(164 days)
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine, at a cutoff value of 300 ng/mL when calibrated against morphine. 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 or (2) permitting laboratories to establish quality control procedures."
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The Opiate Enzyme Immunoasay is a homogeneous enzyme immunoassay 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, morphine-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 morphine-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.
Here's a breakdown of the acceptance criteria and study information for the Lin-Zhi International, Inc. Opiate Enzyme Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance characteristics presented and comparison to the predicate device. The primary performance metrics are precision and agreement with a confirmatory method (GC/MS or LC/MS).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Semi-Quantitative Precision (ng/mL) | Consistent and low variability across the tested range, particularly around the 300 ng/mL cutoff. | Within Run: Mean and SD provided for concentrations from 0 ng/mL to 600 ng/mL. %CV for most concentrations is ≤ 2.7%. At 300 ng/mL, Mean = 297.5 ng/mL, SD = 6.3 ng/mL, %CV = 2.1%. Total Precision: Mean and SD provided. %CV for most concentrations is ≤ 2.9%. At 300 ng/mL, Mean = 297.5 ng/mL, SD = 7.3 ng/mL, %CV = 2.4%. |
| Qualitative Detection (Cutoff: 300 ng/mL) | Accurate classification (positive/negative) at and around the 300 ng/mL cutoff, with minimal false positives/negatives at concentrations far from the cutoff. | Within Run: - 0-225 ng/mL: 22 Negative (100%) - 300 ng/mL: 6 Pos/16 Neg (27.3% Pos, 72.7% Neg) - 375-600 ng/mL: 22 Positive (100%) Total Precision: - 0-225 ng/mL: 88 Negative (100%)- 300 ng/mL: 27 Pos/61 Neg (30.7% Pos, 69.3% Neg) - 375-600 ng/mL: 88 Positive (100%) |
| Qualitative (mA/min) Detection (Cutoff: 300 ng/mL) | Similar to semi-quantitative qualitative detection. | Within Run: - 0-225 ng/mL: 22 Negative (100%) - 300 ng/mL: 16 Pos/6 Neg (72.7% Pos, 27.3% Neg) - 375-600 ng/mL: 22 Positive (100%) Total Precision: - 0-225 ng/mL: 88 Negative (100%)- 300 ng/mL: 51 Pos/37 Neg (58.0% Pos, 42.0% Neg) - 375-600 ng/mL: 88 Positive (100%) |
| Method Comparison with Confirmatory Method (GC/MS or LC/MS) | High percentage agreement for both positive and negative clinical samples. | Semi-Quantitative Results: 98.3% agreement with positive, 95.9% agreement with negative samples (from 130 clinical samples). Qualitative Results: 98.3% agreement with positive, 94.5% agreement with negative samples (from 130 clinical samples). |
| Limit of Detection (LoD) | Clearly defined lowest detectable concentration. | 20 ng/mL (95% confidence). |
| Linearity | Strong linear correlation across the analytical range. | 0 - 1000 ng/mL with a regression equation: y = 1.0619x - 2.3861, and r^2 = 0.9976. |
| Endogenous Compound Interference, Specific Gravity, & Specificity -Cross-Reactivity | No significant undesired cross-reactants or interference from endogenous substances. | "No significant undesired cross reactants or endogenous substance interference was observed." (Refer to product insert for list of compounds tested.) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Studies: N=88 for each concentration level (0, 75, 150, 225, 300, 375, 450, 525, 600 ng/mL) for both semi-quantitative and qualitative precision analyses. This involved 22 determinations within run and 88 total determinations.
- Method Comparison (Clinical Samples): A total of 130 clinical unaltered samples were used.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that "clinical unaltered samples" were used, suggesting a prospective or collected retrospective real-world dataset. The studies were performed on a Hitachi 717 Analyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- For the method comparison study, the ground truth was established by a "more specific alternative chemical method," specifically Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS). These are instrumental methods, not expert human assessment.
- For the precision and linearity studies, the ground truth concentrations were prepared standard solutions of known concentrations.
- The document does not mention human experts establishing ground truth for any part of the device evaluation.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was established by objective analytical methods (GC/MS or LC/MS for clinical samples, and known concentrations for precision/linearity studies), not human judgment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an automated in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. The "readers" are the automated clinical chemistry analyzers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are all standalone performance studies for the immunoassay. The device itself is an automated system (the immunoassay reagents run on a Hitachi 717 Analyzer) designed to provide results without human interpretation of the primary signal; humans only interpret the final quantitative or qualitative result from the analyzer.
7. The Type of Ground Truth Used
- Method Comparison (Clinical Samples): Gold standard instrumental method, specifically Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS).
- Precision, Linearity, LoD: Prepared reference materials with known concentrations of opiates.
