92 Frequently Asked Questions on the New 510(K) Paradigm - Medtox

Opiate (Morphine) Cutoff = 100 ng/mLConc. (ng/mL) Number Tested Positive NegativeNegative 540 0 54025 45 20 2550 45 38 775 45 44 1100 45 45 0125 45 44 1150 45 43 2Oxycodone Cutoff = 100 ng/mLConc. (ng/mL) Number Tested Positive NegativeNegative 54 0 5425 54 0 5450 54 4 5075 54 40 14100 54 50 4125 54 53 1150 54 54 0Phencyclidine (Phencyclidine) Cutoff = 25 ng/mLConc. (ng/mL) Number Tested Positive NegativeNegative 540 0 5406.25 45 1 4412.50 45 0 4518.75 45 17 2825.00 45 43 231.25 45 43 237.50 45 44 1Propoxyphene (Norpropoxyphene) Cutoff = 300 ng/mLConc. (ng/mL) Number Tested Positive NegativeNegative 45 0 4530 45 0 4575 45 1 44150 45 9 36225 45 16 29300 45 37 8375 45 42 3450 45 44 1600 45 45 0Cannabinoids (11-nor-9-carboxy-Δ 9 -THC) Cutoff = 40 ng/mLConc. (ng/mL) Number Tested Positive NegativeNegative 105 0 10510 45 0 4520 45 0 4530 45 1 4440 45 45 050 45 40 560 45 45 0Cutoff Characterization (Buprenorphine)Performance around the specific cutoff for Buprenorphine was evaluated by testing standard drug solutions diluted in drug-free urine in triplicate by 10 in-house operators. Drug-free urine wasalso tested by each individual. The results were interpreted at five minutes and shown below:MEDTOX ® Buprenorphine Cutoff Chracterization ResultsConcentration of sampleNumber of# Positive # Negative(ng/mL)determinations0 30 0 302.5 30 0 305.0 30 0 307.5 30 9 2110 30 20 1012.5 30 29 115 30 29 113B. Non Crossreactive Endogenous CompoundsListed compounds were initially dissolved in appropriate solvents and then added to drug-free urine for evaluation with all SURE-SCREEN tests. Most of thecompounds were evaluated for reactivity with the SURE-SCREEN tests at 100 µg/mL (albumin was evaluated at 20 mg/mL and bilirubin was evaluated at 200μg/mL). Samples were evaluated in triplicate by in-house operators. The listed compounds gave negative results with all of the SURE-SCREEN tests.Acetaldehyde Creatinine Hemoglobin, HumanAcetone Epinephrine Sodium ChlorideAlbumin, Human β-Estradiol TetrahydrocortisoneBilirubin Estriol d,1-ThyroxineCholesterol Glucose Std. Solution Uric AcidPage 7 of 11