ISE INDIRECT NA, K, C1 FOR GEN 2

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 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.

Device Story

The cobas 8000 ISE module is a fully automated clinical chemistry analyzer; it uses ion-selective electrodes (ISE) to measure sodium, potassium, and chloride concentrations in serum, plasma, and urine. The system performs indirect potentiometric measurements by diluting samples with ISE diluent (1:46 ratio for standard range; 1:31 for under-range rerun). The device features an automatic rerun function that triggers when results fall below the standard range (20-59.9 mmol/L for Na/Cl), utilizing an increased sample volume (15 μl vs 10 μl). It employs an LHH (Low/High/High) calibration scheme where three standards are used, with S3 acting as a compensator. The device outputs quantitative electrolyte concentrations to the operator. It is intended for use in clinical laboratory settings by trained personnel. The output assists clinicians in diagnosing and managing electrolyte-related diseases. Benefits include automated range extension and improved calibration accuracy.

Clinical Evidence

Bench testing only. Precision studies (within-run and intermediate) were conducted using human urine pools and controls. Linearity was verified for both standard and extended ranges using CLSI EP6-A. Method comparison studies against reference methods (Flame Photometer, Coulometer) and the predicate device showed high correlation (r > 0.99). Interference testing confirmed no significant impact from common drugs, hemoglobin, bilirubin, or pH variations (3.7-8.7).

Technological Characteristics

Ion-selective electrodes (Na, K, Cl, Reference) with open liquid junction membranes. Indirect potentiometric measurement via 1:46 or 1:31 dilution. LHH calibration scheme. Automated sample handling and rerun logic. Operates on the cobas 8000 ISE Modular Analyzer platform. Complies with CLSI EP5-A2, EP6-A, and EP17-A2 standards.

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 c501 (k132418)
• Flame Photometer IL 943
• Chloride Analyzer 926S

Submission Summary (Full Text)

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| 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br><br>Contact person: David Tribbett<br>Phone: [phone]<br>Fax: [phone]<br><br>Date Prepared: May 8, 2014 | |
| Device name | Proprietary name: | cobas 8000 ISE Indirect Na, K, Cl for Gen. 2. |
| | Common name: | Sodium Test System<br>Potassium Test System<br>Chloride Test System |
| | Classification: | Ion-Specific Electrode Sodium<br>Ion-Specific Electrode Potassium<br>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 | |

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#### 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.

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| Intended use | The ISE module of the Roche/Hitachi cobas c system is intended for the<br>quantitative determination of sodium, potassium and chloride in serum,<br>plasma or urine using ion-selective electrodes. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The cobas 8000 ISE module is a fully automated ion-specific analyzer<br>intended for the in vitro potentiometric determination of chloride, potassium,<br>and sodium in serum, plasma, and urine using ion-selective electrodes.<br>Measurements obtained by this device are used in the diagnosis and treatment<br>of diseases or conditions involving electrolyte imbalance. |
| Substantial<br>equivalence -<br>comparison | The following tables compare the cobas 8000 ISE module using<br>Low/High/High calibration and its predicate device the cobas 8000 ISE<br>Module using Low/High/Serum Compensator calibration cleared under<br>K123726. |

#### Comparison of Systems similarities and differences

| System Comparison | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Parameter | Predicate Device<br>cobas 8000 ISE Module (K123726) | Candidate Device<br>cobas 8000 ISE Module |
| Intended use | The ISE module of the Roche/Hitachi<br>cobas c systems is intended for the<br>quantitative determination of sodium,<br>potassium and chloride in serum, plasma<br>or urine using ion-selective electrodes. | Same |
| Specimen Type | Serum/Plasma/Urine | Same |
| Measurement<br>principle | ISE Potentiometry | Same |
| Reagent<br>container | Plastic bottles closed via screw caps | Same |
| Onboard storage<br>temperature | Room Temperature | Same |
| ISE Module | Separate ISE module connected to Core<br>cobas 8000 module | Same |
| Ion Selective<br>electrodes (ISEs) | Potentiometric chloride, potassium,<br>sodium and reference electrodes | Same |
| Sample Dilution<br>(Serum/plasma) | 1:31 | Same |
| Sample Dilution<br>(Urine) | 1:46 Standard Range | 1:46 Standard Range<br>1:31 Under Range Rerun |
| Throughput | Max 1800 tests/hour | Same |
| Calibration<br>Scheme | ISE Standard Low, High, Serum<br>Compensator<br>(LHSc) | ISE Standard Low, High,<br>High<br>(LHH) |

