STATUS DS OXY

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT TEMPLATE A. 510(k) Number: k130650 B. Purpose for Submission: New device C. Measurand: Oxycodone D. Type of Test: Qualitative immunoassay E. Applicant: Princeton BioMeditech Corporation F. Proprietary and Established Names: Status DS™ OXY G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | DJG | Class II | 21 CFR § 862.3650, Opiates test system | 91-Toxicology | H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Status DS™ OXY is an immunochromatographic test for the qualitative detection of Oxycodone in human urine. The detection cut-off concentration of Oxycodone is 100ng/ml. The test may be read visually or by using a DXpress Reader. It is intended for clinical laboratory use only. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrophotometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the test result, particularly when preliminary positive results are obtained. {1} 3. Special conditions for use statement(s): The assay is for prescription use only. 4. Special instrument requirements: The results contained in the 510(k) were read both visually and using DXpress reader instrument. I. Device Description: The Status DS™ OXY test kit contains complete reagent components and materials to perform all the tests: - Status DS™ OXY test device containing a membrane strip and a dye pad. The membrane strip is coated with Oxycodone-protein (from a purified bovine protein source) conjugate for the test band and sheep anti-mouse antibody for the control band. The dye pads contain colloidal gold coated with monoclonal anti-Oxycodone antibody. - Disposable sample dispenser. - Instructions for use. - DXpress Reader: The DXpress reader captures an image of an inserted compatible test device and uses a software algorithm to calculate the intensity of the test line. The DXpress reader interprets test result automatically by comparing the intensity of the test line to the preset cutoff value. In addition, the software will use the presence of the control line to determine whether or not the test result is valid. J. Substantial Equivalence Information: 1. Predicate device name(s): MedTox Oxycodone 2. Predicate 510(k) number(s): k060351 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Predicate device MedTox Oxycodone (k060351) | Candidate device Status DS™OXY Oxycodone Assay | | Intended Use/Indications for Use | Qualitative detection of Oxycone in human urine | Same | | Cut-off | 100 ng/mL | Same | | Sample Type | Human urine | Same | | Test Principle | Lateral flow Immunochromatographic assay | Same | {2} | Similarities | | | | --- | --- | --- | | Item | Predicate device MedTox Oxycodone (k060351) | Candidate device Status DS^{TM}OXY Oxycodone Assay | | Test procedure | Urine sample is applied into the sample well | Same | | Control | Each strip contains procedural control line | Same | | Antibody | Mouse monoclonal anti-Oxycodone antibody | Same | | Result readout | Visual | Visual and DXpress reader | K. Standard/Guidance Document Referenced (if applicable): The sponsor did not reference any standards in this submission. L. Test Principle: The Status DS™ OXY test is an immunochromatographic assay for the rapid, qualitative detection of oxycodone present in human urine above the cutoff concentration of 100ng/mL. The test may be read visually or by using a DXpress™ Reader. The test relies on the competition between the oxycodone conjugates on the test band and the oxycodone that may be present in the urine sample to bind to the antibodies. In the test procedure, a sample of urine is placed in the Sample well of the device and is allowed to migrate upward. If oxycodone is present in the urine sample, it competes with the oxycodone conjugate which is bound to the membrane, for the limited antioxycodone