IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
Device Facts
| Record ID | K131168 |
|---|---|
| Device Name | IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY |
| Applicant | Immunalysis Corporation |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Jan 17, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The Immunalysis Oxycodone Urine Enzyme Immunoassay is a homogenous enzyme immunoassay with a dual cutoff of 100 ng/mL and 300 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Oxycodone in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxycodone. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Oxycodone Urine Enzyme Immunoassay Kit 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 Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Oxycodone Urine Calibrators are used as calibrators in the Immunalysis Oxycodone Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Oxycodone in urine on automated clinical chemistry analyzers. The Immunalysis Oxycodone Urine Controls are used as control materials in the Immunalysis Oxycodone Urine Enzyme Immunoassay.
Device Story
Homogeneous enzyme immunoassay for qualitative/semi-quantitative detection of Oxycodone in human urine. Input: human urine samples. Principle: competitive binding between drug in sample and enzyme-labeled drug conjugate for recombinant monoclonal antibody binding sites; G6PDH activity measured via absorbance change at 340nm. Output: preliminary analytical result (positive/negative or semi-quantitative concentration). Used in clinical laboratories by trained personnel on automated clinical chemistry analyzers. Results used by clinicians to identify potential Oxycodone presence, necessitating confirmatory testing (GC-MS/LC-MS) before clinical decision-making. Benefits: rapid screening of urine samples for drug abuse monitoring.
Clinical Evidence
Bench testing only. Studies included precision/cutoff characterization, specificity and cross-reactivity, interference, linearity/recovery, method comparison, and stability. No clinical prospective or retrospective studies were required or provided.
Technological Characteristics
Homogenous enzyme immunoassay. Reagents: recombinant monoclonal antibodies, G6P, NAD, G6PDH-labeled oxycodone derivative in Tris buffer with Sodium Azide. Analyzed on automated clinical chemistry analyzers (e.g., Beckman Coulter AU400e). Spectrophotometric detection at 340 nm. Liquid, ready-to-use reagents. Calibrators/controls prepared from synthetic urine and oxycodone standard, verified by LC/MS.
Indications for Use
Indicated for the qualitative and semi-quantitative analysis of Oxycodone in human urine to aid in the detection of Oxycodone use. For prescription use in laboratory settings using automated clinical chemistry analyzers. Provides preliminary analytical results; requires confirmation by GC-MS or LC/MS.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate 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
- DRI Oxycodone Assay, DRI Oxycodone Calibrators and DRI Oxycodone Controls (k040411)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k131168
B. Purpose for Submission:
New device
C. Measurand:
Oxycodone
D. Type of Test:
Homogenous enzyme immunoassay
E. Applicant:
Immunalysis Corporation
F. Proprietary and Established Names:
Immunalysis Oxycodone Urine Enzyme Immunoassay
Immunalysis Oxycodone Urine Calibrators
Immunalysis Oxycodone Urine Controls
G. Regulatory Information:
1. Regulation section:
21 CFR § 862.3650 Opiate Test System
21 CFR § 862.3200 Clinical Toxicology Calibrator
21 CFR § 862.3280 Clinical Toxicology Control Material
2. Classification:
Class II for 862.3650 and 862.3200
Class I, reserved for 862.3280
3. Product code:
DJG Enzyme Immunoassay, Opiates
DLJ Calibrators, Drug Specific
LAS Drug Specific Control Materials
4. Panel:
Toxicology (91)
H. Intended Use:
1. Intended use(s):
The Immunalysis Oxycodone Urine Enzyme Immunoassay is a homogenous enzyme immunoassay with a dual cutoff of 100 ng/mL and 300 ng/mL. The
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assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Oxycodone in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxycodone. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Oxycodone Urine Enzyme Immunoassay Kit 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 Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Immunalysis Oxycodone Urine Calibrators are used as calibrators in the Immunalysis Oxycodone Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Oxycodone in urine on automated clinical chemistry analyzers.
The Immunalysis Oxycodone Urine Controls are used as control materials in the Immunalysis Oxycodone Urine Enzyme Immunoassay.
2. Indication(s) for use:
See intended uses above.
3. Special conditions for use statement(s):
- For prescription use only
- For in vitro diagnostic use only
4. Special instrument requirements:
The Beckman Coulter AU400e Chemistry Analyzer was used to generate the performance data in this submission.
