(164 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic assay intended for the qualitative and semi-quantitative determination of opiates in human urine. It is used for diagnostic purposes and does not provide any form of therapy or treatment to a patient.
Yes
The device is intended for the qualitative and semi-quantitative determination of opiates in human urine, which is a diagnostic purpose to detect the presence and approximate concentration of a substance in a biological sample.
No
The device is a homogeneous enzyme immunoassay, which is a chemical reagent kit, not a software-only device. It is used with automated clinical chemistry analyzers, but the device itself is the reagent.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semi-quantitative determination of opiates in human urine." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a patient's health status (presence of opiates).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses reagents to measure the presence of a substance (opiates) in a sample. This is a common method used in IVD devices.
- Anatomical Site: The sample being tested is "human urine," which is a biological specimen.
- Performance Studies: The document includes performance characteristics like precision, limit of detection, linearity, and method comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K020368) indicates that this device is being compared to a previously cleared IVD device, a common practice in the regulatory pathway for IVDs.
All these factors strongly indicate that this device falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative ' determination of opiates in human urine, at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures."
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The Opiate Enzyme Immunoasay is a homogeneous enzyme immunoassay ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent.
Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, morphine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound morphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use with a number of automated clinical chemistry analyzers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: Semi-Quantitative, N=88. Results shown for various Opiate concentrations from 0 ng/mL to 600 ng/mL, with Mean, SD, and %CV for Within Run and Total Precision. The assay results for 300 ng/mL were 6 Pos/16 Neg for Within Run and 27 Pos/61 Neg for Total Precision. For concentrations above 300 ng/mL, all results were Positive, and for concentrations below 300 ng/mL, all results were Negative within run and total precision.
Precision: Qualitative (mA/min), N=88. Results shown for various Opiate concentrations from 0 ng/mL to 600 ng/mL, with Mean, SD, and %CV for Within Run and Total Precision. The assay results for 300 ng/mL were 16 Pos/6 Neg for Within Run and 51 Pos/37 Neg for Total Precision. For concentrations above 300 ng/mL, all results were Positive, and for concentrations below 300 ng/mL, all results were Negative within run and total precision.
Limit of Detection: 20 ng/mL (95% confidence).
Linearity: Hitachi 717 Instrument: 0 - 1000 ng/mL; y = 1.0619x - 2.3861, r2=0.9976.
Method Comparison: Clinical Samples, 130 samples.
Semi-Quantitative Results: 98.3 % agreement with positive, 95.9 % agreement with negative samples.
Qualitative Results: 98.3 % agreement with positive, 94.5 % agreement with negative samples.
Endogenous Compound Interference, Specific Gravity, & Specificity -Cross-Reactivity: No significant undesired cross reactants or endogenous substance interference was observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Semi-Quantitative Results: 98.3 % agreement with positive, 95.9 % agreement with negative samples
Qualitative Results: 98.3 % agreement with positive, 94.5 % agreement with negative samples
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted is summary of 510(k) sujely and effectiveness information is being stommed
in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. JUL 1 5 2011
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. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax: e-mail: bclin@lin-zhi.com
Contact: Bernice Lin, Ph.D. VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Opiate
Class II, DJG (91 Toxicology),
21 CFR 862.3650 |
|----------------------|---------------------------------------------------------------------------------|
| Common Name: | Homogeneous Opiate Enzyme Immunoassay |
| Proprietary Name: | Opiate Enzyme Immunoassay, |
1
Legally Marketed Predicate Device(s)
The Opiate Enzyme Immunoassay (EIA) is substantially equivalent to the Lin-Zhi International, Inc. Opiate Enzyme Immunoassay for Hitachi 717 Systems (K020368) manufactured by Lin-Zhi International, Inc. The Opiate Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description (Assay Principle)
The Opiate Enzyme Immunoasay is a homogeneous enzyme immunoassay ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent.
Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, morphine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound morphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
Intended Use
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine, at a cutoff value of 300 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Opiate Drugs of Abuse (DAU) Calibrators (from K020769) are for use as calibrators in the qualitative and semi-quantitative calibration of the Opiate Enzyme Immunoassay.
The Opiate Drugs of Abuse (DAU) Controls (from K020769) are for use as assayed quality control materials to monitor the precision of the Opiate Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
2
Comparison to Predicate Device
The Opiate Enzyme Immunoassay is substantially equivalent to the Lin-Zhi International, Inc. Opiate Enzyme Immunoassay for Hitachi 717 Systems cleared by the FDA under the premarket notification K020368 for its stated intended use.
The following table compares the Opiate Enzyme Immunoassay with the predicate device.
| Device
| Characteristics | Subject Device | Predicate Device (K020368) |
|---|---|---|
| Intended Use | The Opiate Enzyme Immunoassay, when | |
| used in conjunction with Hitachi 717 | ||
| automated clinical system analyzers, is | ||
| intended for the qualitative and semi- | ||
| quantitative determination of opiates in | ||
| human urine, at a cutoff value of 300 | ||
| ng/mL. The assay is designed for | ||
| professional use with a number of | ||
| automated clinical chemistry analyzers. |
This assay provides a rapid screening procedure
for determining the presence of Opiates in urine.
The assay provides only a preliminary analytical
result. A more specific alternative chemical
method must be used in order to obtain a
confirmed analytical result. Gas or liquid
chromatography/mass spectrometry (GC/MS or
LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. | The Opiate Enzyme Immunoassay, when
used in conjunction with Hitachi 717
automated clinical system analyzers, is
intended for the qualitative and semi-
quantitative determination of opiates in
human urine, at a cutoff value of 300
ng/mL. The assay is designed for
professional use with a number of
automated clinical chemistry analyzers.
This assay provides a rapid screening procedure
for determining the presence of Opiates in urine.
The assay provides only a preliminary analytical
result. A more specific alternative chemical
method must be used in order to obtain a
confirmed analytical result. Gas or liquid
chromatography/mass spectrometry (GC/MS or
LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. |
| Analyte | Opiates | Opiates |
| Cutoff | 300 ng/ml | 300 ng/mL |
| Matrix | Urine | Urine |
| Calibrators | 5 Levels | 5 Levels |
| Level | (0, 150, 300, 600, 1000 ng/mL) | (0, 150, 300, 600, 1000 ng/mL) |
| Controls Level | 2 Levels | 2 Levels |
| | (225 ng/mL, 375 ng/mL) | (225 ng/mL, 375 ng/mL) |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |
3
Performance Characteristics Summary: Hitachi 717 Analyzer
Precision:
:
Precision: Semi-Quantitative, ng/mL
| N=88 | (ng/mL) | Within Run | Total Precision | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | SD | % CV | Mean | SD | % CV | ||||
| 0 ng/mL | 0.0 | 0.0 | #DIV/0! | 0.0 | 0.0 | #DIV/0! | |||
| 75 ng/mL | 84.0 | 3.5 | 4.2% | 84.0 | 4.5 | 5.4% | |||
| 150 ng/mL | 148.4 | 3.7 | 2.5% | 148.4 | 4.2 | 2.8% | |||
| 225 ng/mL | 228.2 | 5.3 | 2.3% | 228.2 | 6.4 | 2.8% | |||
| 300 ng/mL | 297.5 | 6.3 | 2.1% | 297.5 | 7.3 | 2.4% | |||
| 375 ng/mL | 370.4 | 7.6 | 2.0% | 370.4 | 8.2 | 2.2% | |||
| 450 ng/mL | 453.3 | 9.8 | 2.2% | 453.3 | 10.1 | 2.2% | |||
| 525 ng/mL | 529.0 | 11.5 | 2.2% | 529.0 | 12.7 | 2.4% | |||
| 600 ng/mL | 600.8 | 16.2 | 2.7% | 600.8 | 17.5 | 2.9% |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| N=88
(ng/mL) | Mean | Within Run
Qualitative Response | Mean | Total Precision