antibody which is bound to the dye. If the oxycodone is above the cut off level, the oxycodone will saturate the oxycodone antibody, thus inhibiting the binding of the dye coated with oxycodone antibodies to the conjugate on the membrane. Therefore, an oxycodone positive urine sample will not generate a line in the test window, indicating a preliminary positive result, while an oxycodone negative urine sample (or sample with concentration below the cutoff) will generate a line in the test window, indicating a negative result. In addition to the test line that may appear in the test window (T), there is also a procedural control line present in the control window (C). The control line should always appear if the test is performed correctly. Polyclonal sheep anti-mouse antibody is immobilized on the control line. The monoclonal antibody-dye conjugates that migrate through this region will be captured and produce a colored line in the control window (Control line). The control line works as a procedural control, confirming that proper sample volume was used and the reagent system at the control line and the conjugate-color indicator worked. If insufficient sample volume is used, there may not be a Control line, indicating the test is invalid. {3} M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed internal precision studies by spiking Oxycodone into drug-free urine samples at various concentrations relative to the cutoff concentration (-100%, -50%, -25%, cut off, +25%, +50%, and +100%). Concentrations were confirmed using GC/MS. The results were obtained using visual reads of 3 operators and 3 DXpress readers. The study was carried using two lots in duplicates over two days. Precision Study Data - Visual Test: | | Urine Sample Concentration (ng/mL) | % Cutoff | #of Tested Devices | #of Positive | #of Negative | % Agreement | | --- | --- | --- | --- | --- | --- | --- | | Operator 1 | 0 | 0 | 40 | 0 | 40 | 100 | | | 50 | 50 | 40 | 0 | 40 | 100 | | | 75 | 75 | 40 | 0 | 40 | 100 | | | 100 | 100 | 40 | 6 | 34 | N/A | | | 125 | 125 | 40 | 37 | 3 | 92.5 | | | 150 | 150 | 40 | 40 | 0 | 100 | | | 200 | 200 | 40 | 40 | 0 | 100 | | Operator 2 | 0 | 0 | 40 | 0 | 40 | 100 | | | 50 | 50 | 40 | 0 | 40 | 100 | | | 75 | 75 | 40 | 1 | 39 | 97.5 | | | 100 | 100 | 40 | 12 | 28 | N/A | | | 125 | 125 | 40 | 38 | 2 | 90 | | | 150 | 150 | 40 | 40 | 0 | 100 | | | 200 | 200 | 40 | 40 | 0 | 100 | | Operator 3 | 0 | 0 | 40 | 0 | 40 | 100 | | | 50 | 50 | 40 | 0 | 40 | 100 | | | 75 | 75 | 40 | 0 | 40 | 100 | | | 100 | 100 | 40 | 9 | 31 | N/A | | | 125 | 125 | 40 | 37 | 3 | 92.5 | | | 150 | 150 | 40 | 40 | 0 | 100 | | | 200 | 200 | 40 | 40 | 0 | 100 | | Total | 0 | 0 | 120 | 0 | 120 | 100 | | | 50 | 50 | 120 | 0 | 120 | 100 | | | 75 | 75 | 120 | 1 | 119 | 99.2 | | | 100 | 100 | 120 | 27 | 93 | N/A | | | 125 | 125 | 120 | 112 | 8 | 93.3 | | | 150 | 150 | 120 | 120 | 0 | 100 | | | 200 | 200 | 120 | 120 | 0 | 100 | {4} Precision Study Data - Reader Test: | | Urine Sample Concentration (ng/mL) | % Cutoff | #of Tested Devices | #of Positive | #of Negative | % Agreement | | --- | --- | --- | --- | --- | --- | --- | | Reader 1 | 0 | 0 | 40 | 0 | 40 | 100 | | | 50 | 50 | 40 | 0 | 40 | 100 | | | 75 | 75 | 40 | 4 | 36 | 90 | | | 100 | 100 | 40 | 30 | 10 | N/A | | | 125 | 125 | 40 | 40 | 0 | 100 | | | 150 | 150 | 40 | 40 | 0 | 100 | | | 200 | 200 | 40 | 40 | 0 | 100 | | Reader 2 | 0 | 0 | 40 | 0 | 40 | 100 | | | 50 | 50 | 40 | 0 | 40 | 100 | | | 75 | 75 | 40 | 5 | 35 | 87.5 | | | 100 | 100 | 40 | 31 | 9 | N/A | | | 125 | 125 | 40 | 40 | 0 | 100 | | | 150 | 150 | 40 | 40 | 0 | 100 | | | 200 | 200 | 40 | 40 | 0 | 100 | | Reader 3 | 0 | 0 | 40 | 0 | 40 | 100 | | | 50 | 50 | 40 | 0 | 40 | 100 | | | 75 | 75 | 40 | 3 | 37 | 92.5 | | | 100 | 100 | 40 | 23 | 17 | N/A | | | 125 | 125 | 40 | 40 | 0 | 100 | | | 