(30 days)
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.
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.
This document describes the acceptance criteria and the study performed for the ISE Indirect Na, K, Cl for Gen.2 device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Labeled performance characteristics" for the modified device, and the reported performance is directly listed.
| Feature | Analyte | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Precision (CV) | Sodium (Plasma) | Low CV (e.g., <1%) | Mean 143.0 mmol/L, SD 0.51, CV 0.4%Mean 128.5 mmol/L, SD 0.52, CV 0.4% |
| Potassium (Plasma) | Low CV (e.g., <1%) | Mean 6.95 mmol/L, SD 0.02, CV 0.3%Mean 4.27 mmol/L, SD 0.01, CV 0.3% | |
| Chloride (Plasma) | Low CV (e.g., <1%) | Mean 118.8 mmol/L, SD 0.42, CV 0.4%Mean 92.7 mmol/L, SD 0.42, CV 0.5% | |
| Sodium (Urine) | Low CV (e.g., <3.5%) | Mean 23.7 mmol/L, SD 0.77, CV 3.3%Mean 160.5 mmol/L, SD 0.64, CV 0.4% | |
| Potassium (Urine) | Low CV (e.g., <1.5%) | Mean 19.86 mmol/L, SD 0.15, CV 0.8%Mean 59.67 mmol/L, SD 0.68, CV 1.1% | |
| Chloride (Urine) | Low CV (e.g., <2.5%) | Mean 21.4 mmol/L, SD 0.51, CV 2.4%Mean 154.5 mmol/L, SD 1.00, CV 0.6% | |
| Linearity | Sodium (Serum) | Deviation ± 5% from 40.0-250 mmol/L or ± 3 mmol/L at < 40.0 mmol/L | Demonstrated linearity within 80-180 mmol/L (Serum) and 10-250 mmol/L (Urine) with specified deviations. |
| Potassium (Serum) | Deviation ± 10 % from 10.0-100.0 mmol/L, ± 5% from 1.0-10.0 mmol/L | Demonstrated linearity within 1.5-10 mmol/L (Serum) and 10-100 mmol/L (Urine) with specified deviations. | |
| Chloride (Serum) | Deviation ± 5 % from 45.0-250.0 mmol/L, ± 8 mmol/L from < 45.0 mmol/L | Demonstrated linearity within 60.0-140.0 mmol/L (Serum) and 10.0-250.0 mmol/L (Urine) with specified deviations. | |
| Method Comparison (r) | Sodium (Plasma) | High correlation (e.g., >0.98) with predicate device | y= 1.000x - 1.300, r = 0.988 (n=58) |
| Potassium (Plasma) | High correlation (e.g., >0.99) with predicate device | y= 1.000x - 0.070, r = 0.999 (n=58) | |
| Chloride (Plasma) | High correlation (e.g., >0.99) with predicate device | y= 0.993x - 0.664, r = 0.994 (n=58) | |
| Endogenous Interferences | Hemolysis | No significant interference up to 1000 mg/dL hemoglobin (Na, Cl) | Confirmed for Sodium and Chloride. Potassium showed interference >100 mg/dL. |
| Icterus | No significant interference up to 60 mg/dL bilirubin | Confirmed for conjugated and unconjugated bilirubin. | |
| Lipemia | No significant interference up to 2000 mg/dL | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Test Set):
- Plasma (Na, K, Cl): n=21 for between-day imprecision.
- Urine (Na, K, Cl): n=21 for between-day imprecision.
- Method Comparison (Test Set):
- Plasma (Na, K, Cl): n=58 for comparison against the predicate device (Hitachi 911 reagents).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is implied to be prospective testing conducted by Roche Diagnostics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurements of analytes (Na, K, Cl). Ground truth is established by reference methods or predicate devices, not by expert interpretation of images or clinical assessments.
4. Adjudication Method for the Test Set
Not applicable. Ground truth for quantitative IVD devices typically involves comparisons to established reference methods or predicate devices, not adjudicated expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurements. It is not an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a standalone in vitro diagnostic device. Its performance is evaluated based on its ability to accurately measure electrolyte concentrations without direct human interpretation beyond specimen handling and instrument operation. The studies described (precision, linearity, method comparison) reflect its standalone performance.
7. The Type of Ground Truth Used
- Precision and Linearity: The term "ground truth" for these studies refers to the expected or actual concentration values of the analytes in the control or linearity samples used. These are typically prepared using either gravimetric/volumetric methods with high-purity standards or by using certified reference materials.
