Who is the manufacturer of COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2?

Roche Diagnostics filed the 510(k) submission for COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 (K123726).

What is the FDA product code for COBAS 8000 ISE INDIRECT NA, K, CI 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 COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2?

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

Who can help prepare an FDA 510(k) submission like COBAS 8000 ISE INDIRECT NA, K, CI 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.

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

K123726 · Roche Diagnostics · JGS · May 21, 2013 · Clinical Chemistry

Device Facts

Record ID	K123726
Device Name	COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
Applicant	Roche Diagnostics
Product Code	JGS · Clinical Chemistry
Decision Date	May 21, 2013
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 component; it utilizes ion-selective electrodes (ISE) to measure sodium, potassium, and chloride concentrations in serum, plasma, and urine. The system operates by measuring the electrical potential (electromotive force, EMF) generated across selective membrane materials in contact with test and internal filling solutions; the EMF difference correlates to ion concentration via the Nernst equation. The device is operated by laboratory personnel in clinical settings. Output is provided as quantitative electrolyte concentrations, which clinicians use to diagnose and manage conditions related to electrolyte imbalance. This submission specifically expands the sample type capability to include urine.

Clinical Evidence

Bench testing only. Performance evaluated via repeatability, intermediate precision, LoB, LoD, LoQ, linearity, and method comparison. Method comparison (N=59) against reference methods (flame photometry/coulometry) showed high correlation (r=0.9997 for Na, 0.9993 for K, 0.9985 for Cl). Precision studies demonstrated CVs generally <2%. No clinical prospective/retrospective studies were required.

Technological Characteristics

Ion-selective electrode (ISE) potentiometry; measures EMF based on Nernst equation. Modular analyzer system; automated sample handling. Reagents: ISE Gen 2. Connectivity: Integrated into cobas 8000 modular series. Software: Automated analysis of potentiometric signals.

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 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 INTEGRA ISE (K963627)

Related Devices

K140373 — ISE INDIRECT NA, K, C1 FOR GEN 2 · Roche Diagnostics · May 22, 2014
K132418 — COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 · Roche Diagnostics · Dec 18, 2013
K053165 — ISE INDIRECT NA, K, CL FOR GEN.2 · Roche Diagnostics Corp. · Dec 14, 2005
K230890 — ISE Electrodes · Randox Laboratories, Ltd. · Sep 8, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 | . {3}------------------------------------------------ Type, Continued 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 table compares the cobas 8000 ISE module and its predicate device the COBAS INTEGRA ISE cleared under K963627. Continued on next page {4}------------------------------------------------ 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 | | | | {5}------------------------------------------------ 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 | {6}------------------------------------------------ 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 | | | | | | | | | | 7 T {7}------------------------------------------------ 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 | | | | | | | | · {8}------------------------------------------------ #### 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. {9}------------------------------------------------ #### 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. {10}------------------------------------------------ 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 {11}------------------------------------------------ ### Indications for Use 510(k) Number (if known): k123726 Device Name: cobas 8000 ISE Indirect Na, K, Cl for Gen. 2 · 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. 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