(352 days)
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte Morphine are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
LZI's Oral Fluid Opiate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Opiate in oral fluid with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the saliva sample for a fixed amount of specific antibody. In the absence of free drug from the saliva sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
The provided text describes the LZI Opiate Oral Fluid Homogeneous Enzyme Immunoassay. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on establishing substantial equivalence to a predicate device rather than explicitly stating acceptance criteria in a quantitative table. However, the "Comparison to Predicate Device" section implicitly outlines key performance characteristics that are likely considered for equivalence. The study described focuses on analytical performance, specifically to demonstrate accuracy around the specified cutoff.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy (around cutoff) | Comparable to predicate device | Shown through Spike Recovery Study, Precision Study, Specificity/Cross-reactivity, and Method Comparison with GC/MS. |
| Precision (repeatability) | Acceptable intra-assay and inter-assay variability | Demonstrated through precision study (details not fully provided in this excerpt). |
| Specificity/Cross-reactivity | Minimal cross-reactivity to common prescription and abused drugs | Demonstrated through cross-reactivity study (details not fully provided in this excerpt). |
| Cutoff Concentration | 30 ng/mL | The device is designed to detect opiates with a cutoff of 30 ng/mL. |
| Intended Use | Qualitative determination of opiates in human saliva | Matches the intended use of the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a sample size for a "test set" in the context of a clinical performance study. The studies described appear to be analytical performance studies rather than clinical trials with patient samples.
- Spike Recovery Study: Used samples "spiked" with known concentrations of morphine. The number of samples/replicates is not specified.
- Precision Study: Conducted using "three levels of controls repeatedly" (number of replicates not specified).
- Specificity/Cross-reactivity: Tested "various, common prescription drugs and abused drugs." (Number of drugs and concentrations not specified).
- Method Comparison with GC/MS: Compared 118 oral fluid specimens. The provenance (country of origin, retrospective/prospective) of these 118 specimens is not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the analytical studies was established through:
- Known concentrations: For the spike recovery study.
- Reference method (GC/MS): For the method comparison study. GC/MS results are considered the "gold standard" for drug confirmation. No human experts were involved in establishing the ground truth for these analytical performance studies in this context.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The studies are objective analytical performance evaluations.
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, homogeneous enzyme immunoassay for detecting opiates. It does not involve human readers interpreting images or data where AI assistance would be a factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone analytical performance evaluations of the device's ability to detect opiates. The "algorithm" here refers to the immunoassay's chemical reaction and measurement process.
7. The Type of Ground Truth Used
- Known concentrations: For spike recovery (morphine concentration).
- GC/MS (Gas Chromatography/Mass Spectrometry): For the method comparison study, GC/MS served as the definitive method for confirming the presence and concentration of opiates in oral fluid specimens.
8. The Sample Size for the Training Set
Not explicitly stated. This device is an immunoassay, not a machine-learning algorithm in the modern sense that typically involves a distinct "training set" for model development. The development of such assays involves iterative optimization of reagents and conditions, which would utilize various "samples" during R&D, but not in the formalized machine learning "training set" context.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the machine learning sense. The "ground truth" during the development of this immunoassay would involve:
- Using known concentrations of morphine and its metabolites.
- Testing known positive and negative oral fluid samples (potentially characterized by GC/MS).
- Optimizing reagent concentrations and reaction conditions to achieve desired sensitivity, specificity, and cutoff performance.
