DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: k121122 B. Purpose for Submission: New Device C. Analyte: Quality control materials for Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine (PCP), Codeine, Propoxyphene, Methaqualone, Morphine -3-glucuronide, 6-Monoacetylmorphine, Morphine, d-Amphetamine, d-Methamphetamine, Secobarbital, Butalbital, Phenobarbital, Oxazepam, Methadone, MDMA, MDA, MDEA, Oxycodone, Buprenorphine, EDDP, Nordiazepam, Norpropoxyphene, Cotinine, Fentanyl, Ethanol, Nortriptyline, Creatinine, pH, Specific Gravity D. Type of Test: Not applicable E. Applicant: Biochemical Diagnostics, Inc. F. Proprietary and Established Names: Detectabuse® Liquid Control G. Regulatory Information: 1. Regulation section: 21 CFR 862.3280, Clinical Toxicology Control Material 2. Classification: Class I, reserved 3. Product Code: DIF 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below 2. Indication(s) for use: The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. {1} 3. Special condition for use statement(s): For prescription use only 4. Special instrument Requirements: Not applicable. I. Device Description: Detectabuse® Liquid Control Each bottle contains stabilized human based urine. Positive control urines have been gravimetrically spiked with reference drug standards and/or appropriate metabolites. Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain less than 1% sodium azide as a preservative. For assays sensitive to sodium azide such as ELISA we substitute a proprietary preservative approved by the manufacturers and DEA. J. Substantial Equivalence Information: 1. Predicate device name(s): Detectabuse® Liquid Control Urine 2. Predicate K number(s): k925586 3. Comparison with predicates: | Device | Predicate Device (K925586) | Modified Device (K121122) | | --- | --- | --- | | Intended Use | Same | Is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures | | Form | Same | Liquid | | Matrix | Same | Human Urine | | Storage | Closed vial: The controls are stable until the expiration date when stored at -10 to -20°C and protected from light. The controls are stable until the expiration date when stored at 2-8°C. Open vial: not available | Closed vial: The controls are stable until (1) 36 months when stored at 2-8°C with the exception of oxazepam; (2) 48 months when stored at -10 to -20°C and protected from light with the exception of oxazepam. Open vial: The controls are stable 30 days when stored at 2-8°C. | {2} 3 | Analytes | Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine (PCP), Codeine, Propoxyphene Methaqualone, Morphine -3-glucuronide, 6-Monoacetylmorphine, Morphine, d-Amphetamine, d-Methamphetamine, Secobarbital, Butalbital, Phenobarbital, Oxazepam, Methadone | Same analytes as predicate device A with the additional claims: MDMA, MDA, MDEA, Oxycodone, Buprenorphine, EDDP, Nordiazepam, Norpropoxyphene, Cotinine, Fentanyl, Ethanol, Nortriptyline, Creatinine, pH, Specific Gravity | | --- | --- | --- | K. Standard/Guidance Document Referenced (if applicable): None were referenced. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Not applicable. b. Linearity/assay reportable range: Not applicable. c. Traceability (controls, calibrators, or method): a) Traceability The controls are gravimetrically spiked with reference standards purchased from commercial vendors. The drug values printed within the package insert are validated by using GC/MS, LC/MS, HPLC, or Immunoassay screening. b.) Stability Stability studies have been performed to determine the open vial stability and shelf life stability of the Detectabuse® Liquid control. Product claims are as follows: open vial stability is 30 days when stored tightly capped at 2-8°C; closed vial stability is 10 months at 2-8°C and 4 years at -10°C to -20°C. d. Detection limit: Not applicable. e. Analytical specificity: Not applicable. f. Assay cut-off: Not applicable. {3} 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not applicable. 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 available. 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 substantial equivalence decision. 4