8. The Sample Size for the Training Set
Not applicable. This is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "learning" for this type of device involves biochemical interactions and calibration curves, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an immunoassay. The device relies on its biochemical reaction principles and established calibration against known standards.
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted is summary of 510(k) sujely and effectiveness information is being stommed
in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. JUL 1 5 2011
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 (408) 732-3849 Fax: e-mail: bclin@lin-zhi.com
Contact: Bernice Lin, Ph.D. VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, OpiateClass II, DJG (91 Toxicology),21 CFR 862.3650 |
|---|---|
| Common Name: | Homogeneous Opiate Enzyme Immunoassay |
| Proprietary Name: | Opiate Enzyme Immunoassay, |
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Legally Marketed Predicate Device(s)
The Opiate Enzyme Immunoassay (EIA) is substantially equivalent to the Lin-Zhi International, Inc. Opiate Enzyme Immunoassay for Hitachi 717 Systems (K020368) manufactured by Lin-Zhi International, Inc. The Opiate Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description (Assay Principle)
The Opiate Enzyme Immunoasay is a homogeneous enzyme immunoassay 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, morphine-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 morphine-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.
Intended Use
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine, at a cutoff value of 300 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Opiate Drugs of Abuse (DAU) Calibrators (from K020769) are for use as calibrators in the qualitative and semi-quantitative calibration of the Opiate Enzyme Immunoassay.
The Opiate Drugs of Abuse (DAU) Controls (from K020769) are for use as assayed quality control materials to monitor the precision of the Opiate 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 liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
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Comparison to Predicate Device
The Opiate Enzyme Immunoassay is substantially equivalent to the Lin-Zhi International, Inc. Opiate Enzyme Immunoassay for Hitachi 717 Systems cleared by the FDA under the premarket notification K020368 for its stated intended use.
The following table compares the Opiate Enzyme Immunoassay with the predicate device.
| DeviceCharacteristics | Subject Device | Predicate Device (K020368) |
|---|---|---|
| Intended Use | The Opiate Enzyme Immunoassay, whenused in conjunction with Hitachi 717automated clinical system analyzers, isintended for the qualitative and semi-quantitative determination of opiates inhuman urine, at a cutoff value of 300ng/mL. The assay is designed forprofessional use with a number ofautomated clinical chemistry analyzers.This assay provides a rapid screening procedurefor determining the presence of Opiates in urine.The assay provides only a preliminary analyticalresult. A more specific alternative chemicalmethod must be used in order to obtain aconfirmed analytical result. Gas or liquidchromatography/mass spectrometry (GC/MS orLC/MS) is the preferred confirmatory method.Clinical consideration and professional judgmentshould be exercised with any drug of abuse testresult, particularly when the preliminary test resultis positive. | The Opiate Enzyme Immunoassay, whenused in conjunction with Hitachi 717automated clinical system analyzers, isintended for the qualitative and semi-quantitative determination of opiates inhuman urine, at a cutoff value of 300ng/mL. The assay is designed forprofessional use with a number ofautomated clinical chemistry analyzers.This assay provides a rapid screening procedurefor determining the presence of Opiates in urine.The assay provides only a preliminary analyticalresult. A more specific alternative chemicalmethod must be used in order to obtain aconfirmed analytical result. Gas or liquidchromatography/mass spectrometry (GC/MS orLC/MS) is the preferred confirmatory method.Clinical consideration and professional judgmentshould be exercised with any drug of abuse testresult, particularly when the preliminary test resultis positive. |
| Analyte | Opiates | Opiates |
| Cutoff | 300 ng/ml | 300 ng/mL |
| Matrix | Urine | Urine |
| Calibrators | 5 Levels | 5 Levels |
| Level | (0, 150, 300, 600, 1000 ng/mL) | (0, 150, 300, 600, 1000 ng/mL) |
| Controls Level | 2 Levels | 2 Levels |
| (225 ng/mL, 375 ng/mL) | (225 ng/mL, 375 ng/mL) | |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |
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Performance Characteristics Summary: Hitachi 717 Analyzer
Precision:
:
Precision: Semi-Quantitative, ng/mL
