. No interferences were observed at the +/-50% of the cut-off analyte concentration. The following compounds were found not to cross react when tested at concentrations of 100µg/mL. Endogenous Compounds: Albumin, Bilirubin, Cholesterol, Creatinine, Glucose, Hemoglobin, Riboflavin Sodium Chloride, Uric Acid Structurally unrelated compounds: | Acetaminophen | Dopamine | Oxazepam | | --- | --- | --- | | Acetylsalicylic Acid | Doxylamine | Papaverine | | Amobarbital | (-)-ephedrine | Perphenazine | | Amoxicillin | l-Erythromycin | Phenelzine | | R-(-)-Apomorphine | Estradiol | Pheniramine | | L-Ascorbic Acid | Estrone | Phenobarbital | | Atropine | Ethanol | L-Phenylephrine | | Baclofen | Fenofibrate | Phenylethylamine | | Barbital | Fentanyl | Phenylproanolamine | | Benzocaine | Fotemustine | Prednisone | | Benzoic Acid | Furosemide | Promazine | | Buprenorphine | Gemfibrozil | Promethazine | | Cannabidiol | Guaiacol glyceryl ether | d-Propzyphen | | Carisoprodol | Gentisic acid | d,l Propranolol | | chloral hydrate | Hydralazine | D-Pseudophedrine | | chloramphenicol | Hydrocortisone | Pyridoxal-5-phosphate | {10} | chlordiazepoxide | 3-Hydroxytyramine | Pyridoxine | | --- | --- | --- | | (+)-chlorpheniramine | (+/-)-Isoproterenol | Pyrilamine | | Chlorpromazine | Ketamine | Pyrogallol | | Chlorprothizene | Lorazepam | Quinidine | | Clofibrate | Meprobamate | Quinine | | Clonazepam | Methapyrilene | Quinolinic Acid | | Clonidine | Methylphenidate | Salicylic Acid | | | | Secobarbital Sodium | | Cortisone | Nalidixic Acid | Sulfamethazine | | (-)-Cotinine | Naloxone | Sulindac | | Creatine hydrate | Naltrexone | Tetracycline | | Cyclobenzaprine | (+)-Naproxen | Tetrahydrozoline | | Cyclodextrin-r | Niacinamide | Thiamine | | Cyproheptadine | Nicotinic Acid | Thioridazine | | Deoxycorticosterone | Nifedipine | Tramadol | | Dextromethorphan | Nitrazepam | Triazolam | | Diazepam | 19-Norethindrone | Trifluoperazine | | Diclofenac | Norpropoxyphene | Tryptamine | | Diflunisal | Nortriptyline | Tyramine | | 4-Dimethyl-aminoantipyrine | Noscapine | Zomepirac sodium salt | | Diphenhydramine | Octopamine | | | 5,5-Diphenylhydantoin | Oxalic Acid | | Evaluation of SG and pH on test results: To evaluate the effect of pH value on the test results, urine controls at 50% and 150% of the cutoff value were used. Each control level was adjusted by either 1N NaOH solution or 1N HCl to the pH levels at 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5. Each test sample was tested in duplicates. To evaluate the effect of specific gravity, urine controls at +/-25% and +/-50% of the cut-off values were spiked with DI water or sugar to obtain specific gravities of 1.002, 1.010, 1.015, 1.020, 1.025, and 1.030. The testing results demonstrate that varying specific gravities and pH's do not affect urine testing results around each analyte cut-off. f. Assay cut-off: The assay cut-off for the six analytes (AMP, COC, MET, OPI/MOR 300, PCP {11} and THC) was determined through a reproducibility (precision) study that was performed with three lots of each product format (dip card and cassette) in ten non-consecutive days by three operators using blind coded commercial controls at negative, $50\%$ below the cut-off, $25\%$ below the cut-off, cut-off, $25\%$ above the cut-off, and $50\%$ above the cut-off levels. Results are summarized in the following tables: Testing Results of Chemtrue® Drug Screen Test Cassette: | Control Level | n | AMP | | COC | | THC | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | + | - | + | - | + | - | | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -50% of the cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -25% of the cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | Cut-off | 30 | 12 | 18 | 14 | 16 | 13 | 17 | | +25% of the cutoff | 30 | 29 | 1 | 26 | 4 | 27 | 3 | | +50% of the cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | | Control Level | n | MAMP | | PCP | | OPI (MOR) 300 | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | + | - | + | - | + | - | | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -50% of the cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -25% of the cutoff | 30 | 1 | 29 | 1 | 29 | 0 | 30 | | Cut-off | 30 | 15 | 15 | 16 | 14 | 14 | 16 | | +25% of the cutoff | 30 | 28 | 2 | 29 | 1 | 29 | 1 | | +50% of the cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | Testing Results of Chemtrue® Drug Screen