(280 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic test for the qualitative and semi-quantitative determination of 6-Acetylmorphine in oral fluid, which is used for diagnostic purposes rather than directly treating a disease or condition.
Yes
The device is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in human oral fluid, which is a diagnostic purpose to detect the presence and approximate concentration of the substance.
No
The device is a kit containing chemical reagents (R1 and R2 solutions) and calibrators/controls for an enzyme immunoassay, which are physical components, not software.
Based on the provided information, 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 6-Acetylmorphine in neat human oral fluid." This involves testing a biological sample (oral fluid) in vitro (outside the body) to gain information about a person's health status (presence of 6-Acetylmorphine, a metabolite of heroin).
- Device Description: The description details the reagents and how the assay works, which is a typical characteristic of an IVD. It describes a chemical reaction (enzyme immunoassay) performed on the sample.
- Clinical Chemistry Analyzers: The intended use specifies the device is for "prescription use with a number of automated clinical chemistry analyzers." Clinical chemistry analyzers are instruments used in laboratories to perform in vitro diagnostic tests on biological samples.
- Calibrators and Controls: The description mentions the use of calibrators and controls, which are essential components for ensuring the accuracy and reliability of in vitro diagnostic tests.
- Performance Studies: The document includes a summary of performance studies, which are required for demonstrating the analytical performance of an IVD. These studies evaluate aspects like precision, accuracy (method comparison), and interference.
- Predicate Device: The mention of a predicate device (K101195; Lin-Zhi International, Inc. 6-Acetylmorphine Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
In summary, the device meets the definition of an In Vitro Diagnostic because it is intended for the examination of a human specimen in vitro to provide information for diagnostic purposes (in this case, detecting the presence of a drug metabolite).
N/A
Intended Use / Indications for Use
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value of 4 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 Oral Fluid 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL.
The LZI Oral Fluid 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical 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, DKB, DIF
Device Description
The LZI Oral Fluid 6-Acetylmorphine assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. 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, 6-Acetylmorphine-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 6-Acetylmorphine-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 Oral Fluid 6-Acetylmorphine 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-6-Acetylmorphine antibody, glucose-6phosphate (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 6-Acetylmorphine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay calibrators and controls designated for use at the 4 ng/mL cutoffs contain 0, 2, 4, 6, 10, and 20 ng/mL of 6-Acetylmorphine in synthetic oral fluid matrix 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
Oral fluid (neat human oral fluid)
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)
Performance Characteristics Summary: Beckman AU400e Analyzer
Precision:
Sample concentrations tested from 0 ng/mL to 8 ng/mL.
For 4 ng/mL cutoff result:
Semi-Quantitative Positive/Negative Results:
Total Precision: 80 determinations at each concentration. 32 Pos/48 Neg at 4ng/mL.
Within Run Precision: 20 determinations at each concentration. 8 Pos/12 Neg at 4ng/mL.
Qualitative (ΔΟD Value) Positive/Negative Results:
Total Precision: 80 determinations at each concentration. 18 Pos/62 Neg at 4ng/mL.
Within Run Precision: 20 determinations at each concentration. 4 Pos/16 Neg at 4ng/mL.
Analytical Recovery:
Range of expected values from 1 ng/mL to 20 ng/mL. % Recovery ranged from 96.7% to 120.0%.
Method Comparison: Clinical Samples
Total of 150 clinical unaltered samples.
Clinical Samples Correlation Results: Semi-Quantitative Accuracy Study (4 ng/mL Cutoff)
Agreement for Positive results: 99.0% (10 + 89 positive out of 10 + 89 + 1 (discrepant)).
Agreement for Negative results: 100.0% (20 + 14 + 16 negative).
One discrepant sample (GC/MS 6AM: 4.2 ng/mL, AU400e Immunoassay: 3.5 ng/mL, Negative Result).
Clinical Samples Correlation Results: Qualitative Accuracy Study (ΔΟD, mAu) (4 ng/mL Cutoff)
Agreement for Positive results: 98.0% (9 + 89 positive out of 9 + 89 + 2 (discrepant)).
Agreement for Negative results: 100.0% (20 + 14 + 16 negative).
Two discrepant samples (GC/MS 6AM: 4.2 ng/mL (AU400e Immunoassay: 662.9 mAu, Negative) and 4.4 ng/mL (AU400e Immunoassay: 675.3 mAu, Negative)).
Endogenous Compound Interference and Specificity - Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference observed at physiologically relevant concentrations. Ascorbic Acid concentrations above 3 mg/mL cause false-negative results.
Shipping/Recovery Stability Study:
No significant sample degradation following real-time and accelerated stability studies up to 72 hours.
