LZI Oxycodone III Enzyme Immunoassay
Device Facts
| Record ID | K202007 |
|---|---|
| Device Name | LZI Oxycodone III Enzyme Immunoassay |
| Applicant | Lin-Zhi International, Inc. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Sep 17, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The LZI Oxycodone III Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of oxycodone in human urine at the cutoff values of 100 ng/mL and 300 ng/mL when calibrated against oxycodone. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS or LC/MS, or (2) permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatograpy and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Device Story
LZI Oxycodone III Enzyme Immunoassay is a homogeneous enzyme immunoassay kit; utilizes two liquid reagents (R1: anti-oxycodone antibody; R2: oxycodone-labeled G6PDH conjugate). Operates via competitive binding: drug in urine sample competes with drug-labeled G6PDH for fixed antibody sites. Enzyme activity is inhibited when bound to antibody; free drug in sample displaces conjugate, increasing enzyme activity. Active enzyme converts NAD to NADH, producing absorbance change measured spectrophotometrically at 340 nm. Used in clinical laboratories on automated chemistry analyzers (e.g., Beckman Coulter AU480) by trained technicians. Provides preliminary qualitative/semi-quantitative results to guide specimen dilution for confirmatory testing (GC/MS or LC/MS). Assists clinicians in identifying potential oxycodone presence; requires professional judgment for clinical decision-making.
Clinical Evidence
Bench testing only. Precision studies (N=88 runs) evaluated qualitative and semi-quantitative performance at 100 ng/mL and 300 ng/mL cutoffs. Method comparison against LC/MS using clinical urine samples (N=82 for 100 ng/mL; N=90 for 300 ng/mL) showed high agreement. Cross-reactivity and interference studies (endogenous, preservative, and pharmacological compounds) confirmed assay specificity. No clinical prospective/retrospective studies were required.
Technological Characteristics
Homogeneous enzyme immunoassay; liquid reagents (R1: mouse monoclonal anti-oxycodone antibody, G6P, NAD; R2: oxycodone-labeled G6PDH). Sensing principle: spectrophotometric measurement of NADH production at 340 nm. Connectivity: compatible with automated clinical chemistry analyzers. Storage: 2-8 °C.
Indications for Use
Indicated for the qualitative and semi-quantitative detection of oxycodone in human urine at 100 ng/mL and 300 ng/mL cutoffs. For prescription use in clinical laboratories to aid in identifying specimens for confirmatory testing. Not for diagnostic use; results are preliminary and require 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
- LZI Oxycodone Homogeneous Enzyme Immunoassay, LZI Oxycondone Calibrators, LZI Oxycodone Controls (K120763)
Related Devices
- K131168 — IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY · Immunalysis Corporation · Jan 17, 2014
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K202007
B Applicant
Lin-Zhi International, Inc.
C Proprietary and Established Names
LZI Oxycodone III Enzyme Immunoassay
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Oxycodone
C Type of Test:
Qualitative and semi-quantitative enzyme immunoassay
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The LZI Oxycodone III Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of oxycodone in human urine at the cutoff values of 100 ng/mL and 300 ng/mL when calibrated against oxycodone. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS or LC/MS, or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
Performance characteristics have been validated on the Beckman Coulter® AU480 clinical analyzer.
IV Device/System Characteristics:
A Device Description:
The LZI Oxycodone III Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit. The LZI Oxycodone III Enzyme Immunoassay is traceable to a commercially available oxycodone standard.
The R1 solution contains mouse monoclonal anti-oxycodone antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with oxycodone in buffer with sodium azide (0.09 %) as a preservative.
