← Product Code [DIO](/productcode/DIO) · K062123 # VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062123) _Ortho-Clinical Diagnostics, Inc. · DIO · Nov 16, 2006 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K062123 ## Device Facts - **Applicant:** Ortho-Clinical Diagnostics, Inc. - **Product Code:** [DIO](/productcode/DIO.md) - **Decision Date:** Nov 16, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3250 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use VITROS Chemistry Products COCM Reagent: For in vitro diagnostic use only. VITROS Chemistry Products COCM Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzoylecgonine (cocaine metabolites) in human urine using a cutoff of either a 150 ng/mL or a 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose. The VITROS Chemistry Products COCM assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. VITROS Chemistry Products Calibrator Kit 26: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse. VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems. VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV & V: For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems. ## Device Story VITROS Chemistry Products COCM Reagent is a homogeneous enzyme immunoassay for detecting benzoylecgonine in human urine. Used on VITROS 5,1 FS Chemistry Systems by professional laboratory personnel. Input: urine sample treated with surfactant (DAT Diluent 2). Principle: competition between sample benzoylecgonine and enzyme-labeled benzoylecgonine (G6P-DH) for antibody binding sites. Enzyme activity is inversely proportional to benzoylecgonine concentration; active enzyme converts NAD+ to NADH, measured spectrophotometrically at 340 nm. Output: semi-quantitative or qualitative result (cutoff 150 or 300 ng/mL). Provides preliminary results requiring GC/MS confirmation. Clinical decision-making relies on these results for drug use/overdose management. ## Clinical Evidence No clinical data. Performance established via bench testing: precision (CLSI EP5/EP12), linearity (CLSI EP6-A), and method comparison against a commercial immunoassay and GC/MS reference method. Method comparison (n=108 vs. commercial; n=116 vs. GC/MS) evaluated agreement at 150 and 300 ng/mL cutoffs. Analytical specificity and interference testing (CLSI EP7) performed. ## Technological Characteristics Homogeneous enzyme immunoassay. Reagents: liquid, ready-to-use. Antibody: sheep polyclonal. Detection: spectrophotometric (340 nm). Instrumentation: VITROS 5,1 FS Chemistry System. Calibrators: human urine-based (six levels). Controls: human urine-based (five levels). Standards: CLSI EP9-A2, EP5-A, EP6-A, EP7-P, EP17-A, EP12-A. ## Regulatory Identification A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose. ## Special Controls *Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). ## Predicate Devices - Syva® Emit® II Plus Cocaine Metabolite assay ([K031512](/device/K031512.md)) - Liquichek™ Urine Toxicology Control Levels S1E and S2E ([K022707](/device/K022707.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k062123 B. Purpose for Submission: New product C. Measurand: Benzoylecgonine (cocaine metabolites) D. Type of Test: Semi-quantitative and qualitative homogeneous enzyme immunoassay E. Applicant: Ortho-Clinical Diagnostic F. Proprietary and Established Names: VITROS Chemistry Products COCM Reagent VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I. II, III, IV, and V G. Regulatory Information: 1. Regulation section: 21 CFR §862.3250, Cocaine and Cocaine Metabolite Test System 21 CFR §862.3200, Clinical Toxicology Calibrator 21 CFR §862.3280, Clinical Toxicology Control Material 2. Classification: Class II (Reagent, Calibrator) Class I, Reserved (Control) 3. Product code: DIO; DKB; DIF 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indication(s) for use: VITROS Chemistry Products COCM Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzoylecgonine (cocaine metabolites) in human urine using a cutoff of either 150 ng/mL or 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of benzoylecgonine use or {1} overdose. The VITROS Chemistry Products COCM assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of the drugs of abuse. