(80 days)
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: The device is intended for the qualitative and semiquantitative determination of Oxycodone in human urine, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure any condition.
Yes
The device is described as an "Enzyme Immunoassay" intended for the "qualitative and semiquantitative determination of Oxycodone in human urine." It is designed for "professional use with a number of automated clinical chemistry analyzers" and provides a "preliminary analytical result" for detection of a substance in the human body, which directly aligns with the definition of a diagnostic device.
No
The device is a homogeneous enzyme immunoassay with ready-to-use liquid reagents, calibrators, and controls, which are physical components. It is intended for use with automated clinical chemistry analyzers, which are also hardware.
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 semiquantitative determination of Oxycodone in human urine." This is a diagnostic test performed on a biological sample (urine) to provide information about a person's health status (presence of oxycodone).
- Sample Type: The device analyzes "human urine," which is a biological specimen.
- Purpose: The assay provides a "preliminary analytical result" for the presence of oxycodone, which is used in a clinical context (drug testing).
- Device Description: The description details a "homogeneous enzyme immunoassay" that measures enzyme activity based on the presence of the drug in the sample. This is a common method used in IVD tests.
- Professional Use: The assay is designed for "professional use with a number of automated clinical chemistry analyzers," indicating it is intended for use in a laboratory or clinical setting.
- Calibrators and Controls: The inclusion of calibrators and controls is standard practice for IVD assays to ensure accuracy and quality control.
- Performance Studies: The document includes performance studies (Precision, Linearity, Method Comparison) which are required for demonstrating the analytical performance of an IVD device.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K050733) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the 510(k) submission process.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LZI Oxycodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of Oxycodone in human urine at the cutoff values of 100 and 300 ng/mL. The assay is designed for professional 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 Oxycodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oxycodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL.
The LZI Oxycodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Oxycodone Enzyme Immunoassay at the cutoff value 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
DJG, DLJ, LAS
Device Description
The LZI Oxycodone 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, oxycodone-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 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.
The LZI Oxycodone Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2, which are bottled separately but sold together within the kit.
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 preservative.
The LZI Oxycodone Enzyme Immunoassay (K050733) calibrators and controls designated for use at the 100 and 300 ng/mL cutoffs contain 0, 50, 75, 100, 125, 225, 300, 375, 500, and 800 ng/mL of oxycodone in human urine with sodium azide (0.09%) as preservative. These six calibrators and four 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
professional use
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
Precision Study:
100 ng/mL Cutoff Semi-Quantitative Positive/Negative Results:
Sample Concentration 0 ng/mL (-100.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 25 ng/mL (-75.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 50 ng/mL (-50.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 75 ng/mL (-25.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 100 ng/mL (100.0% of Cutoff): 9 Pos/13 Neg (Within Run), 39 Pos/49 Neg (Total Precision)
Sample Concentration 125 ng/mL (+25.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 150 ng/mL (+50.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 175 ng/mL (+75.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 200 ng/mL (+100.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
100 ng/mL Cutoff Qualitative Positive/Negative Results:
Sample Concentration 0 ng/mL (-100.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 25 ng/mL (-75.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 50 ng/mL (-50.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 75 ng/mL (-25.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 100 ng/mL (100.0% of Cutoff): 6 Pos/ 16 Neg (Within Run), 25 Pos/63 Neg (Total Precision)
Sample Concentration 125 ng/mL (+25.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 150 ng/mL (+50.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 175 ng/mL (+75.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 200 ng/mL (+100.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
300 ng/mL Cutoff Semi-Quantitative Positive/Negative Results:
Sample Concentration 0 ng/mL (-100.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 75 ng/mL (-75.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 150 ng/mL (-50.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 225 ng/mL (-25.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 300 ng/mL (100.0% of Cutoff): 3 Pos/ 19 Neg (Within Run), 26 Pos/ 62 Neg (Total Precision)
Sample Concentration 375 ng/mL (+25.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 450 ng/mL (+50.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 525 ng/mL (+75.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 600 ng/mL (+100.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
300 ng/mL Cutoff Qualitative Positive/Negative Results:
Sample Concentration 0 ng/mL (-100.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 75 ng/mL (-75.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 150 ng/mL (-50.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 225 ng/mL (-25.0% of Cutoff): 22 Negative (Within Run), 88 Negative (Total Precision)
Sample Concentration 300 ng/mL (100.0% of Cutoff): 1 Pos/21 Neg (Within Run), 23 Pos/65 Neg (Total Precision)
Sample Concentration 375 ng/mL (+25.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 450 ng/mL (+50.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 525 ng/mL (+75.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Sample Concentration 600 ng/mL (+100.0% of Cutoff): 22 Positive (Within Run), 88 Positive (Total Precision)
Linearity Study: 100 & 300 ng/mL Cutoff
Hitachi 717 Instrument: 0 - 800 ng/mL, regression equation y = 0.974x + 1.4518, r2 = 0.998.