B Principle of Operation:
The LZI Oxycodone III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between drug in the sample and
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drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available oxycodone standard and referred to as oxycodone-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, oxycodone-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. If free drug is present in the sample, the antibody would bind to free drug; the unbound oxycodone-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
V Substantial Equivalence Information:
A Predicate Device Name(s):
LZI Oxycodone Homogeneous Enzyme Immunoassay, LZI Oxycondone Calibrators, LZI Oxycodone Controls
B Predicate 510(k) Number(s):
K120763
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K202007 | K120763 |
| --- | --- | --- |
| Device Trade Name | LZI Oxycodone III Enzyme Immunoassay | LZI Oxycodone Enzyme Immunoassay |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the qualitative and semiquantitative determination of oxycodone in human urine, at cutoff values of 100 ng/mL and 300 ng/mL. | Same |
| Cutoffs | 100 and 300 ng/mL | Same |
| Matrix | Urine | Same |
| General Device Characteristic Differences | | |
| Calibrator levels | 100 ng/mL Cutoff: 5 Levels: 0, 50, 100, 150, and 300 ng/mL
300 ng/mL Cutoff: 5 Levels: 0, 150, 300, 500, and 800 ng/mL | 0, 50, 100, 300, 500, and 800 ng/mL |
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VI Standards/Guidance Documents Referenced:
None referenced.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
The precision performance of the assay was evaluated in qualitative and semi-quantitative mode.
All samples were run in replicates of two, with two runs a day for 22 days on one Beckman Coulter® AU480 automated clinical analyzer for a total of 88 results per concentration.
The oxycodone sample concentrations were prepared by spiking oxycodone into negative urine samples, and all concentrations for the precision studies were confirmed by LC/MS testing. Results are summarized below:
100 ng/mL cutoff semi-quantitative mode:
| 100 ng/mL Cutoff Result: | | Within Run (N=22) | | Total Precision (N=88) | |
| --- | --- | --- | --- | --- | --- |
| Oxycodone Concentration | % of Cutoff | N | Immunoassay Result | N | Immunoassay Result |
| 0 ng/mL | 0% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 25 ng/mL | 25% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 50 ng/mL | 50% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 75 ng/mL | 75% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 100 ng/mL | 100% | 22 | 5 Negative / 17 Positive | 88 | 26 Negative / 62 Positive |
| 125 ng/mL | 125% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 150 ng/mL | 150% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 175 ng/mL | 175% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 200 ng/mL | 200% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
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100 ng/mL cutoff qualitative mode:
| 100 ng/mL Cutoff Result: | | Within Run (N=22) | | Total Precision (N=88) | |
| --- | --- | --- | --- | --- | --- |
| Oxycodone Concentration | % of Cutoff | N | Immunoassay Result | N | Immunoassay Result |
| 0 ng/mL | 0% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 25 ng/mL | 25% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 50 ng/mL | 50% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 75 ng/mL | 75% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 100 ng/mL | 100% | 22 | 9 Negative / 13 Positive | 88 | 33 Negative / 55 Positive |
| 125 ng/mL | 125% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 150 ng/mL | 150% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 175 ng/mL | 175% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 200 ng/mL | 200% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
300 ng/mL cutoff semi-quantitative mode:
| 300 ng/mL Cutoff Result: | | Within Run (N=22) | | Total Precision (N=88) | |
| --- | --- | --- | --- | --- | --- |
| Oxycodone Concentration | % of Cutoff | N | Immunoassay Result | N | Immunoassay Result |
