Who is the manufacturer of ISE INDIRECT NA, K, C1 FOR GEN 2?

Roche Diagnostics filed the 510(k) submission for ISE INDIRECT NA, K, C1 FOR GEN 2 (K140373).

What is the FDA product code for ISE INDIRECT NA, K, C1 FOR GEN 2?

JGS. It is classified under 21 CFR 862.1665 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ISE INDIRECT NA, K, C1 FOR GEN 2?

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

Who can help prepare an FDA 510(k) submission like ISE INDIRECT NA, K, C1 FOR GEN 2?

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.

ISE INDIRECT NA, K, C1 FOR GEN 2

Q: What are the predicate devices for ISE INDIRECT NA, K, C1 FOR GEN 2?

cobas 8000 ISE Module (K123726).

K140373 · Roche Diagnostics · JGS · May 22, 2014 · Clinical Chemistry

Device Facts

Record ID	K140373
Device Name	ISE INDIRECT NA, K, C1 FOR GEN 2
Applicant	Roche Diagnostics
Product Code	JGS · Clinical Chemistry
Decision Date	May 22, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1665
Device Class	Class 2

Intended Use

The ISE module of the Roche/Hitachi cobas c system is intended for the quantitative determination of sodium, potassium and chloride in serum, plasma or urine using ion-selective electrodes.

Device Story

The cobas 8000 ISE module is a fully automated analyzer for measuring sodium, potassium, and chloride in serum, plasma, and urine. It utilizes ion-selective electrodes (ISE) with selective membranes that develop an electrical potential (EMF) based on the concentration difference between a test solution and an internal filling solution, following the Nernst equation. The system is used in clinical laboratory settings by trained personnel. This submission introduces an expanded measuring range for urine samples at the low end and a new LHH (Low/High/High) calibration method. The device provides quantitative electrolyte results to healthcare providers to assist in diagnosing and managing electrolyte-related conditions. It supports an 'under range' rerun mode using increased sample volume for urine analysis.

Clinical Evidence

Bench testing only. Performance evaluated via repeatability, intermediate precision (CLSI guidelines), LoB, LoD, LoQ, linearity, and method comparison. Method comparison against reference (flame photometry/coulometry) and predicate showed high correlation (r > 0.99) and acceptable bias. Precision studies (repeatability and intermediate) yielded CVs generally < 4%. No clinical prospective/retrospective studies were required.

Technological Characteristics

Ion-selective electrode (ISE) potentiometry. System includes sodium, potassium, chloride, and reference electrodes. Uses LHH calibration scheme. Automated sample dilution (1:31 for serum/plasma; 1:46 standard or 1:31 under-range for urine). Throughput up to 1800 tests/hour. Connectivity via cobas 8000 modular analyzer series. Software-controlled automated analysis.

Indications for Use

Indicated for in vitro potentiometric determination of chloride, potassium, and sodium in serum, plasma, and urine for patients requiring diagnosis and treatment of diseases or conditions involving electrolyte imbalance.

Regulatory Classification

Identification

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.

Predicate Devices

cobas 8000 ISE Module (K123726)

Reference Devices

cobas 8000 modular analyzer series (K100853)
Aqueous ISE standards Low and High (K053165)
cobas 8000 ISE Module (K132418)