I. Device Description:
The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes recombinant monoclonal antibodies to Oxycodone, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes oxycodone derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
Calibrators and control materials are prepared from synthetic negative urine and a commercially available oxycodone drug standard. The concentration of the Oxycodone in these calibrators and control materials is determined by Liquid
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chromatography/Mass Spectroscopy (LC/MS).
The following calibrators are available:
- Oxycodone Calibrator Set (0, 100ng/mL, 300 ng/mL, 500ng/mL and 1000ng/mL) for the semi-quantitative mode.
- 100 ng/mL Oxycodone Calibrator for the 100ng/mL cutoff
- 300 ng/mL Oxycodone Calibrator for the 300ng/mL cutoff
The following control materials are available:
- Oxycodone Controls set for the 100ng/mL cutoff (75ng/mL and 125ng/mL)
- Oxycodone Control set for the 300ng/mL cutoff (225ng/mL and 375ng/mL)
Oxycodone Calibrators and controls are sold separately. Reagents are liquid, ready to use.
J. Substantial Equivalence Information:
1. Predicate device name(s):
DRI Oxycodone Assay, DRI Oxycodone Calibrators and DRI Oxycodone Controls
2. Predicate K number(s):
k040411
3. Comparison with predicate:
| Item | Immunalysis Oxycodone Urine Enzyme Immunoassay | Predicate k040411 |
| --- | --- | --- |
| Similarities | | |
| Intended Use | For the qualitative and semi-quantitative analysis of Oxycodone in human urine at cutoffs of 100 and 300 ng/mL | same |
| Measured Analyte | Oxycodone | same |
| Test Matrix | Human urine | same |
| Cutoff Level | 100 ng/mL and 300 ng/mL | same |
| Technology | Homogenous enzyme immunoassay | same |
| Differences | | |
| Antibodies | Recombinant FAB antibody to oxycodone | Mouse monoclonal anti-oxycodone derivative |
| Item | Immunalysis Oxycodone Urine Calibrators | Predicate k040411 |
| --- | --- | --- |
| Similarities | | |
| Intended Use | For the calibration of the the Immunalysis Oxycodone Urine | For the calibration of the DRI |
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| Item | Immunalysis Oxycodone Urine Calibrators | Predicate k040411 |
| --- | --- | --- |
| | Enzyme Immunoassay | Oxycodone Assay |
| Calibrator Form | Liquid | same |
| Calibrator Levels | Five levels (0, 100, 300, 500 and 1000 ng/mL) | same |
| Item | Immunalysis Oxycodone Urine Controls | Predicate k040411 |
| --- | --- | --- |
| Similarities | | |
| Intended Use | Intended as control materials for the Immunalysis Oxycodone Urine Enzyme Immunoassay | Intended as control materials for the DRI Oxycodone Assay |
| Control Levels | 2 Levels (75 and 125 ng/mL or 225 and 375 ng/mL) | same |
## K. Standard/Guidance Document Referenced (if applicable):
- Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline (EP5-A2)
- Interference Testing in Clinical Chemistry; Approved Guideline (EP7-A2)
- Draft Guidance for Industry and FDA Staff Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests
## L. Test Principle:
The assay uses an Oxycodone specific antibody. The assay is based on the competition of Oxycodone labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine sample and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
a. Precision/Reproducibility:
The sponsor performed precision studies in-house following the guidelines provided in CLSI EP5-A2. The study was performed using drug free urine spiked with Oxycodone and 1 reagent lot using 1 Beckman Coulter AU400e Chemistry Analyzer. Samples were measured in duplicate on 2 runs per day for 20 days (n=80). The data are summarized in the following table:
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Qualitative analysis (100ng/mL cutoff)
| Concentration | % of cutoff | Result |
| --- | --- | --- |
| 0 | -100% | 80 negative |
| 25 | -75% | 80 negative |
| 50 | -50% | 80 negative |