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| Comparison of<br>assays -<br>similarities and<br>differences | Assay Comparison<br>Sodium | | | | | | | | | | |
|--------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------|-----------|--|--|
| (Sodium) | Parameter | Predicate Device<br>cobas 8000 Urine ISE LHSC<br>Calibration Method (K123726) | | | | | Candidate Device<br>cobas 8000 Urine ISE LHH<br>Calibration Method | | | | |
| | Repeatability | | Mean<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] | | Mean<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] | | |
| | | 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<br>diluted | 42.1 | 0.3 | 0.6 | | |
| | | | | | | Liq 2<br>diluted | 32.2 | 0.3 | 0.8 | | |
| | Intermediate<br>precision<br>(CLSI) | | Mean<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] | | Mean<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] | | |
| | | 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<br>diluted | 42.1 | 1.0 | 2.5 | | |
| | | | | | | Liq 2<br>diluted | 32.2 | 1.0 | 3.9 | | |
| | Method<br>Comparison<br>to reference<br>(flame<br>photometer) | | N = 59<br>Days = 2<br>Correlation = 0.9997<br>Slope (Bablok) = 0.976<br>Intercept (Bablok) = 4.3548<br>Range (X) = 65.7 - 327.7 | | | N = 106<br>Days = 2<br>Correlation = 0.9995<br>Slope (Bablok) = 0.997<br>Intercept (Bablok) = 0.984<br>Range (X) = 69.2 - 337.4 | | | | | |
| | Method<br>comparison<br>to predicate | | N = 59<br>Days = 2<br>Correlation = 0.9996<br>Slope (Bablok) = 0.930<br>Intercept (Bablok) = 12.0671<br>Range (X) = 63.8 - 339.2 | | | N = 92<br>Days = 2<br>Correlation = 0.9999<br>Slope (Bablok) = 1.021<br>Intercept (Bablok) = -4.562<br>Range (X) = 65.3 - 342.1 | | | | | |
| | Detection<br>Limits | | LOB = 7.6 mmol/L<br>LOD = 8.9 mmol/L<br>LOQ = 23.2 mmol/L | | | LOB = 8.1 mmol/L<br>LOD = 9.8 mmol/L<br>LOQ = 15.5 mmol/L | | | | | |
| | Standard<br>Measuring<br>range | | 60-350 mmol/L | | | 60-350 mmol/L | | | | | |
| | Under Range | | No Extended Range | | | 20-59.9 mmol/L<br>via rerun with increase sample volume | | | | | |

