(20 days)
Not Found
No.
This device is an immunoassay kit that performs chemical reactions to detect fentanyl. There is no indication of any computational model, machine learning, or AI components in its operation.
No
The device is an in vitro diagnostic (IVD) test intended for the qualitative determination of fentanyl in human urine. It is used to detect the presence of fentanyl and not to treat or prevent a disease or condition.
Yes
The device is intended for the "qualitative determination of fentanyl in human urine" and provides a "preliminary analytical result" for diagnostic purposes. It is explicitly labeled for "prescription use."
No
The device is a chemical reagent kit (enzyme immunoassay) for laboratory analysis, which is a physical product. While it is used with automated clinical chemistry analyzers which contain software, the device itself is a tangible, chemical-based diagnostic test, not a software application.
Yes
The device is intended for the qualitative determination of fentanyl in human urine, which is a test performed on samples taken from the human body outside of the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. 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 (comma separated list FDA assigned to the subject device)
DJG
Device Description
The LZI Fentanyl III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between the drug in the sample and the 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 fentanyl standard and referred to as fentanyl-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 a drug in the sample, fentanyl-labeled G6PDH conjugate is bound to the antibody, and the enzyme activity is inhibited. On the other hand, when the free drug is present in the sample, the antibody would bind to the free drug; the unbound fentanyl-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 III Enzyme Immunoassay is a kit comprised of two reagents, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine (human)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories; Prescription use only
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
A total of one hundred and fifty (150) unaltered clinical samples were tested with the LZI Fentanyl III Enzyme Immunoassay on the Beckman Coulter AU5800 automated clinical analyzer. Samples were evaluated against the cutoff calibrator in qualitative mode. All samples were tested in singlet. All samples were confirmed by LC/MS for fentanyl concentrations. Samples were obtained by LZI and through collaboration with various clinical laboratories across the United States and Canada.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: Tested in qualitative (ΔOD, mAU) mode using a modified NCCLS-EP5 protocol. Samples were prepared by spiking fentanyl standard into negative human urine at cutoff and ±25%, ±50%, ±75%, and ±100% of the cutoff concentration. Samples were tested in replicates of two, two runs a day for 22 days on one Beckman Coulter AU5800 automated clinical analyzer for a total of 88 replicates.
At 0, 0.25, 0.5, 0.75 ng/mL (0%, 25%, 50%, 75% of cutoff), all 88 determinations were negative.
At 1 ng/mL (100% of cutoff), 4 negative and 84 positive results were observed across 88 determinations.
At 1.25, 1.5, 1.75, 2 ng/mL (125%, 150%, 175%, 200% of cutoff), all 88 determinations were positive.
Method Comparison - Clinical Samples: 150 unaltered clinical samples were tested with the LZI Fentanyl III Enzyme Immunoassay on the Beckman Coulter AU5800 automated clinical analyzer. Samples were evaluated against the cutoff calibrator in qualitative mode and confirmed by LC/MS for fentanyl concentrations.
Qualitative Accuracy Study (1 ng/mL Cutoff):
LC/MS Negative (0 ng/mL fentanyl): 35 EIA negative results.
50% above cutoff, > 1.5 ng/mL fentanyl): 61 EIA positive results.
Discrepant samples (samples that were LC/MS negative but EIA positive) were analyzed for norfentanyl concentration, and all were found to contain norfentanyl contributing to the positive results.
Cross-reactivity: Various potentially interfering drugs were spiked into negative human urine and evaluated.
Fentanyl and Metabolites: Fentanyl (1.0 ng/mL) showed 100.00% cross-reactivity. Norfentanyl (2.5 ng/mL) showed 40.00% cross-reactivity.
Structurally Related Compounds: Compounds like 4-Fluoro-isobutyryl fentanyl (25 ng/mL, 4.00%), Acetyl fentanyl (4 ng/mL, 25.00%), Acryl fentanyl (1 ng/mL, 100.00%), Butyryl fentanyl (1 ng/mL, 100.00%), and others exhibited varying degrees of cross-reactivity. Many compounds tested at high concentrations (e.g., Alfentanil, Carfentanil oxalate) were not detected (ND).
Structurally Unrelated Pharmacological Compounds: Most compounds (e.g., Acetaminophen, Alprazolam, Caffeine, Codeine) tested at 100,000 ng/mL did not cause false positive results (Neg) at 0 ng/mL Fentanyl and 0.5 ng/mL Fentanyl (50% below cutoff), and were positive (Pos) at 1.5 ng/mL Fentanyl (50% above cutoff). Dextromethorphan (20,000 ng/mL) showed a positive result at -50% Fentanyl Cutoff (0.5 ng/mL) concentration. Further testing showed Dextromethorphan at 15,000 ng/mL did not cause a discrepant result at 0.5 ng/mL fentanyl concentration.
