(337 days)
Not Found
No
The description details a standard enzyme immunoassay based on competitive binding and spectrophotometric measurement, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is an in vitro diagnostic assay used to detect methadone in oral fluid, providing analytical test results. It does not provide therapy or treatment.
Yes
Explanation: The device is intended for the qualitative determination of Methadone in oral fluid, providing a preliminary analytical test result used for detecting the presence of Methadone. This falls under the definition of a diagnostic device as it aims to identify a substance (Methadone) that may indicate drug abuse.
No
The device description clearly indicates it is a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay" which is a chemical assay, not a software-only device. It relies on a chemical reaction and spectrophotometric measurement, not purely software processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "homogeneous enzyme immunoassay system to detect methadone in human saliva." This involves testing a biological specimen (oral fluid/saliva) in vitro (outside the body) to gain information about a person's health status (presence of methadone).
- Device Description: The description details a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay" that uses antibodies and enzymes to analyze the oral fluid sample. This is a typical description of an IVD reagent system.
- Anatomical Site: The sample is "Oral fluid (saliva)," which is a biological specimen collected from the body for in vitro analysis.
- Intended User / Care Setting: It's designed for "Professional use with a number of automated clinical chemistry analyzers," indicating use in a clinical or laboratory setting for diagnostic purposes.
- Performance Studies: The inclusion of performance studies like "Accuracy: Clinical patients samples (n=119) vs. GC/MS showed 99.2 % Agreement" and "Specificity" are standard for demonstrating the performance of an IVD.
- Predicate Device(s): The mention of a predicate device (K002010; Methadones Intercept® Micro-plate EIA) which is also an IVD for drug testing further supports its classification as an IVD.
The core function of the device is to perform a test on a biological sample in vitro to provide information about the presence of a substance (methadone) in the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Methadone Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methadone 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 (Methadone) 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 Methadone drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone 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 (comma separated list FDA assigned to the subject device)
DJR, DLJ, LAS
Device Description
LZI's Oral Fluid Methadone Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect methadone 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
Not Found
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)
LZI Methadone Oral Fluid Assay:
- Qualitative (Precision): (n=120) measured in mA/min.
- Within Run Precision: Negative (Mean: 328.4, SD: 1.90, %CV: 0.58%), 10 ng/mL (Mean: 347.4, SD: 1.96, %CV: 0.56%), 20 ng/mL (Mean: 368.3, SD: 2.30, %CV: 0.62%), 30 ng/mL (Mean: 390.0, SD: 2.21, %CV: 0.57%), 50 ng/mL (Mean: 433.4, SD: 2.33, %CV: 0.54%).
- Total Precision: Negative (Mean: 328.4, SD: 2.30), 10 ng/mL (Mean: 347.4, SD: 2.72, %CV: 0.78%), 20 ng/mL (Mean: 368.3, SD: 2.58, %CV: 0.70%), 30 ng/mL (Mean: 390.0, SD: 2.66, %CV: 0.68%), 50 ng/mL (Mean: 433.4, SD: 2.65, %CV: 0.61%).
- Accuracy: Clinical patients samples (n=119) vs. GC/MS showed 99.2 % Agreement.
- Specificity: "See attached Assay package insert"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 99.2 % Agreement (LZI Methadone Oral Fluid Assay vs. GC/MS)
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
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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
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 Methadone test system has been placed in Class II by
the Bureau of Medical Devices.
Classification Number: DJR (21 CFR 862.3620)
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: | Methadone Oral Fluid Homogeneous Enzyme
Immunoassays |
| Proprietary Name: | None |
1
Predicate Device(s)
The LZI Methadone Oral Fluid Enzyme Immunoassay is substantially equivalent to the Methadones Intercept® Micro-plate EIA (K002010) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use.
