CARESIDE GLUCOSE

{0}------------------------------------------------ ## MAY 7 1998 K981183 Exigent Diagnostics, Inc. Page 10 IV. CareSide™ Glucose Premarket Notification March 31, 1998 # CareSide™ Glucose Safety and 510(k) Summary: Effectiveness #### I. Applicant Information - A. Applicant Name - Applicant/Manufacturer Address B. - C. Telephone Number - Contact Person D. - E. FAX Number - e-Mail Address F. - Date 510(k) Summary prepared G. ### Device Information II. - Device Name (Trade) A. - B. Device Name (Classification) - C. Device Classification # Exigent Diagnostics, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 asarchk@worldnet.att.net March 31, 1998 # CareSide™ Glucose Glucose test system Clinical chemistry panel Glucose test system Regulation Number: 21 CFR 862.1345 Regulatory Class II Classification Number: 75CGA None applicable - D. Special controls and performance standards #### III. Substantial Equivalence Claim - A. General equivalency claim The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays. Glucose in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including glucose products which utilize glucose oxidase catalyzed generation of hydrogen peroxide which enzymatically reacts with chromogens in a peroxidase catalyzed reaction to form a red dye. - B. Specific equivalency claim This CareSide™ Glucose test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of glucose on the Vitros DT 60 II. | Name of Predicate Device: | Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros Glu Slides for Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak's DT 60 II). | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device 510K number: | K912844/A | | Product Code: | 75CGA | {1}------------------------------------------------ #### IV. Device Description CareSide™ Glucose cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure glucose concentration in whole blood, plasma or serum specimens. The CareSide™ Glucose cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of glucose concentration. The film cartridge (patent pending) contains all reagents necessary to measure glucose concentration. #### A. Explanation of Device Function Each Exigent Diagnostics CareSide™ Glucose cartridge consists of a glucose-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. Once loaded, the CareSide™ analyzer scans the cartridge barcode, spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers, and brings the cartridge and the contained specimen to 37℃. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well. The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film. Protein is removed before the glucose solution diffuses through the reflection layer and reaches the reaction layer. In the reaction layer glucose reacts with oxygen via a glucose oxidasecatalyzed reaction to produce hydrogen peroxide which in turn participates in a peroxidase-catalyzed reaction with the substrate to produce a red dye. The color intensity, as measured by the amount of light reflected at 505 nanometers, is directly related to the specimen glucose concentration. Test Reaction Sequence: B-D-glucose + O2 + H2O __ slucoseoxidase > D-gluconic acid + H2O2 peroxiduse > Red dye 1,7-dihydroxynaphthalene + 4-aminoantipyrine + 2 H2O2- As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate glucose concentration. #### B. Test Summary Determination of whole blood, serum or plasma glucose levels is important in the diagnosis and control of hypoglycemia, diabetes, nonketotic hyperglycemia, and various endocrine diseases of the pituitary and adrenal glands. Glucose is often measured as a tolerance test after the administration of doses of glucose or insulin. While clinical diagnoses should not be based upon glucose measurements alone, the following criteria for the diagnosis of diabetes mellitus have been proposed by the American Diabetes Association (ADA Glucose Guidelines Diabetes Care, Volume 20, Number 7, p. 1183-1197, July 1997), including: 126 mg/dL (fasting), 200 mg/mL (non-fasting with symptoms), 200 mg/dL (2-hour oral glucose tolerance). {2}------------------------------------------------ #### V. Intended Use - Intended Use A. The CareSide™ Glucose cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CareSide™ Analyzer to quantitatively measure glucose concentration in whole blood, plasma or serum by laboratory professionals. The CareSide™ Glucose test aids in the diagnosis and treatment of glucose regulation disorders such as diabetes. - B. Indications for Use This product is indicated for use with patients with glucose regulation disorders such as diabetes. #### Technological Characteristics VI. - Similarities A. | | CareSide™ Glucose | Vitros Glucose DT Slides | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Intended Use | Primarily to aid in the diagnosis<br>and treatment of glucose<br>regulation disorders such as<br>diabetes. | Same | | Indications | For <i>in vitro</i> diagnostic use.