LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS

Q: Who is the manufacturer of LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS?

Lin-Zhi International, Inc. filed the 510(k) submission for LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS (K063024).

Q: What is the FDA product code for LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS?

DKZ. It is classified under 21 CFR 862.3100 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS?

LZI Oral Fluid Cocaine Enzyme Immunoassay (k050945); LZI Opiate Oral Fluid Enzyme Immunoassay (k050988); LZI Oral Fluid Methadone Enzyme Immunoassay (k051058); OraSure Amphetamine-Specific Intercept Micro-plate oral fluid EIA (k992918).

Q: Who can help prepare an FDA 510(k) submission like LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K063024 · Lin-Zhi International, Inc. · DKZ · Oct 30, 2006 · Clinical Toxicology

Device Facts

Record ID	K063024
Device Name	LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
Applicant	Lin-Zhi International, Inc.
Product Code	DKZ · Clinical Toxicology
Decision Date	Oct 30, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2

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.

Device Story

Liquid reagent, homogeneous enzyme immunoassay; detects amphetamine in human saliva. Principle: competition between drug-labeled G6PDH enzyme and free drug in saliva sample for fixed antibody; drug concentration proportional to enzyme activity. Enzyme activity measured spectrophotometrically at 340 nm via conversion of NAD to NADH. Used in clinical laboratories by professionals on automated chemistry analyzers. Provides preliminary qualitative results; requires confirmatory testing (GC/MS) for clinical decision-making. Benefits: rapid screening for drugs of abuse in oral fluid.

Clinical Evidence

Method comparison study performed on 112 clinical oral fluid specimens comparing LZI EIA to GC/MS. Results showed 97.1% agreement (56 true positives, 44 true negatives, 2 false positives, 1 false negative). Precision studies (replicates of 6, twice daily for 10 days) showed within-run CV 0.46-0.63% and total precision CV 0.70-1.02%. Analytical specificity evaluated against various compounds; MDA showed cross-reactivity.

Technological Characteristics

Homogeneous enzyme immunoassay; liquid reagents. Sensing principle: spectrophotometric measurement of G6PDH enzymatic activity at 340 nm. Analyzers: automated clinical chemistry systems (e.g., Hitachi 717). Storage: 2-8 °C. Qualitative assay; no linearity. Calibrators/controls: buffer matrix spiked with d-amphetamine.

Indications for Use

Indicated for the qualitative detection of amphetamine in human saliva specimens collected via Sarstedt Salivette. Intended for professional use in clinical chemistry laboratories for preliminary analytical screening. Not for point-of-care use.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

LZI Oral Fluid Cocaine Enzyme Immunoassay (k050945)
LZI Opiate Oral Fluid Enzyme Immunoassay (k050988)
LZI Oral Fluid Methadone Enzyme Immunoassay (k051058)
OraSure Amphetamine-Specific Intercept Micro-plate oral fluid EIA (k992918)

Related Devices

K062242 — METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS · Lin-Zhi International, Inc. · Sep 29, 2006
K131653 — LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS · Lin-Zhi International, Inc. · Feb 4, 2014
K020395 — AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) · Lin-Zhi International, Inc. · Jun 4, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ 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: | | 12 {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. {5}------------------------------------------------ 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). {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 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 11

LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS

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LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

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Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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