| 0 ng/mL | 0% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 75 ng/mL | 25% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 150 ng/mL | 50% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 225 ng/mL | 75% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 300 ng/mL | 100% | 22 | 6 Negative / 16 Positive | 88 | 27 Negative / 61 positive |
| 375 ng/mL | 125% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 450 ng/mL | 150% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 525 ng/mL | 175% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 600 ng/mL | 200% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
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300 ng/mL cutoff qualitative mode:
| 300 ng/mL Cutoff Result: | | Within Run (N=22) | | Total Precision (N=88) | |
| --- | --- | --- | --- | --- | --- |
| Oxycodone Concentration | % of Cutoff | N | Immunoassay Result | N | Immunoassay Result |
| 0 ng/mL | 0% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 75 ng/mL | 25% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 150 ng/mL | 50% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 225 ng/mL | 75% | 22 | 22 Negative / 0 Positive | 88 | 88 Negative / 0 Positive |
| 300 ng/mL | 100% | 22 | 10 Negative / 12 Positive | 88 | 40 Negative / 48 Positive |
| 375 ng/mL | 125% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 450 ng/mL | 150% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 525 ng/mL | 175% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
| 600 ng/mL | 200% | 22 | 0 Negative / 22 Positive | 88 | 0 Negative / 88 Positive |
2. Linearity:
Linearity and recovery were evaluated in the semi-quantitative mode by analyzing serial dilutions of a sample with an oxycodone concentration of 300 ng/mL (for the 100 ng/mL cutoff) and an 800 ng/mL concentration sample (for the 300 ng/mL cutoff). Results are summarized below:
100 ng/mL cutoff
| Target Concentration (ng/mL) | Mean Concentration (ng/mL) | Mean % Recovery |
| --- | --- | --- |
| 300 | 302.1 | 100.7 % |
| 270 | 282.7 | 104.7 % |
| 240 | 260.4 | 108.5 % |
| 210 | 231.0 | 110.0 % |
| 180 | 197.0 | 109.5 % |
| 150 | 153.6 | 102.4 % |
| 120 | 121.4 | 101.2 % |
| 90 | 88.8 | 98.6 % |
| 60 | 56.9 | 94.8 % |
| 30 | 27.1 | 90.3 % |
| 0 | 0.7 | N/A |
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300 ng/mL cutoff
| Target Concentration (ng/mL) | Mean Concentration (ng/mL) | Mean % Recovery |
| --- | --- | --- |
| 800 | 843.5 | 105.4 % |
| 720 | 784.2 | 108.9 % |
| 640 | 712.8 | 111.4 % |
| 560 | 624.3 | 111.5 % |
| 480 | 514.2 | 107.1 % |
| 400 | 436.8 | 109.2 % |
| 320 | 345.0 | 107.8 % |
| 240 | 250.8 | 104.5 % |
| 160 | 173.9 | 108.7 % |
| 80 | 89.0 | 111.2 % |
| 0 | 0.3 | N/A |
3. Analytical Specificity/Interference:
Cross-reactivity
The cross-reactivity of structurally related compounds was tested by spiking each potential cross-reactant into pooled negative human urine and then evaluating the sample with the candidate assay. Results are summarized below using the 100 ng/mL cutoff. Results obtained using the 300 ng/mL cutoff were nearly identical.
| Potential Cross-Reacting Compound | Test Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100.00 % |
| Oxymorphone | 100 | 100.00 % |
| Noroxycodone | 25,000 | 0.40 % |
| Noroxymorphone | 60,000 | 0.17 % |
| 6-Acetylmorphine | 100,000 | ND |
| Buprenorphine | 100,000 | ND |
| Codeine | 100,000 | ND |
| Codeine-6β-D-Glucuronide | 100,000 | ND |
| Dextromethorphan | 100,000 | ND |
| Dihydrocodeine | 100,000 | ND |
| Hydrocodone | 25,000 | 0.40 % |
| Hydromorphone | 25,000 | 0.40 % |
| Levorphanol | 100,000 | ND |
| Morphine | 100,000 | ND |
| Morphine-3β-D-Glucuronide | 100,000 | ND |
| Morphine-6β-D-Glucuronide | 100,000 | ND |
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Interference Testing - Drugs
Potential interference from structurally unrelated compounds was evaluated by spiking a high concentration (as noted in the table below) of the potential interferent into two sample aliquots with oxycodone concentrations at -25% and +25% of the cutoff concentration. Samples were then evaluated with the candidate assay and the results are summarized below.
There were no deviations from the expected positive or negative results.
