(28 days)
No
The device description and performance studies focus on a traditional enzyme immunoassay method for detecting amphetamine in oral fluid. There is no mention of AI or ML in the intended use, device description, or performance evaluation sections.
No
The device is an in vitro diagnostic assay used to detect amphetamine in oral fluid samples, providing analytical test results rather than directly treating or preventing a disease.
Yes.
This device is designed to detect amphetamine in human saliva, providing a preliminary analytical test result for the presence of drugs of abuse, which is a diagnostic purpose.
No
The device is a homogeneous enzyme immunoassay system, which is a chemical assay involving reagents and enzymatic reactions, not a software-only device. It is intended for use with automated clinical chemistry analyzers, which are hardware devices.
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 amphetamine in human saliva." This involves testing a biological specimen (oral fluid/saliva) in vitro (outside the body) to provide information about a person's health status (presence of amphetamine).
- Device Description: The description details a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay" that uses antibodies and enzymes to measure a substance in a biological sample. This is a classic description of an IVD assay.
- 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 "Qualitative Precision" and "Accuracy" (compared to a reference method like GC/MS) are standard for demonstrating the performance of an IVD.
- Predicate Device(s): The predicate device listed (K992918 Amphetamine-Specific Intercept® Micro-plate EIA) is also an IVD, further supporting the classification of this device as an IVD.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amphetamine-Specific Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect amphetamine 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-amphetamine) 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 amphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Amphetamine-Specific 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
DKZ, DLJ, LAS
Device Description
LZI's Oral Fluid Amphetamine-Specific Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect amphetamine 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
The performance characteristics for the LZI Oral Fluid Amphetamine-Specific Assay include:
- Within Run Precision (n=120): Values provided for Negative, 15 ng/mL, 30 ng/mL, 45 ng/mL, and 90 ng/mL, showing mean mA/min, SD, and %CV. For example, Negative: Mean 250.9, SD 1.58, 0.63% CV; 45 ng/mL: Mean 309.6, SD 1.44, 0.46% CV.
- Total Precision: Values provided for Negative, 15 ng/mL, 30 ng/mL, 45 ng/mL, and 90 ng/mL, showing mean mA/min, SD, and %CV. For example, Negative: Mean 250.9, SD 2.57, 1.02% CV; 45 ng/mL: Mean 309.6, SD 2.15, 0.70% CV.
- Accuracy: Clinical patients samples agreement vs. GC/MS: 97.1 % Agreement.
- Specificity: See attached Assay package insert.
The performance characteristics for the OraSure Amphetamine-Specific Micro-Plate EIA (predicate device) include:
- Precision:
- Intra-assay (N=64): Values for 0, 50, 100, 150, 200 ng/mL showing Mean O.D. and % CV. For example, 100 ng/mL: Mean O.D. 0.709, 4.0% CV.
- Inter-assay (N=4/day, 20 days): Values for 0, 50, 100, 150, 200 ng/mL showing Mean O.D. and % CV. For example, 100 ng/mL: Mean O.D. 0.709, 7.5% CV.
- Accuracy: Clinical patients sample (n=53) agreement vs. GC/MS: 89 % Agreement.
- Specificity: See OraSure product insert.
The summary states that the LZI Oral Fluid Amphetamine-Specific Homogeneous EIA is substantially equivalent to the legally marketed predicated device for its general intended use. 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.
Key Metrics
- Within Run Precision: % CV ranging from 0.46% to 0.63%
- Total Precision: % CV ranging from 0.70% to 1.02%
- Accuracy: 97.1 % Agreement (subject device); 89 % Agreement (predicate device)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).
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Kα63024
OCT 3 0 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 Amphetamine test systems have been placed in Class
II by the Bureau of Medical Devices.
Classification Number: DKZ (21 CFR 862.3100)
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: | Oral Fluid Amphetamine Homogeneous Enzyme
Immunoassays |
| Proprietary Name: | |
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1
Legally Marketed Predicate Device(s)
The LZI Oral Fluid Amphetamine-Specific Enzyme Immunoassay is substantially equivalent to the Amphetamine-Specific Intercept® Micro-plate EIA (K992918) 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 (K050945). Opiate (K050988), and Methadone (K051058) Homogeneous Enzyme Immunoassay for its stated intended use.
Device Description
LZI's Oral Fluid Amphetamine-Specific Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect amphetamine 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 Amphetamine-Specific Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect amphetamine 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-amphetamine) 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 amphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Amphetamine-Specific 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 Amphetamine-Specific Homogeneous Enzyme Immunoassay, including calibrators and controls, is substantially equivalent to OraSure's Amphetamine-Specific Intercept® Micro-plate EIA in its intended use and in for the qualitative determination of amphetamine in human oral fluid.
| Device
Characteristics | Subject Device
(LZI Oral Fluid Amphetamine-Specific
Homogeneous EIA) | Predicate Device
(OraSure Amphetamine-Specific
Intercept® Micro-plate EIA) | Device
Characteristics | Predicate Device
(K050945) | Predicate Device
(K050988) | Predicate Device
(K051058) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Amphetamine-Specific Enzyme
Immunoassays for Drugs of Abuse in
Oral Fluid is a homogeneous enzyme
immunoassay system to detect
amphetamine 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-amphetamine) 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 amphetamine. The
assay is designed for professional use
with a number of automated clinical
chemistry analyzers.