| 75 | -25% | 80 negative |
| 100 | Cutoff | 46 negative
34 positive |
| 125 | +25% | 80 positive |
| 150 | +50% | 80 positive |
| 175 | +75% | 80 positive |
| 200 | +100% | 80 positive |
Qualitative analysis (300ng/mL cutoff)
| Concentration | % of cutoff | Result |
| --- | --- | --- |
| 0 | -100% | 80 negative |
| 75 | -75% | 80 negative |
| 150 | -50% | 80 negative |
| 225 | -25% | 80 negative |
| 300 | Cutoff | 35 negative
45 positive |
| 375 | +25% | 80 positive |
| 450 | +50% | 80 positive |
| 525 | +75% | 80 positive |
| 600 | +100% | 80 positive |
Semi-Quantitative analysis (100ng/mL cutoff)
| Concentration | % of cutoff | Result |
| --- | --- | --- |
| 0 | -100% | 80 negative |
| 25 | -75% | 80 negative |
| 50 | -50% | 80 negative |
| 75 | -25% | 80 negative |
| 100 | Cutoff | 57 negative
23 positive |
| 125 | +25% | 80 positive |
| 150 | +50% | 80 positive |
| 175 | +75% | 80 positive |
| 200 | +100% | 80 positive |
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Semi-Quantitative analysis (300ng/mL cutoff)
| Concentration | % of cutoff | Result |
| --- | --- | --- |
| 0 | -100% | 80 negative |
| 75 | -75% | 80 negative |
| 150 | -50% | 80 negative |
| 225 | -25% | 80 negative |
| 300 | Cutoff | 38 negative
42 positive |
| 375 | +25% | 80 positive |
| 450 | +50% | 80 positive |
| 525 | +75% | 80 positive |
| 600 | +100% | 80 positive |
b. Linearity/assay reportable range:
A drug free urine pool was spiked with a high concentration of Oxycodone and was used as the high value specimen. Additional pools were made by serially diluting the high value specimen with drug free urine in increments of 10%. Aliquots from each pool were analyzed in duplicate in the semi-quantitative mode using all 6 calibrators for the 100 ng/mL and 300 ng/mL cutoffs (0, 100, 300, 500, 1000 ng/mL) using 2 Beckman Coulter AU400e Chemistry Analyzers. For each known concentration, drug recovery was calculated using the mean concentration of the replicates. Summary results are listed below:
| Expected Concentration (ng/mL) | Mean Measured Concentration (ng/mL) | Recovery (%) |
| --- | --- | --- |
| 25 | 27.4 | 110 |
| 50 | 50.2 | 100 |
| 100 | 100.4 | 100 |
| 200 | 228.1 | 114 |
| 300 | 307.3 | 102 |
| 400 | 443.8 | 111 |
| 500 | 514.1 | 103 |
| 600 | 606.6 | 101 |
| 700 | 732.9 | 105 |
| 800 | 787.1 | 98 |
| 900 | 870.9 | 104 |
| 1000 | 937 | 94 |
| 1100 | 969.8 | 88 |
| 1200 | 1001.4 | 83 |
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c. Traceability, Stability, Expected values (controls, calibrators, or methods): The controls and calibrators are prepared using a commercially available Oxycodone standard. The concentration of Oxycodone in these calibrators and controls is determined by LC/MS analysis.
Stability: Protocols and acceptance criteria were reviewed and found to be acceptable. The sponsor claims that when stored at 2-8 °C calibrators and controls are stable for 10 months.
The sponsor claims that once opened, the calibrators and controls are stable for 14 days if stored on-board the instrument at ambient temperature (22 to 28°C).
d. Detection limit: Not applicable
e. Analytical specificity:
Interference studies: Structurally non-similar compounds and endogenous compound were evaluated to ensure that there was no interference that caused a false response relative to the cutoff in the qualitative mode and semi-quantitative mode. Results were analyzed following the recommendations in CLSI EP 7-A2. Potential interfering and endogenous substances were spiked into drug free urine containing Oxycodone at ± 25% of the cutoff (75ng/mL and 125ng/mL for the 100ng/mL cutoff and 225ng/mL and 375ng/mL for the 300ng/mL cutoff). Each sample was tested in replicates of 4 for the qualitative testing and in duplicate for the semi-quantitative testing using 2 Beckman Coulter AU400e Chemistry Analyzers and compared to the corresponding Oxycodone control.