Endogenous and Preservative Compound Interference: Compounds were spiked into pooled negative human urine at 0, 0.5, and 1.5 ng/mL fentanyl.
Interference was observed with Boric Acid at 1,000 mg/dL (1% w/v), causing a negative result at +50% Fentanyl Cutoff (1.5 ng/mL). No other significant cross-reactivity was observed.
Specific Gravity Interference: Samples ranging from 1.000 to 1.030 specific gravity were spiked with 0, 0.5, and 1.5 ng/mL fentanyl. No interference was observed across the specific gravity range.
pH Interference: Urine samples at pH levels from 3 to 11 were spiked with 0, 0.5, and 1.5 ng/mL fentanyl. No major interference was observed between pH 3 to pH 11.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Specific numerical metrics like Sensitivity, Specificity, PPV, NPV are not explicitly stated, but raw data is presented in the "Summary of Performance Studies" section.)
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).
FDA 510(k) Clearance Letter - LZI Fentanyl III Enzyme Immunoassay
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 18, 2025
Lin-Zhi International, Inc.
Chris Wang
Senior Manager, DAU Assay Development
2945 Oakmead Village Court
Santa Clara, California 95051
Re: K251634
Trade/Device Name: LZI Fentanyl III Enzyme Immunoassay
Regulation Number: 21 CFR 862.3650
Regulation Name: Opiate Test System
Regulatory Class: Class II
Product Code: DJG
Dated: May 28, 2025
Received: May 29, 2025
Dear Chris Wang:
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 (the 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 available 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.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251634 - Chris Wang Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K251634 - Chris Wang Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
JOSEPH A. KOTAREK -S
Digitally signed by JOSEPH A. KOTAREK -S
Date: 2025.06.18 14:21:24 -04'00'
Joseph Kotarek
Branch Chief for Toxicology
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251634
Device Name: LZI Fentanyl III Enzyme Immunoassay
Indications for Use (Describe):
The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. 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.
Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
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"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."
Page 5
Lin-Zhi International, Inc.
510(k) Summary
510(k) Number: K251634
Prepared On: June 17, 2025
Submitter Name and Contact Person:
Chris Wang, M.S.
Senior Manager, DAU Assay Development
Phone: (408) 970-8811
Fax: (408) 970-9030
E-mail: cjwang@lin-zhi.com
Company Address:
Lin-Zhi International, Inc.
2945 Oakmead Village Court
Santa Clara, CA 95051
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Lin-Zhi International, Inc.
Introduction
This submission is provided in accordance with 21 CFR 807.92 as a Special 510(k) for the LZI Fentanyl III Enzyme Immunoassay. The purpose of this application is to support modifications made to LZI's legally marketed predicate device, the LZI Fentanyl II Enzyme Immunoassay (K201938). These modifications include a change in target analyte from norfentanyl to fentanyl, an updated cutoff concentration, and changes to assay application parameters.
Verification and validation activities were conducted using well-established methods consistent with those performed for the predicate device. These included method comparison with LC/MS, precision studies, cross-reactivity evaluation, and interference testing. Collectively, the data confirm that the modified device supports its intended use, safety, and effectiveness, and performs substantially equivalent to the predicate.
This submission includes a summary of design control activities and performance characteristics, which together provide a complete basis for a determination of substantial equivalence.
Device Name and Classification
Classification Name: Enzyme Immunoassay, Opiates
Regulation Number: 21 CFR 862.3650
Product Code: Class II, DJG (91 Toxicology)
Common Name: Homogeneous Fentanyl Enzyme Immunoassay
Proprietary Name: LZI Fentanyl III Enzyme Immunoassay
Submission Type: Special 510(k)
510(k) Number: K251634
Legally Marketed Predicate Device
The subject device is compared to the predicate:
Predicate Device: LZI Fentanyl II Enzyme Immunoassay
510(k) Number: K201938
The LZI Fentanyl III Enzyme Immunoassay is substantially equivalent to the LZI Fentanyl II Enzyme Immunoassay (K201938) manufactured by LZI in terms of intended use, method principle, device components, and clinical performance.
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Lin-Zhi International, Inc.
Device Description
The LZI Fentanyl III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between the drug in the sample and the 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 fentanyl standard and referred to as fentanyl-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 a drug in the sample, fentanyl-labeled G6PDH conjugate is bound to the antibody, and the enzyme activity is inhibited. On the other hand, when the free drug is present in the sample, the antibody would bind to the free drug; the unbound fentanyl-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 III Enzyme Immunoassay is a kit comprised of two reagents, 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.
Intended Use
The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. 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.
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Lin-Zhi International, Inc.
