CARESIDE AMMONIA

{0}------------------------------------------------ CARESIDE, Inc. Page 10 ## 510(K) SUMMARY: CARESIDE™ AMMONIA SAFETY V. AND EFFECTIVENESS ## I. Applicant Information - Applicant Name A. - Applicant/Manufacturer Address B. - C. Telephone Number - Contact Person D. - E. FAX Number - F. e-Mail Address - Date 510(k) Summary prepared G. ### II. Device Information - A. Device Name (Trade) - B. Device Name (Classification) - C. Device Classification ## CARESIDE, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 AsarchK@CARESIDE.com April 16, 1999 ## CARESIDE™ Ammonia Ammonia test system Clinical chemistry panel Ammonia test system Regulation Number: 21 CFR 862.1065 Regulatory Class 1 Classification Number: 75JID 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. Ammonia in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market. Ammonia products include those that use bromophenol blue as an ammonia indicator. #### B. Specific equivalency claim This CARESIDE™ Ammonia test is substantially equivalent in intended use and clinical performance to the currently marketed Vitros slides for the quantitative measurement of ammonia on the Vitros DT 60 II system. Both are based on the principle of dry film, both use the bromphenol blue ammonia indicator, and both are read by reflectance photometry. Name of Predicate Device: Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros NH3 Slides for Johnson and Johnson's Vitros DT 60 II system (formerly Eastman Kodak's DT 60 II). Predicate Device 510K number: K912844/A Product Code: 75JID {1}------------------------------------------------ ### IV. Device Description CARESIDE™ Ammonia cartridges are used with the CARESIDE Analyzer™ to measure ammonia in anti-coagulated whole blood or plasma specimens. The CARESIDE™ Ammonia cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of plasma to a dry film to initiate the measurement of ammonia The film cartridge (patent pending) contains all reagents necessary to measure ammonia. #### Explanation of Device Function A. . Each CARESIDE™ Ammonia cartridge consists of an ammonia-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™. Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37°C, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into the Overflow Well. The 8.5 microliters of sample is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film before the sample moves through the reaction, porous, and detection layers where a blue-green dye forms in the presence of ammonia. The color intensity of the resulting blue-green dye, as measured by the amount of reflected light at 590 nanometers, directly relates to the ammonia concentration of the specimen. Test Reaction Sequence: Bromophenol blue (yellow) + NH3 -- > Blue-green dye As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate ammonia concentration. - B. Test Summary The majority of ammonia in the body is generated in the gastrointestinal tract through the action of bacterial enzymes on dietary protein in the colon and from the catabolism of amino acids. Ammonia is detoxified in the liver by conversion to urea. Elevated ammonia levels are caused by liver dysfunction from such causes as viral hepatitis, cirrhosis, or Reye's syndrome, and inherited deficiencies of enzymes involved in the conversion of ammonia to urea. Excess ammonia exerts toxic effects on the central nervous system, ### V. Intended Use 11 23 - A. Intended Use The CARESIDE™ Ammonia cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure ammonia in anticoagulated whole blood or plasma. - B. Indications for Use This product is indicated for use in the diagnosis and treatment of patients with severe liver disorders such as cirrhosis, hepatitis, and Reye's syndrome. {2}------------------------------------------------ t ## VI. Technological Characteristics - Similarities A. | | CARESIDE™ Ammonia | Vitros NH3 DT Slides | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Primarily to aid in the<br>diagnosis and treatment of<br>patients with severe liver<br>disorders such as cirrhosis,<br>hepatitis, and Reye's<br>syndrome. | Primarily to aid in the<br>diagnosis of hepatic coma and<br>Reye's syndrome, as an<br>indicator during the final<br>stages of terminal cirrhosis. | | Indications | For <i>in vitro</i> diagnostic use.<br><br>For professional laboratory:<br>not for point of care or<br>physician office laboratory<br>use. | For <i>in vitro</i> diagnostic use. | | Measurement | Quantitative | Same | | Method Principle | Dry film, bromophenol blue<br>dye. | Dry film, bromophenol blue<br>dye. | | Materials | Bromophenol blue | Bromophenol blue | | Detector | Reflectance (590 nm) | Reflectance (605 nm) | | Test time | 4 minute warm-up (on-board)<br>plus 3 minute test time. | 15 minute warm-up (off-line)<br>plus 5 minutes test time. | | Reference Method | Glutamate dehydrogenase | Glutamate dehydrogenase | | Sample Type | Anti-coagulated whole blood<br>or plasma. | Heparinized plasma | | Specimen volume | 8.5 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 | µmol/L NH3 | Same | | Reaction Temp. | 37 °C | Same | ## B. Differences Qaran | | CARESIDE™ Ammonia | Vitros NH3 DT Slides | |-------------------------|-------------------|----------------------| | Specimen<br>Processing | Not required | Required | | Accurate<br>pipetting | Not required | Required | | Reagent pre-<br>warming | Not required | Required | {3}------------------------------------------------ ## C. Comparative Performance Characteristics | | CARESIDE™ Ammonia | Vitros NH3 DT Slides | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Detection limit | 7 µmol/L | 1 µmol/L | | Reportable range | 7 to 350 µmol/L | 1 to 500 µmol/L | | Accuracy | Mean recovery 99% | Not provided | | Precision | Total CV, 109 µmol/L, 11% | Total CV, 100 µmol/L, 10% | | Method<br>comparison | CARESIDE™ = 0.98 (RAICHEM) + 3.9 µmol/L, r = 0.99 | | | Linearity | Linearity yielded slope and<br>correlation coefficient within<br>acceptable limits. | Not provided | | Interference | No significant interference<br>observed at tested<br>concentration of interferent:<br>Ascorbic Acid, ........20 mg/dL<br>Total Protein, ........12 g/dL<br>Hemoglobin ........500 mg/dL<br>Triglycerides ........3000 mg/dL<br>Urea (BUN).........40 mg/dL | No reported interference | ## D. Conclusion · .............................................................................................................................................................................. The nonclinical and clinical data provided demonstrate that the CARESIDE™ Ammonia product is as safe, effective, and performs as well as or better than the legally marketed predicate device. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG - 3 1999 Kenneth B. Asarch, Ph.D. VP Quality Systems and Regulatory Affairs CARESIDE, Inc. 6100 Bristol Parkway Culver City, California 90230 Re: K991371 > Trade Name: CARESIDE™ AMMONIA Regulatory Class: I reserved Product Code: JID Dated: June 15, 1999 Received: June 16, 1999 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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 (OS) for Medical Devices: General regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations. {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/dsma/dsmamain.html". Sincerely yours, Steven Gutman 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}------------------------------------------------ CARESIDE, Inc. Page 15 # VII. INDICATIONS FOR USE 510(k) Number: Device Name: CARESIDE™ Ammonia Indications for use: For in vitro diagnostic use with the CARESIDE Analyzer™ to measure ammonia from anti-coagulated whole blood or plasma specimens to aid in the diagnosis and treatment of patients with severe liver disorders such as cirrhosis, hepatitis, and Reye's syndrome. Dean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510/k) Number (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ✓ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)