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METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS

Q: Who is the manufacturer of METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS?

Lin-Zhi International, Inc. filed the 510(k) submission for METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS (K062242).

Q: What is the FDA product code for METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS?

LAF. It is classified under 21 CFR 862.3610 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS?

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

K062242 · Lin-Zhi International, Inc. · LAF · Sep 29, 2006 · Clinical Toxicology

Device Facts

Record ID	K062242
Device Name	METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS
Applicant	Lin-Zhi International, Inc.
Product Code	LAF · Clinical Toxicology
Decision Date	Sep 29, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3610
Device Class	Class 2

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 specimens collected with a 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.

Device Story

Ready-to-use liquid reagent homogeneous enzyme immunoassay; detects methamphetamine in human saliva. Principle: competition between drug-labeled G6PDH enzyme and free drug in saliva sample for fixed amount of specific antibody. In absence of free drug, antibody binds labeled enzyme, decreasing activity. Enzyme activity measured spectrophotometrically at 340 nm via conversion of NAD to NADH; drug concentration proportional to enzyme activity. Used in clinical laboratories by professionals on automated clinical chemistry analyzers. Provides preliminary analytical results; requires confirmation by GC/MS. Assists clinicians in identifying methamphetamine presence in oral fluid specimens.

Clinical Evidence

Bench testing only. Method comparison study of 112 clinical oral fluid specimens against GC/MS reference method. Results: 71 true positives, 39 true negatives, 2 false positives (near cutoff). Overall agreement 98.2%. Precision studies (n=6, twice daily for 10 days) showed within-run %CV 0.39-0.64% and total precision %CV 0.58-0.80%. Analytical specificity evaluated against various cross-reactants and interferents.

Technological Characteristics

Homogeneous enzyme immunoassay; liquid reagents (mouse monoclonal antibodies, G6PDH conjugate). Sensing principle: spectrophotometric measurement of NADH at 340 nm. Designed for automated clinical chemistry analyzers. Storage: 2-8 °C. Stability: 18 months shelf life; 22 days for collected samples (refrigerated or frozen).

Indications for Use

Indicated for qualitative detection of methamphetamine in human saliva for professional use in clinical chemistry laboratories. Not for point-of-care settings.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

OraSure Methamphetamine Intercept® Micro-plate EIA (k993208)
LZI Oral Fluid Cocaine Enzyme Immunoassay (k050945)
LZI Oral Fluid Opiate Enzyme Immunoassay (k050988)
LZI Oral Fluid Methadone Enzyme Immunoassay (k051058)

Related Devices

K063024 — LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS · Lin-Zhi International, Inc. · Oct 30, 2006
K051058 — METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS · Lin-Zhi International, Inc. · Mar 29, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ K062242 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 K062242 Page 1 of 1

METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS

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METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

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Special Control Matches

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