(50 days)
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No
The description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
This device is an immunoassay intended for the qualitative and semi-quantitative determination of hydrocodone in human urine. It is used for diagnostic purposes (detection of a substance) and not for treating or preventing a disease or condition.
Yes
The device is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine, which provides information for diagnosis, monitoring, or screening of drug use.
No
The device is a homogeneous enzyme immunoassay kit comprised of liquid reagents, calibrators, and controls, which are physical components used in a laboratory setting. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semi-quantitative determination of hydrocodone in human urine." This is a diagnostic test performed in vitro (outside the body) on a biological sample (urine).
- Device Description: The description details the components of the assay kit (reagents, calibrators, controls) which are used to perform the test in vitro.
- Performance Studies: The performance studies described (Precision, Linearity, Method Comparison - Clinical Samples, Cross-reactivity, Interference, Stability) are typical studies conducted to validate the performance of an IVD device.
- Predicate Device: The mention of a predicate device (K120763; Lin-Zhi International. Inc. Oxycodone Enzyme Immunoassay) which is also an IVD, further supports the classification of this device as an IVD.
- Intended User/Care Setting: The intended users are "laboratories" and the device is designed for use with "automated clinical chemistry analyzers," which are common settings for performing IVD tests.
The entire description points to a device designed to perform a diagnostic test on a biological sample in a laboratory setting, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LZI Hydrocodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of hydrocodone in human urine at the cutoff values of 100 and 300 ng/mL when calibrated against hydrocodone. 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 GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Hydrocodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Hydrocodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL.
The LZI Hydrocodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Hydrocodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
Device Description
The LZI Hydrocodone assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. 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, hydrocodone-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound hydrocodone-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.
The LZI Hydrocodone Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The Ri solution contains mouse monoclonal anti-hydrocodone 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 hydrocodone in buffer with sodium azide (0.09%) as preservative.
The LZI Hydrocodone Enzyme Immunoassay calibrators and controls designated for use at the 100 ng/mL cutoff contain 0, 50, 75, 100, 125, 150, and 300 ng/mL of hydrocodone in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Hydrocodone Enzyme Immunoassay calibrators and controls designated for use at the 300 ng/mL cutoff contain 0. 150. 225. 300. 375. 500. and 800 ng/mL of hydrocodone in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use with a number of automated clinical chemistry analyzers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: The precision was evaluated at 100 ng/mL and 300 ng/mL cutoffs for both semi-quantitative and qualitative results.
-
100 ng/mL Cutoff (Semi-Quantitative & Qualitative):
- Within Run (N=22): Samples at 0, 25, 50, 75 ng/mL were negative. Samples at 125, 150, 175, 200 ng/mL were positive. At 100 ng/mL, semi-quantitative showed 8 Pos/14 Neg, and qualitative showed 7 Pos/15 Neg.
- Total Precision (N=88): Samples at 0, 25, 50, 75 ng/mL were negative. Samples at 125, 150, 175, 200 ng/mL were positive. At 100 ng/mL, semi-quantitative showed 43 Pos/45 Neg, and qualitative showed 28 Pos/60 Neg.
-
300 ng/mL Cutoff (Semi-Quantitative & Qualitative):
- Within Run (N=22): Samples at 0, 75, 150, 225 ng/mL were negative. Samples at 375, 450, 525, 600 ng/mL were positive. At 300 ng/mL, semi-quantitative showed 14 Pos/8 Neg, and qualitative showed 11 Pos/11 Neg.
- Total Precision (N=88): Samples at 0, 75, 150, 225 ng/mL were negative. Samples at 375, 450, 525, 600 ng/mL were positive. At 300 ng/mL, semi-quantitative showed 47 Pos/41 Neg, and qualitative showed 51 Pos/37 Neg.
Linearity:
- 100 ng/mL Cutoff: A drug-free urine pool spiked with hydrocodone at 300 ng/mL was serially diluted and run in 10 replicates. Regression equation: y = 1.0139x - 1.174, r^2 = 0.9995. Percent recovery ranged from 73.6% (for 5 ng/mL) to 102.8% (for 200 ng/mL).