| N=88 | (ng/mL) | Within Run | Total Precision | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | SD | % CV | Mean | SD | % CV | ||||
| 0 ng/mL | 0.0 | 0.0 | #DIV/0! | 0.0 | 0.0 | #DIV/0! | |||
| 75 ng/mL | 84.0 | 3.5 | 4.2% | 84.0 | 4.5 | 5.4% | |||
| 150 ng/mL | 148.4 | 3.7 | 2.5% | 148.4 | 4.2 | 2.8% | |||
| 225 ng/mL | 228.2 | 5.3 | 2.3% | 228.2 | 6.4 | 2.8% | |||
| 300 ng/mL | 297.5 | 6.3 | 2.1% | 297.5 | 7.3 | 2.4% | |||
| 375 ng/mL | 370.4 | 7.6 | 2.0% | 370.4 | 8.2 | 2.2% | |||
| 450 ng/mL | 453.3 | 9.8 | 2.2% | 453.3 | 10.1 | 2.2% | |||
| 525 ng/mL | 529.0 | 11.5 | 2.2% | 529.0 | 12.7 | 2.4% | |||
| 600 ng/mL | 600.8 | 16.2 | 2.7% | 600.8 | 17.5 | 2.9% |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| N=88(ng/mL) | Mean | Within RunQualitative Response | Mean | Total PrecisionQualitative Response |
|---|---|---|---|---|
| 0 ng/mL | 0.0 | - | 0.0 | - |
| 75 ng/mL | 84.0 | - | 84.0 | - |
| 150 ng/mL | 148.4 | - | 148.4 | - |
| 225 ng/mL | 228.2 | - | 228.2 | - |
| 300 ng/mL | 297.5 | - | 297.5 | - |
| 375 ng/mL | 370.4 | + | 370.4 | + |
| 450 ng/mL | 453.3 | + | 453.3 | + |
| 525 ng/mL | 529.0 | + | 529.0 | + |
| 600 ng/mL | 600.8 | + | 600.8 | + |
Semi-Quantitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| SampleConcentration | % of Cutoff | Number ofDetermination | ImmunoassayResult | Number ofDetermination | ImmunoassayResult |
| 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 | 6 Pos/16 Neg | 88 | 27 Pos/61 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 |
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Precision: Qualitative, mA/min
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (mA/min) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 261.0 | 2.1 | 0.8% | 261.0 | 2.4 | 0.9% |
| 75 ng/mL | 310.4 | 1.8 | 0.6% | 310.4 | 2.4 | 0.8% |
| 150 ng/mL | 345.6 | 2.1 | 0.6% | 345.6 | 3.2 | 0.9% |
| 225 ng/mL | 383.6 | 2.4 | 0.6% | 383.6 | 3.7 | 1.0% |
| 300 ng/mL | 410.9 | 2.3 | 0.6% | 410.9 | 3.7 | 0.9% |
| 375 ng/mL | 432.1 | 2.5 | 0.6% | 432.1 | 3.6 | 0.8% |
| 450 ng/mL | 454.3 | 2.8 | 0.6% | 454.3 | 4.0 | 0.9% |
| 525 ng/mL | 471.0 | 2.5 | 0.5% | 471.0 | 4.4 | 0.9% |
| 600 ng/mL | 482.6 | 2.5 | 0.5% | 482.6 | 3.6 | 0.8% |
Qualitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| SampleConcentration | % of Cutoff | Number ofDetermination | ImmunoassayResult | Number ofDetermination | ImmunoassayResult |
| 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 | 16 Pos/6 Neg | 88 | 51 Pos/37 Neg |
| 375 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Limit of Detection:
The lowest concentration that can be differentiated from the negative urine with 95% confidence is determined as 20 ng/mL.
Linearity:
Hitachi 717 Instrument: 0 - 1000 ng/mL When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow: y = 1.0619x - 2.3861, r2=0.9976
Method Comparison: Clinical Samples
From a total of One-hundred-thirty (130) clinical unaltered samples:
Semi-Quantitative Results: 98.3 % agreement with positive, 95.9 % agreement with negative samples
Qualitative Results: 98.3 % agreement with positive, 94.5 % agreement with negative samples
Endogenous Compound Interference, Specific Gravity, & Specificity -Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference was observed. See product insert for list of compounds tested.
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Summary:
The information provided in this pre-market notification demonstrates that the LZI Opiate 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 gas or liquid 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 Opiate Enzyme Immunoassay is safe and effective for its stated intended use.
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Image /page/6/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-GSA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted in a minimalist, flowing design. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
15 2011
Lin-Zhi International, Inc. c/o Dr. Bernice Lin VP Operations 670 Almanor Avenue Sunnyvale, CA 94085
Re: K110298 Trade name: Opiate Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: June 17, 2011 Received: June 20, 2011
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International 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 yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Premarket Notification
Indications for Use Statement
510(k) Number (if known): K110298
Device Name: Opiate Enzyme Immunoassay
Indications for Use:
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative ' determination of opiates in human urine, at a cutoff value of 300 ng/mL when calibrated against morphine. 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 or (2) permitting laboratories to establish quality control procedures."
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Per 21 CFR 801.109)
Qur
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110298
§ 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).