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems. 3. Special conditions for use statement(s): This device is for prescription use by professional laboratory personnel. For in vitro diagnostic use only. 4. Special instrument requirements: Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System I. Device Description: The VITROS COCM Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect benzoylecgonine (cocaine metabolite) in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibody reactive to benzoylecgonine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD⁺), followed by Reagent 2 containing benzoylecgonine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). VITROS Chemistry Products Calibrator Kit 26 is prepared from human urine to which drugs of abuse, metabolites of drugs of abuse, organic salts, surfactants and preservative have been added. VITROS Chemistry Products FS Calibrator 1 is prepared from sodium chloride and processed water. VITROS DAT Performance Verifiers I, II, III, IV & V are prepared from a human urine pool to which analytes, surfactant and preservative have been added. The product labeling for the Calibrator Kit 26 and Performance Verifiers contain {2} warnings regarding the presence of human sourced materials and recommend the use of Universal Precautions when handling these products. ## J. Substantial Equivalence Information: 1. Predicate device name(s): EMIT II Plus Cocaine Metabolite Assay Liquicheck Urine Toxicology Controls 2. Predicate 510(k) number(s): k031512; k022707 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | For use in the qualitative and semi-quantitative analysis of methadone in human urine. | Same | | Reagent | Liquid, ready to use | Same | | Principle | Homogeneous enzyme immunoassay | Same | | Matrix | Urine | Same | | Antibody | Sheep polyclonal | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Instrumentation | VITROS 5,1 FS Chemistry Systems | Multiple automated clinical chemistry analyzers | | Calibrators | Six levels | Five levels | | Controls | Five levels | Two levels | ## K. Standard/Guidance Document Referenced (if applicable): CSLI EP9-A2: Method Comparison and Bias Estimation Using Patient Samples CLSI EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures, A Statistical Approach CLSI EP7-P: Interference Testing in Clinical Chemistry CLSI EP17-A: Protocols for Demonstration, Verification and Evaluation of Limits of Detection and Quantitation CLSI EP12-A: User Protocols for Evaluation of Qualitative Test Performance ## L. Test Principle: The VITROS COCM assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products COCM Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 26 and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems. {3} The assay is based on competition between benzoylecgonine in the treated urine sample and the benzoylecgonine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of benzoylecgonine in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide $(\mathrm{NAD}^{+})$ to NADH, resulting in an absorbance change that is measured spectrophotometrically at $340~\mathrm{nm}$ . ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: #### a. Precision/Reproducibility: Imprecision was evaluated with human urine-based quality control materials on the VITROS 5,1 FS Chemistry System following CLSI Protocol EP5 and CLSI protocol EP12. The sponsor cautions that variables such as instrument maintenance, environment, reagent storage/handling, control material reconstitution, and sample handling can affect the reproducibility of test results. Imprecision for COCM: Semi-Quantitative | System | Conventional Units (ng/mL) and SI Units (μg/L) | | | Within Lab CV%** | No. Observ. | No. Days | | --- | --- | --- | --- | --- | --- | --- | | | Mean Conc. | Within Day SD* | Within Lab SD** | | | | | VITROS 5,1 FS | 98 | 4.8 | 9.4 | 9.6 | 86 | 22 | | | 181 | 5.6 | 11.5 | 6.4 | 86 | 22 | | | 227 | 7.1 | 13.5 | 5.9 | 86 | 22 | | | 369 | 10.3 | 19.2 | 5.2 | 84 | 22 | | | 567 | 21.0 | 46.7 | 8.2 | 86 | 22 | * Within Day imprecision was determined using one to two runs per day with two replications per run. ** Within Lab imprecision was determined using a single lot of reagents with one analyzer and four calibrations. Qualitative imprecision was assessed using test fluids targeted at $\pm 25\%$ of each cutoff. The imprecision was determined as the confidence level of obtaining a correct result with known positive or negative fluids. Imprecision for COCM: Qualitative* | System | Cutoff Level (ng/mL & μg/L) | Test Fluid at ±25% Cutoff | Number of Observations | Number of Correct Interpretations | Confidence Level | | --- | --- | --- | --- | --- | --- | | VITROS 5,1 FS | 150 | -25% | 86 | 86 | >95% negative reading | | | 150 | +25% | 86 | 86 | >95% positive reading | | | 300 | -25% | 86 | 86 | >95% negative reading | | | 300 | +25% | 84 | 84 | >95% positive reading | * Determined using one to two runs per day with two replicates per run for 22 days, using a single lot of reagents with one analyzer and four calibrations {4} b. Linearity/assay reportable range: The sponsor followed CLSI EP6-A in determining the linear range of their device. Two urine pools were prepared with benzoylecgonine concentrations at the low (0 ng/mL) and high (1200 ng/mL) end of the calibration range. The two pools were mixed to give 18 admixtures of intermediate concentrations. Linearity was evaluated using three assay reagent lots and comparing the measured results against the expected results from 18 pooled samples. A linear regression was performed and the results indicated acceptable linearity across the benzoylecgonine concentration range tested 47 to 1007 ng/mL. This linearity determination in conjunction with determination of the limit of quantation was used to establish the semi-quantitative range of the VITROS COCM assay (50-1000 ng/mL). Recovery study Eleven admixtures were prepared from two human urine pools. Benzoylecgonine values for the admixtures were calculated based on the gravimetric addition with GC/MS verification of the high pool and the percentage of high pool to the low pool (a drug-free urine based matrix). Percent recovery was calculated using the concentration obtained by the VITROS Chemistry Products COCM Assay versus the calculated benzoylecgonine value. Recovery of Benzoylecgonine | Benzoylecgonine (ng/mL) | VITROS COCM Assay (ng/mL) | % Recovery | | --- | --- | --- | | 50 | 57 | 113.3 | | 100 | 105 | 105.1 | | 200 | 219 | 109.4 | | 300 | 316 | 105.3 | | 400 | 403 | 100.6 | | 500 | 484 | 96.9 | | 600 | 593 | 98.8 | | 700 | 721 | 103.0 | | 800 | 774 | 96.8 | | 900 | 880 | 97.8 | | 1000 | 998 | 99.8 | c. Traceability, Stability, Expected values (controls, calibrators, or methods): The assigned values for the calibrators and controls are traceable to the Cerilliant benzoylecgonine standard catalogue B-028 and are verified by GC/MS. Real time and accelerated stability studies were conducted; protocols and acceptance criteria were described and found to be acceptable. These studies support the manufacturer's stability claims. Real time studies are ongoing. {5} d. Detection limit: The limit of quantitation (LOQ) is defined as the minimum amount of analyte whose presence can be quantitatively determined with stated acceptable precision and trueness under defined experimental conditions. The limit of detection (LOD) is the minimum amount of analyte whose presence can be quantitatively detected under defined conditions. For the VITROS COCM assay, the LOD was determined to be 31 ng/mL. The limit of quantitation (LOQ) was determined to be 50 ng/mL. e. Analytical specificity: The specificity of the VITROS COCM assay for