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.

Device Description

The cobas 8000 ISE module is an Ion-Selective Electrode (ISE) system for 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.

AI/ML Overview

This document describes the performance of the cobas 8000 ISE Indirect Na, K, Cl for Gen. 2 device, specifically focusing on its use for urine samples with an expanded measuring range for sodium and chloride.

1. Acceptance Criteria and Reported Device Performance

The device performance is compared to a predicate device (cobas 8000 ISE Module using Low/High/Serum Compensator calibration cleared under K123726) and a reference method (flame photometry for Na and K, coulometry for Cl). The acceptance criteria are implicitly demonstrated by showing substantial equivalence to the predicate device and by meeting established performance metrics for analytical devices (repeatability, intermediate precision, linearity, detection limits).

Parameter	Analyte	Acceptance Criteria (Implied by Predicate/Reference Performance)	Reported Device Performance (Candidate Device)
Repeatability (CV%)	Sodium	Low: ≤ 0.6% (Predicate: 0.6%)	Low: 0.3%
		Med: ≤ 0.5% (Predicate: 0.5%)	Med: 0.3%
		High: ≤ 0.2% (Predicate: 0.2%)	High: 0.3%
		Under Range Low: N/A (Predicate: N/A)	Under Range Low: 0.9%
	Potassium	Low: ≤ 1.2% (Predicate: 1.2%)	Low: 0.3%
		Med: ≤ 0.6% (Predicate: 0.6%)	Med: 0.5%
		High: ≤ 0.8% (Predicate: 0.8%)	High: 0.6%
	Chloride	Low: ≤ 0.7% (Predicate: 0.7%)	Low: 0.4%
		Med: ≤ 0.5% (Predicate: 0.5%)	Med: 0.3%
		High: ≤ 0.3% (Predicate: 0.3%)	High: 0.5%
		Under Range Low: N/A (Predicate: N/A)	Under Range Low: 1.0%
Intermediate Precision (CV%)	Sodium	Low: ≤ 1.6% (Predicate: 1.6%)	Low: 1.8%
		Med: ≤ 0.6% (Predicate: 0.6%)	Med: 0.7%
		High: ≤ 0.7% (Predicate: 0.7%)	High: 0.8%
		Under Range Low: N/A (Predicate: N/A)	Under Range Low: 3.7%
	Potassium	Low: ≤ 1.7% (Predicate: 1.7%)	Low: 1.1%
		Med: ≤ 1.3% (Predicate: 1.3%)	Med: 1.2%
		High: ≤ 1.6% (Predicate: 1.6%)	High: 1.9%
	Chloride	Low: ≤ 1.7% (Predicate: 1.7%)	Low: 1.3%
		Med: ≤ 0.7% (Predicate: 0.7%)	Med: 0.7%
		High: ≤ 1.0% (Predicate: 1.0%)	High: 1.0%
		Under Range Low: N/A (Predicate: N/A)	Under Range Low: 3.7%
Method Comparison (Correlation to Reference)	Sodium	High correlation, e.g., >0.99 (Predicate: 0.9997)	0.9995
	Potassium	High correlation, e.g., >0.99 (Predicate: 0.9993)	0.9997
	Chloride	High correlation, e.g., >0.99 (Predicate: 0.9985)	0.9995
Method Comparison (Correlation to Predicate)	Sodium	High correlation, e.g., >0.99 (Predicate: 0.9996)	0.9999
	Potassium	High correlation, e.g., >0.99 (Predicate: 0.9997)	0.9998
	Chloride	High correlation, e.g., >0.99 (Predicate: 0.9997)	0.9998
LOB (mmol/L)	Sodium	N/A (Predicate: 7.6)	8.1
	Potassium	N/A (Predicate: 0.3)	0.3
	Chloride	N/A (Predicate: 8.7)	7.8
LOD (mmol/L)	Sodium	N/A (Predicate: 8.9)	9.8
	Potassium	N/A (Predicate: 0.4)	0.4
	Chloride	N/A (Predicate: 9.7)	9.0
LOQ (mmol/L)	Sodium	N/A (Predicate: 23.2)	15.5
	Potassium	N/A (Predicate: 2.3)	1.1
	Chloride	N/A (Predicate: 13.4)	18.3
Measuring Range	Sodium	60-350 mmol/L (Standard), No Extended Range (Predicate)	60-350 mmol/L (Standard), 20-59.9 mmol/L (Under Range Rerun)
	Potassium	3-100 mmol/L (Standard), No Extended Range (Predicate)	3-100 mmol/L (Standard), No Extended Range
	Chloride	60-350 mmol/L (Standard), No Extended Range (Predicate)	60-350 mmol/L (Standard), 20-59.9 mmol/L (Under Range Rerun)