- 300 ng/mL Cutoff: A drug-free urine pool spiked with hydrocodone at 800 ng/mL was serially diluted and run in 10 replicates. Regression equation: y = 1.0316x + 1.1461, r^2 = 0.9988. Percent recovery ranged from 100.8% (for 800 ng/mL) to 124.6% (for 10 ng/mL).
Method Comparison - Clinical Samples:
- 100 ng/mL Cutoff: 80 unaltered clinical urine specimens were tested and confirmed with GC/MS or LC/MS.
- Agreement: 92.5 %.
- 3 false positives (GC/MS or LC/MS negative, EIA positive) were close to the cutoff (85.1, 97.0, 97.0 ng/mL).
- 3 false negatives (GC/MS or LC/MS positive, EIA negative) were above the cutoff (128.8, 138.5, 146.5 ng/mL).
- 300 ng/mL Cutoff: 80 unaltered clinical urine specimens were tested and confirmed with GC/MS or LC/MS.
- Agreement: 95.0 %.
- 2 false positives (GC/MS or LC/MS negative, EIA positive) were close to the cutoff (206.9, 246.0 ng/mL).
- 2 false negatives (GC/MS or LC/MS positive, EIA negative) were above the cutoff (301.0, 306.2 ng/mL).
Cross-reactivity:
- 100 ng/mL Cutoff:
- Hydrocodone showed 101.60% cross-reactivity.
- Hydromorphone showed 85.08% cross-reactivity.
- Other structurally related compounds showed low cross-reactivity (e.g., Codeine 3.5%, Oxycodone 2.1%).
- 300 ng/mL Cutoff:
- Hydrocodone showed 99.70% cross-reactivity.
- Hydromorphone showed 78.13% cross-reactivity.
- Other structurally related compounds showed low cross-reactivity (e.g., Codeine 2.16%, Oxymorphone 0.90%).
Interference:
- Endogenous Compound Interference Study (100 ng/mL & 300 ng/mL Cutoff): No significant interference was observed with acetone, ascorbic acid, creatinine, ethanol, galactose, γ-globulin, glucose, hemoglobin, HSA, oxalic acid, riboflavin, urea, and sodium chloride at tested concentrations.
- pH Interference Study (100 ng/mL & 300 ng/mL Cutoff): No significant interference was observed across pH values ranging from 3 to 11.
- Specific Gravity (100 ng/mL & 300 ng/mL Cutoff): No significant interference was observed with urine samples having specific gravity ranging from 1.000 to 1.030.
Stability for Calibrators and Controls:
- Open-vial stability studies at Cold (2-8°C), Room (~25°C), and Accelerated (30°C) temperatures indicate minimal degradation up to Day 92 (100 ng/mL cutoff) and Day 225 (300 ng/mL cutoff), suggesting an open-vial stability of up to 18 months based on the Arrhenius Equation.
- Real-time closed-vial stability studies at Cold Temperature (2-8°C) indicate minimal degradation up to Day 114.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Method Comparison - Clinical Samples (100 ng/mL Cutoff):
- % Agreement: 92.5 %
- Method Comparison - Clinical Samples (300 ng/mL Cutoff):
- % Agreement: 95.0 %
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
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.(b)
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).
0
JUN 1 3 2014
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Name, Address, and Contact:
Lin-Zhi International, Inc. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849 e-mail: bclin@lin-zhi.com
Contact: Bernice Lin, Ph.D. VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Hydrocodone | |
|---|---|---|
| Class II, DJG (91 Toxicology), | ||
| 21 CFR 862.3650 |
Drug Specific Calibrators, Class II, DLJ (91 Toxicology), 21 CFR 862.3200
Drug Specific Controls, Class I, LAS (91 Toxicology), 21 CFR 862.3280
Common Name: Proprietary Name: Homogeneous Hydrocodone Enzyme Immunoassay LZI Hydrocodone Enzyme Immunoassay, LZI Hydrocodone Drugs of Abuse (DAU) Calibrators LZI Hydrocodone Drugs of Abuse (DAU) Controls
1
Legally Marketed Predicate Device(s)
The LZI Hydrocodone Enzyme Immunoassay (EIA) is substantially equivalent to the Lin-Zhi International. Inc. Oxycodone Enzyme Immunoassay (K120763) manufactured by Lin-Zhi International. Inc. The LZI Hydrocodone Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
The LZI Hydrocodone assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. 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, hydrocodone-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound hydrocodone-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.
