Who is the manufacturer of CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

Iris International Inc., A Division of Iris Iris I filed the 510(k) submission for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (K101852).

What is the FDA product code for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

KQO. It is classified under 21 CFR 862.2900 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

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

What are the predicate devices for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

iChem 100 Urine Chemistry Analyzer and iChem 10SG strips; IRISpec Gravity Control 1™ and IRISpec Gravity Control 2™ (K960054); Arkray Check Strips (K013783).

Who can help prepare an FDA 510(k) submission like CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

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.

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

K101852 · Iris International Inc., A Division of Iris Iris I · KQO · Mar 23, 2011 · Clinical Chemistry

Device Facts

Record ID	K101852
Device Name	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
Applicant	Iris International Inc., A Division of Iris Iris I
Product Code	KQO · Clinical Chemistry
Decision Date	Mar 23, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2900
Device Class	Class 1

Intended Use

The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem®VELOCITY™ can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChem®VELOCITY™ strips are intended for use only with the iChem®VELOCITY™ analyzer. In particular they are not intended for visual reading. The iChem® VELOCITY™ test strips are not intended for visual reading. The iChem®VELOCITY™ is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem® VELOCITY™ are intended for clinical laboratory use and in vitro diagnostic use only.

Device Story

Fully automated, computer-controlled urine chemistry analyzer; processes urine samples via automated probe aspiration and dispensing onto reagent strips. System utilizes fixed-time end-point reflectance photometry (three LEDs and CMOS camera) to measure color changes on reagent pads; electronic refractometer assembly measures specific gravity; optical absorbance/scattering methods determine color and clarity. Used in clinical laboratories; operated by trained personnel. Output includes quantitative specific gravity, semi-quantitative chemistry results, and qualitative color/clarity data. Integrated into iRICELL™ configuration with iQ200 Series systems. Results aid clinicians in diagnosing metabolic, renal, urinary, and liver conditions. Includes CalChek kit for performance monitoring.

Clinical Evidence

Bench testing only. Precision evaluated over 20 non-consecutive runs using negative, low, and high positive pools (N=540 per level). Method comparison performed against iChem 100 analyzer and Atago PEN Refractometer using clinical urine samples. Results showed high concordance (exact agreement and +/- 1 color block agreement) across all analytes. Interference testing conducted for common substances (e.g., ascorbic acid, glucose, hemoglobin) to define limitations.

Technological Characteristics

Fully automated analyzer; CMOS digital camera for reflectance photometry; electronic refractometer for specific gravity. Reagent strips use enzymatic/colorimetric reactions. Connectivity: Standalone or integrated with iQ200 Series (iRICELL™). Calibration: Quarterly using CalChek strips. Software: Computer-controlled. Materials: CalChek reagents (glycerol, salts, food dyes, preservatives).

Indications for Use

Indicated for clinical laboratory use to automate urine chemistry analysis in patients requiring diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Not for Point of Care (POC) use. Prescription use only.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Predicate Devices

iChem 100 Urine Chemistry Analyzer and iChem 10SG strips
IRISpec Gravity Control 1™ and IRISpec Gravity Control 2™ (K960054)
Arkray Check Strips (K013783)