various cocaine metabolites and structurally similar compounds was estimated by generating a dose response curve for each of the compounds listed below. The quantity (ng/mL) of compound that produces a value equivalent to the benzoylecgonine quantity (ng/mL) at each cutoff value is listed below. The combined effects of more than one compound detected in a sample may cause levels lower than those listed below to produce a value approximately equivalent to or greater than the cutoff value. Substances that Cross-react with COCM | Compound | Quantity (ng/mL) equivalent to 150 ng/mL of BE | % cross-reactivity * | Quantity (ng/mL) equivalent to 300 ng/mL of BE | % cross-reactivity * | | --- | --- | --- | --- | --- | | Benzoylecgonine (BE) | 150 | 100.0 | 300 | 100.0 | | m-hydroxybenzoylecgonine | 153 | 98.0 | 304 | 98.7 | | ecognine | 4450 | 3.4 | 15,325 | 2 | | cocaine | 39,500 | 0.4 | 81,300 | 0.4 | | ecognine methyl ester | >100,000 | <0.2% | >100,000 | <0.3% | | cocaethylene | >100,000 | <0.2% | >100,000 | <0.3% | * The VITROS COCM Assay cutoff value (ng/mL) divided by the amount of cross-reactant (ng/mL) that produces a value equivalent to the cutoff value, multiplied by 100. The substances listed in the table, at the concentrations shown, were tested according to CLSI Protocol EP7 and found not to interfere (defined by the sponsor as bias <28.7 ng/mL at 150 ng/mL COCM and bias <57.4 ng/mL at 300 ng/mL COCM). {6} Substances that Do Not Interfere with COCM | Compound | Concentration | | | --- | --- | --- | | ammonia | 570 mg/dL | 335 μmol/L | | amobarbitol | 10 mg/dL | 442 μmol/L | | ascorbic acid | 500 mg/dL | 28 mmol/L | | benzocaine | 10 mg/dL | 605 μmol/L | | bilirubin | 26 mg/dL | 445 μmol/L | | brompheniramine | 0.01 mg/dL | 313 μmol/L | | calcium | 30 mg/dL | 8 mmol/L | | ciprofloxacin | 10 mg/dL | 300 μmol/L | | citric Acid | 100 mg/dL | 5 mmol/L | | cloxacillin | 10 mg/dL | 229 μmol/L | | creatinine | 300 mg/dL | 27 mmol/L | | desipramine HCl | 10 mg/dL | 330 μmol/L | | dextromethorphan | 10 mg/dL | 369 μmol/L | | dicyclomine | 10 mg/dL | 289 μmol/L | | diethylproprione | 10 mg/dL | 487 μmol/L | | doxylamine | 10 mg/dL | 370 μmol/L | | ethacrynic acid | 10 mg/dL | 330 μmol/L | | ethanol | 780 mg/dL | 169 mmol/L | | glucose | 4000 mg/dL | 222 mmol/L | | hemoglobin | 500 mg/dL | 5 g/L | | human IgG | 200 mg/dL | 2 g/L | | human serum albumin | 200 mg/dL | 2 g/L | | imipramine HCl | 10 mg/dL | 357 μmol/L | | indomethacin | 10 mg/dL | 280 μmol/L | | iron | 100 μg/dL | 18 μmol/L | | KCl | 1118 mg/dL | 150 mmol/L | | L-hyoscyamine | 10 mg/dL | 346 μmol/L | | Compound | Concentration | | | --- | --- | --- | | lidocaine | 10 mg/dL | 427 μmol/L | | magnesium | 60 mg/dL | 25 mmol/L | | meperidine | 10 mg/dL | 404 μmol/L | | methoxyphenamine HCl | 10 mg/dL | 371 μmol/L | | metronidazole | 10 mg/dL | 584 μmol/L | | NaCl | 6000 mg/dL | 1027 mmol/L | | nylidrine HCl | 10 mg/dL | 334 μmol/L | | ofloxacin | 10 mg/dL | 277 μmol/L | | oxalic Acid | 300 mg/dL | 24 mmol/L | | pH = 4 | 4 | 4 | | pH = 9 | 9 | 9 | | phenylbutazone | 10 mg/dL | 324 μmol/L | | phenyltoloxamine | 10 mg/dL | 392 μmol/L | | phosphate | 1420 mg/dL | 100 mM/L | | promethazine | 10 mg/dL | 312 μmol/L | | propranolol HCl | 10 mg/dL | 338 μmol/L | | pyruvate | 100 mg/dL | 11 mmol/L | | ranitidine HCl | 10 mg/dL | 285 μmol/L | | riboflavin | 2 mg/dL | 53 μmol/L | | tolmetin/tolectin | 10 mg/dL | 389 μmol/L | | trihexylphenidyl | 10 mg/dL | 296 μmol/L | | trimethobenzamide HCl | 10 mg/dL | 257 μmol/L | | tripelannamine | 10 mg/dL | 392 μmol/L | | triprolidine | 10 mg/dL | 359 μmol/L | | tyramine | 10 mg/dL | 729 μmol/L | | urea | 3000 mg/dL | 500 mmol/L | | uric acid | 120 mg/dL | 7 mmol/L | f. Assay cut-off: The stated cutoff of this assay is either 150 ng/mL or 300 ng/mL. 2. Comparison studies: a. Method comparison with predicate device: A total of 108 human urine samples were assayed using the VITROS Chemistry Products COCM Reagent and a commercially available