(58 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 technologies.
No
The device is an in vitro diagnostic assay used to detect methamphetamine in human saliva, providing a preliminary analytical test result. It is not designed to treat, cure, or prevent disease.
Yes
Explanation: The device is an immunoassay system intended for the qualitative determination of methamphetamine in human saliva, which is used to detect the presence of a substance indicative of drug use. This falls under the definition of a diagnostic device, as it provides a preliminary analytical test result.
No
The device description clearly indicates it is a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay," which is a chemical assay and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "detect methamphetamine in human saliva." This involves testing a biological specimen (saliva) outside of the body (in vitro).
- Device Description: The description details a "homogeneous enzyme immunoassay system" that uses "specific antibodies" and measures "enzyme activity" spectrophotometrically. These are all characteristic components and methods of in vitro diagnostic tests.
- Specimen Type: The device analyzes "human saliva," which is a biological specimen.
- Performance Studies: The document includes performance studies comparing the device's results to GC/MS, a common method for confirming drug presence in biological samples. This further supports its use as a diagnostic tool.
- Predicate Device: The mention of a "Predicate Device(s)" with K numbers (K993208 Methamphetamine Intercept® Micro-plate EIA) indicates that this device is being compared to other legally marketed IVDs.
The key elements of an IVD are that it is used to examine specimens derived from the human body to provide information for diagnostic purposes. This device fits that description perfectly by analyzing saliva to detect the presence of methamphetamine.
N/A
Intended Use / Indications for Use
The Methamphetamine Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methamphetamine in human saliva with a cutoff of 45 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 (d-methamphetamine) 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 methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Methamphetamine 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)
LAF, DLJ, LAS
Device Description
LZI's Oral Fluid Methamphetamine Enzyme Immunoassay is a ready-to-use, Iiquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect methamphetamine 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. (for clinical laboratories)
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:
Negative: Mean 284.8 mA/min, SD 1.83 mA/min, % CV 0.64 %
15 ng/mL: Mean 332.0 mA/min, SD 1.82 mA/min, % CV 0.55 %
30 ng/mL: Mean 351.9 mA/min, SD 1.84 mA/min, % CV 0.52 %
45 ng/mL: Mean 373.2 mA/min, SD 1.97 mA/min, % CV 0.53 %
90 ng/mL: Mean 400.4 mA/min, SD 1.54 mA/min, % CV 0.39 %
Total Precision:
Negative: Mean 284.8 mA/min, SD 2.27 mA/min, % CV 0.80 %
15 ng/mL: Mean 332.0 mA/min, SD 2.13 mA/min, % CV 0.64 %
30 ng/mL: Mean 351.9 mA/min, SD 2.13 mA/min, % CV 0.60 %
45 ng/mL: Mean 373.2 mA/min, SD 2.50 mA/min, % CV 0.67 %
90 ng/mL: Mean 400.4 mA/min, SD 2.33 mA/min, % CV 0.58 %
Accuracy: Clinical patients samples (n=112) vs. GC/MS
98.2 % Agreement
Specificity:
See attached Assay package insert
OraSure Methamphetamine Micro=Plate EIA Performance Characteristics:
Precision - Intra-assay (N=64)
0 ng/mL: Mean O.D. 2.056, % CV 7.8
20 ng/mL: Mean O.D. 0.978, % CV 7.0
40 ng/mL: Mean O.D. 0.710, % CV 6.2
60 ng/mL: Mean O.D. 0.554, % CV 7.8
80 ng/mL: Mean O.D. 0.480, % CV 6.4
Precision - Inter-assay (N=4/day, 20 days)
0 ng/mL: Mean O.D. 2.056, % CV 7.5
20 ng/mL: Mean O.D. 0.978, % CV 7.7
40 ng/mL: Mean O.D. 0.710, % CV 7.9
60 ng/mL: Mean O.D. 0.554, % CV 7.5
80 ng/mL: Mean O.D. 0.480, % CV 8.4
Accuracy: Clinical patients sample (n=50) vs. GC/MS
98 % Agreement
Specificity:
See OraSure product insert
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 98.2 % Agreement (for subject device)
Accuracy: 98 % Agreement (for predicate device)
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.
K993208, K0509045, K050988, K051058
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
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
SEP 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
Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849 Email: mtlin@lin-zhi.com
Contact: Marie Lin, Ph.D. President, R&D Director
Device Name and Classification
| Classification Name: | The Methamphetamine test systems have been placed in Class II by the Bureau of Medical Devices. |
|---|---|
| Classification Number: LAF (21 CFR 862.3600) | |
| Panel: 91 Toxicology 862.3610 | |
| 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: | Oral Fluid Methamphetamine Homogeneous Enzyme Immunoassays |
Proprietary Name:
1
Legally Marketed Predicate Device(s)
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay is substantially equivalent . to the Methamphetamine Intercept® Micro-plate EIA (K993208) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use. The current subject device is also substantially equivalent to other LZI test systems cleared by FDA, e.g., the Oral Fluid Cocaine (K0509045), Opiate (K050988), and Methadone (K051058) Homogeneous Enzyme Immunoassay for its stated intended use.
Device Description
LZI's Oral Fluid Methamphetamine Enzyme Immunoassay is a ready-to-use, Iiquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect methamphetamine 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 Methamphetamine Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methamphetamine in human saliva with a cutoff of 45 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 (d-methamphetamine) 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 methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Methamphetamine Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific atternative 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.