Related Devices

K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT · Siemens Healthcare Diagnostics · Nov 17, 2014
K063276 — CLINITEK ADVANTUS, MODEL 1420 · Bayer Healthcare, LLC · Dec 28, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ 510(k) Summary 10 852 MAR 2 3 2011 Applicant: Iris Diagnostics, a Division of IRIS International Inc 9172 Eton Avenue Chatsworth, CA 91311 (818) 709-1244 David W. Gates, Ph.D. VP Quality Assurance and Regulatory Affairs #### I. iChem VELOCITY Automated Urine Chemistry System #### Proprietary and Established Names: Proprietary names: iChem® VELOCITY™ Automated Urine Chemistry System and iChem VELOCITY™ Chemistry Strips. Common names: Automated Urinalysis System, Urinary Test System (non-quantitative). | Regulation Section: | Code | Test | |---------------------|------|------------------------------------------------------------------------| | 21 CFR § 862.2900 | KQO | Automated Urinalysis System | | 21 CFR § 862.1340 | JIL | Urinary Glucose (Non Quantitative) Test System | | 21 CFR § 864.6550 | JIO | Occult Blood test | | 21 CFR § 862.1785 | CDM | Urinary Urobilinogen (Non-Quantitative) | | 21 CFR § 862.1550 | CEN | Urinary pH (Non-Quantitative) Test System | | 21 CFR § 862.1510 | JMT | Nitrite (Non-Quantitative) Test System | | 21 CFR § 862.2800 | JRE | Refractometer for Clinical Use | | 21 CFR § 864.7675 | LJX | Leukocyte Peroxidase Test | | 21 CFR § 862.1095 | JMA | Ascorbic Acid Test System | | 21 CFR § 862.1435 | JIN | Ketones (Non-Quantitative) Test System | | 21 CFR § 862.1645 | JIR | Urinary Protein or Albumin (Non-Quant.) Test System | | 21 CFR § 862.1115 | JJB | Urinary Bilirubin and its conjugates (Non-Quantitative) Test System | Classification names: Automated Urinalysis System; Urinary Test Systems (Non Quantitative); Refractometer for Clinical Use Class II: Urinary Glucose and Occult Blood Class I: Automated Urinalysis System, Urinary Urobilinogen, Urinary pH, Ketones, Urinary Protein, Urinary Bilirubin, Nitrite, Leukocyte Peroxidase, Ascorbic Acid, Refractometer. #### Indication For Use: The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL ™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid, and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not {1}------------------------------------------------ intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only. #### Devices to which substantial equivalence is claimed iChem 100 Urine Chemistry Analyzer and iChem 10SG strips #### Description of the proposed device: The proposed device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVelocity Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively. {2}------------------------------------------------ | Device | Proposed iChem VELOCITY, iChem VELOCITY strips | Predicate iChem 100 Analyzer 10SG strips | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only. | The iChem100 is a semi- automated urine analyzer intended for the in vitro measurement of the following analytes: glucose (GLU), protein (PRO), bilirubin (BIL), urobilinogen (URO), pH, blood (BLD), ketones (KET), nitrite (NIT), leukocytes (LEU), specific gravity (SG) and color. | | | 1. Uses similar well-proven design methods as predicate. | 1. Uses well-proven chemistry strip methods, and optical absorbance and scattering for determination of analytes in and physical properties of urine. | | | 2. Same as predicate | 2. Is capable of stand-alone, as well as joint operation with an Iris iQ200 Series System. | | | 3. Same as predicate | 3. Tests for the concentration of ascorbic acid in urine. | | | 4. Same as predicate | 4. Uses fixed-time end-point reflectance for all chemistry determinations. | | Design | 5. Same as predicate | 5. LED's with three different wavelengths are used to illuminate the test strips for measurement. It utilizes a (CMOS) image sensor that captures a color image of each of the test pads. The CMOS image sensor is able to photograph almost the whole length (100mm) of the urine test strip and all of its width. | | | 6. Urine color is measured by the absorbance of white light through a flowcell containing urine. Intensities of RGB wavelengths are measured with a solid-state photodetector array. | 6. Urine color is measured from the color compensation . pad on the iChem 10 SG strip | | | 7. Specific gravity is measured by determining the refractive index of the specimen. | 7. Specific Gravity is measured using a test pad that contains a detergent and Bromthymol blue that indicates the presence of ionic constituents in the urine by changing color from green to yellow. The test pad for specific gravity is impregnated with a reddish dye so that the color produced is yellow-brown tan. | | Materials | D.C. by an internal switching mode power supply | VD.C. by an external power converter. | | | Materials are generally same as predicate | Commodity materials and purchased components used in most bench top laboratory instruments, i.e. aluminum frames, thermoplastic enclosures and various molded parts; switching mode power supplies, solder-plated printed circuit board assemblies, programmable and general purpose microprocessors, discrete wire harnesses, flat flexible cables etc. | | Safety | The proposed device has been certified to comply with latest applicable safety standards for U.S., Canada, and the European Union, including CB Scheme Certificate and Report. Specifically, these include UL61010-1, CAN/CSA C22.2 #61010-1, IEC 61010-1, CENELEC EN61010-1, IEC61010-2-101, and CENELEC EN 61010-2-81 | The predicate device was tested to U.S. (U.L.) Part 1: General Requirements, UL61010A-1, First Edition. and to the Canadian Standards for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use; Part 1: General Requirements, CAN/CSA-C22.2 No. 1010.1-92, First Edition. It was also tested to the European/International versions of those norms IEC 61010-1/ EN 61010-1: 2001 "Safety requirements for electrical equipment for measurement, control, and laboratory use: Part I General requirements" | | Electromagnetic Compatibility | The proposed device has been tested and certified to CENELEC EN 61326-1 EMC requirements-general and CENELEC EN 61326-2-6 EMC requirements-particular requirements for IVD medical equipment. | Was tested and certified to IEC61326-1:1997+A1 1998+A2:2001 | | Chemistry strips | 1. The iChem VELOCITY is intended for use only with Iris VELOCITY chemistry strips 2. Analyte detection chemistry composition very similar | 1. The iChem100 is intended for use only with the iChem 10 SG multi-parameter test strips. 