Method Comparison - Clinical Samples:
100 ng/mL Cutoff: from a total of eighty-nine (89) clinical unaltered samples, 93.75% agreement with positive, 100.0% agreement with negative samples.
300 ng/mL Cutoff: from a total of one-hundred and one (101) clinical unaltered samples, 96.1% agreement with positive, 98.0% agreement with negative samples.
Endogenous Compound Interference & Specificity & Cross-Reactivity:
No significant undesired cross-reactants or endogenous substance interference was observed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
120763
CONFIDENTIAL
JUN - 1 2012
Lin-Zhi International, Inc.
...
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, Oxycodone 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 Oxycodone Enzyme Immunoassay LZI Oxycodone Enzyme Immunoassay, LZI Oxycodone Drugs of Abuse (DAU) Calibrators LZI Oxycodone Drugs of Abuse (DAU) Controls
1
CONFIDENTIAL
Legally Marketed Predicate Device(s)
The LZI Oxycodone Enzyme Immunoassay (EIA) is substantially equivalent to the Lin-Zhi International, Inc. Oxycodone Enzyme Immunoassay (K050733) manufactured by Lin-Zhi International, Inc. The LZI Oxycodone 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 Oxycodone 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, oxycodone-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 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.
The LZI Oxycodone Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2, which are bottled separately but sold together within the kit.
The R. 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 preservative.
The LZI Oxycodone Enzyme Immunoassay (K050733) calibrators and controls designated for use at the 100 and 300 ng/mL cutoffs contain 0, 50, 75, 100, 125, 225, 300, 375, 500, and 800 ng/mL of oxycodone in human urine with sodium azide (0.09%) as preservative. These six calibrators and four controls are sold as individual bottles.
2
CONFIDENTIAL
Lin-Zhi International, Inc.
Intended Use
The LZI Oxycodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of Oxycodone in human urine at the cutoff values of 100 and 300 ng/mL. The assay is designed for professional 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 Oxycodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oxycodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL.
The LZI Oxycodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Oxycodone Enzyme Immunoassay at the cutoff value 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.
3
CONFIDENTIAL
Comparison to Predicate Device
The LZI Oxycodone 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 K050733 for its stated intended use.
The following table compares LZI's Oxycodone Enzyme Immunoassay with the predicate device.
