K Number

Device Name

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2

Manufacturer

Roche Diagnostics

Date Cleared

2013-05-21

(168 days)

Product Code

JGS CEM CGZ

Regulation Number

862.1665

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. 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 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. 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. 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 ions 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 K100853 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 standard calibrators (S1, S2, and S3) were cleared under K053165 and ISE Compensator under K052193.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K963627

Reference Devices

K100853, K053165, K052193

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard ion-selective electrode technology and statistical analysis of results, with no mention of AI or ML.

Therapeutic

No
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of certain electrolytes in biological samples, primarily for diagnosis and monitoring, not for direct therapeutic intervention.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance." This directly indicates its role as a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "Ion-Selective Electrode (ISE) system" and describes the physical process of using electrodes and membranes to measure ions, indicating it is a hardware device with associated software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine. It also states that the measurements are "used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance." This clearly indicates that the device is used to test samples taken from the human body to provide information for diagnostic purposes.
Device Description: The description details how the device works to measure ions in biological samples (serum, plasma, and urine).
Performance Studies: The performance studies evaluate the device's ability to accurately measure these analytes in the specified sample types, which is a requirement for IVD devices.
Predicate Device: The mention of a "Predicate Device" (K963627; COBAS INTEGRA ISE) is common in regulatory submissions for IVD devices, as it demonstrates substantial equivalence to a previously cleared device.

All of these points align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JGS, CEM, CGZ

Device Description

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 ions 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 K100853 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 standard calibrators (S1, S2, and S3) were cleared under K053165 and ISE Compensator under K052193.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Sodium:
Repeatability: Low 66.4 mmol/L, SD 0.4, CV 0.6%; Med 178.9 mmol/L, SD 0.9, CV 0.5%; High 321.7 mmol/L, SD 0.7, CV 0.2%; Liq 1 81.1 mmol/L, SD 0.3, CV 0.4%; Liq 2 170.6 mmol/L, SD 0.5, CV 0.3%.
Intermediate precision (CLSI): Low 68.6 mmol/L, SD 1.1, CV 1.6%; Med 180.3 mmol/L, SD 1.0, CV 0.6%; High 318.0 mmol/L, SD 2.1, CV 0.7%; Liq 1 82.7 mmol/L, SD 1.2, CV 1.4%; Liq 2 171.3 mmol/L, SD 1.0, CV 0.6%.
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.
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.
Detection Limits: LOB = 7.55 mmol/L, LOD = 8.88 mmol/L, LOQ = 49.53 mmol/L.
Reportable range: 60-350 mmol/L.

Potassium:
Repeatability: Low 3.65 mmol/L, SD 0.00, CV 1.2%; 51.10 mmol/L, SD 0.30, CV 0.6%; 83.78 mmol/L, SD 0.66, CV 0.8%; 32.19 mmol/L, SD 0.19, CV 0.6%; 69.47 mmol/L, SD 0.39, CV 0.6%.
Intermediate precision (CLSI): Low 3.75 mmol/L, SD 0.06, CV 1.7%; 49.48 mmol/L, SD 0.65, CV 1.3%; 80.60 mmol/L, SD 1.32, CV 1.6%; 31.32 mmol/L, SD 0.37, CV 1.2%; 67.49 mmol/L, SD 1.17, CV 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.
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.
Detection Limits: LOB = 0.32 mmol/L, LOD = 0.35 mmol/L, LOQ = 2.33 mmol/L.
Reportable range: 3-100 mmol/L.
Extended Range: No Extended Range.

Chloride:
Repeatability: Low 63.6 mmol/L, SD 0.5, CV 0.7%; Med 180.8 mmol/L, SD 0.9, CV 0.5%; High 341.7 mmol/L, SD 1.1, CV 0.3%; Liq 1 92.3 mmol/L, SD 0.4, CV 0.5%; Liq 2 189.6 mmol/L, SD 0.6, CV 0.3%.
Intermediate precision (CLSI): Low 64.7 mmol/L, SD 1.1, CV 1.7%; Med 179.7 mmol/L, SD 1.2, CV 0.7%; High 336.5 mmol/L, SD 3.5, CV 1.0%; Liq 1 92.6 mmol/L, SD 1.1, CV 1.2%; Lig 2 187.6 mmol/L, SD 1.6, CV 0.9%.
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.
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.
Detection Limits: LOB = 8.70 mmol/L, LOD = 9.66 mmol/L, LOQ = 48.03 mmol/L.
Reportable range: 60-350 mmol/L.
Extended Range: No Extended Range.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K963627

Reference Device(s)

K100853, K053165, K052193

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

12372:6

MAY 2 1 2013

Introduction The information in this 510(k) summary is being submitted in accordance with requirements of 21 CFR 807.92.

