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

Roche Diagnostics Corp. filed the 510(k) submission for ISE INDIRECT NA, K, CL FOR GEN.2 (K053165).

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

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

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

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

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

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ISE INDIRECT NA, K, CL FOR GEN.2

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

original ISE Na, K, Cl (K953239).

K053165 · Roche Diagnostics Corp. · JGS · Dec 14, 2005 · Clinical Chemistry

Device Facts

Record ID	K053165
Device Name	ISE INDIRECT NA, K, CL FOR GEN.2
Applicant	Roche Diagnostics Corp.
Product Code	JGS · Clinical Chemistry
Decision Date	Dec 14, 2005
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1665
Device Class	Class 2

Intended Use

The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes. Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

Device is an Ion-Selective Electrode (ISE) module for Roche/Hitachi automated analyzers. It measures electrical potential (EMF) generated across selective membranes in contact with test samples and internal filling solutions. Sodium/potassium electrodes use neutral carriers; chloride electrode uses ion exchanger. System processes EMF via electronic circuits to calculate ion concentration based on Nernst equation. Used in clinical laboratories by technicians to analyze serum, plasma, or urine. Output provides quantitative electrolyte levels, aiding clinicians in diagnosing/treating metabolic and electrolyte disorders. Benefits include rapid, automated electrolyte monitoring.

Clinical Evidence

Bench testing only. Precision studies (n=21) showed CVs for serum/plasma (0.3-0.5%) and urine (0.4-3.3%). Linearity and method comparison (Passing-Bablok) against predicate (n=58) showed high correlation (r=0.988-0.999). Interference testing evaluated hemolysis, icterus, and lipemia.

Technological Characteristics

Ion-Selective Electrode (ISE) system. Sodium/potassium electrodes use neutral carriers; chloride electrode uses ion exchanger. System includes reference electrode and electronic processing circuits. Reagents include HEPES/Triethanolamine-based diluents and internal standards. Connectivity: Integrated into Roche/Hitachi automated analyzer family. Calibration: Two-point (S1/S2) with S3 compensator.

Indications for Use

Indicated for quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine to diagnose and treat electrolyte imbalances, aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate ADH secretion, cystic fibrosis, and diabetic acidosis.

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

original ISE Na, K, Cl (K953239)