- Method Comparison: The predicate device (original ISE Na, K, Cl, K953239, specifically the Hitachi 911 reagent) serving on the "x method" acts as the reference or "ground truth" for evaluating the modified device's agreement. The document also mentions "Flame Photometry, Coulometry with NIST reference material" as traceability for the modified device, implying these highly accurate methods serve as the ultimate ground truth for the measurements.
8. The Sample Size for the Training Set
Not applicable. This device is an Ion-Selective Electrode (ISE) based system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is based on electrochemical principles and calibration using known standards.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device. The device is calibrated using ISE Standard Low (S1) and ISE Standard High (S2) and an ISE Compensator (S3), for which the "ground truth" concentrations are established through methods traceable to NIST reference materials, flame photometry, and coulometry.
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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 informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence | ||
|---|---|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3723Contact person: Kerwin Kaufman | ||
| Date prepared: November 11, 2005 | |||
| Device Name | Proprietary name: ISE Indirect Na, K, Cl for Gen.2 | ||
| Common names:Sodium Test SystemPotassium Test SystemChloride Test System | |||
| Classification names:Ion-Specific Electrode SodiumIon-Specific Electrode PotassiumIon-Specific Electrode Chloride |
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| DeviceDescription | An Ion-Selective Electrode (ISE) makes use of the unique properties ofcertain membrane materials to develop an electrical potential (electromotiveforce, EMF) for the measurements of ions in solution. The electrode has aselective membrane in contact with both the test solution and an internalfilling solution. The internal filling solution contains the test ion at a fixedconcentration. Because of the particular nature of the membrane, the test ionswill closely associate with the membrane on each side. The membrane EMFis determined by the difference in concentration of the test ion in the testsolution and the internal filling solution. The EMF develops according to theNernst equation for a specific ion is solution (see package insert for furtherexplanation). |
|---|---|
| The complete measurement system for a particular ion includes the ISE, areference electrode and electronic circuits to measure and process the EMF togive the test ion concentration. The sodium and potassium electrodes arebased on neutral carriers and the chloride electrode is based on an ionexchanger. | |
| Intended use /Indications foruse | The ISE module of the Roche / Hitachi systems is intended for thequantitative determination of sodium, potassium, and chloride in serum,plasma, or urine using ion-selective electrodes. |
| Sodium measurements are used in the diagnosis and treatment ofaldosteronism (excessive secretion of the hormone aldosterone), diabetesinsipidus (chronic excretion of large amounts of dilute urine, accompanied byextreme thirst), adrenal hypertension, Addison's disease (caused bydestruction of the adrenal glands), dehydration, inappropriate antidiuretichormone secretion, or other diseases involving electrolyte imbalance.Potassium measurements are used to monitor electrolyte balance in thediagnosis and treatment of disease conditions characterized by low or highblood potassium levels. Chloride measurements are used in the diagnosis andtreatment of electrolyte and metabolic disorders such as cystic fibrosis anddiabetic acidosis. | |
| PredicateDevice | We claim substantial equivalence to the predicate device, original ISE Na, K,Cl, cleared in K953239. |
| Continued on next page |
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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: originalISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,K, Cl for Gen.2 |
|---|---|---|
| GeneralInstruments | Roche Hitachi automated analyzerfamily | Same |
