(349 days)
Not Found
No
The device description details a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic tool used to detect cocaine metabolite in oral fluid, providing a preliminary analytical test result for drugs of abuse. It does not provide any therapy or treatment.
Yes
The device is described as an "enzyme immunoassay system to detect cocaine metabolite in human saliva" that provides a "preliminary analytical test result" for the "qualitative determination for cocaine/cocaine metabolite drugs." These functions directly align with the definition of a diagnostic device, which is used to identify or detect specific substances or conditions to aid in diagnosis.
No
The device is a homogeneous enzyme immunoassay system, which is a chemical assay involving reagents and a spectrophotometer, not a software-only device.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "homogeneous enzyme immunoassay system to detect cocaine metabolite in human saliva". This describes a test performed in vitro (outside the body) on a biological specimen (oral fluid) to provide information about a person's health status (presence of a drug metabolite).
- Device Description: The description details the components and mechanism of the assay, which is a laboratory-based test.
- Performance Studies: The inclusion of performance data like precision and accuracy against a reference method (GC/MS) is typical for IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K001197) and the name "Cocaine Metabolite Intercept® Micro-plate EIA" strongly indicates that this device is being compared to a previously cleared IVD device.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cocaine Metabolite (Benzoylecgonine) Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect cocaine metabolite in human saliva with a cutoff of 15 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 (Benzoylecgonine) 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 cocaine/cocaine metabolite drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Cocaine Metabolite (Benzoylecgonine) Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoasay 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.
Product codes (comma separated list FDA assigned to the subject device)
DIO, DLJ, LAS
Device Description
LZI's Oral Fluid Cocaine Metabolite (Benzoylecgonine) Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect benzoylecgonine in oral fluid with minimal crossreactivity 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Within Run Precision:
Qualitative : (n=120) mA/min
Negative: Mean 240.0, SD 1.71, % CV 0.71%
5 ng/mL: Mean 255.1, SD 2.00, % CV 0.78%
10 ng/mL: Mean 270.3, SD 2.17, % CV 0.80%
20 ng/mL: Mean 285.8, SD 2.32, % CV 0.81%
50 ng/mL: Mean 321.9, SD 2.49, % CV 0.77%
Total Precision:
Negative: Mean 240.0, SD 2.10
5 ng/mL: Mean 255.1, SD 2.26, % CV 0.88%
10 ng/mL: Mean 270.3, SD 2.37, % CV 0.88%
20 ng/mL: Mean 285.8, SD 2.51, % CV 0.88%
50 ng/mL: Mean 321.9, SD 2.68, % CV 0.83%
Accuracy: Clinical patients samples (n=118) vs. GC/MS, 95.8 % Agreement
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity: See attached Assay package insert
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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
MAR 2 9 2006 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 20, 2006
Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849
Contact: Marie Lin, Ph.D. President, R&D Director
Device Name and Classification
| Classification Name: | The Cocaine and Cocaine Metabolite test system has been
placed in Class II by the Bureau of Medical Devices.
Classification Number: DIO (21 CFR 862.3250)
Panel: 91Toxicology |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The “Drug Specific, Calibrators” has been placed in
Class II by the Bureau of Medical Devices.
Classification No.: DLJ, 21 CFR 862.3200
Panel: 91Toxicology |
| | 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: 91Toxicology |
| Common Name: | Cocaine Oral Fluid Homogeneous Enzyme Immunoassays |
| Proprietary Name: | None |
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Predicate Device(s)
The LZI Cocaine Metabolite (Benzoylecgonine) Oral Fluid Enzyme Immunoassay is substantially equivalent to the Cocaine Metabolite Intercept® Micro-plate EIA (K001197) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use.
Device Description
LZI's Oral Fluid Cocaine Metabolite (Benzoylecgonine) Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect benzoylecgonine in oral fluid with minimal crossreactivity 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 Cocainc Metabolite (Benzoylecgonine) Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogencous enzyme immunoassay system to detect benzoylecgonine in human saliva with a cutoff of 15 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 (Benzoylecgonine) 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 cocaine metabolite drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Cocaine Metabolite (Benzoylecgonine) 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.
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Comparison to Predicate Device
The LZI Cocaine Metabolite (Benzoylecgonine) Oral Fluid Homogeneous Enzyme Immunoassay, including calibrators and controls, is substantially equivalent to OraSure's Cocaine Metabolite Intercept® Micro-plate EIA in its intended use and in for the qualitative determination of cocaine metabolite drugs in human oral fluid.