Dip card: | Control Level | n | AMP | | COC | | THC | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | + | - | + | - | + | - | | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -50% of the cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -25% of the cutoff | 30 | 1 | 29 | 0 | 30 | 0 | 30 | {12} | Cut-off | 30 | 14 | 16 | 12 | 18 | 12 | 18 | | --- | --- | --- | --- | --- | --- | --- | --- | | +25% of the cutoff | 30 | 28 | 2 | 27 | 3 | 29 | 1 | | +50% of the cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | | Control Level | n | MAMP | | PCP | | OPI (MOR) 300 | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | + | - | + | - | + | - | | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -50% of the cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | | -25% of the cutoff | 30 | 1 | 29 | 0 | 30 | 1 | 29 | | Cut-off | 30 | 13 | 17 | 16 | 14 | 15 | 15 | | +25% of the cutoff | 30 | 29 | 1 | 27 | 3 | 28 | 2 | | +50% of the cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | # 2. Comparison studies: # a. Method comparison with predicate device: Performance of the Chemtron Biotech's Chemtrue® 6-panel Drug Screen Dip Card and Cassette was established by comparing the results of unaltered clinical urine samples against GC/MS. Both the cassette and dipstick versions of the test were evaluated. The correlation between testing results of Chemtrue® products and the confirmed GC/MS values of the clinical specimens were evaluated and summarized below: # Chemtrue® Drug Screen Dip card: Amphetamine (The GC/MS values contributed to the total amount of amphetamine in the specimens tested): In this study, one hundred-thirty five (135) negative and positive urine samples (0 to $63,378~\mathrm{ng / mL}$ ) were tested and compared with GC/MS. The results are summarized below: Positive Agreement: $100\%$ and Negative Agreement: $98.4\%$ | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 1 | 9 | 63 | 100 % | | (-) | 0 | 1 | 9 | 63 | 100 % | | (-) | 1 | 1 | 9 | 63 | 100 % | {13} | (-) | 48 | 14 | 0 | 0 | 98.4 % | | --- | --- | --- | --- | --- | --- | | Total | 48 | 15 | 9 | 63 | 99.3 % | One discordant result is listed below: | Cutoff Value (ng/mL) | Analyte assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | | | --- | --- | --- | --- | | | | Drug/ Metabolite | GC/MS Value (ng/mL) | | Amphetamine 1,000 | + | AMP | 996 | The concentration of this discordant result was confirmed at the cutoff level. Chemtrue® Drug Screen Test Cassette: Amphetamine (The GC/MS values contributed to the total amount of amphetamine in the specimens tested): In this study, one hundred-thirteen (113) negative and positive urine samples (0 to 63,378 ng/mL) were tested and compared with GC/MS. The results are summarized below: Positive Agreement: 100% and Negative Agreement: 98.2% | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 1 | 5 | 52 | 100 % | | (-) | 44 | 11 | 0 | 0 | 98.2 % | | Total | 44 | 12 | 5 | 52 | 99.1 % | One discordant result is listed below: | Cutoff Value (ng/mL) | Analyte assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | | | --- | --- | --- | --- | | | | Drug/ Metabolite | GC/MS Value (ng/mL) | | Amphetamine 1,000 | + | AMP | 996 | The concentration of this discordant result was confirmed at the cutoff level. Chemtrue® Drug Screen Dip card: Cocaine (The GC/MS values contributed to the total amount of benzoylecgonine in the specimens tested): In this study, one hundred-fifteen (115) negative and positive urine samples (0 to 59818 ng/mL) were tested and compared with GC/MS. The results are summarized below: Positive Agreement: 100% and Negative Agreement: 100% {14} 15 | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 0 | 10 | 51 | 100% | | (-) | 44 | 10 | 0 | 0 | 100% | | Total | 44 | 10 | 10 | 51 | 100% | Chemtrue® Drug Screen Test Cassette: **Cocaine**: Same results as obtained from the dipcard method – see description above **Chemtrue® Drug Screen Dip card**: **Methamphetamine** (The GC/MS values contributed to the total amount of methamphetamine in the specimens tested): In this study, one hundred-thirteen (113) negative and positive urine samples (0 to &gt;50,000 ng/mL), were tested and compared with GC/MS. The results are summarized below: Positive Agreement: 96.8% and Negative Agreement: 100% | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 0 | 14 | 46 | 96.8% | | (-) | 39 | 12 | 1 | 1 | 100% | | Total | 39 | 12 | 15 | 47 | 