The Oral Fluid Amphetamine-Specific
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 Amphetamine-Specific
Intercept® Micro-plate EIA is
intended for use by clinical
laboratories in the qualitative
determination of amphetamine in oral
fluid collected with the Intercept®
DOA Oral Specimen Collection
Device using a 100 ng/mL cutoff. For
In Vitro Diagnostic Use.
The OraSure Amphetamine-Specific
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. | 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. |
| Analyte | d-amphetamine | d-amphetamine | | 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. |
| Matrix | Saliva | Saliva | Analyte | Benzoylecgonine | Morphine | Methadone |
| Calibrators/
Controls Level | 5 levels including a negative | 4 levels including a negative | Matrix | Saliva | Saliva | Saliva |
| Calibrators/
Controls Level | 5 levels including a negative | 5 levels including a
negative | 5 levels including a
negative | | | |
3
The LZI Oral Fluid Amphetamine-Specific 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 (K050945), Opiate (K050988), and Methadone (K051058) Homogeneous Enzyme Immunoassay for its stated intended use.
4
Performance Characteristics
LZI Oral Fluid Amphetamine-Specific Assay
| Feature | Oral Fluid Amphetamine-Specific EIA | |||
|---|---|---|---|---|
| Qualitative : (n=120) mA/min | Mean. | SD | % CV | |
| Within Run Precision: | Negative | 250.9 | 1.58 | 0.63% |
| 15 ng/mL | 284.6 | 1.60 | 0.56% | |
| 30 ng/mL | 297.9 | 1.46 | 0.49% | |
| 45 ng/mL | 309.6 | 1.44 | 0.46% | |
| 90 ng/mL | 331.2 | 1.67 | 0.50% | |
| Mean. | SD | % CV | ||
| Total Precision: | Negative | 250.9 | 2.57 | 1.02 % |
| 15 ng/mL | 284.6 | 2.43 | 0.85 % | |
| 30 ng/mL | 297.9 | 2.07 | 0.70 % | |
| 45 ng/mL | 309.6 | 2.15 | 0.70 % | |
| 90 ng/mL | 331.2 | 2.51 | 0.76 % | |
| Accuracy: Clinical patients samples | ||||
| (n=) vs. GC/MS | 97.1 % Agreement | |||
| Specificity: | See attached Assay package insert |
OraSure Amphetamine-Specific Micro-Plate EIA
| Feature | Amphetamine | Mean O.D. | % CV |
|---|---|---|---|
| Precision | |||
| Intra-assay | |||
| N=64 | 0 ng/mL | 1.905 | 3.9 |
| 50 ng/mL | 1.005 | 3.5 | |
| 100 ng/mL | 0.709 | 4.0 | |
| 150 ng/mL | 0.563 | 4.5 | |
| 200 ng/mL | 0.438 | 6.4 | |
| Inter-assay | |||
| N=4/day, 20 days | 0 ng/mL | 1.905 | 6.7 |
| 50 ng/mL | 1.005 | 6.7 | |
| 100 ng/mL | 0.709 | 7.5 | |
| 150 ng/mL | 0.563 | 7.7 | |
| 200 ng/mL | 0.438 | 7.9 | |
| Accuracy: Clinical patients sample (n=53) | |||
| vs. GC/MS | 89 % Agreement | ||
| Specificity | See OraSure product insert |
Summary
The information provided in this pre-market notification demonstrates that the LZI Oral Fluid Amphetamine-Specific 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 Amphetamine-Specific Homogeneous EIA is safe and effective for its stated intended use.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The seal is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Marie Lin, Ph.D. President, R&D Director Lin-Zhi International, Inc. 687 North Pastoria Ave Sunnyvale, CA 94085
OCT 3 0 2006
Re: K063024 Trade/Device Name: Oral Fluid Amphetamine-Specific Enzyme Immunoassay, Calibrators and Controls Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DLJ, LAS Dated: September 27, 2006
Received: October 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. Iisting 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 Gutierrez
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
7
Premarket Notification
Indications for Use
510(k) Number (if known): K063024
Device Name: Oral Fluid Amphetamine-Specific Homogeneous Enzyme Immunoassay, Calibrators and Controls.
Indications For Use:
The Amphetamine-Specific Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect amphetamine 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-amphetamine) 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 amphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Amphetamine-Specific 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)
Page 1 of 1
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
5106(K) k06,3024
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