The LZI Hydrocodone Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The Ri solution contains mouse monoclonal anti-hydrocodone 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 hydrocodone in buffer with sodium azide (0.09%) as preservative.
The LZI Hydrocodone Enzyme Immunoassay calibrators and controls designated for use at the 100 ng/mL cutoff contain 0, 50, 75, 100, 125, 150, and 300 ng/mL of hydrocodone in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Hydrocodone Enzyme Immunoassay calibrators and controls designated for use at the 300 ng/mL cutoff contain 0. 150. 225. 300. 375. 500. and 800 ng/mL of hydrocodone in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
2
Intended Use
The LZI Hydrocodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of hydrocodone in human urine at the cutoff values of 100 and 300 ng/mL. 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 GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Hydrocodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative callbration of the LZI Hydrocodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL.
The LZI Hydrocodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Hydrocodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
3
Comparison to Predicate Device
The LZI Hydrocodone Enzyme Immunoassay is substantially equivalent to the Lin-Zhi International, Inc. Oxycodone Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K120763 for its stated intended use.
The following table compares LZI's Hydrocodone Enzyme Immunoassay with the predicate device.
| Device
| Characteristics | Subject Device | Predicate Device (K120763) |
|---|---|---|
| LZI Hydrocodone Enzyme Immunoassay, | ||
| Calibrators and Controls | LZI Oxycodone Enzyme Immunoassay, | |
| Calibrators and Controls | ||
| Intended Use | The LZI Hydrocodone Enzyme | |
| Immunoassay, when used in conjunction | ||
| with the AU480 automated clinical | ||
| system analyzers, is intended for the | ||
| qualitative and semi-quantitative | ||
| determination of hydrocodone in human | ||
| urine at cutoff values of 100 or 300 | ||
| ng/mL. The assay is designed for | ||
| professional use with a number of | ||
| automated clinical chemistry analyzers. |
This assay provides a rapid screening procedure
for determining the presence of hydrocodone and
hydromorphone in urine. The assay provides only
a preliminary analytical result. A more specific
alternative chemical method must be used in order
to obtain a confirmed analytical result. Gas or
liquid chromatography/mass spectrometry (GC/MS
or LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. | The LZI Oxycodone Enzyme
Immunoassay, when used in conjunction
with Hitachi 717 automated clinical
system analyzers, is intended for the
qualitative and semi-quantitative
determination of oxycodone and
oxymorphone in human urine at cutoff
values of 100 or 300 ng/mL. The assay is
designed for professional use with a
number of automated clinical chemistry
analyzers.
This assay provides a rapid screening procedure
for determining the presence of oxycodone and
oxymorphone in urine. The assay provides only a
preliminary analytical result. A more specific
alternative chemical method must be used in order
to obtain a confirmed analytical result. Gas or
liquid chromatography/mass spectrometry (GC/MS
or LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. |
| Analyte | Hydrocodone | Oxycodone |
| Cutoff | 100 or 300 ng/ml | 100 or 300 ng/ml |
| Matrix | Urine | Urine |
| Calibrators
Level | 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 |
| Controls Level | 100 ng/mL Cutoff: 2 Levels
(75 ng/mL, 125 ng/mL)
300 ng/mL Cutoff: 2 Levels
(225 ng/mL, 375 ng/mL) | 100 ng/mL Cutoff: 2 Levels
(75 ng/mL, 125 ng/mL)
300 ng/mL Cutoff: 2 Levels
(225 ng/mL, 375 ng/mL) |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |
(
4
Performance Characteristics Summary:
AU480 Analyzer
Precision: 100 ng/mL Cutoff
Semi-Quantitative Positive/Negative Results:
The following concentrations were determined with reference curves from 5 calibrators. Typical results were measured as ng/mL. Positive/Negative results are as follows:
| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Hydrocodone | % of Cutoff | Number of | Immunoassay | Number of | Immunoassay |
| Concentration | Determination | Result | Determination | Result | |
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 100 ng/mL | 100.0% | 22 | 8 Pos/14 Neg | 88 | 43 Pos/45 Neg |