150 | 150 | 40 | 40 | 0 | 100 | | | 200 | 200 | 40 | 40 | 0 | 100 | | Total | 0 | 0 | 120 | 0 | 120 | 100 | | | 50 | 50 | 120 | 0 | 120 | 100 | | | 75 | 75 | 120 | 12 | 108 | 90 | | | 100 | 100 | 120 | 84 | 36 | N/A | | | 125 | 125 | 120 | 120 | 0 | 100 | | | 150 | 150 | 120 | 120 | 0 | 100 | | | 200 | 200 | 120 | 120 | 0 | 100 | The performance of the Status $\mathrm{DS^{TM}}$ OXY test device was also evaluated at 3 different sites by 6 operators/intended users (nurse, lead clinical assistant, laboratory supervisor, etc), 2 operators per site. Each urine sample containing concentration of $0, 50\%, 75\%, 125\%, 150\%$ , and $200\%$ of cutoff, was tested on 10 devices (5 per operator) and results obtained both visually and using DXpress reader. The urine samples were prepared by spiking a commercial standard material into drug-free urine and by serially diluting to the concentrations above. After preparation, the concentration of each level is confirmed by GC/MS. {5} For the visual test, the results of the 0, $50\%$ , $125\%$ , $150\%$ and $200\%$ cutoff concentrations showed $100\%$ agreement with the expected results. The urine samples of $75\%$ cutoff showed $80\%$ agreement. The results for the visual test are summarized in the table below: Study Data for 3 sites for Visual test: | | Urine Sample Concentration (ng/mL) | % Cutoff | #of Tested Devices | #of Positive | #of Negative | % Agreement | | --- | --- | --- | --- | --- | --- | --- | | Site 1 | 0 | 0 | 10 | 0 | 10 | 100 | | | 50 | 50 | 10 | 0 | 10 | 100 | | | 75 | 75 | 10 | 1 | 9 | 90 | | | 125 | 125 | 10 | 10 | 0 | 100 | | | 150 | 150 | 10 | 10 | 0 | 100 | | | 200 | 200 | 10 | 10 | 0 | 100 | | Site 2 | 0 | 0 | 10 | 0 | 10 | 100 | | | 50 | 50 | 10 | 0 | 10 | 100 | | | 75 | 75 | 10 | 4 | 6 | 60 | | | 125 | 125 | 10 | 10 | 0 | 100 | | | 150 | 150 | 10 | 10 | 0 | 100 | | | 200 | 200 | 10 | 10 | 0 | 100 | | Site 3 | 0 | 0 | 10 | 0 | 10 | 100 | | | 50 | 50 | 10 | 0 | 10 | 100 | | | 75 | 75 | 10 | 1 | 9 | 90 | | | 125 | 125 | 10 | 10 | 0 | 100 | | | 150 | 150 | 10 | 10 | 0 | 100 | | | 200 | 200 | 10 | 10 | 0 | 100 | | Total | 0 | 0 | 30 | 0 | 30 | 100 | | | 50 | 50 | 30 | 0 | 30 | 100 | | | 75 | 75 | 30 | 6 | 24 | 80 | | | 125 | 125 | 30 | 30 | 0 | 100 | | | 150 | 150 | 30 | 30 | 0 | 100 | | | 200 | 200 | 30 | 30 | 0 | 100 | For the DXpress™ reader test, the results of the 0, $50\%$ , $125\%$ , $150\%$ , and $200\%$ cutoff concentrations showed $100\%$ agreement with the expected results. The urine samples of $75\%$ cutoff showed $93\%$ agreement. The results for the reader test are summarized in the table below: {6} Study Data for 3 sites for Reader test | | Urine Sample Concentration (ng/mL) | % Cutoff | #of Tested Devices | #of Positive | #of Negative | % Agreement | | --- | --- | --- | --- | --- | --- | --- | | Site 1 | 0 | 0 | 10 | 0 | 10 | 100 | | | 50 | 50 | 10 | 0 | 10 | 100 | | | 75 | 75 | 10 | 2 | 8 | 80 | | | 125 | 125 | 10 | 10 | 0 | 100 | | | 150 | 150 | 10 | 10 | 0 | 100 | | | 200 | 200 | 10 | 10 | 0 | 100 | | Site 2 | 0 | 0 | 10 | 0 | 10 | 100 | | | 50 | 50 | 10 | 0 | 10 | 100 | | | 75 | 75 | 10 | 0 | 10 | 100 | | | 125 | 125 | 10 | 10 | 0 | 100 | | | 150 | 150 | 10 | 10 | 0 | 100 | | | 200 | 200 | 10 | 10 | 0 | 100 | | Site 3 | 0 | 0 | 10 | 0 | 10 | 100 | | | 50 | 50 | 10 | 0 | 10 | 100 | | | 75 | 75 | 10 | 0 | 10 | 100 | | | 125 | 125 | 10 | 10 | 0 | 100 | | | 150 | 150 | 10 | 10 | 0 | 100 | | | 200 | 200 | 10 | 10 | 0 | 100 | | Total | 0 | 0 | 30 | 0 | 30 | 100 | | | 50 | 50 | 30 | 0 | 30 | 100 | | | 75 | 75 | 30 | 2 | 28 | 80 | | | 125 | 125 | 30 | 30 | 0 | 100 | | | 150 | 150 | 30 | 30 | 0 | 100 | | | 200 | 200 | 30 | 30 | 0 | 100 | b. Linearity/assay reportable range: Not applicable. The assay is intended for qualitative use. c. Traceability, Stability, Expected values (controls, calibrators, or