CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000

{0}------------------------------------------------ 3/18/99 CARESIDE, Inc. Page 11 K990036 CARESIDE LYTES™ December 29, 1998 # 510(K) SUMMARY: CARESIDE LYTES™ SAFETY IV. AND EFFECTIVENESS ### I. Applicant Information - Applicant Name A. - Applicant/Manufacturer Address B. - Telephone Number C. - Contact Person D. - FAX Number E. - F. e-Mail Address - G. Date 510(k) Summary prepared #### II. Device Information C. - Device Name (Trade) A. - Device Name (Classification) B. ## 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 December 29, 1998 ## CARESIDE LYTESTM, CARESIDE Analyzer™ | Sodium Test System | (75JGS) | |-------------------------------------------|---------| | Potassium Test System | (75CEM) | | Chloride Test System | (75CGZ) | | Micro chemistry analyzer for clinical use | (75JJF) | | Device Classification | Clinical Chemistry Panel<br>Test System Name | Regulation<br>Number | Regulatory<br>Class | |-----------------------|----------------------------------------------|----------------------|---------------------| | | Sodium test System | 862.1665 | 2 | | | Potassium Test System | 862.1600 | 2 | | | Chloride Test system | 862.1170 | 2 | | | Micro chemistry analyzer<br>for clinical use | 862.2170 | 1 | - None applicable D. Special controls and performance standards ### Substantial Equivalence Claim III. ### General equivalency claim A. The ability to monitor sodium, potassium and chloride by ion-selective electrodes based upon the technique of direct differential potentiometry is widely recognized and has gained widespread acceptance. Sodium, Potassium and Chloride in vitro diagnostic products and associated instruments to measure these analytes using direct and indirect differential potentiometry in conjunction with ion-specific electrodes are already on the U.S. market. - B. Specific equivalency claim The CARESIDE LYTESTM test cartridge is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of sodium, potassium and chloride ions on the Vitros DT 60 II / DTE II. The CARESIDE Analyzer™ is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros DT 60 II / DTE II. Johnson and Johnson (formerly Eastman Kodak, Inc.) manufactures all three slides and the instrument. | Name of Predicate Devices: | Predicate Device 510K number | Product Code | |----------------------------|------------------------------|--------------| | Vitros Na+ DT Slides | K912844 | 75JGS/75CHH | | Vitros K+ DT Slides | K912844 | 75CEM/75CHH | | Vitros Cl- DT Slides | K912844 | 75CGZ/75CHH | | Vitros DT 60 II / DTE II | K912844 | 75JFF/75CHH | {1}------------------------------------------------ #### IV. Device Description The CARESIDE LYTES™, a single-use disposable in vitro diagnostic test cartridge, is used with the CARESIDE Analyzer™ to perform a simultaneous quantitative measurement of sodium, potassium and chloride ion concentrations from a single sample of anti-coagulated whole blood, plasma or serum. Each cartridge has a test element containing sodium-, potassium-, and The CARESIDE LYTESTM test cartridge aids in specimen chloride-selective electrodes. separation and delivers a measured volume of plasma or serum to the electrochemistry to initiate the measurement of sodium, potassium and chloride ion concentrations. The cartridge (patent pending) contains all reagents necessary to measure the concentration of sodium, potassium and chloride ions. ### Explanation of Device Function A. The measurement of sodium, potassium, and chloride ion concentration is each based upon the technique of differential potentiometry using a direct (undiluted) specimen. Each CARESIDE LYTES™ cartridge consists of a slide containing two identical sodium-, potassium-, and chloride-selective electrodes mounted in a plastic base with a hinged lid. Each electrode consists of a silver and silver chloride layer with an overlying membrane that is selective for the particular ion. A reference solution containing known concentrations of sodium, potassium, and chloride ions is contained within a pouch in the test cartridge. The user introduces the whole blood 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. Forty-five microliters of sample remain in the metering passage. Any excess sample flows into an overflow well. A plunger opens the reference solution pouch and dispenses the reference solution. The metered volume of specimen is dispensed onto the test element by a plunger displacing a flexible seal that covers the Sample Well while a second plunger seals the cartridge vent. As the flexible seal is displaced, air is pushed through