Related Devices

K123726 — COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 · Roche Diagnostics · May 21, 2013
K132418 — COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 · Roche Diagnostics · Dec 18, 2013
K230890 — ISE Electrodes · Randox Laboratories, Ltd. · Sep 8, 2023
K963627 — (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE · Roche Diagnostic Systems, Inc. · Oct 24, 1996
K102959 — PROLYTE ELECTROLYTE ANALYZER · Diamond Diagnostics, Inc. · Jan 14, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ : Continued on next page l {1}------------------------------------------------ | Introduction | The information in this 510(k) summary is being submitted in accordance with requirements of 21 CFR 807.92. | | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Submitter name, address, and contact | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Contact person: David Tribbett Phone: 317-521-2964 Fax: 317-521-2324 Date Prepared: May 8, 2014 | | | Device name | Proprietary name: | cobas 8000 ISE Indirect Na, K, Cl for Gen. 2. | | | Common name: | Sodium Test System Potassium Test System Chloride Test System | | | Classification: | Ion-Specific Electrode Sodium Ion-Specific Electrode Potassium Ion-Specific Electrode Chloride | | Establishment registration | For the cobas 8000 ISE module, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126. The establishment registration number for Roche Diagnostics, United States is 1823260. | | | | Continued on next page | | 2 : {2}------------------------------------------------ #### Classification The FDA has classified the Sodium, Potassium, and Chloride Test Systems as Class II devices. | Panel | Code | Product Classification Name | Regulation | |----------------|------|----------------------------------|------------| | Clinical | IGS | Ion Specific Electrode, Sodium | 21 CFR | | Chemistry (75) | | | 862.1665 | | Clinical | CEM | Ion Specific Electrode. | 21 CFR | | Chemistry (75) | | Potassium | 862.1600 | | Clinical | CGZ | Ion Specific Electrode, Chloride | 21 CFR | | Chemistry (75) | | | 862.1170 | #### Draft labeling sufficient to describe the device, its intended use, and the Proposed labeling directions for use on the cobas 8000 ISE analyzer module for serum, plasma. and urine samples is included in the submission. Device The cobas 8000 ISE module is an Ion-Selective Electrode (ISE) system for description the determination of sodium, potassium, and chloride in serum, plasma, and urine. The cobas 8000 ISE module and the ISE Gen 2 reagents were previously cleared for serum and plasma sample types under K100853 and urine sample type on K123726. > This premarket notification seeks to obtain FDA review and clearance for the urine sample type for the ISE Gen 2 reagents on the cobas 8000 ISE module using an expanded measuring range for sodium and chloride analytes at the low end of the measuring range and the new calibration method cleared in K132418. > An ISE makes use of the unique properties of certain membrane materials to develop an electrical potential (electromotive force, EMF) for the measurements of ions in solution. The electrode has a selective membrane in contact with both the test solution and an internal filling solution. The internal filling solution contains the test ion at a fixed concentration. Because of the particular nature of the membrane, the test jons will closely associate with the membrane on each side. The membrane EMF is determined by the difference in concentration of the test ion in the test solution and the internal filling solution. The EMF develops according to the Nernst equation for a specific ion in solution (see package insert for further explanation). Please refer to K 100853 for detailed hardware and software information relating to the cobas 8000 modular analyzer series. Commercially available controls are