98.2% | The two (2) discordant results are listed below: | Cutoff Value (ng/mL) | Analyte assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | | | --- | --- | --- | --- | | | | Drug/ Metabolite | GC/MS Value (ng/mL) | | Methamphetamine 1000 | - | MAMP | 1050 | | Methamphetamine 1000 | - | MAMP | 3471 | The two (2) discrepant specimens were confirmed with GC/MS. The result for one specimen was close to the cutoff value. The result for the second specimen was confirmed negative using a commercially available predicate test device. **Chemtrue® Drug Screen Test Cassette**: **Methamphetamine** (The GC/MS values contributed to the total amount of methamphetamine in the specimens tested): In this study, one hundred-six (106) negative {15} and positive urine samples (0 to $&gt;50,000 \mathrm{ng/mL}$ ), were tested and compared with GC/MS. The results are summarized below: Positive Agreement: $96.4\%$ and Negative Agreement: $100\%$ | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 0 | 9 | 45 | 96.4% | | (-) | 39 | 11 | 1 | 1 | 100% | | Total | 39 | 11 | 10 | 46 | 98.1% | The two (2) discordant results are listed below: | Cutoff Value (ng/mL) | Analyte assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | | | --- | --- | --- | --- | | | | Drug/Metabolite | GC/MS Value (ng/mL) | | Methamphetamine 1000 | - | MAMP | 1050 | | Methamphetamine 1000 | - | MAMP | 3471 | The two (2) discrepant specimens were confirmed with GC/MS. The result for one specimen was close to the cutoff value. The result for the second specimen was confirmed negative using a commercially available predicate test device. # Chemtrue® Drug Screen Dip card: Opiates (Morphine)300 (The GC/MS values contributed to the total amount of morphine or codeine in the specimens tested): In this study, one hundred-nineteen (119) negative and positive urine samples (0 to $25,606~\mathrm{ng / mL}$ ) were tested and compared with GC/MS. The results are summarized below: Positive Agreement: $98.2\%$ and Negative Agreement: $98.4\%$ | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 1 | 14 | 41 | 98.2% | | (-) | 40 | 22 | 1 | 0 | 98.4% | | Total | 40 | 23 | 15 | 41 | 98.3% | The two (2) discordant results were summarized below: | Cutoff Value (ng/mL) | Analyte assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | | | --- | --- | --- | --- | | | | Drug/ | GC/MS Value | | | | Metabolite | | | (+) | 0 | 0 | 0 | | (-) | 40 | 22 | 1 | | Total | 40 | 23 | 15 | {16} The concentration of two discrepant specimens was confirmed with GC/MS to be close to the cutoff value. Chemtrue® Drug Screen Test Cassette: Opiates (Morphine)300: Same results as obtained from the dipcard method - see description above Chemtrue® Drug Screen Dip card: PCP (The GC/MS values contributed to the total amount of phencyclidine in the specimens tested): In this study, one hundred-fourteen (114) negative and GC/MS confirmed positive urine samples (0 to $&gt;2,000\mathrm{ng/mL}$ ) were tested and compared with GC/MS. The results are summarized below: Positive Agreement: $98.4\%$ and Negative Agreement: $100\%$ | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 0 | 7 | 45 | 100 % | | (-) | 53 | 9 | 0 | 0 | 100 % | | Total | 53 | 9 | 7 | 45 | 100 % | Chemtrue® Drug Screen Test Cassette: PCP: Same results as obtained from the dipcard method - see description above Chemtrue® Drug Screen Dip card: THC (The GC/MS values contributed to the total amount of 11-nor- $\Delta^9$ -THC-9-COOH in the specimens tested): In this study, one hundred-six (106) negative and positive urine samples (0 to $588~\mathrm{ng / mL}$ ) were tested and compared with GC/MS. The results are summarized below: Positive Agreement: $100\%$ and Negative Agreement: $100\%$ | | (-) | | (+) | | % Agreement with GC/MS | | --- | --- | --- | --- | --- | --- | | Chemtrue® Drug Screen Test | Low Negative by GC/MS (< -50%) | Near cutoff (Between - 50% and cutoff) | Near cutoff (Between cutoff to +50%) | High positive (> +50% cutoff) | | | (+) | 0 | 0 | 10 | 46 | 100% | | (-) | 10 | 10 | 10 | 46 | 100% | | Total | 10 | 10 | 10 | 46 | 100% | {17} 18 | (-) | 25 | 25 | 0 | 0 | 100% | | --- | --- | --- | --- | --- | --- | | Total | 25 | 25 | 10 | 46 | 100% | Chemtrue® Drug Screen Test Cassette: THC: Same results as obtained from the dipcard method – see description above 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): Not Applicable 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.