(216 days)
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No
The device description details a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for qualitative determination of norfentanyl in human urine. It is used to provide analytical results for diagnostic purposes and does not exert any therapeutic effect on a patient.
Yes
This device is a diagnostic device because it is "intended for the qualitative determination of norfentanyl in human urine," which provides preliminary analytical results that contribute to a diagnosis of norfentanyl presence.
No
The device is a laboratory assay kit consisting of chemical reagents (R1 and R2 solutions) and calibrators/controls. It is designed for use with automated clinical chemistry analyzers, which are hardware devices. The description focuses on the chemical components and their interaction, not on software functionality as the primary or sole component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of norfentanyl in human urine." This is a test performed on a biological sample (urine) outside of the body to provide information about a person's health status (presence of norfentanyl, a metabolite of fentanyl).
- Device Description: The description details a "homogeneous enzyme immunoassay with ready-to-use liquid reagents" that measures enzyme activity in the sample. This is a typical format for an in vitro diagnostic test.
- Anatomical Site: The test is performed on "human urine," which is a biological specimen.
- Intended User/Care Setting: It's designed for "prescription use with a number of automated clinical chemistry analyzers," indicating it's used in a clinical laboratory setting.
- Performance Studies: The document includes details about performance studies using "clinical unaltered samples," which is standard for evaluating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K161216) and name ("Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay") strongly suggests this device is being compared to a previously cleared IVD.
All of these characteristics align with the definition and typical features of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LZI Fentanyl Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
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.
Product codes
DJG
Device Description
The LZI Fentanyl 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 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, norfentanyl-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 norfentanyl-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 Fentanyl 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-fentanyl 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 fentanyl in buffer with sodium azide (0.09 %) as a preservative.
The LZI Fentanyl Enzyme Immunoassay calibrators and controls are designated for use at the 5 ng/mL cutoff contain 0, 2.5, 3.75, 5, 6.25, 10, and 20 ng/mL of norfentanyl in human urine with sodium azide (0.09 %) as a 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
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Intended User / Care Setting
prescription 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
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Summary of Performance Studies
Precision: 5 ng/mL Cutoff
- Within Run (N=22) and Total Precision (N=88) studies were conducted for norfentanyl concentrations from 0 ng/mL to 10 ng/mL, measuring Mean, SD, and % CV of ΔOD (mAU).
- Qualitative Positive/Negative Results for 5 ng/mL Cutoff:
- Within Run (N=22) based on 22 determinations: showed negative results for 0, 1.25, 2.5, 3.75 ng/mL; 2 Pos/20 Neg for 5 ng/mL; and 22 Positive for 6.25, 7.5, 8.75, 10 ng/mL.
- Total Precision (N=88) based on 88 determinations: showed negative results for 0, 1.25, 2.5, 3.75 ng/mL; 26 Pos/62 Neg for 5 ng/mL; and 88 Positive for 6.25, 7.5, 8.75, 10 ng/mL.
Method Comparison - Clinical Samples:
- A total of one-hundred and one (101) clinical unaltered samples were used.
- Qualitative Data: 100.0 % agreement with positive samples, 86.5 % agreement with negative samples.
Endogenous Compound Interference, Specificity, and Cross-Reactivity:
- Interference was observed with Boric Acid at 1% w/v and with dextromethorphan.
- No other significant undesired cross-reactants or endogenous substance interference was observed.
Key Metrics
Precision:
- For 0 ng/mL, Within Run and Total Precision Mean ΔOD = 0.1, SD = 0.1 (Within Run) / 0.3 (Total Precision).
- For 5 ng/mL, Within Run Mean ΔOD = 84.4, SD = 2.7, % CV = 3.1%; Total Precision Mean ΔOD = 84.4, SD = 3.3, % CV = 4.0%.
- For 10 ng/mL, Within Run Mean ΔOD = 169.2, SD = 3.8, % CV = 2.3%; Total Precision Mean ΔOD = 169.2, SD = 4.3, % CV = 2.6%.
Qualitative Results (at 5 ng/mL Cutoff):
- At 5 ng/mL concentration: Within Run (N=22) - 2 Pos/20 Neg; Total Precision (N=88) - 26 Pos/62 Neg.
- At 6.25 ng/mL concentration: Within Run (N=22) - 22 Positive; Total Precision (N=88) - 88 Positive.
Method Comparison - Clinical Samples:
- Agreement with positive samples: 100.0 %
- Agreement with negative samples: 86.5 %
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 3, 2018
Lin-Zhi International, Inc. Bernice Lin, VP Operations 2945 Oakmead Village Court Santa Clara. CA 95051
Re: K181159
Trade/Device Name: LZI Fentanyl Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: October 25, 2018 Received: October 25, 2018
Dear Bernice 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181159
Device Name LZI Fentanyl Enzyme Immunoassay
Indications for Use (Describe)
The LZI Fentanyl Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentany. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K181159
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.