recommended for the urine sample type. Aqueous ISE standards Low and High were cleared under K053165. The LHH calibration scheme was cleared under K132418. {3}------------------------------------------------ | Intended use | The ISE module of the Roche/Hitachi cobas c system is intended for the quantitative determination of sodium, potassium and chloride in serum, plasma or urine using ion-selective electrodes. | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The cobas 8000 ISE module is a fully automated ion-specific analyzer intended for the in vitro potentiometric determination of chloride, potassium, and sodium in serum, plasma, and urine using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance. | | Substantial equivalence - comparison | The following tables compare the cobas 8000 ISE module using Low/High/High calibration and its predicate device the cobas 8000 ISE Module using Low/High/Serum Compensator calibration cleared under K123726. | #### Comparison of Systems similarities and differences | System Comparison | | | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Parameter | Predicate Device cobas 8000 ISE Module (K123726) | Candidate Device cobas 8000 ISE Module | | Intended use | The ISE module of the Roche/Hitachi cobas c systems is intended for the quantitative determination of sodium, potassium and chloride in serum, plasma or urine using ion-selective electrodes. | Same | | Specimen Type | Serum/Plasma/Urine | Same | | Measurement principle | ISE Potentiometry | Same | | Reagent container | Plastic bottles closed via screw caps | Same | | Onboard storage temperature | Room Temperature | Same | | ISE Module | Separate ISE module connected to Core cobas 8000 module | Same | | Ion Selective electrodes (ISEs) | Potentiometric chloride, potassium, sodium and reference electrodes | Same | | Sample Dilution (Serum/plasma) | 1:31 | Same | | Sample Dilution (Urine) | 1:46 Standard Range | 1:46 Standard Range 1:31 Under Range Rerun | | Throughput | Max 1800 tests/hour | Same | | Calibration Scheme | ISE Standard Low, High, Serum Compensator (LHSc) | ISE Standard Low, High, High (LHH) | {4}------------------------------------------------ | Comparison of assays - similarities and differences | Assay Comparison Sodium | | | | | | | | | | | |--------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------|-----------|--|--| | (Sodium) | Parameter | Predicate Device cobas 8000 Urine ISE LHSC Calibration Method (K123726) | | | | | Candidate Device cobas 8000 Urine ISE LHH Calibration Method | | | | | | | Repeatability | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | | | | Low | 66.4 | 0.4 | 0.6 | Low | 69.9 | 0.2 | 0.3 | | | | | | Med | 178.9 | 0.9 | 0.5 | Med | 174.5 | 0.5 | 0.3 | | | | | | High | 321.7 | 0.7 | 0.2 | High | 347.2 | 0.9 | 0.3 | | | | | | Liq 1 | 81.1 | 0.3 | 0.4 | Liq 1 | 83.4 | 0.3 | 0.3 | | | | | | Liq 2 | 170.6 | 0.5 | 0.3 | Liq 2 | 175.6 | 1.3 | 0.8 | | | | | | | | | | Under Range Rerun using increased sample: | | | | | | | | | | | | | Low | 24.7 | 0.2 | 0.9 | | | | | | | | | | Med | 37.7 | 0.2 | 0.6 | | | | | | | | | | MDL | 31.7 | 0.2 | 0.7 | | | | | | | | | | High | 56.8 | 0.4 | 0.6 | | | | | | | | | | Liq 1 diluted | 42.1 | 0.3 | 0.6 | | | | | | | | | | Liq 2 diluted | 32.2 | 0.3 | 0.8 | | | | | Intermediate precision (CLSI) | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | | | | Low | 68.6 | 1.1 | 1.6 | Low | 69.9 | 1.3 | 1.8 | | | | | | Med | 180.3 | 1.0 | 0.6 | Med | 174.5 | 1.1 | 0.7 | | | | | | High | 318.0 | 2.1 | 0.7 | High | 347.2 | 2.8 | 0.8 | | | | | | Liq 1 | 82.7 | 1.2 | 1.4 | Liq 1 | 83.4 | 1.3 | 1.6 | | | | | | Liq 2 | 171.3 | 1.0 | 0.6 | Liq 2 | 175.6 | 1.7 | 1.0 | | | | | | | | | | Under Range Rerun using increased sample: | | | | | | | | | | | | | Low | 24.7 | 0.9 | 3.7 | | | | | | | | | | Med | 37.7 | 1.0 | 2.7 | | | | | | | | | | MDL | 31.7 | 1.0 | 3.0 | | | | | | | | | | High | 56.8 | 1.1 | 1.9 | | | | | | | | | | Liq 1 diluted | 42.1 | 1.0 | 2.5 | | | | | | | | | | Liq 2 diluted | 32.2 | 1.0 | 3.9 | | | | | Method Comparison to reference (flame photometer) | | N = 59 Days = 2 Correlation = 0.9997 Slope (Bablok) = 0.976 Intercept (Bablok) = 4.3548 Range (X) = 65.7 - 327.7 | | | N = 106 Days = 2 Correlation = 0.9995 Slope (Bablok) = 0.997 Intercept (Bablok) = 0.984 Range (X) = 69.2 - 337.4 | | | | | | | | Method comparison to predicate | | N = 59 Days = 2 Correlation = 0.9996 Slope (Bablok) = 0.930 Intercept (Bablok) = 12.0671 Range (X) = 63.8 - 339.2 | | | N = 92 Days = 2 Correlation = 0.9999 Slope (Bablok) = 1.021 Intercept (Bablok) = -4.562 Range (X) = 65.3 - 342.1 | | | | | | | | Detection Limits | | LOB = 7.6 mmol/L LOD = 8.9 mmol/L LOQ = 23.2 mmol/L | | | LOB = 8.1 mmol/L LOD = 9.8 mmol/L LOQ = 15.5 mmol/L | | | | | | | | Standard Measuring range | | 60-350 mmol/L | | | 60-350 mmol/L | | | | | | | | Under Range | | No Extended Range | | | 20-59.9 mmol/L via rerun with increase sample volume | | | | | | {5}------------------------------------------------ | Comparison of assays – similarities and differences (Potassium) | Assay Comparison Potassium | | | |-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------|--------------------------------------------------------------------------------------------------------------------------------| | Parameter | Predicate Device cobas 8000 Urine ISE LHSc Calibration Method (K123726) | | Candidate Device cobas 8000 Urine ISE LHH Calibration Method | | Repeatability | Mean [mmol/L] SD [mmol/L] CV [%] | | Mean [mmol/L] SD [mmol/L] CV [%] | | | Low 3.65 0.00' 1.2 | Low | 3.47 0.01 0.3 | | | Med 51.10 0.30 0.6 | Med | 50.70 0.26 0.5 | | | High 83.78 0.66 0.8 | High | 93.48 0.58 0.6 | | | Liq 1 32.19 019 0.6 | Liq 1 | 30.64 0.20 0.6 | | | Liq 2 69.47 0.39 0.6 | Liq 2 | 66.22 0.61 0.9 | | Intermediate precision (CLSI) | Mean [mmol/L] SD [mmol/L] CV [%] | | Mean [mmol/L] SD [mmol/L] CV [%] | | | Low 3.75 0.06 1.7 | Low | 3.47 0.04 1.1 | | | Med 49.48 0.65 1.3 | Med | 50.70 0.63 1.2 | | | High 80.60 1.32 1.6 | High | 93.48 1.82 1.9 | | | Liq I 31.32 0.37 1.2 | Liq 1 | 30.64 0.32 1.0 | | | Liq 2 67.49 1.17 1.7 | Liq 2 | 66.22 1.14 1.7 | | Method Comparison to reference (flame photometry) | N = 59 Days = 2 Correlation = 0.9993 Slope (Bablok) = 0.962 Intercept (Bablok) = 1.7605 Range (X) = 4.20 -91.90 | | N = 99 Days = 2 Correlation = 0.9997 Slope (Bablok) = 1.014 Intercept (Bablok) = 0.507 Range (X) = 3.80 - 86.30 | | Method comparison to predicate | N = 59 Days = 2 Correlation = 0.9997 Slope (Bablok) = 0.920 Intercept (Bablok) = 1.4589 Range (X) = 3.98-97.74 | | N = 92 Days = 2 Correlation = 0.9998 Slope (Bablok) = 1.021 Intercept (Bablok) = -0.208 Range (X) = 4.87-96.94 | | Detection Limits | LoB = 0.3 mmol/L LoD = 0.4 mmol/L LoQ = 2.3 mmol/L | | LoB = 0.3 mmol/L LoD = 0.4 mmol/L LoQ = 1.1 mmol/L | | Reportable range | 3-100 mmol/L | | 3-100 mmol/L | | Extended Range | No Extended Range | | No Extended Range | б . {6}------------------------------------------------ | | Parameter | Chloride Predicate Device cobas 8000 Urine ISE LHSc Calibration Method (K123726) | | | Candidate Device cobas 8000 Urine ISE LHH Calibration Method | | | |-------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------| | Comparison of assays - similarities and differences (Chloride) | Repeatability | Mean [mmol/L] | SD [mmol/L] | CV [%] | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | Low | 63.6 | 0.5 | 0.7 | 65.3 | 0.3 | 0.4 | | | Med | 180.8 | 0.9 | 0.5 | 167.6 | 0.5 | 0.3 | | | High | 341.7 | 1.1 | 0.3 | 333.5 | 1.6 | 0.5 | | | Liq 1 | 92.3 | 0.4 | 0.5 | 97.5 | 0.5 | 0.5 | | | Liq 2 | 189.6 | 0.6 | 0.3 | 193.2 | 1.5 | 0.8 | | | | Under Range Rerun using increased sample: | | | | | | | | Low | | | | 21.6 | 