| Device | Subject Device | Predicate Device |
|---|---|---|
| Characteristics | (LZI Cocaine Metabolite | (OraSure Cocaine Metabolite |
| (Benzoylecgonine) Oral Fluid | Intercept® Micro-plate EIA) | |
| Homogeneous EIA) | ||
| Intended Use | The LZI Cocaine Metabolite | The OraSure Cocaine Metabolite |
| (Benzoylecgonine) Oral Fluid | Intercept® Micro-plate EIA is | |
| Homogeneous EIA is a homogeneous | intended for use by clinical | |
| enzyme immunoassay system to detect | laboratories in the qualitative | |
| cocaine metabolite in human saliva | determination of cocaine and cocaine | |
| with a cutoff of 15 ng/mL when testing | metabolite in oral fluid collected with | |
| oral fluid specimen collected with | Intercept® DOA Oral Specimen | |
| Salivette collector (manufactured by | Collection Device using a 5.0 ng/mL | |
| Sarstedt ) and diluted with 1 mL of | ||
| buffer. The calibrators and controls of | cutoff. For In Vitro Diagnostic Use. | |
| the analyte (Benzoylecgonine) are | ||
| prepared with oral fluid buffer so that it | The OraSure Cocaine Metabolite | |
| can be used to verify and validate the | Intercept® Micro-plate EIA provides | |
| only a preliminary analytical test | ||
| assay. The assay is intended for use in | result. A more specific alternative | |
| the qualitative determination for | chemical method should be used in | |
| cocaine/cocaine metabolite drugs. | order to obtain a confirmed analytical | |
| The Cocaine Metabolite | ||
| (Benzoylecgonine) 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. | result. Gas chromatography/mass | |
| spectrometry (GC/MS) is the | ||
| preferred confirmatory method. | ||
| Clinical consideration and | ||
| professional judgement should be | ||
| applied to any drugs of abuse test | ||
| result, particularly when a | ||
| preliminary, positive result is | ||
| observed. | ||
| Analyte | Benzoylecgonine | Benzoylecgonine |
| Matrix | Saliva | Saliva |
| Calibrators/ | 5 levels including a negative | 4 levels including a negative |
| Controls Level |
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| Feature | | Oral Fluid Cocaine Metabolite (Benzoylecgonine)
EIA | | |
|----------------------------------------------------------|-----------------------------------|--------------------------------------------------------|------|-------|
| Qualitative : (n=120) mA/min | | Mean. | SD | % CV |
| Within Run Precision: | Negative | 240.0 | 1.71 | 0.71% |
| | 5 ng/mL | 255.1 | 2.00 | 0.78% |
| | 10 ng/mL | 270.3 | 2.17 | 0.80% |
| | 20 ng/mL | 285.8 | 2.32 | 0.81% |
| | 50 ng/mL | 321.9 | 2.49 | 0.77% |
| Total Precision: | Negative | 240.0 | 2.10 | |
| | 5 ng/mL | 255.1 | 2.26 | 0.88% |
| | 10 ng/mL | 270.3 | 2.37 | 0.88% |
| | 20 ng/mL | 285.8 | 2.51 | 0.88% |
| | 50 ng/mL | 321.9 | 2.68 | 0.83% |
| Accuracy: Clinical patients samples
(n=118) vs. GC/MS | 95.8 % Agreement | | | |
| Specificity: | See attached Assay package insert | | | |
LZI Cocaine Metabolite (Benzoylecgonine) Oral Fluid Assay
OraSure Cocaine Metabolite Micro=Plate EIA
| Feature | Benzoylecgonine | % CV |
|---|---|---|
| Precision | ||
| Intra-assay | ||
| N=64 | 0 ng/mL | 3.7 |
| 2.5 ng/mL | 3.4 | |
| 5.0 ng/mL | 4.3 | |
| 7.5 ng/mL | 7.6 | |
| Inter-assay | ||
| N=4/day, 20 days | 0 ng/mL | 8.0 |
| 2.5 ng/mL | 9.0 | |
| 5.0 ng/mL | 9.6 | |
| 7.5 ng/mL | 10.5 | |
| Accuracy: Clinical patients samples | ||
| (n=220) vs. GC/MS | 93.2 % Agreement | |
| Specificity | See OraSure product insert |
Summary
The information provided in this pre-market notification demonstrates that the LZI Oral Fluid Cocaine Metabolite (Benzoylecgonine) Homogeneous EIA is substantially equivalent to the legally marketed predicated device for its general intended use. Data and results provided in this premarket notification were collected and propared in accordance with the NCCLS guidance. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry, an independent analytical method. The information supplied in this pre-market notification
4
provides reasonable assurance that the LZI Oral Fluid Cocaine Metabolite provides reasonable assurates ous EIA is safe and effective for its stated intended use.
:
:
·
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 9 2006
Ms. Marie Lin, Ph.D. President, R&D Director Lin-Zhi International, Inc. 687 North Pastoria Ave Sunnyvale, CA 94085-2917
Re: K050945
Trade/Device Name: Oral Fluid Metabolite (Benzoylecgonine) Homogeneous Enzyme Immunoassay, Calibrators and Controls Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO, DLJ, LAS Dated: March 08, 2006 Received: March 10, 2006
Dear Ms. 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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Page 2 –
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. A.
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):_ K050945
Device Name: Oral Fluid Cocaine Metabolite (Benzoylecgonine) Homogeneous Enzyme Immunoassay, Calibrators and Controls.
Indications For Use:
The Cocaine Metabolite (Benzoylecgonine) Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect cocaine metabolite in human saliva with a cutoff of 15 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 (Benzoylecgonine) 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 cocaine/cocaine metabolite drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Cocaine Metabolite (Benzoylecgonine) Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoasay 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.
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-or
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