2. Analyte detection pads for glucose and pH are more hydrophobic. | ( {3}------------------------------------------------ . {4}------------------------------------------------ · {5}------------------------------------------------ #### ll. iChem VELOCITY CalChek Kit #### Proprietary and Established Names: #### Proprietary name: iChem VELOCITY CalChek Kit Classification name: Quality control material (assayed and unassayed). Common name: Urinalysis controls | Regulation Section: | Code | Test | |---------------------|------|----------------------------------------------------------------| | 21 CFR § 862.1660 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I: Single (Specified) Analyte Controls, Assayed. Unclassified: Urinary Color, Urinary Clarity (Turbidity) #### Device to which substantial equivalence is claimed IRISpec Gravity Control 1 ™ and IRISpec Gravity Control 2™ File No. K960054 Arkray Check Strips K013783 #### Description of the proposed device: iChem VELOCITY CalChek Reagents are a set of buffer-based solutions intended for the in vitro monitoring of specific gravity, color and clarity. #### Intended Use: The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer. The controls include assayed liguid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements. These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. #### Comparison of the proposed device with the predicate device | Comparison | iChem VELOCITY Specific Gravity Calcheks (Proposed Device) | IRISpec Gravity Control 1™ IRISpec Gravity Control 2™ (Predicate Devices) | |-------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Composition | Glycerol, salts, food dyes, preservative, dissolved in deionized water. No biological material. | Salts, food coloring,glycerin,stabilizers, preservative in deionized water | | Form | Same as predicate | Liquid, ready to use | {6}------------------------------------------------ | Preservatives | Yes | Yes | |-----------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | Storage | 20-28°C (68-82°F) | Dark, dry place (2-8C) | | Stability-closed vial | 1 year | 1 year | | Stability-open vial | Single use | 30 days | | S.G. Cal value -low | 1.002 ± 0.002 | NA | | S.G. Cal value-med | 1.030 ± 0.002 | 1.025 ± 0.001 | | S.G. Cal value-high | 1.060 ± 0.002 | 1.060 ± 0.001 | | Intended use | Assayed QC materials for monitoring of urine chemistry specific gravity on the iChem VELOCITY Urine Analyzer. | For IVD use in the operation of IRIS Urinalysis workstations | | Analytes | SG at three levels | Specific Gravity at two levels | | Usage | Vial is intended for one time use | Contents dispensed for multiple uses | | Packaging-container | 10 mL Vacutainers | 500 ml. glass container | | Comparison | IRIS Reflectance Calchecks (Proposed Device) | Arkray Check Strips (Predicate Devices) | |----------------------------------|------------------------------------------------------------------|-------------------------------------------------------------| | | | | | Composition | Munsell paper of various reflectances laminated to mylar foil | One plain mylar foil, one laminate | | No. sets per package | Same as predicate | 2 | | Reflectance acceptance ranges | Same as predicate | Programmed into instrument | | Packaging | Same as predicate | Clear polystyrene cylindrical tube with press-on stopper | | No. of strips/set | 5 | 2 | | Distinct reflectance values | 89.8%,72.3%,39.4%, 19.4%,5.8%, | White (90-110%), gray (~30-40) | | Measurement wavelengths | 472,525,630nm | 430,500,565,635,760 nm | | Reusable | No | Yes, until results are out of range | | Shelf-life | 1 year | Not specified | | Storage temperature | 18-25°C | 20-28° C | | Package Insert | P/N 300-1226 | No | : 、 1 く {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993 HAR 2 3 2011 IRIS International Inc. c/o Mr. David Gates 9172 Eton Avenue Chatsworth, CA 91311 Re: k101852 > Trade Name: iChem® VELOCITY™ Automated Urine Chemistry System iChem® VELOCITY™ Chemistry Strips iChem® VELOCITY™ CalChek Kit Regulation Number: 21 CFR §862.1340 Regulation Name: Urinary Glucose (non-quantitative test system) Regulatory Class: Class II Product Codes: JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JIO, JRE, JMA, KQO Dated: March 2, 2011 Received: March 4, 2011 Dear Mr. Gates: 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). {8}------------------------------------------------ Page 2 – If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. CJC. Courtney 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 {9}------------------------------------------------ # Indication for Use 510(k) Number (if known): K101852 Device Names: iChem® VELOCITY TM Urine Chemistry System Indication For Use: The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL ™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for qlucose. blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only. X Prescription Use __ (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K10/852 11 - 10 - 12 - 11 - {10}------------------------------------------------ ## Indications for Use KI01852 510(k) Number (if known): Device Names: ### iChem® VELOCITY ™ CalChek Kit Indication For Use: The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer. The controls include assayed liquid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements. These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Prescription Use X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) Signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k/0/852 ・・・・・