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| Comparison of<br>assays –<br>similarities and<br>differences<br>(Potassium) | Assay Comparison<br>Potassium | | |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------|--------------------------------------------------------------------------------------------------------------------------------|
| Parameter | Predicate Device<br>cobas 8000 Urine ISE LHSc<br>Calibration Method (K123726) | | Candidate Device<br>cobas 8000 Urine ISE LHH<br>Calibration Method |
| Repeatability | Mean [mmol/L]<br>SD [mmol/L]<br>CV [%] | | Mean [mmol/L]<br>SD [mmol/L]<br>CV [%] |
| | Low 3.65<br>0.00' 1.2 | Low | 3.47 0.01 0.3 |
| | Med 51.10<br>0.30 0.6 | Med | 50.70 0.26 0.5 |
| | High 83.78<br>0.66 0.8 | High | 93.48 0.58 0.6 |
| | Liq 1 32.19<br>019 0.6 | Liq 1 | 30.64 0.20 0.6 |
| | Liq 2 69.47<br>0.39 0.6 | Liq 2 | 66.22 0.61 0.9 |
| Intermediate<br>precision<br>(CLSI) | Mean [mmol/L]<br>SD [mmol/L]<br>CV [%] | | Mean [mmol/L]<br>SD [mmol/L]<br>CV [%] |
| | Low 3.75<br>0.06 1.7 | Low | 3.47 0.04 1.1 |
| | Med 49.48<br>0.65 1.3 | Med | 50.70 0.63 1.2 |
| | High 80.60<br>1.32 1.6 | High | 93.48 1.82 1.9 |
| | Liq I 31.32<br>0.37 1.2 | Liq 1 | 30.64 0.32 1.0 |
| | Liq 2 67.49<br>1.17 1.7 | Liq 2 | 66.22 1.14 1.7 |
| Method<br>Comparison<br>to reference<br>(flame<br>photometry) | N = 59<br>Days = 2<br>Correlation = 0.9993<br>Slope (Bablok) = 0.962<br>Intercept (Bablok) = 1.7605<br>Range (X) = 4.20 -91.90 | | N = 99<br>Days = 2<br>Correlation = 0.9997<br>Slope (Bablok) = 1.014<br>Intercept (Bablok) = 0.507<br>Range (X) = 3.80 - 86.30 |
| Method<br>comparison<br>to predicate | N = 59<br>Days = 2<br>Correlation = 0.9997<br>Slope (Bablok) = 0.920<br>Intercept (Bablok) = 1.4589<br>Range (X) = 3.98-97.74 | | N = 92<br>Days = 2<br>Correlation = 0.9998<br>Slope (Bablok) = 1.021<br>Intercept (Bablok) = -0.208<br>Range (X) = 4.87-96.94 |
| Detection<br>Limits | LoB = 0.3 mmol/L<br>LoD = 0.4 mmol/L<br>LoQ = 2.3 mmol/L | | LoB = 0.3 mmol/L<br>LoD = 0.4 mmol/L<br>LoQ = 1.1 mmol/L |
| Reportable<br>range | 3-100 mmol/L | | 3-100 mmol/L |
| Extended<br>Range | No Extended Range | | No Extended Range |

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| | Parameter | Chloride<br>Predicate Device<br>cobas 8000 Urine ISE LHSc<br>Calibration Method (K123726) | | | Candidate Device<br>cobas 8000 Urine ISE LHH<br>Calibration Method | | |
|-------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|
| Comparison of assays - similarities and differences<br>(Chloride) | Repeatability | Mean<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] | Mean<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] |
| | 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<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] | Mean<br>[mmol/L] | SD<br>[mmol/L] | CV<br>[%] |
| | 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<br>Days = 2<br>Correlation = 0.9985<br>Slope (Bablok) = 1.092<br>Intercept (Bablok) = -11.2893<br>Range (X) = 66.0 - 324.0 | | | N = 100<br>Days = 2<br>Correlation = 0.9995<br>Slope (Bablok) = 1.029<br>Intercept (Bablok) = -3.996<br>Range (X) = 66.0 - 287.0 | | |
| | Method comparison to predicate | N = 59<br>Days = 2<br>Correlation = 0.9997<br>Slope (Bablok) = 0.952<br>Intercept (Bablok) = 0.5078<br>Range (X) = 65.2 - 350.0 | | | N = 92<br>Days = 2<br>Correlation = 0.9998<br>Slope (Bablok) = 1.023<br>Intercept (Bablok) = -3.284<br>Range (X) = 62.2 - 330.5 | | |
| | Detection Limits | LOB = 8.7 mmol/L<br>LOD = 9.7 mmol/L<br>LOQ = 13.4 mmol/L | | | LOB = 7.8 mmol/L<br>LOD = 9.0 mmol/L<br>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 | | |

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| Evaluations<br>summary | The cobas 8000 ISE Module, Urine Sample Type was evaluated for several<br>performance characteristics, including repeatability, intermediate precision,<br>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<br>calibration and increased sample rerun mode is substantially equivalent to the<br>predicate cobas 8000 ISE analyzer using LHSc calibration cleared under<br>K123726. |

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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)

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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)

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