510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k103161 B. Purpose for Submission: New device C. Measurand: Opiates, oxycodone and hydrocodone in hair D. Type of Test: Qualitative ELISA Immunoassay E. Applicant: Omega Laboratories, Inc. F. Proprietary and Established Names: Omega Laboratories Hair Drug Screening Assays for Opiates, Oxycodone and Hydrocodone G. Regulatory Information: Product Code Classification Regulation Section Panel DJG, Enzyme immunoassay Class II 862.3650 91-Toxicology Opiates H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: 1 The Omega Laboratories Hair Drug Screening Assays are test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in head hair samples. The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone provide only preliminary analytical test results. A more specific alternate chemical method must be used in order to obtain a confirmed result. Gas Chromatograph– Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. These tests are intended exclusively for in-house use only and are not intended for sale to anyone. Omega offers these tests as services to its clients. 3. Special conditions for use statement(s): The assay is for Over the Counter Use. 4. Special instrument requirements: The screening assay is for use with an automated microplate reader capable of measuring at 450 nm. For confirmation testing, the sponsor uses an Agilent GC/MS in selected ion monitoring (SIM) mode using deuterated internal standards. I. Device Description: The assay consists of the following: • Hair sample collection kit • Micro strip plates coated with either anti-morphine mouse monoclonal or anti- oxycodone rabbit polyclonal antibody, enzyme conjugate (horseradish peroxidase conjugated to morphine or oxycodone), substrate (containing tetramethylbenzidine), an enzyme diluent, and wash solution • In-house prepared calibrators and controls are used. These are prepared solutions of morphine and oxycodone added to negative hair matrix tubes. J. Substantial Equivalence Information: 1. Predicate device name(s): Quest Diagnostic HairCheck-DT (Opiates) American BioMedica Corporation, RapidOne–OXY Test (Oxycodone) 2 2. Predicate K number(s): k042725 k014101 3. Comparison with predicate: Item Proposed Device Quest Hair Drug Screening RapidOne – OXY Test k042725 K014101 Indications/ The Omega Laboratories Quest Diagnostics RapidOne-OXY Test is a Intended Use Hair Drug Screening HairCheck-DT (Opiates) is one-step, lateral flow Assays are test systems a test system that utilizes immunoassay for the that utilize ELISA assays the IDS One step ELISA detection of oxycodone in for the qualitative detection Opiates Kit for the urine. RapidOne-OXY of morphine and related qualitative detection of Test is intended for the opiates, oxycodone and opiates at concentrations at qualitative detection of hydrocodone at or above or above 300 pg/mg hair oxycodone inhuman urine 300 pg/mg in head hair for the purpose of at 100 ng/mL. RapidOne- samples. identifying chronic use of OXY Test is intended for heroine. This test system professional use. It is not The Omega Laboratories has not been evaluated for intended for over the Hair Drug Screening Assay use with other populations counter sales to for Opiates, Oxycodone or with hair specimens nonprofessionals. and Hydrocodone provide other than head. It is an in RapidOne-OXY provides only preliminary analytical vitro diagnostic device only preliminary analytical test results. A more intended exclusively for in- test results. A more specific alternate chemical house professional use only specific alternate chemical method must be used in and not intended for sale to method must be used in order to obtain a anyone. order to obtain a confirmed result. Gas The Quest Diagnostics confirmed result GC/MS is Chromatography – HairCheck-DT (Opiates) the preferred confirmatory Mass Spectrometry provides only preliminary method operating in the selected analytical test results. A ion monitoring (SIM) more specific alternate mode or GC/MS/MS in chemical method must be selected reaction mode used in order to obtain a (SRM) is the preferred confirmed result. Gas method with deuterated Chromatography – internal standards. Other Mass Spectrometry chemical confirmation operating in the selected methods are available. ion monitoring (SIM) Clinical consideration and mode or GC/MS/MS in professional judgment selected reaction mode should be applied to any (SRM) is the