Related Devices

K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER · Thermo Fisher Scientific · Sep 4, 2007
K230890 — ISE Electrodes · Randox Laboratories, Ltd. · Sep 8, 2023
K123726 — COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 · Roche Diagnostics · May 21, 2013
K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl) · Siemens Healthcare Diagnostics, Inc. · Jul 25, 2023
K102959 — PROLYTE ELECTROLYTE ANALYZER · Diamond Diagnostics, Inc. · Jan 14, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ K053/65 ### 510(k) Summary – ISE Indirect Na, K, CI for Gen.2 | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence | | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Submitter name, address, contact | Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-3723 Contact person: Kerwin Kaufman | | | | | Date prepared: November 11, 2005 | | | | Device Name | Proprietary name: ISE Indirect Na, K, Cl for Gen.2 | | | | | Common names: Sodium Test System Potassium Test System Chloride Test System | | | | | Classification names: Ion-Specific Electrode Sodium Ion-Specific Electrode Potassium Ion-Specific Electrode Chloride | | | Continued on next page : {1}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Device Description | An Ion-Selective Electrode (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 is solution (see package insert for further explanation). | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The complete measurement system for a particular ion includes the ISE, a reference electrode and electronic circuits to measure and process the EMF to give the test ion concentration. The sodium and potassium electrodes are based on neutral carriers and the chloride electrode is based on an ion exchanger. | | Intended use / Indications for use | The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes. | | | Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. | | Predicate Device | We claim substantial equivalence to the predicate device, original ISE Na, K, Cl, cleared in K953239. | | | Continued on next page | : {2}------------------------------------------------ Substantial equivalency -Similarities The table below indicates the similarities between the modified ISE Indirect Na, K, Cl for Gen.2 device and its predicate device (original ISE Na, K, Cl, K953239). | Feature | Predicate device: original ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na, K, Cl for Gen.2 | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Instruments | Roche Hitachi automated analyzer family | Same | | Intended Use/ Indications for Use | For the quantitative determination of sodium, potassium, and chloride in serum, plasma, and urine. Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. | The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes. Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. | | Feature | Predicate device: original ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na, K, Cl for Gen.2 | | Test principle | | | | Sample types | Serum, Plasma (Lithium heparin) or Urine | Same | | Determination of Sodium, Potassium and Chloride | An Ion-Selective Electrode (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 is solution (see package insert for further explanation). The complete measurement system for a particular ion includes the ISE, a reference electrode and electronic circuits to measure and process the EMF to give the test ion concentration. The sodium and potassium electrodes are based on neutral carriers and the chloride electrode is based on an ion exchanger. | Same | | Feature | Predicate device: original ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na, K, Cl for Gen.2 | | Electrode / Reagent information | | | | Ion-Specific Electrodes | Sodium Electrode/ Cartridge Potassium Electrode/ Cartridge Chloride Electrode/ Cartridge Reference Electrode/ Cartridge | Same | | Electrode Onboard Stability | Sodium, Potassium and Chloride Electrodes, 2 months or 9000 tests Reference Electrode, at least 6 months | Same | | Calibrators S1, S2 for two-point calibration | S1: ISE Standard Low S2: ISE Standard High | Same | | Auxiliary Reagents | ISE 1 N potassium chloride (Reference Electrolyte) | Same | | Performance characteristics | | | | Reportable Range | Serum/Plasma: $Na^+: 80 - 180 mmol/L$ $K^+: 1.5 - 10 mmol/L$ $Cl^-: 60-140 mmol/L$ Urine: $Na^+: 10 - 250 mmol/L$ $K^+: 1 - 100 mmol/L$ $Cl^-: 20 - 250 mmol/L$ | Serum/Plasma: $Na^+$ : Same $K^+$ : Same $Cl^-$ : Same Urine: $Na^+$ : Same $K^+$ : Same $Cl^-$ : 10 - 250 mmol/L | {3}------------------------------------------------ Continued on next page 本体育 {4}------------------------------------------------ Continued on next page 、 : {5}------------------------------------------------ The table below indicates the differences between the modified ISE Indirect Substantial Na, K, Cl for Gen.2 device and its predicate device (original ISE Na, K, Cl, equivalency -Differences K953239). and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of | Feature | Predicate device: original ISE Na, K, Cl (K953239) Electrode / Reagent information | Modified device: ISE Indirect Na, K, Cl for Gen.2 | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISE Diluent Composition | 650 mmol/L Boric acid Preservative (Gentamicin based) | 10 mmol/L HEPES buffer 7 mmol/L Triethanolamine Preservative | | ISE Internal Standard Composition | 650 mmol/L Boric acid 32.3 mmol/L Sodium Chloride 12.9 mmol/L Sodium bicarbonate 1.6 mmol/L Potassium phosphate Preservative (Gentamicin based) | 10 mmol/L HEPES buffer 7 mmol/L Triethanolamine 3.06 mmol/L Sodium chloride 1.45 mmol/L Sodium acetate 0.16 mmol/L Potassium chloride Preservative | | Electrode Slope Ranges | Sodium: 32.0 to 68.0 mV/decade Potassium: 32.0 to 68.0 mV/decade Chloride: -35.0 to -68.0 mV/decade | Sodium: 50 to 68 mV/decade Potassium: 50 to 68 mV/decade Chloride: -40 to -68 mV/decade | | Calibrator, S3 for compensation | Precical Calibrator Serum | ISE Compensator (serum based) | | Quality control | Precitrol-N Control Serum and Precitrol-A Control Serum or other commercially available controls | Precinorm U and Precipath U or other commercially available controls | | ISE Cleaning Solution | 4 N NaOH/System Cleaning Solution | ISE Cleaning Solution: Sodium hydroxide, 12% with Sodium hypochlorite solution < 2% active Cl (4 N NaOH/System Cleaning Solution can also be used) | | Traceability | NIST reference material | Flame Photometry, Coulometry with NIST reference material | | Reagent On board Stability | ISE 1N KCl, ISE Diluent working solution and ISE Internal Reference working solution, stable at 20-25 C until expiration date on bottle label. | ISE 1N KCl, up to the expiration date ISE Diluent and ISE Internal Reference, 6 weeks on board. | {6}------------------------------------------------ | Feature | Predicate device: original ISE Na, K, Cl (K953239) | | Modified device: ISE Indirect Na, K, Cl for Gen.2 | | |-------------------------------------|-------------------------------------------------------|----------------|-----------------------------------------------------------|----------------| | Labeled performance characteristics | | | | | | Precision | Total Imprecision, Serum Sodium (mmol/L), n=63: | | Between day Imprecision, Plasma Sodium (mmol/L), n=21: | | | | Mean | 151.6 128.0 | Mean | 143.0 128.5 | | | Total SD | 0.89 0.79 | SD | 0.51 0.52 | | | Total CV | 0.6% 0.6% | CV | 0.4% 0.4% | | | Potassium (mmol/L), n=63: | | Potassium (mmol/L), n=21: | | | | Mean | 6.32 3.50 | Mean | 6.95 4.27 | | | Total SD | 0.05 0.03 | SD | 0.02 0.01 | | | Total CV | 0.8% 0.8% | CV | 0.3% 0.3% | | | Chloride (mmol/L), n=63: | | Chloride (mmol/L), n=21: | | | | Mean | 120.4 98.7 | Mean | 118.8 92.7 | | | Total SD | 1.39 0.71 | SD | 0.42 0.42 | | | Total CV | 1.2% 0.7% | CV | 0.4% 0.5% | | | Total Imprecision, Urine Sodium (mmol/L): | | Between day Imprecision, Urine Sodium (mmol/L), n=21: | | | | N | 60 63 | Mean | 23.7 160.5 | | | Mean | 59.4 163.3 | SD | 0.77 0.64 | | | Total SD | 0.93 0.91 | CV | 3.3% 0.4% | | | Total CV | 1.6% 0.6% | | | | | Potassium (mmol/L): | | Potassium (mmol/L), n=21: | | | | N | 60 63 | Mean | 19.86 59.67 | | | Mean | 23.58 52.64 | SD | 0.15 0.68 | | | Total SD | 0.22 0.70 | CV | 0.8% 1.1% | | | Total CV | 0.9% 1.3% | | | | | Chloride (mmol/L): | | Chloride (mmol/L), n=21: | | | | N | 60 63 | Mean | 21.4 154.5 | | | Mean | 52.7 144.7 | SD | 0.51 1.00 | | | Total SD | 0.92 1.50 | CV | 2.4% 0.6% | | | Total CV | 1.7% 1.0% | | | {7}------------------------------------------------ | Feature | Predicate device: original ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na, K, Cl for Gen.2 | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Labeled performance characteristics | | | | Linearity | Sodium (serum): 59.8–199.6 mmol/L with deviation of less than 2.0 mmol/L or 3% Potassium (serum): 0.52-12.20 mmol/L with deviation of less than 0.1 mmol/L or 1% Chloride (serum): 43.4-164.5 mmol/L with deviation of less than 0.4 mmol/L or 1% | Sodium: Serum = 80-180 mmol/L Urine = 10-250 mmol/L Deviation ± 5% from 40.0-250 mmol/L or ± 3 mmol/L at concentrations < 40.0 mmol/L Potassium: Serum = 1.5-10 mmol/L Urine = 10-100 mmol/L Deviation ± 10 % from 10.0-100.0 mmol/L, ± 5% from 1.0-10.0 mmol/L Chloride: Serum = 60.0-140.0 mmol/L Urine = 10.0 to 250.0 mmol/L Deviation ± 5 % from 45.0-250.0 mmol/L, ± 8 mmol/L from < 45.0 mmol/L | | Feature | Predicate device: original ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na, K, Cl for Gen.2 | | Labeled performance characteristics | | | | Method Comparison | Sodium (serum), Passing-Bablok: x method = Hitachi 717 y method = Hitachi 917 n = 99 y= 1.013x - 2.21, r = 0.998 | Sodium (plasma), Passing-Bablok: x method = Hitachi 911 (predicate reagent) y