| 125 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 150 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 175 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 200 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Qualitative Positive/Negative Results:
The following concentrations were evaluated. Typical qualitative results were measured as ΔOD (mAu). Positive/Negative results are as follows:
| 100 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Hydrocodone | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 100 ng/mL | 100.0% | 22 | 7 Pos/ 15 Neg | 88 | 28 Pos/60 Neg |
| 125 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 150 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 175 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 200 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
5
AU480 Analyzer
Precision: 300 ng/mL Cutoff
Semi-Quantitative Positive/Negative Results:
The following concentrations were determined with reference curves from 5 calibrators. Typical results were measured as ng/mL. Positive/Negative results are as follows:
| 300 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Hydrocodone | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100.0% | 22 | 14 Pos/ 8 Neg | 88 | 47 Pos/ 41 Neg |
| 375 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Qualitative Positive/Negative Results:
The following concentrations were evaluated. Typical qualitative results were measured as ΔOD (mAu). Positive/Negative results are as follows:
| 300 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Hydrocodone | % of Cutoff | Number of | Immunoassay | Number of | Immunoassay |
| Concentration | Determination | Result | Determination | Result | |
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100.0% | 22 | 11 Pos/11 Neg | 88 | 51 Pos/37 Neg |
| 375 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
6
Linearity: 100 ng/mL Cutoff
To demonstrate linearity for purposes of sample dilution and quality control (see semiquantitative results section) over the entire assay range, a drug free-urine pool spiked with hydrocodone at 300 ng/ml. was serially diluted. Each sample was run in 10 replicates on the AU480 instrument and the average was used to determine percent recovery compared to the expected target value. When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow:
v = 1.0139x - 1.174. r2 = 0.9995
| Target Concentration
(ng/mL) | Determined
(ng/mL) | % Recovery |
|---------------------------------|-----------------------|------------|
| 300 | 299.0 | 99.7% |
| 250 | 254.2 | 101.7% |
| 200 | 205.6 | 102.8% |
| 175 | 177.3 | 101.3% |
| 150 | 152.6 | 101.7% |
| 125 | 124.9 | 99.9% |
| 100 | 98.2 | 98.2% |
| 75 | 73.3 | 97.8% |
| 50 | 48.1 | 96.1% |
| 25 | 24.1 | 96.4% |
| 5 | 3.7 | 73.6% |
| 0 | 0.4 | N/A |
Linearity: 300 ng/mL Cutoff
To demonstrate linearity for purposes of sample dilution and quality control (see semiquantitative results section) over the entire assay range, a drug free-urine pool spiked with hydrocodone at 800 ng/mL was serially diluted. Each sample was run in 10 replicates on the A U480 instrument and the average was used to determine percent recovery compared to the expected target value. When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow:
y = 1.0316x + 1.1461, r2 = 0.9988
| Target Concentration
(ng/mL) | Determined
(ng/mL) | % Recovery |
|---------------------------------|-----------------------|------------|
| 800 | 806.3 | 100.8% |
| 700 | 736.9 | 105.3% |
| 500 | 510.1 | 102.0% |
| 425 | 445.5 | 104.8% |
| 375 | 393.2 | 104.9% |
| 300 | 304.4 | 101.5% |
| 225 | 230.7 | 102.5% |
| 150 | 152.9 | 101.9% |
| 100 | 104.0 | 104.0% |
| 10 | 12.5 | 124.6% |
| 0 | 0.5 | N/A |
7
Method Comparison - Clinical Samples: 100 ng/mL Cutoff
Eighty (80) unaltered clinical urine specimens were tested with the LZI Hydrocodone Enzyme Immunoassay and confirmed with GC/MS or LC/MS. Specimens having a hydrocodone and hydromorphone total concentration greater than 100 ng/mL by GC/MS or LC/MS are defined as positive, and specimens with total concentrations below 100 ng/mL by GC/MS or LC/MS are defined as negative in the table below. The correlation results are summarized as follows: (near cutoff samples are defined as ± 50% of the cutoff value). Adjusted Total hydrocodone and hydromorphone GC/MS or LC/MS values corrected for cross-reactivity (Hydrocodone Cross = 100%, Hydromorphone Cross = 85%) were compared with the EIA result.
| 100 ng/mL
Cutoff | Neg | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."