Qualitative Response |
|-----------------|-------|------------------------------------|-------|-----------------------------------------|
| 0 ng/mL | 0.0 | - | 0.0 | - |
| 75 ng/mL | 84.0 | - | 84.0 | - |
| 150 ng/mL | 148.4 | - | 148.4 | - |
| 225 ng/mL | 228.2 | - | 228.2 | - |
| 300 ng/mL | 297.5 | - | 297.5 | - |
| 375 ng/mL | 370.4 | + | 370.4 | + |
| 450 ng/mL | 453.3 | + | 453.3 | + |
| 525 ng/mL | 529.0 | + | 529.0 | + |
| 600 ng/mL | 600.8 | + | 600.8 | + |
Semi-Quantitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100.0% | 22 | 6 Pos/16 Neg | 88 | 27 Pos/61 Neg |
| 375 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
4
Precision: Qualitative, mA/min
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (mA/min) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 261.0 | 2.1 | 0.8% | 261.0 | 2.4 | 0.9% |
| 75 ng/mL | 310.4 | 1.8 | 0.6% | 310.4 | 2.4 | 0.8% |
| 150 ng/mL | 345.6 | 2.1 | 0.6% | 345.6 | 3.2 | 0.9% |
| 225 ng/mL | 383.6 | 2.4 | 0.6% | 383.6 | 3.7 | 1.0% |
| 300 ng/mL | 410.9 | 2.3 | 0.6% | 410.9 | 3.7 | 0.9% |
| 375 ng/mL | 432.1 | 2.5 | 0.6% | 432.1 | 3.6 | 0.8% |
| 450 ng/mL | 454.3 | 2.8 | 0.6% | 454.3 | 4.0 | 0.9% |
| 525 ng/mL | 471.0 | 2.5 | 0.5% | 471.0 | 4.4 | 0.9% |
| 600 ng/mL | 482.6 | 2.5 | 0.5% | 482.6 | 3.6 | 0.8% |
Qualitative Positive/Negative Results:
| 300 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 225 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 300 ng/mL | 100.0% | 22 | 16 Pos/6 Neg | 88 | 51 Pos/37 Neg |
| 375 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 450 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 525 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 600 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Limit of Detection:
The lowest concentration that can be differentiated from the negative urine with 95% confidence is determined as 20 ng/mL.
Linearity:
Hitachi 717 Instrument: 0 - 1000 ng/mL When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow: y = 1.0619x - 2.3861, r2=0.9976
Method Comparison: Clinical Samples
From a total of One-hundred-thirty (130) clinical unaltered samples:
Semi-Quantitative Results: 98.3 % agreement with positive, 95.9 % agreement with negative samples
Qualitative Results: 98.3 % agreement with positive, 94.5 % agreement with negative samples
Endogenous Compound Interference, Specific Gravity, & Specificity -Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference was observed. See product insert for list of compounds tested.
5
Summary:
The information provided in this pre-market notification demonstrates that the LZI Opiate Enzyme Immunoassay is substantially equivalent to the legally marketed predicate 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 or liquid chromatography/mass spectrometry (GC/MS or LC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Opiate Enzyme Immunoassay is safe and effective for its stated intended use.
6
Image /page/6/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-GSA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted in a minimalist, flowing design. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
15 2011
Lin-Zhi International, Inc. c/o Dr. Bernice Lin VP Operations 670 Almanor Avenue Sunnyvale, CA 94085
Re: K110298 Trade name: Opiate Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: June 17, 2011 Received: June 20, 2011
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
7
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Premarket Notification
Indications for Use Statement
510(k) Number (if known): K110298
Device Name: Opiate Enzyme Immunoassay
Indications for Use:
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative ' determination of opiates in human urine, at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures."
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Per 21 CFR 801.109)
Qur
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110298