2
Comparison to Predicate Device(s)
The LZI Oral Fluid Methamphetamine Homogeneous Enzyme Immunoassay, including calibrators and controls, is substantially equivalent to OraSure's Methamphetamine Intercept® Micro-plate EIA in its intended use and in for the qualitative determination of methamphetamine in human oral fluid.
| Device
Characteristics | Subject Device
(LZI Oral Fluid Methamphetamine
Homogeneous EIA) | Predicate Device
(OraSure Methamphetamine
Intercept® Micro-plate EIA) | Feature | Oral Fluid Methamphetamine EIA | | | | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------|--------|--------|
| Intended Use | The Methamphetamine Enzyme
Immunoassays for Drugs of Abuse in
Oral Fluid is a homogeneous enzyme
immunoassay system to detect
methamphetamine in human saliva with
a cutoff of 45 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
(d-methamphetamine) 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
methamphetamine. The assay is
designed for professional use with a
number of automated clinical chemistry
analyzers.
The Oral Fluid Methamphetamine
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 Methamphetamine
Intercept® Micro-plate EIA is
intended for use by clinical
laboratories in the qualitative
determination of methamphetamine in
oral fluid collected with the InterceptⓇ
DOA Oral Specimen Collection
Device using a 40 ng/mL cutoff. For
In Vitro Diagnostic Use.
The OraSure Methamphetamine
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. | Qualitative : (n=120) mA/min | | Mean. | SD | % CV | |
| Analyte | d-methamphetamine | d-methamphetamine | Within Run Precision: | Negative | 284.8 | 1.83 | 0.64 % | |
| Matrix | Saliva | Saliva | | 15 ng/mL | 332.0 | 1.82 | 0.55 % | |
| Calibrators/
Controls Level | 5 levels including a negative | 4 levels including a negative | | 30 ng/mL | 351.9 | 1.84 | 0.52 % | |
| Device
Characteristics | Predicate Device
(K0509045) | Predicate Device
(K0509088) | | Predicate Device
(K051058) | 45 ng/mL | 373.2 | 1.97 | 0.53 % |
| Intended Use | The LZI Cocaine Metabolite
(Benzoylecgonine) Oral
Fluid Homogeneous EIA 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 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 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. | 90 ng/mL | 400.4 | 1.54 | 0.39 % |
| | 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. | 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 judgement should
be applied to any drug-of-
abuse test result, particularly
when preliminary positive
results are used. | 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 judgement should
be applied to any drug-of-abuse
test result, particularly when
preliminary positive results are
used. | | | Mean. | SD | % CV |
| Analyte | Benzoylecgonine | Morphine | Methadone | Total Precision: | Negative | 284.8 | 2.27 | 0.80 % |
| Matrix | Saliva | Saliva | Saliva | | 15 ng/mL | 332.0 | 2.13 | 0.64 % |
| Calibrators/
Controls Level | 5 levels including a negative | 5 levels including a
negative | 5 levels including a
negative | | 30 ng/mL | 351.9 | 2.13 | 0.60 % |
| 45 ng/mL | 373.2 | 2.50 | 0.67 % | | | | | |
| 90 ng/mL | 400.4 | 2.33 | 0.58 % | | | | | |
| Accuracy: Clinical patients samples
(n=112) vs. GC/MS | 98.2 % Agreement | | | | | | | |
| Specificity: | See attached Assay package insert | | | | | | | |
3
The LZI Oral Fluid Methamphetamine Homogeneous Enzyme Immunoassay, including calibrators and controls, is also substantially equivalent to other LZI test systems cleared by FDA, e.g., the Oral Fluid Cocaine (K0509045), Opiate (K050988), and Methadone (K051058) Homogeneous Enzyme Immunoassay for its stated intended use.
4
Performance Characteristics
LZI Oral Fluid Methamphetamine Assay
OraSure Methamphetamine Micro=Plate EIA
| Feature | Methamphetamine | Mean O.D. | % CV |
|---|---|---|---|
| Precision | |||
| Intra-assay | |||
| N=64 | 0 ng/mL | 2.056 | 7.8 |
| 20 ng/mL | 0.978 | 7.0 | |
| 40 ng/mL | 0.710 | 6.2 | |
| 60 ng/mL | 0.554 | 7.8 | |
| 80 ng/mL | 0.480 | 6.4 | |
| Inter-assay | |||
| N=4/day, 20 days | 0 ng/mL | 2.056 | 7.5 |
| 20 ng/mL | 0.978 | 7.7 | |
| 40 ng/mL | 0.710 | 7.9 | |
| 60 ng/mL | 0.554 | 7.5 | |
| 80 ng/mL | 0.480 | 8.4 | |
| Accuracy: Clinical patients sample (n=50) | |||
| vs. GC/MS | 98 % Agreement | ||
| Specificity | See OraSure product insert |
Summary
The information provided in this pre-market notification demonstrates that the LZI Oral Fluid Methamphetamine Homogeneous ELA 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 Methamphetamine Homogeneous EIA is safe and effective for its stated intended use.
5
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 caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 9 2006
Marie Lin. Ph.D. President, R&D Director Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085
K062242 Re:
Oral Eluid Methamphetamine Homogeneous Enzyme ्
Immunoassay, Calibrators and Controls Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF, DLJ, LAS Dated: July 31, 2006 Received: August 2, 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).
6
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 catitied, "Misteranding by reserves to promarket notification" (21 CFR 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 Gutierrez
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Premarket Notification
Indications for Use
510(k) Number (if known): K062242
Device Name: Oral Fluid Methamphetamine Homogeneous Enzyme Immunoassay, Calibrators and Controls.
Indications For Use:
The Methamphetamine Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methamphetamine in human saliva with a cutoff of 45 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 (d-methamphetamine) 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 methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Methamphetamine 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 Diagnostic Device Evaluation and Safety
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