Sample Storage Stability Study:
No significant sample degradation following real-time stability studies. Samples stable at 2-8 ℃ for up to 15 Days. Samples stable at -20 ℃ for up to 113 Days.
Open (and re-capped) vial Stability for Reagent and Calibrator/Control:
Opened and recapped calibrators and controls stable for 6 months when stored at (2-8℃).
Closed vial Stability for Calibrator/Control:
Unopened calibrators and controls stable for 6 months when stored at 2-8℃.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly provided as Sensitivity, Specificity, PPV, NPV. Instead, Accuracy Studies with % Agreement for positive and negative results are provided.
Semi-Quantitative Accuracy Study:
% Agreement for Positive: 99.0% (Positive samples were 10 + 89 = 99. Total positive results in study: 10 + 89 = 99. Out of 100 actual positives, 99 were called positive)
% Agreement for Negative: 100.0% (Negative samples were 20 + 14 + 16 = 50. All 50 were called negative)
Qualitative Accuracy Study:
% Agreement for Positive: 98.0% (Positive samples were 9 + 89 = 98. Total positive results in study: 9 + 89 = 98. Out of 100 actual positives, 98 were called positive)
% Agreement for Negative: 100.0% (Negative samples were 20 + 14 + 16 = 50. All 50 were called negative)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
LIN-ZHI INTERNATIONAL, INC. BERNICE LIN, PH.D. VP OF OPERATIONS 670 ALMANOR AVE SUNNYVALE CA 94085
Re: K141205
Trade/Device Name: LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay LZI Oral Fluid 6-Acetylmorphine Calibrators LZI Oral Fluid 6-Acetylmorphine Controls Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DKB, DIF Dated: February 2, 2015 Received: February 4, 2015
Dear Dr. 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Stayce Beck -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
2
Indications for Use
510(k) Number (if known) K141205
Device Name LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay LZI Oral Fluid 6-Acetylmorphine Calibrators LZI Oral Fluid 6-Acetylmorphine Controls
Indications for Use (Describe)
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value of 4 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 Oral Fluid 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL.
The LZI Oral Fluid 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical 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.
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) |
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3
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 |
Preparation Date
February 12, 2015
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Opiates |
|---|---|
| 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: | Homogeneous Oral Fluid 6-Acetylmorphine Enzyme Immunoassay |
| Proprietary Name: | LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, |
| LZI Oral Fluid 6-Acetylmorphine Calibrators | |
| LZI Oral Fluid 6-Acetylmorphine Controls |
4
Legally Marketed Predicate Device(s)
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay (EIA) (K141205) is substantially equivalent to the Lin-Zhi International, Inc. 6-Acetylmorphine Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (K101195) manufactured by Lin-Zhi International. Inc. The LZI Oral Fluid 6-Acetylmorphine 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 Oral Fluid 6-Acetylmorphine assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. 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, 6-Acetylmorphine-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 6-Acetylmorphine-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 Oral Fluid 6-Acetylmorphine 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-6-Acetylmorphine antibody, glucose-6phosphate (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 6-Acetylmorphine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay calibrators and controls designated for use at the 4 ng/mL cutoffs contain 0, 2, 4, 6, 10, and 20 ng/mL of 6-Acetylmorphine in synthetic oral fluid matrix with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
5
Intended Use
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value of 4 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 GC/MS or (2) permitting laboratories to establish quality control procedures.
The LZI Oral Fluid 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL.
The LZI Oral Fluid 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 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 chromatography/mass spectrometry (GC/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.
6
Comparison to Predicate Device
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay (K141205) is substantially equivalent to the Lin-Zhi International, Inc. 6-Acetylmorphine Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K101195 for its stated intended use.
The following table compares LZI's Oral Fluid 6-Acetylmorphine Enzyme Immunoassay with the predicate device.
| Device
Characteristics | Subject Device (K141205)
LZI Oral Fluid 6-Acetylmorphine
Enzyme Immunoassay, Calibrators and
Controls | Predicate Device (K101195)
LZI 6-Acetylmorphine Enzyme
Immunoassay, Calibrators and Controls |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Oral Fluid 6-Acetylmorphine
Enzyme Immunoassay, when used in
conjunction with the Beckman AU400e
automated clinical system analyzers, is
intended for the qualitative and semi-
quantitative determination of 6-
Acetylmorphine in neat human oral fluid,
collected into the LZI Oral Fluid
Collector, at the cutoff value 4 ng/mL.
The assay is designed for prescription use
with a number of automated clinical
chemistry analyzers.