method = Hitachi 917 (modified reagent) n = 58 y= 1.000x - 1.300, r = 0.988 | | | Potassium (serum), Passing-Bablok: x method = Hitachi 717 y method = Hitachi 917 n = 94 y= 0.980x + 0.087, r = 1.000 | Potassium (plasma), Passing-Bablok: x method = Hitachi 911 (predicate reagent) y method = Hitachi 917 (modified reagent) n = 58 y= 1.000x - 0.070, r = 0.999 | | | Chloride (serum), Passing-Bablok: x method = Hitachi 717 y method = Hitachi 917 n = 99 y= 1.004x + 0.65, r = 0.997 | Chloride (plasma), Passing-Bablok: x method = Hitachi 911 (predicate reagent) y method = Hitachi 917 (modified reagent) n = 58 y= 0.993x - 0.664, r = 0.994 | | Endogenous interferences | Reference Literature | Hemolysis: Sodium and Chloride, no significant interference up to 1000 mg/dL hemoglobin Potassium, hemoglobin >100 mg/dL increase apparent potassium levels significantly Icterus: No significant interference from conjugated and unconjugated bilirubin up to 60 mg/dL Lipemia: No significant interference up to 2000 mg/dL | のお気になると、その他のお気になる。 {8}------------------------------------------------ : 上一篇: {9}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest wings and a body. The bird is oriented towards the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 4 2005 Mr. Kerwin Kaufman, MBA, MT (ASCP) Regulatory Affairs Consultant Centralized Diagnostics Roche Diagnostics 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250 k053165 Re: K055105 Trade/Device Name: ISE Indirect Na, K, CI for Gen.2 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ Dated: November 11, 2005 Received: November 14, 2005 Dear Mr. Kaufman: We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section - 10(tr) premainer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosme) to regally mancessa provice Americal Device Americans, or to commerce pror to May 20, 1970, the chaemient auto crowisions of the Federal Food, Drug, devices that have been reclassified in accordance who a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premissions of the Act and Cosment Act (Act) that to not require approvine of the general controls provisions of the Act. The Act. The You may, therefore, market the devreet, basjocrequirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (See above) into . Existing major regulations affecting your device it may be subject its such additional comicr. Parts 800 to 895. In additions (CFR), Parts 800 to 895 Can oc louid in This 21, Courselects concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a backers with other requirements of the Act that FDA has made a determination that your device complies with other requirements of that FDA has made a decemmanon mac Jour ac-rooms of each agencies. You must or any Federal statutes and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, intrans, intrans 800); and good manufacturing practice CFK Part 807), laoching (21 OF N F its systems (QS) regulation (21 CFR Part 820). {10}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin maneting your article equivalence of your device to a legally prematic notification: "The PDF interestion for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, IT you teche specific information and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v lure Diagnostic DoMo Broading by reference to premarket notification" (21CFR Part 807.97). I cludion chittled, "Milonanaing of responsibilities under the Act from the r ou may other general miermational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours, Alberto G. Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ #### Indications for Use 510(k) Number (if known): #### Device Name: ISE Indirect Na, K, Cl for Gen.2 Indications For Use: The ISE module of the Roche / Hitachi systems is intended for the quantitative electrodes The ISH module of the Koche / Hitachi byticine is not and ing ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive in the survey and the states and the stakes is avaration of large amount Sodium measurements are used in the diagnosis and a chronic excetion of large amounts of secretion of the normolie aldosterone), diabeted institution is disease (caused by dilute urne, accompanied by extreme mirst), actival includes and intentionals are used to monitor other diseases involving electrolyte imbalance. Potassium measurements are used to monitor other diseases involving electionyle infounditions characterized by low of electrolyte balance in the diagnosis and treatment of disements and treatment of electrolyte balance in the dragnosis and neasurements are used in the diagnosis and treatment of high blood potassium levels. Chloride measurement diskations asidenis high blood polassium revels. Onlorido has cystic fibrosis and diabetic acidosis. electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of Confidential Office and gritter Diagnostic perfore twon. allon and Safety 053/6.5 27