0.2 | 1.0 | | | Med | | | | 34.2 | 0.3 | 0.9 | | | MDL | | | | 28.0 | 0.2 | 0.9 | | | High | | | | 55.0 | 0.4 | 0.8 | | | Liq 1 Diluted | | | | 43.7 | 0.3 | 0.7 | | | Liq 2 Diluted | | | | 29.0 | 0.4 | 1.5 | | | Intermediate precision (CLSI) | Mean [mmol/L] | SD [mmol/L] | CV [%] | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | Low | 64.7 | 1.1 | 1.7 | 65.3 | 0.9 | 1.3 | | | Med | 179.7 | 1.2 | 0.7 | 167.6 | 1.1 | 0.7 | | | High | 336.5 | 3.5 | 1.0 | 333.5 | 3.5 | 1.0 | | | Liq 1 | 92.6 | 1.1 | 1.2 | 97.5 | 0.9 | 0.9 | | | Liq 2 | 187.6 | 1.6 | 0.9 | 193.2 | 2.0 | 1.0 | | | | Under Range Rerun using increased sample: | | | | | | | | Low | | | | 21.6 | 0.8 | 3.7 | | | Med | | | | 34.2 | 0.9 | 2.5 | | | MDL | | | | 28.0 | 0.8 | 3.0 | | | High | | | | 55.0 | 0.9 | 1.7 | | | Liq 1 Diluted | | | | 43.7 | 1.0 | 2.3 | | | Liq 2 Diluted | | | | 29.0 | 0.9 | 3.2 | | | Method Comparison to reference (coulometry) | N = 59 Days = 2 Correlation = 0.9985 Slope (Bablok) = 1.092 Intercept (Bablok) = -11.2893 Range (X) = 66.0 - 324.0 | | | N = 100 Days = 2 Correlation = 0.9995 Slope (Bablok) = 1.029 Intercept (Bablok) = -3.996 Range (X) = 66.0 - 287.0 | | | | | Method comparison to predicate | N = 59 Days = 2 Correlation = 0.9997 Slope (Bablok) = 0.952 Intercept (Bablok) = 0.5078 Range (X) = 65.2 - 350.0 | | | N = 92 Days = 2 Correlation = 0.9998 Slope (Bablok) = 1.023 Intercept (Bablok) = -3.284 Range (X) = 62.2 - 330.5 | | | | | Detection Limits | LOB = 8.7 mmol/L LOD = 9.7 mmol/L LOQ = 13.4 mmol/L | | | LOB = 7.8 mmol/L LOD = 9.0 mmol/L LOQ = 18.3 mmol/L | | | | | Standard Measuring range | 60-350 mmol/L | | | 60-350 mmol/L | | | | | Under Range | No Extended Range | | | 20-59.9 mmol/L | | | : {7}------------------------------------------------ | Evaluations summary | The cobas 8000 ISE Module, Urine Sample Type was evaluated for several performance characteristics, including repeatability, intermediate precision, LoB, LoD, LoQ, method comparison, recovery in controls, and linearity. | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | The ISE Gen 2 reagents applied to the cobas 8000 ISE analyzer using LHH calibration and increased sample rerun mode is substantially equivalent to the predicate cobas 8000 ISE analyzer using LHSc calibration cleared under K123726. | {8}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with three wave-like lines emanating from its side. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 22, 2014 ROCHE DIAGNOSTICS MR DAVID TRIBBETT REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250 Re: K140373 Trade/Device Name: cobas 8000 ISE Indirect Na. K. Cl for Gen.2 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, CEM, CGZ Dated: May 8, 2014 Received: May 12, 2014 Dear Mr. David Tribbett: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading, If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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 (2) CFR Part 807): labeling (2) CFR Parts 801 and 809): medical device reporting of medical device-related adverse events) (21 CFR 803); 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050. {9}------------------------------------------------ Page 2-Mr. David Tribbett If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Courtney H. Lias -S Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. 510(k) Number (if known) k140373 Device Name cobas 8000 ISE Indirect Na, K. CI for Gen. 2 Indications for Use (Describe) The cobas 8000 ISE module is a fully automated ion-specific analyzer intended for the in vitro potentionetric determination of chloride, potassium, and sodium in serum, plasma, and urine ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance. Type of Use (Select one or both, as applicable) [ Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) FORM FDA 3881 (9/13) .. PSC Publishing Services (JD) ) 443-6740 11