immunoassay method. Percent agreement was evaluated at assay cutoff values of 150 and 300 ng/mL. {7} Commercial Method Comparison for COCM | Cutoff Value (ng/mL) | Commercial Method** | | | | %Agreement | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | Low Negative | Near Cutoff Negative | Near Cutoff Positive | High Positive | %Agreement Negative | %Agreement Positive | %Agreement Overall | | 150 | | (<-50%) <75 ng/mL | (-50% to cutoff) 75-150 ng/mL | (cutoff to +50%) 150-225 ng/mL | (>+50%) >225 ng/mL | 97.6% | 100.0% | 99.1% | | | VITROS Positive | 0 | 1* | 11 | 56 | | | | | | VITROS Negative | 31 | 9 | 0 | 0 | | | | | 300 | | (<-50%) <500 ng/mL | (-50% to cutoff) 150-300 ng/mL | (cutoff to +50%) 300-450 ng/mL | (>+50%) >450 ng/mL | 100.0% | 100.0% | 100.0% | | | VITROS Positive | 0 | 0 | 11 | 38 | | | | | | VITROS Negative | 41 | 18 | 0 | 0 | | | | * See Summary of Discordant Results below ** Syva® Emit® II Plus Cocaine Metabolite Assay Summary of Discordant Results: Commercial Method | Cutoff Value (ng/mL) | VITROS COCM Assay (ng/mL) | Commercial Method (ng/mL) | | --- | --- | --- | | 150 | 154 | 141 | A total of 116 human urine samples were assayed using the VITROS Chemistry Products COCM Reagent and a GC/MS reference method for benzoylecgonine (a cocaine metabolite). Percent agreement was evaluated at assay cutoff values of 150 and 300 ng/mL. To challenge performance at the 150 ng/mL cutoff value, 34 of the 116 samples tested had concentrations within +/-50% of the cutoff value, 21 samples below the cutoff value and 13 samples above the cutoff value. To challenge performance at the 300 ng/mL cutoff value, 34 of the 116 samples tested had concentrations within +/-50% of the cutoff value, 25 samples below the cutoff value and 9 samples above the cutoff value {8} GC/MS Reference Method Comparison for COCM | | | GC/MS Reference Method | | | | % Agreement | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Cutoff Value (ng/mL) | | Low Negative | Near Cutoff Negative | Near Cutoff Positive | High Positive | % Agreement Negative | % Agreement Positive | % Agreement Overall | | 150 | | (<-50%) <75 ng/mL | (-50% to cutoff) 75-150 ng/mL | (cutoff to +50%) 150-225 ng/mL | (>+50%) >225 ng/mL | 69.1% | 96.7% | 83.6% | | | VITROS Positive | 3* | 14* | 11 | 48 | | | | | | VITROS Negative | 31 | 7 | 2* | 0 | | | | | 300 | | (<-50%) <150 ng/mL | (-50% to cutoff) 150-300 ng/mL | (cutoff to +50%) 300-450 ng/mL | (>+50%) >450 ng/mL | 76.3% | 100.0% | 83.6% | | | VITROS Positive | 2* | 17* | 9 | 27 | | | | | | VITROS Negative | 53 | 8 | 0 | 0 | | | | *See GC/MS Summary of Discordant Results below | Summary of Discordant Results: GC/MS | | | | | --- | --- | --- | --- | | Cutoff Value (ng/mL) | VITROS COCM (ng/mL) | GC/MS (ng/mL) | Major Drug Present by GC/MS | | 150 | 104 | 170 | benzoylecgonine | | | 120 | 187 | | | | 171 | 142 | | | | 172 | 131 | | | | 178 | 90 | | | | 184 | 81 | | | | 184 | 61 | | | | 184 | 134 | | | | 185 | 61 | | | | 191 | 119 | | | | 199 | 104 | | | | 204 | 97 | | | | 217 | 126 | | | | 234 | 146 | | | | 250 | 117 | | | | 267 | 92 | | | | 276 | 134 | | | | 314 | 76 | | | | 442 | 62 | | | 300 | 314 | 76 | benzoylecgonine | | | 323 | 184 | | | | 350 | 299 | | | | 368 | 277 | | | | 373 | 290 | | {9} | Summary of Discordant Results: GC/MS | | | | | --- | --- | --- | --- | | Cutoff Value (ng/mL) | VITROS COCM (ng/mL) | GC/MS (ng/mL) | Major Drug Present by GC/MS | | | 377 | 169 | | | | 393 | 253 | | | | 423 | 232 | | | | 434 | 299 | | | | 441 | 235 | | | | 442 | 62 | | | | 445 | 181 | | | | 452 | 259 | | | | 479 | 221 | | | | 531 | 224 | | | | 555 | 186 | | | | 575 | 214 | | | | 788 | 243 | | | | >1000 | 296 | | b. Matrix comparison: Not applicable; this device is for use with urine only. 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. --- **Source:** [https://fda-staging.innolitics.com/device/K062123](https://fda-staging.innolitics.com/device/K062123) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com