Substantial Equivalence Comparison to Predicate Device
The LZI Fentanyl III Enzyme Immunoassay is substantially equivalent to the LZI Fentanyl II Enzyme Immunoassay which was cleared by the FDA under the premarket notification K201938 for its stated intended use.
The following table compares the LZI Fentanyl III Enzyme Immunoassay with the predicate device.
| Device Characteristics | Subject Device
LZI Fentanyl III Enzyme Immunoassay | Predicate Device (K201938)
LZI Fentanyl II Enzyme Immunoassay |
|---|---|---|
| Intended Use | The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. 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. | The LZI Fentanyl II Enzyme Immunoassay is intended for the qualitative detection of norfentanyl in human urine at the cutoff value of 5 ng/mL. 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. |
| Analyte | Fentanyl | Norfentanyl |
| Cutoff | 1 ng/mL | 5 ng/mL |
| Matrix | Urine | same |
| Calibrator Level | 1 ng/mL | 5 ng/mL |
| Controls Level | 0.5 ng/mL and 1.5 ng/mL | 3.75 ng/mL and 6.25 ng/mL |
| Storage | 2-8 ºC until expiration date | same |
| Application Volume | R1: 65 µL; R2: 25 µL; Sample: 15 µL | R1: 120 µL; R2: 45 µL; Sample: 15 µL |
| Detection | Absorbance change measured spectrophotometrically at 340 nm. | same |
| User Environment | Clinical laboratories; Prescription use only | same |
| Mass Spectrometry Confirmation | Required to confirm preliminary positive analytical results | same |
| Platform Required | Automated clinical chemistry analyzer | same |
| Reagents Form | Liquid ready-to-use | same |
| Reagent Materials | Two (2) reagent system: Antibody/substrate reagent (R1) and enzyme labeled conjugates (R2) with sodium azide preservative | same |
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Lin-Zhi International, Inc.
Performance Characteristics Summary:
All 510(k) studies below were conducted on the Beckman Coulter AU5800 Analyzer
Precision: 1 ng/mL Cutoff
The assay was tested in qualitative (ΔOD, mAU) mode using a modified NCCLS-EP5 protocol. Fentanyl sample concentrations were prepared by spiking a fentanyl standard into a pool of negative human urine at the cutoff concentration and ±25%, ±50%, ±75%, and ±100% of the cutoff concentration.
The results shown below were obtained by testing all samples in replicates of two, two runs a day (one in the morning and one in the afternoon) for 22 days on one Beckman Coulter AU5800 automated clinical analyzer for a total of 88 replicates. Samples were evaluated against the cutoff calibrator in qualitative mode. One single lot of reagents, calibrators, and controls was used and stored at 2-8ºC when not in use.
Precision: 1 ng/mL Cutoff
Qualitative Positive/Negative Results:
| 1 ng/mL Cutoff Result: | Within Run (N=22) | Total Precision (N=88) | ||
|---|---|---|---|---|
| Fentanyl Concentration | % of Cutoff | Number of Determination | Immunoassay Result | Number of Determination |
| 0 ng/mL | 0% | 22 | 22 Negative | 88 |
| 0.25 ng/mL | 25% | 22 | 22 Negative | 88 |
| 0.5 ng/mL | 50% | 22 | 22 Negative | 88 |
| 0.75 ng/mL | 75% | 22 | 22 Negative | 88 |
| 1 ng/mL | 100% | 22 | 22 Positive | 88 |
| 1.25 ng/mL | 125% | 22 | 22 Positive | 88 |
| 1.5 ng/mL | 150% | 22 | 22 Positive | 88 |
| 1.75 ng/mL | 175% | 22 | 22 Positive | 88 |
| 2 ng/mL | 200% | 22 | 22 Positive | 88 |
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Lin-Zhi International, Inc.
Method Comparison - Clinical Samples:
A total of one hundred and fifty (150) unaltered clinical samples were tested with the LZI Fentanyl III Enzyme Immunoassay on the Beckman Coulter AU5800 automated clinical analyzer. Samples were evaluated against the cutoff calibrator in qualitative mode. All samples were tested in singlet.
All samples were confirmed by LC/MS for fentanyl concentrations. Samples were obtained by LZI and through collaboration with various clinical laboratories across the United States and Canada, including:
- APC Health (Tampa, Florida)
- Calgary Labs (Calgary, Canada)
- Carolina Liquid Chemistries Corporation (Greensboro, North Carolina)
- DTPM (Fort Payne, Alabama)
- Northwest Physicians Laboratories (Bellevue, Washington)
- Soloniuk Pain Clinic (Redding, California)
- Sterling Labs (Chicago, Illinois)
- TriCore Reference Laboratories (Santa Clara, California)
- University of California, San Francisco (San Francisco, California)
Qualitative Accuracy Study:
| FEN Results 1 ng/mL Cutoff | Negative by LC/MS analysis | **