The following structurally non-similar compounds (each tested at 100,000 ng/mL) were found not to interfere with the test result at either cutoff in both qualitative and semi-quantitative modes:
Acetaminophen, Alprazolam, d-Amphetamine, Amitryptyline, Amobarbital, Benzoylecgonine, Bromazepam, Caffeine, Clonazepam, Carbamazine, Carisoprodol, Chlorpromazine, Desipramine, Dextromethorphan, Diazepam, Diphenhydramine, Doxepine, Doxylamine, Flunitrazepam, Flurazepam, Fluoxetine, Ibuprofen, Imipramine, Ketamine, Lidocaine, LSD, Lorazepam, 3,4-MDA, 3,4-MDEA, 3,4-MDMA, PMA, Medazepam, Methadone, Metabolite (EDDP), Methaqualone, d-Methamphetamine, Meprobamate, Mephenytoin, Methylphenidate, Methadone, Naproxen, Nordiazepine, Nortriptyline, Oxazepam, Phenobarbital, Phencyclidine (PCP), Pentobarbital, Phenothiazine, Propoxyphene, Pentazocine, Protriptyline, Salicylic acid,
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Secobarbital, Sertraline, Pseudo-ephedrine, Ranitidine, Temazepam, 11-nor-carboxy-Δ9-THC, Tramadol, Triazolam, Zolpidem
The following endogenous substances at the tested concentrations did not interfere with the results of the assay at either cutoff:
| Compound | Concentration Tested |
| --- | --- |
| Acetone | 1.0 g/dL |
| Ascorbic Acid | 1.5 g/dL |
| Bilirubin | 0.002 g/dL |
| Creatinine | 0.5 g/dL |
| Ethanol | 1.0 g/dL |
| γ-Globulin | 0.5 g/dL |
| Glucose | 2.0 g/dL |
| Hemoglobin | 0.300 g/dL |
| Human Serum Albumin | 0.5 g/dL |
| Oxalic Acid | 0.1 g/dL |
| Riboflavin | 0.0075 g/dL |
| Sodium Azide | 1% w/v |
| Sodium Chloride | 6.0 g/dL |
| Sodium Fluoride | 1% w/v |
| Urea | 6.0 g/dL |
Boric acid at 1% w/v resulted in a false negative results at both cutoffs. The sponsor included the following limitation in the labeling:
"Boric acid at 1% w/v resulted in false negative results at both cutoffs. Boric Acid is not recommended as a preservative for urine."
Effect of pH: The sponsor evaluated the effect of pH on the test results using both qualitative and semi-quantitative modes. Drug free urine containing Oxycodone at ±25% of the cutoff (75ng/mL and 125ng/mL for the 100ng/mL cutoff and 225ng/mL and 375ng/mL for the 300ng/mL cutoff) were pH adjusted using hydrochloric acid or sodium hydroxide. pH values of 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0 did not interfere with the test result at either cutoff.
Effect of specific gravity: The sponsor evaluated the effect of specific gravity on the test results using both qualitative and semi-quantitative modes. Drug free urine containing Oxycodone at ±25% of the cutoff (75ng/mL and 125ng/mL for the 100ng/mL cutoff and 225ng/mL and 375ng/mL for the 300ng/mL cutoff) were adjusted using salt/albumin. Specific Gravity values of 1.000, 1.002, 1.005, 1.010, 1.015, 1.020, 1.025 and 1.030 did not interfere with the test result at either cutoff.
Cross reactivity from structurally related compounds was evaluated in the qualitative and semi-quantitative modes. Oxycodone and the structurally
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similar compound (listed below) were spiked into drug free urine at levels that will trigger the 100ng and 300ng/mL Oxycodone cutoff. Each sample was tested in singlicate for the semi-quantitative mode and in replicates of 4 for the qualitative mode using 2 Beckman Coulter AU400e Chemistry Analyzers. The results are summarized below and are expressed as the minimum concentration of metabolite or compound required to produce a response approximately equivalent to each cutoff concentration of the assay. If no cross-reactivity was observed, then the concentration in the table is the concentration tested and "N.D." or none detected is reported.