methods): External control materials are not supplied with this device, however controls are commercially available and are recommended in the labeling instructions to be tested at regular intervals as good laboratory testing process. The labeling instructions also recommend that a control be tested before using a new lot or a new shipment. Users are further instructed to follow their laboratory's standard Q.C. procedures, federal, state, and local guidelines when determining when to run external controls. (See Test Principle section above regarding procedural controls). {7} d. Detection limit: See precision studies above (M.1.a.) for information on test performance around the cutoff concentration. e. Analytical specificity: The cross-reactivity of the Status $\mathrm{DS^{TM}}$ OXY test with oxycodone metabolites and related compounds was evaluated by adding these to drug-free urine at various concentrations and testing these samples with test devices from two production lots. The results below are expressed in terms of the lowest concentration of metabolite or compound required to produce a positive result. Specificity: | Compound | Concentration (ng/mL) that yields a response equivalent to that of oxycodone at the cutoff concentration | Percent Cross-Reactivity (%) | | --- | --- | --- | | Oxycodone | 100 | 100 | | 6-Acetylcodeine | >100,000 | <1 | | 6-Acetylmorphine | >100,000 | <1 | | Amorphone | >100,000 | <1 | | Codeine | 1,500 | 6.7 | | Dihydrocodeine | 3,000 | 3.3 | | Dihydromorphine | 10,000 | 1 | | Ethylmorphine | 1,000 | 10 | | Heroin | >100,000 | <1 | | Hydrocodone | 5,000 | 2 | | Hydromorphone | 7,500 | 13.3 | | Levorphanol | >100,000 | <1 | | Meperidine | >100,000 | <1 | | Morphine | 5,000 | 2 | | Morphine-3b-d-glucuronide | >100,000 | <1 | | Nalorphine | >100,000 | <1 | | Naloxone | 4,000 | 2.5 | | Norcodeine | 20,000 | <1 | | Oxymorphone | 150 | 67 | | Procaine | >100,000 | <1 | | Thebaine | >100,000 | <1 | {8} 9 # Endogenous substances: The potential interference of the following endogenous compounds on the Status DS™ OXY test devices was evaluated by testing spiked urine samples. Each substance was dissolved in urine containing oxycodone at a concentration of 50% of the cutoff and 150% of the cutoff. All samples containing oxycodone at 50% of the cutoff produced negative results and all samples containing oxycodone at 150% of the cutoff produced positive results at the tested concentrations indicating no interference at those concentrations. The potential interferent concentrations tested are shown below: | Compound | Concentration (mg/dL) | | --- | --- | | Bilirubin | 2 | | Creatinine | 20 | | Glucose | 1500 | | Hemoglobin | 25 | | Protein (BSA) | 2000 | | Sodium Chloride | 1500 | | Sodium Nitrate | 100 | | Acetaldehyde | 20 | | Acetone | 60 | | Albumin | 2000 | | D,L Thyroxin | 20 | | Epinephrine | 20 | | Estriol | 10 | # Exogenous substances (Chemical/Drug Interference): The following compounds were tested to evaluate the interference of externally ingested compounds on the performance of Status DS™ OXY test device. Each compound was added into urine samples containing oxycodone at 50% cutoff and oxycodone at 150% cutoff urine samples. Potential interferents were added to a concentration of 100μg/mL and then tested in duplicate per sample with the exception of 11-Nor-9-carboxy-Δ9-THC tested at 25μg/mL and Oxazepam glucoronide which were tested at 50μg/mL. All samples with oxycodone at 150% of the cutoff gave positive results and all samples with oxycodone at 50% of the cutoff gave negative results at the tested concentration indicating no interference at those concentrations. The compounds tested for potential interference included the following: | (-) Ephedrine | dl-Tryptophan | Normeperidine | | --- | --- | --- | | (-) Isoproterenol | dl-Tyrosine | Norpropoxyphene | | (-) Norpseudoephedrine | D-Methamphetamine | Nortriptyline | | (+) Ephedrine | Domperidone | Noscapine | | (±) Ephedrine | Dopamine | Nylidin | | (-)ψ Ephedrine | Doxepin | Ofloxacin | | Δ 8-THC | Doxylamine | o-hydroxyhippuric acid | {9} | Δ 9-THC | Ecgonine | Olanzapine | | --- | --- | --- | | 11-Nor-9-carboxy-delta 8-THC | Ecgonine methyl ester | Omeprazole | | 11-Nor-9-carboxy-delta 9-THC | EDDP | Orphenadrine | | 1-hydroxy alprazolam | Efavirenz (Sustiva) | Oxalic acid | | 1-hydroxy triazolam | EMDP | Oxazepam | | 3-hydroxytyramine | Equilin | Oxazepam glucuronide | | 7-amino-clonazepam | Erythromycin | Oxolinic acid | | 7-amino-flunitrazepam | Estradiol | Oxymetazoline | | Acecainide | Estrone | p-Aminobenzoic acid | | Acetamidophenol | Ethanol | Pantoprazole | | Acetaminophen | Ethyl-p-aminobenzoate | Papaverine HCl | | Acetophenetidine | Fenfluramine | Penicillin-G | | Acetylsalicylic acid | Fenoprofen | Pentazocine | | Allobarbital | Fentanyl | Pentobarbital | | Alprazolam | Flunitrazepam | Perphenazine | | Aminoglutethimide | Fluoxetine | Phenacetin | | Aminopyrine | Flurazepam | Phencyclidine | | Amitriptyline | Furosemide | Phenelzine | | Amobarbital | Fuvoxamine | Phenethylamine | | Amoxapien | Gentisic acid | Pheniramine | | Amoxicillin | Glutethimide | Phenobarbital | | Ampicillin | Guaiacol Glyceryl ether | Phenothiazine | | Aprobarbital | Guaifenesin | Phentermine | | Aspartame | Haloperidol | Phenylephrine | | Atenolol | Hexobarbital | 2-Phenylethylamine | | Atropine | Hippuric acid | Phenylpropanolamine | | Barbital | Hydralazine | Phenytoin | | Barbituric acid | Hydrochlorothiazide | Piroxicam | | Benxocaine | Hydrocortison | Prazosin | | Benzilic acid | Hydroxybupropion | Prednisolone | | Benzoic acid | Hydroxyzine | Prednisone | | Benzoylecgonine | Ibuprofen | Procainamide | | Benzphetamine | Imapramine | Procaine | | Brompheniramine | I-methamphetamine | Promazine | | Buprenorphine | Iproniazid | Promethazine | | Bupropion | Isoxsuprine | Propiomazine | | Butabarbital | Ketamine | Propoxyphene | | Butalbital | Ketoprofen | Propranolol | | Caffeine | Ketorolac Tromethamine | Protriptyline | | Cannabidol | 1-11-hydroxy-delta 9-THC | Pyrilamine | | Cannabinol | 1-Amphetamine | Quetiapine | 10 {10} | Captopril | l-Ascorbic acid | Quinine | | --- | --- | --- | | Carbamazepine | Lebetalol | R(+)-Methcathinone | | Carbamazepine-10,11epoxide | Leverphanol | Ranitidine | | Carisoprodol | Lidocaine | Riboflavin | | Chloralhydrate | Lithium carbonate | S(-)-Methcathinone | | Chloramphenicol | l-norpseudoephedrine | Salicylic acid | | Chlordiaxepoxide | Lorazepam | Scopolamine | | Chlorothiazide | Lormetazepam | Secobarbital | | Chlorpheniramine | Loxapine Succinate | Serotonine | | Chlorpromazine | l-Phenylephrine | Sertraline | | Chlorprothixene | LSD | Sildenafil | | Chlorquine | L-α-Acetylmethadol (LAAM) | Sulfamethazine | | Cholesterol | Maprotiline | Sulinac | | Cimetidine | MDA | Temazepam | | Clobazam | MDE (MDEA) | Tetracycline | | Clomipramine | MDMA | Tetrahydrocortisone | | Clonazepam | Melanin | Tetrahydrozoline | | Clonidine | Meperidine | Theophylline | | Clorazepate | Mepivacaine | Thiamine | | Clozapine | Mesoridazine | Thiopental | | Cocaine | Methadone | Thioridazine | | Codeine | Methaqualone | d-Thyroxine | | Cortisone | Methoxyphenylamine | Tolbutamide | | Cotinine | Metoprolol | Tramadol | | Creatinine | Midazolam | Trazodone | | Cyclobenzaprine | Mirtazapine | Triamterene | | D-Amphetamine | Morniflumate | Triazolam | | Deoxycorticosterone | Morphine | Trifluoperazine | | Desalkylflurazepam | N-Acetylprocainamide (NAPA) | Trimethoprim | | Desipramine | Nalidixic acid | Trimipramine | | Desmethylflunitrazepam | Naltrexone | Tryptamine | | Dexamethasone | Naproxen | Tryptophan | | Dextromethorphan | Niacinamide | Tyramine | | Diazepam | Nicotine | Uric acid | | Diclofanac | Nifedipine | Valproic acid | | Diethylpropion | Nitrazepam | Venlafaxine | | Diflunisal | Nitrofurantoin | Verapamil | | Digoxin | Norclomipramine | Zidovudine (AZT) | | Dimenhydrinate | Nordiazepam | Zolpidem | | Diphenhydramine | Norethindrone | Zomepirac | | dl-Octopamine | dl-Tryptophan | Normeperidine | | dl-Propanolol | | | 11 {11} In addition, the performance of the assay was evaluated under varying pH levels of: 3.0, 4.0, 4.5, 5.0, 6.0, 6.5, 7.0, 8.0 and 9 at $\pm 50\%$ of the cut-off concentration and showed no effect on results with exception of pH 3.0 at which the device should not be used. This limitation is stated in the labeling. Further, variations in specific gravity of 1.002, 1.01, 1.015, 1.020, 1.025, 1.030, 1.035 and 1.04 had no effect on results. The package insert includes the complete list of all structurally related and unrelated compounds and metabolites tested. f. Assay cut-off: Analytical performance of the device around the claimed cut-off is described in precision section (1 a.) above. 2. Comparison studies: a. Method comparison with predicate device: A total of ninety-seven (97) clinical urine samples were evaluated by comparing the Status DS™ OXY test results to GC/MS. The Status DS™ OXY test results were read visually and with the DXpress™ reader. Samples were masked to the operators. Further, the visual test and the DXpress reader test were performed by two different operators, respectively, who were unaware of each other's results. There was 100% agreement between the reader test results and the visual test results. The summarized test results are shown in the table below. Comparison of Status DS™ OXY test with GC/MS values: | Status DX™OXY test results (Visual and DXpress Reader) | GC/MS values | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | Negative | | | Positive | | | | | Negative (Oxycodone free) | Less than half the Cut-Off | Near Cut-off (between 50% below the cut-off) | Near Cut-off (between 50% above the cut-off) | High Positive (>150% cut-off) | Percent Agreement with GC/MS for Oxycodone (based on cross reactivity profile) | | Positive | 0 | 0 | 2 | 4 | 36 | 97.6% | | Negative | 45 | 5 | 4 | 1 | 0 | 96.4% | {12} GC/MS Summary of Discordant Results: | Cut-off value (ng/mL) for Oxycodone | Status DS^{TM}OXY (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) based on cross reactivity profile | | | --- | --- | --- | --- | | | | Oxycodone | Oxymorphone | | 100 | POS | 26 | 71 | | | POS | 32 | 92 | | | NEG | 18 | 129 | b. Matrix comparison: Not applicable. The test is only for urine specimens. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. Not reviewed for this device type. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable. N. Instrument Name: DXpress reader This reader was previously cleared as part of a test system under k050955 and the sponsor has referenced information provided as part of that submission. Information pertaining to this instrument used with the Status DS Oxycodone test was also reviewed and a summary is included below. O. System Descriptions: 1. Modes of Operation: Stat 2. Software: FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types: Yes ☐ X ☑ or No ☐ 3. Specimen Identification: Barcode sample identification function. {13} 4. Specimen Sampling and Handling: Manual 5. Calibration: Lot specific calibration information for each quantitative test is loaded into the DXpress™ Reader. 6. Quality Control: Controls should be tested: - For new lots or shipments. - As otherwise required by the laboratory’s standard quality control procedures. - As otherwise required by federal, state and local guidelines. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: N/A Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 14