MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)

{0}------------------------------------------------ # DEC 1 82001 ## 510(k) SUMMARY ## 1.0 Submitted By: K014034 Annette Hellie Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123 ### 2.0 Date Submitted December 6, 2001 ### 3.0 Device Name(s): - Proprietary Names 3.1 SYNCHRON LX® Clinical Systems (ISE Module Chemistries) - Classification Names 3.2 862.1160, pH Rate Measurement, Carbon Dioxide 862.1665 Electrode, Ion Specific, Sodium 862.1600 Electrode, Ion Specific, Potassium 862.1170 Electrode, lon Specific, Chloride 862.1145 Electrode, Ion Specific, Calcium ### 4.0 Legally Marketed Device The SYNCHRON LX® Systems (ISE Module Chemistries) claim substantial equivalence to the SYNCHRON LX® Systems currently in commercial distribution. FDA 510(k) Numbers K965240 (LX20 System) and K011213 (LX20 PRO System). ### Device Description 5.0 The SYNCHRON LX® Clinical Systems are manufactured by Beckman Coulter, Inc. The SYNCHRON LX Clinical Systems are fully automated, computer controlled, clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid {1}------------------------------------------------ (sample type is chemistry dependent). The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with the system. The instruments feature bar code identification of samples and reagents. Thev automatically dilute samples and deliver them to the associated reaction vessel for each system module (cuvette, cup, or ISE flowcell) along with reagents and reaction constituents. The systems analyze up to 41 analytes per sample. Major hardware components include a reagent compartment, sample and reagent cranes, cartridge chemistry section, modular chemistry section, sample carousel and crane, hydropneumatics, electronics, and power supplies. The LX20 PRO is differentiated from the standard LX20 system with the following hardware: LPIA (Large Particle Immunoassay) Module and TS-CTS (Thick Stopper-Closed Tube Sampling) Module The fixed menu ISE flow cell module is contained in the modular chemistry area. The ISE flow cell contains ISE electrodes for the measurement of Sodium (NA), Potassium (K), Chloride (CL), carbon dioxide (CO2), and Calcium (CALC). ### 6.0 Intended Use The SYNCHRON LX Clinical Systems are fully automated, computer controlled, clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependant). ## Comparison to the Predicate 7.0 (Description of the Modification to the Legally Marketed Device) The modified SYNCHRON LX Systems utilize a new ISE (Ion Selective Electrode) sample volume of 40 µL. The prior sample volume was 62µL. These SYNCHRON LX ISE methods include: Sodium (NA) Potassium (K) Chloride (CI) Carbon Dioxide (CO2) Calcium (CALC) ### 8.0 Summary of Performance Data Performance data from validation testing supports equivalency. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Annette Hellie Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd M/S W-104 Box 8000 Brea, CA 92822-8000 Re: DEC 1 3 2001 k014034 Trade/Device Name: Synchron LX® Systems Carbon Dioxide (CO2) Assay; Synchron LX® Systems Calcium (CALC) Assay; Synchron LX® Systems Chloride (CL) Assay; Synchron LX® Systems Potassium (K) Assay; Synchron LX® Systems Sodium (NA) Assay; Regulation Number: 21 CFR 862.1160; 21 CFR 862.1665; 21 CFR.1600; 21 CFR 862.1170; 21 CFR 862.1145 Regulation Name: Bicarbonate/carbon dioxide test system; Sodium test system; Potassium test system; Chloride test system; Calcium test system Regulatory Class: Class II; Class II; Class II; Class II; Class II Product Code: JFL; JGS; CGM; CGZ; JFP Dated: December 7, 2001 Received: December 7, 2001 Dear Ms. Hellie: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ ## Page 2 be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 {4}------------------------------------------------ 510(k) Number (if known): KOI4034 Device Name: # SYNCHRON LX® Systems Carbon Dioxide (CO2) Assay Indications for Use: SYNCHRON LX ISE Electrolyte Buffer Reagent, SYNCHRON LX ISE Electrolyte Reference Reagent, and CO2 Alkaline Buffer and Acid Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 3, are intended for quantitative determination of carbon dioxide (CO2) in serum or plasma on SYNCHRON LX Systems. Clinical Significance: A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Ours for Jean Commer (Division Sign-Off) Division of Clinical Laboratory Devices 1014034 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 {5}------------------------------------------------ page 2 of 5 510(k) Number (if known): Device Name: # SYNCHRON LX® Systems Calcium (CALC) Assay Indications for Use: SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of calcium (CALC) in serum, plasma or urine on SYNCHRON LX Systems. Clinical Significance: A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Thomas Plata for Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number 1014034 (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 801.199) OR {6}------------------------------------------------ Kol4034 510(k) Number (if known): Device Name: # SYNCHRON LX® Systems Chloride (CL) Assay Indications for Use: SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of chloride (CL) in serum, plasma, urine or cerebrospinal fluid (CSF) on SYNCHRON LX Systems. Clinical Significance: A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K014034 - (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 {7}------------------------------------------------ page 4 of 5 K014034 510(k) Number (if known): Device Name: ## SYNCHRON LX® Systems Potassium (K) Assay Indications for Use: SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium (K) in serum, plasma or urine on the SYNCHRON LX System. Clinical Significance: A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Rannel Kust for Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number k014034 (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 {8}------------------------------------------------ page 5 of 5 510(k) Number (if known): Device Name: ## SYNCHRON LX® Systems Sodium (NA) Assay Indications for Use: SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of sodium (NA) in serum, plasma or urine on the SYNCHRON LX System. Clinical Significance: A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Moment Thate for Sean Coxen Division Sign Off Division of Clinical Laboratory Devices 510(k) Number K014039 (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