This assay provides a rapid screening procedure
for determining the presence of 6-Acetylmorphine
in oral fluid. 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
chromatography/mass spectrometry (GC/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 6-Acetylmorphine Enzyme
Immunoassay, when used in conjunction
with Hitachi 717 automated clinical
system analyzers, is intended for the
qualitative and semi-quantitative
determination of 6-Acetylmorphine in
human urine, at a cutoff value of 10
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 6-Acetylmorphine
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 | 6-Acetylmorphine | 6-Acetylmorphine |
| Cutoff | 4 ng/ml | 10 ng/mL |
| Matrix | Oral fluid | Urine |
| Calibrator | 5 Levels | 5 Levels |
| Levels | (0, 2, 4, 10, 20 ng/mL) | (0, 5, 10, 20, 40 ng/mL) |
| Control Levels | 2 Levels | 2 Levels |
| | (2 ng/mL, 6 ng/mL) | (7.5 ng/mL, 12.5 ng/mL) |
| Storage | 2-8 ℃ until expiration date | 2-8 ℃ until expiration date |
7
Performance Characteristics Summary: Beckman AU400e Analyzer
Precision:
| 4 ng/mL Cutoff Result: | |||||
|---|---|---|---|---|---|
| Sample Concentration | % of Cutoff | Total Precision | Within Run Precision | ||
| Number of Determination | Immunoassay Result | Number of Determination | Immunoassay Result | ||
| 0 ng/mL | -100.0% | 80 | 80 Negative | 20 | 20 Negative |
| 1 ng/mL | -75.0% | 80 | 80 Negative | 20 | 20 Negative |
| 2 ng/mL | -50.0% | 80 | 80 Negative | 20 | 20 Negative |
| 3 ng/mL | -25.0% | 80 | 80 Negative | 20 | 20 Negative |
| 4 ng/mL | 100.0% | 80 | 32 Pos/48 Neg | 20 | 8 Pos/12 Neg |
| 5 ng/mL | +25.0% | 80 | 80 Positive | 20 | 20 Positive |
| 6 ng/mL | +50.0% | 80 | 80 Positive | 20 | 20 Positive |
| 7 ng/mL | +75.0% | 80 | 80 Positive | 20 | 20 Positive |
| 8 ng/mL | +100.0% | 80 | 80 Positive | 20 | 20 Positive |
Semi-Quantitative Positive/Negative Results:
Qualitative (ΔΟD Value) Positive/Negative Results:
| 4 ng/mL Cutoff Result: | Total Precision | Within Run Precision | ||||
|---|---|---|---|---|---|---|
| Sample | ||||||
| Concentration | % of Cutoff | Number of | ||||
| Determination | Immunoassay | |||||
| Result | Number of | |||||
| Determination | Immunoassay | |||||
| Result | ||||||
| 0 ng/mL | -100.0% | 80 | 80 Negative | 20 | 20 Negative | |
| 1 ng/mL | -75.0% | 80 | 80 Negative | 20 | 20 Negative | |
| 2 ng/mL | -50.0% | 80 | 80 Negative | 20 | 20 Negative | |
| 3 ng/mL | -25.0% | 80 | 80 Negative | 20 | 20 Negative | |
| 4 ng/mL | 100.0% | 80 | 18 Pos/62 Neg | 20 | 4 Pos/16 Neg | |
| 5 ng/mL | +25.0% | 80 | 80 Positive | 20 | 20 Positive | |
| 6 ng/mL | +50.0% | 80 | 80 Positive | 20 | 20 Positive | |
| 7 ng/mL | +75.0% | 80 | 80 Positive | 20 | 20 Positive | |
| 8 ng/mL | +100.0% | 80 | 80 Positive | 20 | 20 Positive |
Analytical Recovery:
| Expected Value
(ng/mL) | Observed Value
(ng/mL) | % Recovery |
|---------------------------|---------------------------|------------|
| 1 | 1.2 | 120.0 |
| 2 | 2.2 | 110.0 |
| 4 | 4.3 | 107.5 |
| 6 | 5.8 | 96.7 |
| 8 | 8.1 | 101.3 |
| 10 | 10.1 | 101.0 |
| 12 | 12.1 | 100.8 |
| 14 | 15.0 | 107.1 |
| 16 | 16.8 | 105.0 |
| 18 | 18.8 | 104.4 |
| 20 | 20.6 | 103.0 |
8
Method Comparison: Clinical Samples
From a total of one-hundred-fifty (150) clinical unaltered samples
Clinical Samples Correlation Results: Semi-Quantitative Accuracy Study
| 4 ng/mL
Cutoff | Negative |