Notes on Acceptance Criteria:

The document implies that the device meets acceptance criteria if its performance is substantially equivalent to the predicate device and the reference methods, and if the within-run precision (repeatability), total precision (intermediate precision), and detection limits are within acceptable analytical limits for clinical chemistry devices.
For the expanded measuring range for Sodium and Chloride (20-59.9 mmol/L), the acceptance criteria are demonstrated by the stated precision (repeatability and intermediate precision) within that new range.
The high correlation coefficients (e.g., 0.9995 for Sodium to reference method) and slopes close to 1 with small intercepts indicate good agreement with the reference methods and predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Sizes for Method Comparison Studies:
- Sodium:
  - Method Comparison to Reference (flame photometer): N = 106
  - Method Comparison to Predicate: N = 92
- Potassium:
  - Method Comparison to Reference (flame photometry): N = 99
  - Method Comparison to Predicate: N = 92
- Chloride:
  - Method Comparison to Reference (coulometry): N = 100
  - Method Comparison to Predicate: N = 92
Data Provenance: The document does not explicitly state the country of origin of the data. The "Date Prepared: May 8, 2014" and the submitter being Roche Diagnostics (Indianapolis, IN, USA) with manufacturing in Mannheim, Germany (K100853 reference), suggests an international context, but the specific location of sample collection for the studies is not specified. The studies appear to be prospective as they are conducted to demonstrate the performance of the candidate device for a 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of analytical device (Ion-Selective Electrode system for chemical determination) relies on established reference methods (e.g., flame photometry, coulometry) rather than expert interpretation of images or clinical cases. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic imaging or clinical decision support systems is not directly applicable here. The "ground truth" is typically defined by the accurate results obtained from the reference methods, which are performed by trained laboratory personnel following standardized protocols. No specific number or qualification of "experts" for ground truth establishment is mentioned, as it's an analytical performance study.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an analytical performance study of a laboratory device measuring chemical analytes, not a diagnostic interpretation task requiring adjudication of results from multiple observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This device is an automated in vitro diagnostic instrument; its performance is evaluated through analytical studies, not human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are standalone performance evaluations. The data provided (repeatability, intermediate precision, method comparison, detection limits) are direct measurements of the instrument's analytical capabilities without human intervention in the measurement process itself, beyond standard laboratory operation and quality control.

7. The Type of Ground Truth Used

The ground truth for the method comparison studies was established using reference methods:

Sodium: Flame photometer
Potassium: Flame photometry
Chloride: Coulometry

For repeatability, intermediate precision, and detection limit studies, the "ground truth" is intrinsic to the statistical analysis of the measurements themselves, often against a known concentration of controls or calibrators.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device is an automated analytical instrument based on established electrochemical principles (Ion-Selective Electrodes) and conventional calibration methods, not an AI/ML-based device that learns from a training dataset in the same way. The instrument is "trained" or calibrated using "ISE Standard Low, High, High" (LHH) calibrators, which are commercially available standards with known concentrations. The exact number of calibrator measurements for system calibration or "training" (in the sense of instrument calibration) is not provided but is typically specified by the manufacturer's protocol.