preferred drug of abuse test result, method with deuterated particularly when internal standards. Other 3 preliminary positive chemical confirmation results are obtained. methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. Product Code DJG Same as the proposed Same as the proposed device device Measurand Opiates, Oxycodone and Opiates in hair Oxycodone in urine Hydrocodone in hair Test System International Diagnostics International Diagnostics American Bio Medica Systems Corp Forensic Systems Corp Forensic Corp. Human Drugs of Abuse Human Drugs of Abuse 'RapidOne--OXY' Test One-Step Morphine and IDS One-Step Opiates Oxycodone ELISA for ELISA for Hair Testing Kit Hair Testing Kits Sample Head Hair Same as the proposed Urine matrix device Method of Microplate reader, read at Same as the proposed Lateral flow immunoassay, measurement 450 nm device visually read endpoint Cutoff 300 pg Opiates/mg hair 500 pg Opiates/mg hair 100 ng Oxycodone/mL 300 pg Oxycodone/mg hair urine 300 pg Hydrocodone/mg hair Type of test ELISA Same as the proposed Immunoassay device Extraction Acid-methanol Methanol Not Applicable methods Confirmation GC/MS Same as the proposed Same as the proposed method device device K. Standard/Guidance Document Referenced (if applicable): None were referenced L. Test Principle: 4 Screening Assay: The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay. The screening assay is an Enzyme-Linked ImmunoSorbent Assay (ELISA). Sample is added to a well of the micro strip plate and enzyme conjugate is added, followed by incubation. During this phase the enzyme-labeled drug conjugate competes with drug in the sample for a limited number of binding sites on the antibody-coated micro wells. The two bind in proportion to their concentrations. A wash solution is applied to remove unbound materials. Enzyme substrate solution containing a chromagen is added. The reaction is stopped with a stop solution and absorbance is read using a plate reader at 450 nm. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug presented in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision studies were performed by taking commercially available materials consisting of morphine in methanol, oxycodone in methanol and hydrocodone in methanol (all with a Certificate of Analysis traceable to NIST) to prepare spiking solutions at the following concentrations; negative, ±75%, ±50%, ±25% and 200% of the cutoff. The concentration of each sample was confirmed by GC/MS. The morphine and oxycodone solutions were then used to spike 11 replicates of negative hair samples. The hydrocodone solution was used to spike 10 replicates of negative hair samples. Intra-assay precision was performed in one run and inter-assay precision was performed over 20 non-consecutive days (10 non-consecutive days for hydrocodone). The results are presented in the tables below: Intra-assay Morphine Cutoff = 300 pg/mg Conc. (pg/mg) % of Cutoff Number Tested Negative Positive 0 Negative 11 11 0 75 -75 11 11 0 150 -50 11 11 0 225 -25 11 11 0 375 125 11 0 11 450 150 11 0 11 525 175 11 0 11 600 200 11 0 11 5 Intra-assay Oxycodone Cutoff = 300 pg/mg Conc. (pg/mg) % of Cutoff Number Tested Negative Positive 0 Negative 11 11 0 75 -75 11 11 0 150 -50 11 11 0 225 -25 11 11 0 375 125 11 0 11 450 150 11 0 11 525 175 11 0 11 600 200 11 0 11 Intra-assay Hydrocodone Cutoff = 300 pg/mg Conc. (pg/mg) % of Cutoff Number Tested Negative Positive 0 Negative 10 10 0 75 -75 10 10 0 150 -50 10 10 0 225 -25 10 9 1 375 125 10 0 10 450 150 10 0 10 525 175 10 0 10 600 200 10 0 10 Inter–assay Morphine Cutoff = 300 pg/mg Conc. (pg/mg) % of Cutoff Number Tested Negative Positive 0 Negative 220 220 0 75 -75 220 220 0 150 -50 220 220 0 225 -25 220 220 0 375 125 220 0 220 450 150 220 0 220 525 175 220 0 220 600 200 220 0 220 Inter–assay Oxycodone Cutoff = 300 pg/mg Conc. (pg/mg) % of Cutoff Number Tested Negative Positive 0 Negative 220 220 0 75 -75 220 220 0 150 -50 220 220 0 225 -25 220 220 0 375 125 220 0 220 450 150 220 0 220 6 525 175 220 0 220 600 200 220 0 220 Inter–assay Hydrocodone Cutoff = 300 pg/mg Conc. (pg/mg) % of Cutoff Number Tested Negative Positive 0 Negative 100 100 0 75 -75 100 100 0 150 -50 100 100 0 225 -25 100 61 39 375 125 100 0 100 450 150 100 0 100 525 175 100 0 100 600 200 100 0 100 The sponsor also performed an intra-assay precision for morphine, oxycodone and hydrocodone using 5 hair specimens for each drug analyte previously found to be positive.