Submitted On
April 26, 2018
Last Updated On
November 27, 2018
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. 2945 Oakmead Village Court Santa Clara, CA 95051 Phone: (408) 970-8811 Fax: (408) 970-9030 e-mail: bclin@lin-zhi.com
Bernice Lin. Ph.D. Contact: VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Opiates
Class II, DJG (91 Toxicology),
21 CFR 862.3650 |
|----------------------|----------------------------------------------------------------------------------|
| Common Name: | Homogeneous Fentanyl Enzyme Immunoassay |
| Proprietary Name: | LZI Fentanyl Enzyme Immunoassay |
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Legally Marketed Predicate Device(s)
The LZI Fentanyl Enzyme Immunoassay is substantially equivalent to the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay (K161216) manufactured by Immunalysis Corporation. The LZI Fentanyl 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 Fentanyl Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-touse 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, norfentanyl-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 norfentanyl-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 Fentanyl 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-fentanyl 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 fentanyl in buffer with sodium azide (0.09 %) as a preservative.
The LZI Fentanyl Enzyme Immunoassay calibrators and controls are designated for use at the 5 ng/mL cutoff contain 0, 2.5, 3.75, 5, 6.25, 10, and 20 ng/mL of norfentanyl in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.
5
Intended Use
The LZI Fentanyl Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
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.
6
Comparison to Predicate Device
Levels
Storage
Control Levels
The LZI Fentanyl Enzyme Immunoassay is substantially equivalent to the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay which was cleared by the FDA under the premarket notification K161216 for its stated intended use.
Predicate Device (K161216) Subject Device Device Immunalysis SEFRIA Fentanyl Urine LZI Fentanyl Enzyme Immunoassay, Characteristics Enzyme Immunoassay and Fentanyl Norfentanyl Calibrators and Controls Calibrators The LZI Fentanyl Enzyme Immunoassay, For the qualitative determination of Intended Use when used in conjunction with the AU680 the presence of Fentanyl in human automated clinical system analyzer, is urine at a cutoff of 1 ng/mL intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. 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. Absorbance change measured Absorbance change measured Detection spectrophotometrically at 340 nm spectrophotometrically at 570 nm Analyte Norfentanyl Fentanyl Cutoff 5 ng/mL 1 ng/mL Matrix Urine Urine Calibrator One negative and three levels (0, 1, 5 ng/mL
3.75 and 6.25 ng/mL
2-8 ℃ until expiration date
2 and 4 ng/mL
2-8 °C until expiration date
N/A
The following table compares the LZI Fentanyl Enzyme Immunoassay with the predicate device.
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Performance Characteristics Summary:
AU680 Analyzer
Precision: 5 ng/mL Cutoff
| Norfentanyl
Concentration | | Within Run (N=22) | | Total Precision
(N=88) | | |
|------------------------------|-------|-------------------|-------|---------------------------|-----|-------|
| | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 0.1 | 0.1 | N/A | 0.1 | 0.3 | N/A |
| 1.25 ng/mL | 17.2 | 2.9 | 16.5% | 17.2 | 3.6 | 20.8% |
| 2.5 ng/mL | 38.4 | 2.7 | 7.2% | 38.4 | 3.2 | 8.4% |
| 3.75 ng/mL | 62.5 | 2.3 | 3.8% | 62.5 | 3.6 | 5.7% |
| 5 ng/mL | 84.4 | 2.7 | 3.1% | 84.4 | 3.3 | 4.0% |
| 6.25 ng/mL | 107.3 | 2.8 | 2.6% | 107.3 | 3.6 | 3.4% |
| 7.5 ng/mL | 128.9 | 3.0 | 2.3% | 128.9 | 4.1 | 3.2% |
| 8.75 ng/mL | 151.5 | 3.0 | 2.0% | 151.5 | 4.1 | 2.7% |
| 10 ng/mL | 169.2 | 3.8 | 2.3% | 169.2 | 4.3 | 2.6% |
Precision: Qualitative, results in ΔΟD, mAU
Qualitative Positive/Negative Results:
| 5 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | |||
|---|---|---|---|---|---|
| Norfentanyl | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | EIA Result | Number of | |||
| Determination | EIA Result | ||||
| 0 ng/mL | 0 % | 22 | 22 Negative | 88 | 88 Negative |
| 1.25 ng/mL | 25.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 2.5 ng/mL | 50.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 3.75 ng/mL | 75.0 % | 22 | 22 Negative | 88 | 88 Negative |
| 5 ng/mL | 100.0 % | 22 | 2 Pos/ | ||
| 20 Neg | 88 | 26 Pos/ | |||
| 62 Neg | |||||
| 6.25 ng/mL | 125.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 7.5 ng/mL | 150.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 8.75 ng/mL | 175.0 % | 22 | 22 Positive | 88 | 88 Positive |
| 10 ng/mL | 200.0 % | 22 | 22 Positive | 88 | 88 Positive |
Method Comparison - Clinical Samples:
From a total of one-hundred and one (101) clinical unaltered samples, Qualitative Data: 100.0 % agreement with positive, 86.5 % agreement with negative samples
Endogenous Compound Interference, Specificity, and Cross-Reactivity:
Interference was observed with Boric Acid at 1% w/v and with dextromethorphan. No other significant undesired cross-reactants or endogenous substance interference was observed.
8
Performance Characteristics Summary: (continued) AU680 Analyzer
Summary:
The information provided in this pre-market notification demonstrates that the LZI Fentanyl Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device 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 or LC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Fentanyl Enzyme Immunoassay is safe and effective for its stated intended use.