| Compound | Test Concentration (ng/mL) | -25 % Oxycodone Cutoff (75 ng/mL) | +25 % Oxycodone Cutoff (125 ng/mL) |
| --- | --- | --- | --- |
| | | Result | Result |
| Amlodipine Besylate | 100,000 | Neg | Pos |
| Amoxicillin | 100,000 | Neg | Pos |
| d-Amphetamine | 100,000 | Neg | Pos |
| Atorvastatin | 20,000 | Neg | Pos |
| Benzoylecgonine | 100,000 | Neg | Pos |
| Bupropion | 100,000 | Neg | Pos |
| Caffeine | 100,000 | Neg | Pos |
| Carbamazepine | 100,000 | Neg | Pos |
| Cetirizine | 100,000 | Neg | Pos |
| Chlorpheniramine | 100,000 | Neg | Pos |
| Chlorpromazine | 100,000 | Neg | Pos |
| Clomipramine | 100,000 | Neg | Pos |
| Desipramine | 100,000 | Neg | Pos |
| Diphenhydramine | 100,000 | Neg | Pos |
| Duloxetine | 100,000 | Neg | Pos |
| Fentanyl | 100,000 | Neg | Pos |
| Fluoxetine | 100,000 | Neg | Pos |
| Fluphenazine | 100,000 | Neg | Pos |
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| Compound | Test Concentration (ng/mL) | -25 % Oxycodone Cutoff (75 ng/mL) | +25 % Oxycodone Cutoff (125 ng/mL) |
| --- | --- | --- | --- |
| | | Result | Result |
| Gabapentin | 100,000 | Neg | Pos |
| Ibuprofen | 100,000 | Neg | Pos |
| Imipramine | 100,000 | Neg | Pos |
| Lisinopril | 100,000 | Neg | Pos |
| Losartan | 10,000 | Neg | Pos |
| Loratadine | 100,000 | Neg | Pos |
| MDA (3,4-methylenedioxyamphetamine) | 100,000 | Neg | Pos |
| MDEA | 100,000 | Neg | Pos |
| MDMA (3,4-methylenedioxymethamphetamine) | 100,000 | Neg | Pos |
| Meperidine | 100,000 | Neg | Pos |
| Metformin | 100,000 | Neg | Pos |
| Metoprolol | 100,000 | Neg | Pos |
| Methadone | 100,000 | Neg | Pos |
| d-Methamphetamine | 100,000 | Neg | Pos |
| Nicotine | 100,000 | Neg | Pos |
| Nortriptyline | 100,000 | Neg | Pos |
| Omeprazole | 100,000 | Neg | Pos |
| Oxazepam | 100,000 | Neg | Pos |
| Phenobarbital | 100,000 | Neg | Pos |
| (1S,2S)-(+)Pseudoephedrine | 100,000 | Neg | Pos |
| Quetiapine | 100,000 | Neg | Pos |
| Ranitidine | 100,000 | Neg | Pos |
| Salbutamol (Albuterol) | 100,000 | Neg | Pos |
| Sertraline | 100,000 | Neg | Pos |
| THC-COOH (11-Nor-Delta-9-THC-9-carboxylic acid) | 1000 | Neg | Pos |
| l-Thyroxine | 10,000 | Neg | Pos |
| Tramadol | 100,000 | Neg | Pos |
| Zolpidem | 10,000 | Neg | Pos |
Potential interference from endogenous compounds and urine preservatives was also evaluated in a separate study. Results indicated that there is interference from boric acid at 1000 mg/dL. No other compounds showed interference concentrations at the concentrations tested. Results are summarized below:
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Interference Testing – Endogenous
| Potential Interfering Endogenous Substance | Concentration of Compound (mg/dL) | -25 % Oxycodone Cutoff (75 ng/mL) | +25 % Oxycodone Cutoff (125 ng/mL) |
| --- | --- | --- | --- |
| | | Result | Result |
| Acetone | 1000 | Neg | Pos |
| Ascorbic Acid | 1500 | Neg | Pos |
| Bilirubin | 2 | Neg | Pos |
| Calcium Chloride (CaCl2) | 300 | Neg | Pos |
| Citric Acid (pH 3) | 800 | Neg | Pos |
| Creatinine | 500 | Neg | Pos |
| Ethanol | 1000 | Neg | Pos |
| Galactose | 10 | Neg | Pos |
| γ-Globulin | 500 | Neg | Pos |
| Glucose | 3000 | Neg | Pos |
| Hemoglobin | 300 | Neg | Pos |
| β-hydroxybutyric Acid | 100 | Neg | Pos |
| Human Serum Albumin | 500 | Neg | Pos |
| Oxalic Acid | 100 | Neg | Pos |
| Potassium Chloride | 6000 | Neg | Pos |
| Riboflavin | 7.5 | Neg | Pos |
| Urea | 6000 | Neg | Pos |
| Uric Acid | 10 | Neg | Pos |
| Sodium Azide | 1000 | Neg | Pos |
| Sodium Chloride | 6000 | Neg | Pos |
| Sodium Fluoride | 1000 | Neg | Pos |
| Sodium Phosphate | 300 | Neg | Pos |
Boric acid at 1000 mg/dL was found to cause false negative results at +25 and +50% of the cutoff. The following limitation is included in the device labeling: Boric Acid at 1% w/v may cause false negative results. Boric Acid is not recommended as a preservative for urine.