| Device
Characteristics | Subject Device
LZI Oxycodone Enzyme Immunoassay,
Calibrators and Controls | Predicate Device (K050733)
LZI Oxycodone Enzyme Immunoassay,
Calibrators and Controls |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | 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. | 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 | Oxycodone | Oxycodone |
| Cutoff | 100 or 300 ng/ml | 100 or 300 ng/mL |
| Matrix | Urine | Urine |
| Calibrators
Level | 0, 50, 100, 300, 500, and 800
ng/mL | 100 ng/mL Cutoff: 5 Levels
(0, 75, 100, 225, 300 ng/mL)
300 ng/mL Cutoff: 5 Levels
(0, 100, 300, 500, 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: 100 ng/mL Cutoff Hitachi 717 Analyzer
Precision: 100 ng/mL Cutoff Semi-Quantitative Positive/Negative Results:
| 100 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| 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 | 9 Pos/13 Neg | 88 | 39 Pos/49 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:
| 100 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| 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 | 6 Pos/ 16 Neg | 88 | 25 Pos/63 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 |
Precision: 300 ng/mL Cutoff Semi-Quantitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| 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 | 3 Pos/ 19 Neg | 88 | 26 Pos/ 62 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 |
5
Precision: 300 ng/mL Cutoff Continued Oualitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| 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 | 1 Pos/21 Neg | 88 | 23 Pos/65 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 |
Performance Characteristics Summary: 100 & 300 ng/mL Cutoff
Hitachi 717 Analyzer
Linearity: 100 & 300 ng/mL Cutoff
Hitachi 717 Instrument: 0 - 800 ng/mL When comparing the result (y) and target (x) value, using the least squares regression i technique, the regression equation and correlation are as follows: y = 0.974x + 1.4518, r2 = 0.998
Method Comparison - Clinical Samples: 100 ng/mL Cutoff
From a total of eighty-nine (89) clinical unaltered samples: Semi-Quantitative & Qualitative Data: 93.75% agreement with positive, 100.0% agreement with negative samples
Method Comparison - Clinical Samples: 300 ng/mL Cutoff
From a total of one-hundred and one (101) clinical unaltered samples: Semi-Quantitative & Qualitative Data: 96.1% agreement with positive, 98.0% agreement with negative samples
Endogenous Compound Interference & Specificity & Cross-Reactivity:
No significant undesired cross-reactants or endogenous substance interference was observed.
Summary:
The information provided in this pre-market notification demonstrates that the LZI Oxycodone Enzyme Immunoassay is substantially equivalent to the legally marketed Oxycodone Emerine for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by chromatography/mass spectrometry (GC/MS
6
or LC/MS), an independent analytical method. The information supplied in this premarket notification provides reasonable assurance that the LZI Oxycodone Enzyme Immunoassay is safe and effective for its stated intended use.
.
·
: 上
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7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird figure with three curved lines representing its wings and body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Lin-Zhi International, Inc c/o Bernice Lin, Ph.D. 670 Almanor Avenue Sunnyvale, CA 94085
JUN - 1 2012
K120763 Re:
Trade Name: LZI Oxycodone Enzyme Immunoassay
LZI Oxycodone Drugs of Abuse (DAU) Calibrators,
LZI Oxycodone Drugs of Abuse (DAU) Controls
Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Codes: DJG, DLJ, LAS Dated: April 27, 2012 Received: April 30, 2012
Dear Dr. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your as . Device Evaluation and Safety at (301) 796-5450. Also, comaci the Office of In Viro Diaghostics Dolive by reference to premarket notification" (2) please note the regulation entition, "Milion nownarket surveillance, please contact CDRH 's CI's Fat 607.97). I of questions regarding postmarket Surveillance at (01) Office of Surveinance and Dromotive of OSE of of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Tou may other builer general memational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely vours,
Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
9
Lin-Zhi International, Inc.
CONFIDENTIAL
Premarket Notification
Indications for Use Statement
510(k) Number (if known):
Device Name: LZI Oxycodone Enzyme Immunoassay
Indications for Use:
The LZI Oxycodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of Oxycodone in human urine at the cutoff values of 100 and 300 ng/mL. The assay is designed for professional 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 Oxycodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oxycodone Enzyme Immunoassay.
The LZI Oxycodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Oxycodone Enzyme Immunoassay.
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.
Prescription Use V V AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D). (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Per 21 CFR 801.109)
Division Sign-Off Office of In Vitro Diagnostic
Office of in wills brand Safety
510(k) K120763
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