the metering passage, forcing the specimen onto the test element. Reference fluid is applied to one set of electrodes (reference electrodes) at the same time as the specimen is applied to the second set of electrodes (specimen electrode). The reference and specimen fluids spread towards each other over a thread that serves as an ionic bridge, forming a stable liquid junction at the center. A voltage develops at each electrode in response to the concentration of the ion to which it is selective. Terminals move into contact with the test element electrodes and measure the voltage difference between the specimen and reference side of the test element. The difference in voltage between the reference and specimen electrode for each ion is proportional to the logarithm of the ion concentration in the specimen. Based upon the principle of differential potentiometry, the CARESIDE Analyzer™ uses the voltage difference to calculate sodium, potassium, and chloride ions concentrations. {2}------------------------------------------------ ### B. Test Summary Measurement of sodium, potassium, and chloride ions from blood is useful in the diagnosis and treatment of patients with electrolyte imbalance. ### Sodium Blood sodium levels can be elevated due to dehydration, diabetes insipidus, salt poisoning, skin losses, hyperaldosteronism, and CNS disorders. Conditions that can decrease sodium levels include cirrhosis, dehydration, and syndrome of inappropriate anti-diuretic hormone. ### Potassium Blood potassium levels can be elevated due to renal glomerular disease, adrenocortical insufficiency, diabetic ketoacidosis, sepsis, and in vitro hemolysis. Decreases in potassium levels can be caused by renal tubular disease, hyperaldostronism, treatment of diabetic ketoacidsosis, hyperinsulinism, metabolic alkalosis, and diuretic therapy. ### Chloride Blood chloride levels can be elevated due to prolonged diarrhea, renal tubular disease, hyperparathyroidism, and dehydration. Decreased blood chloride levels can be caused by prolonged vomiting, burns, salt-losing renal disease, over-hydration, and diuretic therapy. ### V. Intended Use ### A. Intended Use The CARESIDE LYTES™ cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE™ Analyzer to quantitatively measure sodium, potassium and chloride ion concentrations in anti-coagulated whole blood, plasma or serum. #### B. Indications for Use CARESIDE LYTESTM To be used with the CARESIDE Analyzer™ to measure sodium, potassium, and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with disorders of electrolyte imbalance. CARESIDE Analyzer™ For in vitro diagnostic use by laboratory professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes. {3}------------------------------------------------ ### Technological Characteristics VI. - A. Similarities | | CARESIDE LYTEST™<br>Test Cartridge | Vitros<br>Na+, K+, Cl- DT Slides | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Intended Use | CARESIDE LYTEST™<br>To measure sodium, potassium, and chloride ions<br>to aid in the diagnosis and treatment of patients with electrolyte imbalance.<br><br>CARESDIE Analyzer™<br>Intended for the measurement of various analytes using reflectance photometry measurements and electrochemical detection. | Vitros Na+, K+, Cl- Slides<br>Same.<br><br>Vitros DT 60 II / DTE II<br>Same. | | Indications | For in vitro diagnostic use.<br>For professional laboratory use. | For in vitro diagnostic use | | Measurement | Quantitative | Same | | Method Principle | Measurement is based upon the technique of differential potentiometry using a direct (undiluted) specimen. The test element contains two identical ion-selective electrodes for each ion. Each electrode consists of a silver and silver chloride layer with an overlying membrane that is selective for the particular electrolyte. | Same | | Specimen dilution | Not required | Same | | Materials | Sodium/Potassium/Chloride<br>The active ingredients include silver, silver chloride, and salts of sodium, potassium, and chloride ions. | Same | | Test time | Approx. 4-minute warm-up (on-board) plus 1 minute test time. | 3 minutes test time. | | Reference Method | Sodium<br>Flame Photometry<br><br>Potassium<br>Flame Photometry<br><br>Chloride<br>Coulometry | Sodium<br>Flame Photometry<br><br>Potassium<br>Flame Photometry<br><br>Chloride<br>Coulometry | | Sample Type | Whole blood, serum, plasma | serum, plasma | | Specimen volume | 45 µl test volume/3 tests<br>(85 ± 15µl applied volume) | 10 µl for each test | | Calibration | Calibration information bar-coded on each cartridge.