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, Address, and Contact
March 24, 2006
Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax:
Contact: Marie Lin, Ph.D. President, R&D Director
Device Name and Classification
| Classification Name: | The Opiate test system has been placed in Class II by the Bureau of Medical Devices. Classification Number: DJG (21 CFR 862.3650) Panel: 91 Toxicology |
|---|---|
| The “Drug Specific, Calibrators” has been placed in Class II by the Bureau of Medical Devices. Classification No.: DLJ, 21 CFR 862.3200 Panel: 91 Toxicology | |
| The “Single (Specified) Analyte Controls” has been placed in Class I by the Bureau of Medical Devices. Classification No.: LAS, 21 CFR 862.3280 Panel: 91 Toxicology | |
| Common Name: | Opiate Oral Fluid Homogeneous Enzyme Immunoassays |
| Proprietary Name: | None |
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Predicate Device(s)
The LZI Opiate Oral Fluid Enzyme Immunoassay is substantially equivalent to the Opiates Intercept® Micro-plate EIA (K981341) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use.
Device Description
LZI's Oral Fluid Opiate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Opiate in oral fluid with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the saliva sample for a fixed amount of specific antibody. In the absence of free drug from the saliva sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Opiate Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect Opiate in human saliya with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt ) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (Morphine) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for Opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.
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Comparison to Predicate Device
The LZI Opiate Oral Fluid Homogeneous Enzyme Immunoassay, including calibrators and controls, is substantially equivalent to OraSure's Opiates Intercept® Micro-plate EIA in its intended use and in for the qualitative determination of opiates in human oral fluid.
| DeviceCharacteristics | Subject Device(LZI Opiate Oral Fluid HomogeneousEIA) | Predicate Device(OraSure Opiate Intercept® Micro-plate EIA) |
|---|---|---|
| Intended Use | The LZI Opiate Oral FluidHomogeneous EIA is a homogeneousenzyme immunoassay system to detectopiates in human saliva with a cutoff of30 ng/mL when testing oral fluidspecimen collected with Salivettecollector (manufactured by Sarstedt )and diluted with 1 mL of buffer. Thecalibrators and controls of the analyte(Opiate) are prepared with oral fluidbuffer so that it can be used to verifyand validate the assay. The assay isintended for use in the qualitativedetermination for Opiate drugs.The Opiate Oral Fluid EnzymeImmunoassay is a homogeneousenzyme immunoassay system providesonly a preliminary analytical testresult. A more specific alternativechemical method must be used toobtain a confirmed analytical result.Gas chromatography/massspectrometry (GC/MS) is the preferredconfirmatory method. Clinicalconsideration and professionaljudgment should be applied to anydrug-of-abuse test result, particularlywhen preliminary positive results areused. | The OraSure Opiate Intercept®Micro-plate EIA is intended for use byclinical laboratories in the qualitativedetermination of opiates in oral fluidcollected with Intercept® DOA OralSpecimen Collection Device using a10 ng/mL cutoff. For In VitroDiagnostic Use.The OraSure Opiate Intercept®Micro-plate EIA provides only apreliminary analytical test result. Amore specific alternative chemicalmethod should be used in order toobtain a confirmed analytical result.Gas chromatography/massspectrometry (GC/MS) is thepreferred confirmatory method.Clinical consideration andprofessional judgement should beapplied to any drugs of abuse testresult, particularly when apreliminary, positive result isobserved. |
| Analyte | Morphine | Morphine |
| Matrix | Saliva | Saliva |
| Calibrators/Controls Level | 5 levels including a negative | 4 levels including a negative |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird symbol in the center. The text around the perimeter reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird symbol in the center is composed of three curved lines that form the shape of a bird in flight.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 2006 APR
Marie Lin, Ph.D. President Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085-2917
Re: K050988
Trade/Device Name: LZI Oral Fluid Opiate Enzyme Immunoassay. Calibrators and Controls Regulation Number: 21 CFR§862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DLJ, LAS Dated: March 24, 2006 Received: March 28, 2006
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, 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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Indications for Use
510(k) Number (if known): K050988
Device Name: LZI Oral Fluid Opiate Enzyme Immunoassay, Calibrators and Controls.
Indications For Use:
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte Morphine are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Dinanostic Device Evaluation and Safety
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§ 862.2250 Gas liquid chromatography system for clinical use.
(a)
Identification. A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.