<br>For laboratory professional use. | For <i>in vitro</i> diagnostic use | | Measurement | Quantitative | Same | | Method Principle | Dry film based glucose oxidase<br>generation of hydrogen<br>peroxide from glucose.<br>Reaction of chromogen with<br>hydrogen peroxide to form red<br>dye. Dye quantitated by<br>reflectance measurement after<br>fixed time. | Same | | Specimen dilution | Not required | Same | | Materials Source | Glucose oxidase from<br><i>Aspergillus niger</i> ; peroxidase<br>from horseradish | Glucose oxidase, peroxidase:<br>sources unknown | | Detector | Reflectance (505 nm) | Reflectance (555 nm) | | Test time | Approximately 4 minute warm-<br>up (on-board) plus 5 minute test<br>time. | 15 minutes slide warm-up (off-<br>line) plus 5 minutes test time. | | Reference Method | Hexokinase | Hexokinase | | Sample Type | Serum, plasma, whole blood<br>(wb) [wb applied sample,<br>plasma test sample] | serum, plasma | | Specimen volume | 10 µl test volume<br>(85 ± 15 µl applied volume) | 10 µl | | Calibration | Calibration information bar-<br>coded on each cartridge.<br>Calibration information may<br>change with each lot. | Run Vitros DT II calibrators<br>whenever a new slide lot is<br>used or when necessary. | | Quality Control | 2 levels | Same | | Reporting Units | mg/dL or mmol/L | Same | | Reaction Temp. | 37 °C | Same | {3}------------------------------------------------ ### B. Differences | | CareSide™ Glucose | Vitros Glucose DT Slides | |--------------------------|-------------------|--------------------------------------------------------------------------| | Direct blood<br>specimen | Yes, whole blood | No, requires separation of<br>whole blood prior to sample<br>application | | Reportable range | 20 to 600 mg/dL | 20 to 450 mg/dL | | Accurate<br>pipetting | Not required | Required | | Reagent pre-<br>warming | Not required | Required | ## Comparative Performance Characteristics C. | | CareSide™ Glucose | Vitros Glucose DT Slides | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | Detection limit | 20 mg/dL | 20 mg/dL | | Reportable range | 20 to 600 mg/dL | 20 to 450 mg/dL | | Accuracy | Mean recovery 98% | Not provided | | Precision | Total CV, 94 mg/dL, 5.8% | Total CV, 117 mg/dL, 1.4% | | Method comparison | CareSide™ = 1.04 (Vitros Glucose DT) - 7.0 mg/dL, r = 1.00 | | | Linearity | Mean deviation approx 99%,<br>r = 1.00 | Not provided | | Interference | No significant interference observed at tested concentration of interferent:<br>Ascorbic Acid, 20 mg/dL<br>Bilirubin, 20 mg/dL<br>Creatinine, 40 mg/dL<br>Hemoglobin, 500 mg/dL<br>Protein 3.5 - 9.5 g/dL<br>Triglycerides 3000 mg/dL<br>Uric Acid 20 mg/dL | Interference observed for:<br>Asocrbic acid<br>Hemolgobin @ 250 mg/dL<br>Protein < 5 g/dL<br>Protein > 10 g/dL | | Specimen Types & Anticoagulants | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum, heparin plasma, or EDTA plasma. Whole blood is unsuitable. | | Expected Values | 68 to 101 mg/dL (fasting)<br>Central 95% interval | 65 - 110 mg/dL (fasting)<br>Central 95% interval | ## D. Conclusion The nonclinical and clinical data provided demonstrate that the CareSide™ Glucose product is as safe, effective, and performs as well as or better than the legally marketed predicate device {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAY 7 1998 Kenneth B. Asarch, Ph.D. VP Quality Systems and Regulatory Affairs Exigent Diagnostics Inc. 6100 Bristol Parkway 90230 Culver City, California K981183 Re : CareSide™ Glucose Regulatory Class: II Product Code: CGA Dated: March 31, 1998 Received: April 1, 1998 Dear Dr. Asarch: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {5}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" a Sincerely yours, Steven Litman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Exigent Diagnostics, Inc. Page 15 # CareSide™ Glucose Premarket Notification Revised April 22, 1998 Indications for Use 510(k) Number: Device Name: CareSide™ Glucose Indications for use: For in vitro diagnostic use with Exigent Diagnostics' CareSide™ Analyzer to measure glucose from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and management of disorders of blood glucose regulation such as diabetes. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) OR Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Eormat 1-2-96) (Division Sign-Off) Division of Clinical Laboratory 510(k) Number C