Device Description
LZI's Oral Fluid Methadone Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect methadone 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 Methadone Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methadone 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 (Methadone) 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 Methadone drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone 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 Methadone Oral Fluid Homogeneous Enzyme Immunoassay, including calibrators and controls, is substantially equivalent to OraSure's Methadone Intercept® Micro-plate EIA in its intended use and in for the qualitative determination of Methadone in human oral fluid.
| Device
Characteristics | Subject Device
(LZI Methadone Oral Fluid
Homogeneous EIA) | Predicate Device
(OraSure Methadone Intercept®
Micro-plate EIA) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Methadone Oral Fluid
Homogeneous EIA is a homogeneous
enzyme immunoassay system to detect
methadone 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
(Methadone) 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 Methadone drugs.
The Methadone 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 Methadone Intercept®
Micro-plate EIA is intended for use by
clinical laboratories in the qualitative
determination of methadone in oral
fluid collected with Intercept® DOA
Oral Specimen Collection Device
using a 5.0 ng/mL cutoff. For In Vitro
Diagnostic Use.
The OraSure Methadone 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 | Methadone | Methadone |
| Matrix | Saliva | Saliva |
| Calibrators/
Controls Level | 5 levels including a negative | 4 levels including a negative |
3
LZI Methadone Oral Fluid Assay
| Feature | Oral Fluid Methadone EIA | |||
|---|---|---|---|---|
| Qualitative : (n=120) mA/min | Mean. | SD | % CV | |
| Within Run Precision: | Negative | 328.4 | 1.90 | 0.58% |
| 10 ng/mL | 347.4 | 1.96 | 0.56% | |
| 20 ng/mL | 368.3 | 2.30 | 0.62% | |
| 30 ng/mL | 390.0 | 2.21 | 0.57% | |
| 50 ng/mL | 433.4 | 2.33 | 0.54% | |
| Mean. | SD | % CV | ||
| Total Precision: | Negative | 328.4 | 2.30 | |
| 10 ng/mL | 347.4 | 2.72 | 0.70% | |
| 0.78% | ||||
| 20 ng/mL | 368.3 | 2.58 | 0.70% | |
| 30 ng/mL | 390.0 | 2.66 | 0.68% | |
| 50 ng/mL | 433.4 | 2.65 | 0.61% | |
| Accuracy: Clinical patients samples | ||||
| (n=119) vs. GC/MS | 99.2 % Agreement | |||
| Specificity: | See attached Assay package insert |
OraSure Methadone Micro=Plate EIA
| Feature | |||
|---|---|---|---|
| Precision | Methadone | % CV | Mean OD. |
| Intra-assay | |||
| N=64 | 0 ng/mL | 6.3 | 1.932 |
| 2.5 ng/mL | 6.6 | 0.687 | |
| 5.0 ng/mL | 6.7 | 0.507 | |
| 7.5 ng/mL | 6.8 | 0.426 | |
| Inter-assay | |||
| N=4/day, 20 days | 0 ng/mL | 9.9 | 1.932 |
| 2.5 ng/mL | 12.3 | 0.687 | |
| 5.0 ng/mL | 12.9 | 0.507 | |
| 7.5 ng/mL | 13.6 | 0.426 | |
| Accuracy: Clinical patients sample | |||
| (n=102) vs. GC/MS | 97.1 % Agreement | ||
| Specificity | See OraSure product insert |
Summary
The information provided in this pre-market notification demonstrates that the LZI Oral Fluid Methadone 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 prepared 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 provides reasonable assurance that the LZI Oral Fluid Methadone Homogeneous EIA is safe and effective for its stated intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The logo is black and white, with the text and symbol in black against a white background.
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: K051058
Trade/Device Name: Oral Fluid Methadone Homogeneous Enzyme Immunoassay, Calibrator and Controls Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR, DLJ, LAS Dated: March 08, 2006 Received: March 13, 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 af 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 practic t requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
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 Guti
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
6
Indications for Use
510(k) Number (if known): K051058
Device Name: Oral Fluid Methadone Homogeneous Enzyme Immunoassay, Calibrators and Controls.
Indications For Use:
The Methadone Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methadone 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 (Methadone) 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 Methadone drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone 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)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
05/057-CFC
"" " " Vitro Diagnostic Device 11 200 Na