9. How the Ground Truth for the Training Set Was Established

Not applicable as an AI/ML training set. The "ground truth" for the device's calibration refers to the assigned values of the calibrator materials (ISE Standard Low, High, High). These values are established by the manufacturer, typically through highly accurate and traceable reference methods, and are verified for consistency and accuracy. The document mentions that "Aqueous ISE standards Low and High were cleared under K053165. The LHH calibration scheme was cleared under K132418," indicating that the standards themselves and the calibration methodology have been previously reviewed and deemed acceptable.

Summary

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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 Diagnostics9115 Hague RoadIndianapolis, IN 46250Contact person: David TribbettPhone: 317-521-2964Fax: 317-521-2324Date Prepared: May 8, 2014
Device name	Proprietary name:	cobas 8000 ISE Indirect Na, K, Cl for Gen. 2.
	Common name:	Sodium Test SystemPotassium Test SystemChloride Test System
	Classification:	Ion-Specific Electrode SodiumIon-Specific Electrode PotassiumIon-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 thequantitative determination of sodium, potassium and chloride in serum,plasma or urine using ion-selective electrodes.
Indications foruse	The cobas 8000 ISE module is a fully automated ion-specific analyzerintended 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 treatmentof diseases or conditions involving electrolyte imbalance.
Substantialequivalence -comparison	The following tables compare the cobas 8000 ISE module usingLow/High/High calibration and its predicate device the cobas 8000 ISEModule using Low/High/Serum Compensator calibration cleared underK123726.

Comparison of Systems similarities and differences

System Comparison
Parameter	Predicate Devicecobas 8000 ISE Module (K123726)	Candidate Devicecobas 8000 ISE Module
Intended use	The ISE module of the Roche/Hitachicobas c systems is intended for thequantitative determination of sodium,potassium and chloride in serum, plasmaor urine using ion-selective electrodes.	Same
Specimen Type	Serum/Plasma/Urine	Same
Measurementprinciple	ISE Potentiometry	Same
Reagentcontainer	Plastic bottles closed via screw caps	Same
Onboard storagetemperature	Room Temperature	Same
ISE Module	Separate ISE module connected to Corecobas 8000 module	Same
Ion Selectiveelectrodes (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 Range1:31 Under Range Rerun
Throughput	Max 1800 tests/hour	Same
CalibrationScheme	ISE Standard Low, High, SerumCompensator(LHSc)	ISE Standard Low, High,High(LHH)

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Comparison ofassays -similarities anddifferences	Assay ComparisonSodium
(Sodium)	Parameter	Predicate Devicecobas 8000 Urine ISE LHSCCalibration Method (K123726)					Candidate Devicecobas 8000 Urine ISE LHHCalibration 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 1diluted	42.1	0.3	0.6
						Liq 2diluted	32.2	0.3	0.8
	Intermediateprecision(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 1diluted	42.1	1.0	2.5
						Liq 2diluted	32.2	1.0	3.9
	MethodComparisonto reference(flamephotometer)		N = 59Days = 2Correlation = 0.9997Slope (Bablok) = 0.976Intercept (Bablok) = 4.3548Range (X) = 65.7 - 327.7			N = 106Days = 2Correlation = 0.9995Slope (Bablok) = 0.997Intercept (Bablok) = 0.984Range (X) = 69.2 - 337.4
	Methodcomparisonto predicate		N = 59Days = 2Correlation = 0.9996Slope (Bablok) = 0.930Intercept (Bablok) = 12.0671Range (X) = 63.8 - 339.2			N = 92Days = 2Correlation = 0.9999Slope (Bablok) = 1.021Intercept (Bablok) = -4.562Range (X) = 65.3 - 342.1
	DetectionLimits		LOB = 7.6 mmol/LLOD = 8.9 mmol/LLOQ = 23.2 mmol/L			LOB = 8.1 mmol/LLOD = 9.8 mmol/LLOQ = 15.5 mmol/L
	StandardMeasuringrange		60-350 mmol/L			60-350 mmol/L
	Under Range		No Extended Range			20-59.9 mmol/Lvia rerun with increase sample volume