<br>Calibration information may change with each lot. | Run Vitros DT calibrators whenever a new slide lot is used or when necessary. | | Quality Control | 2 levels | Same | | Reporting Units | mEq/L or mmol/L | mmol/L | | Reaction Temp. | 37 °C | Same | | | CARESIDE LYTESTM<br>Test Cartridge | Vitros<br>Na+, K+, Cl- DT Slides | | Specimen<br>Processing | No. Either unprocessed<br>whole blood or processed<br>serum or plasma may be used | Yes, requires separation of<br>serum or plasma from whole blood prior to sample<br>application | | Accurate pipetting | Not required | Required | | Reagent pre-<br>warming | Not required | Required | | Reagents required | Single cartridge yields results<br>for all three analytes | Three separate (analyte-<br>specific) slides required for<br>the three results. | {4}------------------------------------------------ ### B. Differences ### C. Comparative Performance Characteristics | | CARESIDE LYTESTM<br>Test Cartridge | Vitros<br>Na+, K+, Cl DT Slides | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Detection limit | Sodium 75 mmol/L<br>Potassium 1.0 mmol/L<br>Chloride 50 mmol/L | Sodium 95 mmol/L<br>Potassium 1.0 mmol/L<br>Chloride 65 mmol/L | | Reportable range | Sodium 75 to 240 mmol/L<br>Potassium 1.0 to 14.0 mmol/L<br>Chloride 50 to 170 mmol/L | Sodium 95 to 215 mmol/L<br>Potassium 1.0 to 11.0 mmol/L<br>Chloride 65 to 140 mmol/L | | Accuracy | Na Mean recovery 99%<br>K Mean recovery 99%<br>Cl Mean recovery 102% | Not provided | | Precision | Na Total CV, 146 mmol/L, 1.5%<br>K Total CV, 5.4 mmol/L, 1.8%<br>Cl Total CV, 107 mmol/L, 1.3% | Na Total CV, 143 mmol/L, 1.3%<br>K Total CV, 5.2 mmol/L, 1.4%<br>Cl Total CV, 108 mmol/L, 1.5% | | Method<br>comparison<br>(vs. Reference) | CARESIDE™ Na = 1.01 (Flame Photometry) - 1.34 mmol/L, r= 1.00<br>CARESIDE™ K=1.00 (Flame Photometry) + 0.01 mmol/L, r= 1.00<br>CARESIDE™ Cl = 0.98 (Coulometry) + 2.13 mmol/L, r= 0.99 | | | Method<br>comparison<br>(vs. Predicate) | CARESIDE™ Na = 1.04 (Vitros Na⁺) - 2.78 mmol/L, r = 0.99<br>CARESIDE™ K = 1.07 (Vitros K⁺) - 0.16 mmol/L, r = 1.00<br>CARESIDE™ Cl = 0.97 (Vitros Cl⁻) + 2.54 mmol/L, r = 0.99 | | | Linearity | Linearity yielded slope and<br>correlation coefficient within<br>acceptable limits. | Not provided | | Interference | Sodium/Potassium/Chloride<br>No significant interference observed at tested concentration<br>of interferent for sodium, potassium, and chloride:<br>Bilirubin..................................20 mg/dL<br>Ethanol...................................33 mmol/L<br>Hemoglobin............................50 mg/dL<br>Iodide.....................................2 mmol/L<br>Triglyceride..........................2000 mg/dL<br>Chloride<br>Bromide causes positive interference | Sodium<br>Ethanol and benzalkonium chloride cause positive interference.<br>Potassium<br>None<br>Chloride<br>Bromide and iodide cause positive interference. | ### D. Conclusion The nonclinical and clinical data provided demonstrate that the individual constituent tests of the CARESIDE LYTES™ cartridge (sodium, potassium, and chloride) and its associated CARESIDE Analyzer™ is as safe, effective, and performs as well as or better than the legally marketed predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The overall design is simple and conveys a sense of health and well-being. MAR 1 8 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Kenneth B. Asarch, Ph.D. Vice President Ouality Systems and Regulatory Affairs CARESIDE, Inc. 6100 Bristol Parkway Culver City, California 90230 Re: K990036 Trade Name: CARESIDE LYTES™, CARESIDE Analyzer TM Regulatory Class: II Product Code: JGS, CEM, CGZ, JJE Dated: December 29, 1998 Received: January 6, 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 (QS) 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. {6}------------------------------------------------ ## 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 Sutman 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 {7}------------------------------------------------ ### INDICATIONS FOR USE VI. 510(k) Number: CARESIDE LYTESTM and CARESIDE Analyzer™ Device Name: Indications for use: CARESIDE LYTESTM diagnostic use with the For in vitro CARESIDE Analyzer™ to measure sodium, potassium and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with electrolyte imbalance. CARESIDE Analyzer™ laboratory For in vitro v diagnostic use by professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes. ean Coogen (Division Sign-Off) Division of Clinical Laboratory . view 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 Usel (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)