100 ng/mL cutoff
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| --- | --- | --- |
| Oxymorphone | 100 | 100 |
| Noroxymorphone | 5,000 | 2.00 |
| Oxymorphone-3β-Glucuronide | 500 | 20.00 |
| Noroxycodone | 7,500 | 1.33 |
| Naloxone | 3,750 | 2.67 |
| Naloxone, 3-Glucuronide | 50,000 | 0.20 |
| Naltrexone | 30,000 | 0.33 |
| Morphine | 350,000 | <0.10 |
| Normorphine | 1,000,000 | N.D. |
| Codeine | 500,000 | N.D. |
| Dihydrocodeine | 100,000 | N.D. |
| Norcodeine | 1,000,000 | N.D. |
| Heroin | 300,000 | N.D. |
| Hydromorphone | 50,000 | N.D. |
| Hydrocodone | 100,000 | N.D. |
| Meperidine | 50,000 | N.D. |
| Levorphanol | 200,000 | N.D. |
| Buprenorphine | 10,000 | N.D. |
| Morphine-3β-Glucuronide | 500,000 | N.D. |
| 6-Acetyl Morphine | 100,000 | N.D. |
300 ng/mL cutoff
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| --- | --- | --- |
| Oxymorphone | 300 | 100 |
| Noroxymorphone | 50,000 | 0.60 |
| Oxymorphone-3β-Glucuronide | 4,000 | 7.50 |
| Noroxycodone | 75,000 | 0.40 |
| Naloxone | 37,500 | 0.80 |
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| Naloxone, 3-Glucuronide | 500,000 | <0.10 |
| --- | --- | --- |
| Naltrexone | 300,000 | 0.10 |
| Morphine | 350,000 | N.D. |
| Normorphine | 1,000,000 | N.D. |
| Codeine | 500,000 | N.D. |
| Dihydrocodeine | 100,000 | N.D. |
| Norcodeine | 1,000,000 | N.D. |
| Heroin | 300,000 | N.D. |
| Hydromorphone | 50,000 | N.D. |
| Hydrocodone | 100,000 | N.D. |
| Meperidine | 50,000 | N.D. |
| Levorphanol | 200,000 | N.D. |
| Buprenorphine | 10,000 | N.D. |
| Morphine-3β-Glucuronide | 500,000 | N.D. |
| 6-Acetyl Morphine | 100,000 | N.D. |
f. Assay cut-off:
Analytical performance of the device around the claimed cutoff is described in the precision section (1 a.) above.
2. Comparison studies:
a. Method comparison with predicate device:
The method comparison study was performed in-house using 169 unaltered, leftover clinical urine samples obtained from clinical testing laboratories and were analyzed using one lot of the proposed device using 2 Beckman Coulter AU400e Chemistry Analyzers. The sponsor compared the results of their device to results obtained using liquid chromatography/mass spectroscopy (LC/MS). The results of the assay performance compared to LC/MS are summarized below:
The following table summarizes the performance of the assay for the 100ng/mL cutoff:
100 ng/mL cutoff
| Candidate Device Result | Oxycodone Concentration (ng/mL) | | | | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- |
| | NEG | <50 | 50-99 | 100-150 | >150 | |
| Qualitative/POS | 0 | 0 | 0 | 11 | 78 | 100 |
| Qualitative/NEG | 63 | 8 | 9 | 0 | 0 | 100 |
| Semi-quant/POS | 0 | 0 | 0 | 11 | 78 | 100 |
| Semi-quant/NEG | 63 | 8 | 9 | 0 | 0 | 100 |
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The following tables summarize the performance of the assay for the 300ng/mL cutoff:
300 ng/mL cutoff
| Candidate Device Result | Oxycodone Concentration (ng/mL) | | | | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- |
| | NEG | <150 | 150-299 | 300-450 | >450 | |
| Qualitative/POS | 0 | 2* | 5** | 15 | 67 | 100 |
| Qualitative/NEG | 43 | 27 | 10 | 0 | 0 | 92 |
| Semi-quant/POS | 0 | 2* | 5** | 15 | 67 | 100 |
| Semi-quant/NEG | 43 | 27 | 10 | 0 | 0 | 92 |
Discordant samples at the 300 ng/mL cutoff
| Candidate Device Result | | | | LC/MS Result (ng/mL) |
| --- | --- | --- | --- | --- |
| Sample | Qualitative | Semi-Quantitative | | |
| | | Value | Result | |
| 10478* | POS | 479 | POS | Oxycodone at 60 and Oxymorphone at 45 |
| 10203** | POS | 407 | POS | Oxycodone at 61 and Oxymorphone at 91 |
| 10466* | POS | 431 | POS | Oxycodone at 100 and Oxymorphone 38 |
| 10472** | POS | 841 | POS | Oxycodone at 157 and Oxymorphone at 11 |
| 10477** | POS | 1409 | POS | Oxycodone at 173 and Oxymorphone at 75 |
| 10192** | POS | 603 | POS | Oxycodone at 180 and Oxymorphone at 8 |
| 10471** | POS | 553 | POS | Oxycodone at 196 and Oxymorphone at 60 |
* The Sponsor investigated the cause of these false positive results and suspected sample integrity issues though this could not be verified. Therefore the Sponsor conducted testing of additional samples and the false results were not replicated in this study.
b. Matrix comparison:
This device is intended for use on urine samples only.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
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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.
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