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Comparison ofassays –similarities anddifferences(Potassium)	Assay ComparisonPotassium
Parameter	Predicate Devicecobas 8000 Urine ISE LHScCalibration Method (K123726)		Candidate Devicecobas 8000 Urine ISE LHHCalibration Method
Repeatability	Mean [mmol/L]SD [mmol/L]CV [%]		Mean [mmol/L]SD [mmol/L]CV [%]
	Low 3.650.00' 1.2	Low	3.47 0.01 0.3
	Med 51.100.30 0.6	Med	50.70 0.26 0.5
	High 83.780.66 0.8	High	93.48 0.58 0.6
	Liq 1 32.19019 0.6	Liq 1	30.64 0.20 0.6
	Liq 2 69.470.39 0.6	Liq 2	66.22 0.61 0.9
Intermediateprecision(CLSI)	Mean [mmol/L]SD [mmol/L]CV [%]		Mean [mmol/L]SD [mmol/L]CV [%]
	Low 3.750.06 1.7	Low	3.47 0.04 1.1
	Med 49.480.65 1.3	Med	50.70 0.63 1.2
	High 80.601.32 1.6	High	93.48 1.82 1.9
	Liq I 31.320.37 1.2	Liq 1	30.64 0.32 1.0
	Liq 2 67.491.17 1.7	Liq 2	66.22 1.14 1.7
MethodComparisonto reference(flamephotometry)	N = 59Days = 2Correlation = 0.9993Slope (Bablok) = 0.962Intercept (Bablok) = 1.7605Range (X) = 4.20 -91.90		N = 99Days = 2Correlation = 0.9997Slope (Bablok) = 1.014Intercept (Bablok) = 0.507Range (X) = 3.80 - 86.30
Methodcomparisonto predicate	N = 59Days = 2Correlation = 0.9997Slope (Bablok) = 0.920Intercept (Bablok) = 1.4589Range (X) = 3.98-97.74		N = 92Days = 2Correlation = 0.9998Slope (Bablok) = 1.021Intercept (Bablok) = -0.208Range (X) = 4.87-96.94
DetectionLimits	LoB = 0.3 mmol/LLoD = 0.4 mmol/LLoQ = 2.3 mmol/L		LoB = 0.3 mmol/LLoD = 0.4 mmol/LLoQ = 1.1 mmol/L
Reportablerange	3-100 mmol/L		3-100 mmol/L
ExtendedRange	No Extended Range		No Extended Range

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	Parameter	ChloridePredicate Devicecobas 8000 Urine ISE LHScCalibration Method (K123726)			Candidate Devicecobas 8000 Urine ISE LHHCalibration 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 = 59Days = 2Correlation = 0.9985Slope (Bablok) = 1.092Intercept (Bablok) = -11.2893Range (X) = 66.0 - 324.0			N = 100Days = 2Correlation = 0.9995Slope (Bablok) = 1.029Intercept (Bablok) = -3.996Range (X) = 66.0 - 287.0
	Method comparison to predicate	N = 59Days = 2Correlation = 0.9997Slope (Bablok) = 0.952Intercept (Bablok) = 0.5078Range (X) = 65.2 - 350.0			N = 92Days = 2Correlation = 0.9998Slope (Bablok) = 1.023Intercept (Bablok) = -3.284Range (X) = 62.2 - 330.5
	Detection Limits	LOB = 8.7 mmol/LLOD = 9.7 mmol/LLOQ = 13.4 mmol/L			LOB = 7.8 mmol/LLOD = 9.0 mmol/LLOQ = 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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Evaluationssummary	The cobas 8000 ISE Module, Urine Sample Type was evaluated for severalperformance 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 LHHcalibration and increased sample rerun mode is substantially equivalent to thepredicate cobas 8000 ISE analyzer using LHSc calibration cleared underK123726.

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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 (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

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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)

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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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

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
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.(b)
Classification. Class II.