Submitter Roche Diagnostics name, address, 9115 Hague Road and contact Indianapolis, IN 46250

Contact person: David Tribbett Phone: 317-521-2964 Fax: 317-521-2324

Date Prepared: November 30, 2012

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

Type, Continued

The FDA has classified the Sodium, Potassium, and Chloride Test Systems as Classification Class II devices.

Panel	Product Code	Classification Name	Regulation
Clinical
Chemistry (75)	JGS	Ion Specific Electrode, Sodium	21 CFR
862.1665
Clinical
Chemistry (75)	CEM	Ion Specific Electrode,
Potassium	21 CFR
862.1600
Clinical
Chemistry (75)	CGZ	Ion Specific Electrode, Chloride	21 CFR
862.1170

Proposed labeling

Draft labeling sufficient to describe the device, its intended use, and the directions for use on the cobas 8000 Urine ISE analyzer module is included in the submission.

Continued on next page

Type, Continued

| 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. 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. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 ions 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
K100853 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 standard calibrators (S1, S2, and S3) were cleared under
K053165 and ISE Compensator under K052193. |
| 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. |
| | Continued on next page |

Type, Continued

Indications for use

Substantial equivalence comparison

The following table compares the cobas 8000 ISE module and its predicate device the COBAS INTEGRA ISE cleared under K963627.

Continued on next page

Type, Continued

| Comparison of

Systems -	System Comparison
similarities and
differences	Parameter
, 标	Predicate
COBAS INTEGRA ISE ->>>
K963627	cobas 8000 ISE Module,
Urine Sample Type
	Intended use	The COBAS INTEGRA ISE
module applications are intended
for use for the quantitative
determination of sodium,
potassium, chloride, and lithium in
serum, plasma or urine using ion-
selective electrodes.	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.
	Specimen
Type	Serum, Plasma, Urine	Same
(this submission only applies to the
urine sample type)
	Measurement
principle	ISE Potentiometry	Same
	Reagent
container	Plastic bottles closed via screw
caps	Same
	Onboard
storage
temperature	Room Temperature	Same
	ISE Module	Integrated into Integra analyzer	Separate ISE module connected to
Core cobas 8000 module
	Ion Selective
electrodes
(ISEs)	Potentiometric chloride, potassium,
sodium and reference electrodes	Same
	Sample
Dilution	1:6	1:46
	Throughput	Max 600 tests/hour	Max 1800 tests/hour

Type, Continued

Comparison of assays similarities and . differences (Sodium)

Assay Comparison
Sodium
Parameter	Predicate
Cobas Integra ISE (K963627)	cobas 8000 Urine ISE
Repeatability	Mean [mmol/L] CV [%]	Mean [mmol/L] SD [mmol/L] CV [%]
	Low 56 1.0	Low 66.4 0.4 0.6
	High 259 0.49	Med 178.9 0.9 0.5
		High 321.7 0.7 0.2
		Liq 1 81.1 0.3 0.4
		Liq 2 170.6 0.5 0.3
Intermediate
precision
(CLSI)	Mean [mmol/L] CV [%]	Mean [mmol/L] SD [mmol/L] CV [%]
	Low 56 3.0	Low 68.6 1.1 1.6
	High 259 1.2	Med 180.3 1.0 0.6
		High 318.0 2.1 0.7
		Liq 1 82.7 1.2 1.4
		Liq 2 171.3 1.0 0.6
Method
Comparison
to reference
(flame
photometer)	Not provided in labeling	N = 59
Days = 2
Correlation = 0.9997
Slope (Bablok) = 0.976
Intercept (Bablok) = 4.3548
Range (X) = 65.7 - 327.7
Method
comparison
to predicate	N = 174
Correlation = 0.996
Slope = 0.95
Intercept = 3.4	N = 59
Days = 2
Correlation = 0.9996
Slope (Bablok) = 0.930
Intercept (Bablok) = 12.0671
Range (X) = 63.8-339.2
Detection
Limits	Not determined	LOB = 7.55 mmol/L
LOD = 8.88 mmol/L
LOQ = 49.53 mmol/L
Reportable
range	20-350 mmol/L	60-350 mmol/L