## Effect of pH
The sponsor evaluated the effect of pH on the results by preparing aliquots with oxycodone concentrations at -25% and +25% of the cutoff and adjusting the pH from 3 to 11 in increments of one pH unit. There were no deviations from the expected positive or negative results.
## Effect of specific gravity
The sponsor evaluated the effect of specific gravity on the results by preparing aliquots with oxycodone concentrations at -25% and +25% of the cutoff and adjusting the specific gravity
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from 1.000 to 1.030. There were no deviations from the expected positive or negative results.
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The LZI Oxycodone III Enzyme Immunoassay is traceable to a commercially available oxycodone standard.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
The performance of the assay around the claimed cutoffs is presented in sections VII.A.1 and VII.A.2 above.
B Comparison Studies:
1. Method Comparison with Predicate Device:
For the 100 ng/mL cutoff, the sponsor conducted a method comparison study using 82 unaltered clinical urine samples comparing results on the candidate device to those using a validated LC-MS/MS method. Since the assay demonstrated 100% cross-reactivity with oxymorphone, samples were binned according to the sum of the oxycodone and oxymorphone concentrations, which ranged from 0 to 400.0 ng/mL. The results were identical between the qualitative and semi-quantitative modes and are summarized in the tables below:
| Candidate device results | < 50 % of the cutoff concentration by LC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration by LC/MS analysis) | Near Cutoff Positive (Between the cutoff and 50 % above the Cutoff concentration by LC/MS analysis | High Positive (Greater than 50 % above the cutoff concentration by LC/MS analysis) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2* | 12 | 25 |
| Negative | 29 | 10 | 4** | 0 |
*concentrations of the discordant samples were 89.9 and 91.0 ng/mL.
**concentrations of the discordant samples were 102.7, 107.0, 131.1, and 138.7 ng/mL.
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For the 300 ng/mL cutoff, the sponsor conducted a method comparison study using 90 unaltered clinical urine samples comparing results on the candidate device to those using a validated LC-MS/MS method. Since the assay demonstrated 100% cross-reactivity with oxymorphone, samples were binned according to the sum of the oxycodone and oxymorphone concentrations, which ranged from 0 to 1302.5 ng/mL. There were slight differences between the qualitative and semi-quantitative modes and results for both modes are summarized in the tables below:
Semi-quantitative mode
| Candidate device results | < 50 % of the cutoff concentration by LC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration by LC/MS analysis) | Near Cutoff Positive (Between the cutoff and 50 % above the Cutoff concentration by LC/MS analysis | High Positive (Greater than 50 % above the cutoff concentration by LC/MS analysis) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2* | 11 | 33 |
| Negative | 26 | 17 | 1** | 0 |
*concentrations of the discordant samples were 249.7 and 256.5 ng/mL.
**concentration of the discordant sample was 414.0 ng/mL.
Qualitative mode
| Candidate device results | < 50 % of the cutoff concentration by LC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration by LC/MS analysis) | Near Cutoff Positive (Between the cutoff and 50 % above the Cutoff concentration by LC/MS analysis | High Positive (Greater than 50 % above the cutoff concentration by LC/MS analysis) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2* | 10 | 33 |
| Negative | 26 | 17 | 2** | 0 |
*concentrations of the discordant samples were 249.7 and 256.5 ng/mL.
**concentrations of the discordant samples were 389.3 and 414.0 ng/mL.
2. Matrix Comparison:
Not applicable. The assay is for use with urine samples only.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
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2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D. Clinical Cut-Off:
Not applicable.
E. Expected Values/Reference Range:
Not applicable.
VIII. Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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