(352 days)
No
The 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 (IVD) test intended to detect opiates in human saliva for diagnostic purposes, not to treat or mitigate a disease or condition.
No
Explanation: The device provides only a preliminary analytical test result for the presence of opiates and explicitly states that a more specific alternative chemical method must be used for confirmation. This indicates it is a screening tool, not a definitive diagnostic device on its own.
No
The device is a homogeneous enzyme immunoassay system, which is a laboratory test kit involving chemical reagents and reactions, 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 the device is used to "detect opiates in human saliva." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of opiates).
- Device Description: The description details a "homogeneous enzyme immunoassay system" that uses "specific antibodies" and measures "enzyme activity" in a "saliva sample." This is a classic description of an in vitro diagnostic test.
- Anatomical Site: The specified anatomical site is "human saliva," which is a biological specimen collected from the body for in vitro analysis.
- Intended User / Care Setting: The device is intended for "professional use with a number of automated clinical chemistry analyzers," which are typically found in clinical laboratories where in vitro diagnostic testing is performed.
The entire description aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for 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-of-abuse test result, particularly when preliminary positive results are used.
Product codes
DJG, DLJ, LAS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human saliva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 862.2250 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.
0
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 |
1
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.
2
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.
| Device
Characteristics | Subject Device
(LZI Opiate Oral Fluid Homogeneous
EIA) | Predicate Device
(OraSure Opiate Intercept® Micro-
plate EIA) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Opiate Oral Fluid
Homogeneous EIA 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
(Opiate) 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 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. | The OraSure Opiate Intercept®
Micro-plate EIA is intended for use by
clinical laboratories in the qualitative
determination of opiates in oral fluid
collected with Intercept® DOA Oral
Specimen Collection Device using a
10 ng/mL cutoff. For In Vitro
Diagnostic Use.
The OraSure Opiate Intercept®
Micro-plate EIA provides only a
preliminary analytical test result. A
more specific alternative chemical
method should 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 judgement should be
applied to any drugs of abuse test
result, particularly when a
preliminary, positive result is
observed. |
| Analyte | Morphine | Morphine |
| Matrix | Saliva | Saliva |
| Calibrators/
Controls Level | 5 levels including a negative | 4 levels including a negative |
3
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).
4
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
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
5
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
Page 1 of 1