Type, Continued

Comparison of assays similarities and differences, (Potassium)

Assay Comparison
Potassium
Parameter		Predicate
	Cobas Integra ISE (K963627)			cobas 8000 Urine ISE
Repeatability		Mean	CV [%]		Mean	SD	CV
		[mmol/L]			[mmol/L]	[mmol/L]	[%]
	Low	33	0.26		3.65	0.00	1.2
	High	125	2.0		51.10	0.30	0.6
					83.78	0.66	0.8
					32.19	0.19	0.6
					69.47	0.39	0.6
Intermediate		Mean	CV [%]		Mean	SD	CV
precision		[mmol/L]			[mmol/L]	[mmol/L]	[%]
(CLSI)	Low	33	1.4		3.75	0.06	1.7
	High	125	2.0		49.48	0.65	1.3
					80.60	1.32	1.6
					31.32	0.37	1.2
					67.49	1.17	1.7
Method					N = 59
Comparison		Not provided in labeling			Days = 2
to reference
(flame					Correlation = 0.9993
photometry)					Slope (Bablok) = 0.962
					Intercept (Bablok) = 1.7605
					Range (X) = 4.20 - 91.90
Method		N = 162			N = 59
comparison					Days = 2
to predicate					Correlation = 0.9997
		Correlation = 0.999				Slope (Bablok) = 0.920
		Slope = 1.04			Intercept (Bablok) = 1.4589
		Intercept = -0.7			Range (X) = 3.98 - 97.74
Detection					LOB = 0.32 mmol/L
Limits		Not determined			LOD = 0.35 mmol/L
					LOQ = 2.33 mmol/L
Reportable		1-150 mmol/L			3-100 mmol/L
range
Extended		No Extended Range			No Extended Range
Range

Type, Continued

Comparison of assays similarities and differences, (Chloride)

Assay Comparison
Chloride
Parameter	Predicate
	Cobas Integra ISE (K963627)			cobas 8000 Urine ISE
Repeatability		Mcan	CV [%]		Mean	SD	CV
		{mmol/L]			[mmol/L]	[mmol/L]	1%
	Low	147	0.44	Low	63.6	0.5	0.7
	I-ligh	274	0.30	Med	180.8	0.9	0.5
				High	341.7	1.1	0.3
				Liq l	92.3	0.4	0.5
				Liq 2	189.6	0.6	0.3
Intermediate		Mean	CV [%]		Mean	SD	CV
precision		[mmol/L]			[mmol/L]	[mmol/L]	1%
(CLSI)	Low	147	1.1	Low	64.7	1.1	1.7
	High	274	2.1	Med	179.7	1.2	0.7
				High	336.5	3.5	1.0
				Liq 1	92.6	1 . 1	1.2
				Lig 2	187.6	1.6	0.9
Method	N = 164			N = 59
Comparison
to reference				Days = 2
(coulometry)	Correlation = 0.981			Correlation = 0.9985
	Slope = 0.95			Slope (Bablok) = 1.092
	Intercept = 11.0			Intercept (Bablok) = - 11.2893
Range (X) = 66.0 - 324.0
Method
comparison	Not provided in labeling			N = 59
Days = 2
to predicate				Correlation = 0.9997
				Slope (Bablok) = 0.952
				Intercept (Bablok) = 0.5078
					Range (X) = 65.2 - 350.0
Detection				LOB = 8.70 mmol/L
Limits	Not determined			LOD = 9.66 mmol/L
				LOQ = 48.03 mmol/L
Reportable	20-350 mmol/L			60-350 mmol/L
range
Extended	No Extended Range			No Extended Range
Range

Type, Continued

The cobas 8000 ISE Module, Urine Sample Type was evaluated for several Evaluations summary 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 is substantially equivalent to the predicate COBAS INTEGRA ISE cleared under K963627.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three wavy lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 21, 2013

Roche Diagnostics C/O David Tribbett 9115 Hague Road INDIANAPOLIS IN 46250

Re: K123726

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: April 4, 2013 Received: April 9, 2013

Dear Mr. 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 (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2-Mr. Tribbett

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/MedicalDeyices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

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

Indications for Use

510(k) Number (if known): K123726

Device Name: cobas 8000 ISE Indirect Na, K, Cl for Gen. 2

· Indications for Use:

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W.J.Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123726