| Intended Use/Indications forUse | For the quantitative determination ofsodium, potassium, and chloride inserum, plasma, and urine.Sodium measurements are used inthe diagnosis and treatment ofaldosteronism (excessive secretionof the hormone aldosterone),diabetes insipidus (chronic excretionof large amounts of dilute urine,accompanied by extreme thirst),adrenal hypertension, Addison'sdisease (caused by destruction of theadrenal glands), dehydration,inappropriate antidiuretic hormonesecretion, or other diseasesinvolving electrolyte imbalance.Potassium measurements are used tomonitor electrolyte balance in thediagnosis and treatment of diseaseconditions characterized by low orhigh blood potassium levels.Chloride measurements are used inthe diagnosis and treatment ofelectrolyte and metabolic disorderssuch as cystic fibrosis and diabeticacidosis. | The ISE module of the Roche / Hitachisystems is intended for the quantitativedetermination of sodium, potassium,and chloride in serum, plasma, orurine using ion-selective electrodes.Sodium measurements are used in thediagnosis and treatment ofaldosteronism (excessive secretion ofthe hormone aldosterone), diabetesinsipidus (chronic excretion of largeamounts of dilute urine, accompaniedby extreme thirst), adrenalhypertension, Addison's disease(caused by destruction of the adrenalglands), dehydration, inappropriateantidiuretic hormone secretion, orother diseases involving electrolyteimbalance. Potassium measurementsare used to monitor electrolyte balancein the diagnosis and treatment ofdisease conditions characterized bylow or high blood potassium levels.Chloride measurements are used in thediagnosis and treatment of electrolyteand metabolic disorders such as cysticfibrosis and diabetic acidosis. |
| Feature | Predicate device: originalISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,K, Cl for Gen.2 |
| Test principle | ||
| Sample types | Serum, Plasma (Lithium heparin) orUrine | Same |
| Determination ofSodium,Potassium andChloride | An Ion-Selective Electrode (ISE)makes use of the unique propertiesof certain membrane materials todevelop an electrical potential(electromotive force, EMF) for themeasurements of ions in solution.The electrode has a selectivemembrane in contact with both thetest solution and an internal fillingsolution. The internal fillingsolution contains the test ion at afixed concentration. Because of theparticular nature of the membrane,the test ions will closely associatewith the membrane on each side.The membrane EMF is determinedby the difference in concentration ofthe test ion in the test solution andthe internal filling solution. TheEMF develops according to theNernst equation for a specific ion issolution (see package insert forfurther explanation).The complete measurement systemfor a particular ion includes the ISE,a reference electrode and electroniccircuits to measure and process theEMF to give the test ionconcentration. The sodium andpotassium electrodes are based onneutral carriers and the chlorideelectrode is based on an ionexchanger. | Same |
| Feature | Predicate device: originalISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,K, Cl for Gen.2 |
| Electrode / Reagent information | ||
| Ion-SpecificElectrodes | Sodium Electrode/ CartridgePotassium Electrode/ CartridgeChloride Electrode/ CartridgeReference Electrode/ Cartridge | Same |
| ElectrodeOnboardStability | Sodium, Potassium and ChlorideElectrodes, 2 months or 9000 testsReference Electrode, at least 6months | Same |
| Calibrators S1,S2 for two-pointcalibration | S1: ISE Standard LowS2: ISE Standard High | Same |
| AuxiliaryReagents | ISE 1 N potassium chloride(Reference Electrolyte) | Same |
| Performance characteristics | ||
| ReportableRange | 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$Cl^-$ : SameUrine:$Na^+$ : Same$K^+$ : Same$Cl^-$ : 10 - 250 mmol/L |
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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: originalISE Na, K, Cl (K953239)Electrode / Reagent information | Modified device: ISE Indirect Na,K, Cl for Gen.2 |
|---|---|---|
| ISE DiluentComposition | 650 mmol/L Boric acidPreservative (Gentamicin based) | 10 mmol/L HEPES buffer7 mmol/L TriethanolaminePreservative |
| ISE InternalStandardComposition | 650 mmol/L Boric acid32.3 mmol/L Sodium Chloride12.9 mmol/L Sodium bicarbonate1.6 mmol/L Potassium phosphatePreservative (Gentamicin based) | 10 mmol/L HEPES buffer7 mmol/L Triethanolamine3.06 mmol/L Sodium chloride1.45 mmol/L Sodium acetate0.16 mmol/L Potassium chloridePreservative |
| Electrode SlopeRanges | Sodium: 32.0 to 68.0 mV/decadePotassium: 32.0 to 68.0 mV/decadeChloride: -35.0 to -68.0 mV/decade | Sodium: 50 to 68 mV/decadePotassium: 50 to 68 mV/decadeChloride: -40 to -68 mV/decade |
| Calibrator, S3for compensation | Precical Calibrator Serum | ISE Compensator (serum based) |
| Quality control | Precitrol-N Control Serum andPrecitrol-A Control Serum or othercommercially available controls | Precinorm U and Precipath U orother commercially availablecontrols |
| ISE CleaningSolution | 4 N NaOH/System CleaningSolution | ISE Cleaning Solution:Sodium hydroxide, 12% withSodium hypochlorite solution < 2%active Cl(4 N NaOH/System CleaningSolution can also be used) |
| Traceability | NIST reference material | Flame Photometry, Coulometry withNIST reference material |
| Reagent Onboard Stability | ISE 1N KCl, ISE Diluent workingsolution and ISE Internal Referenceworking solution, stable at 20-25 Cuntil expiration date on bottle label. | ISE 1N KCl, up to the expirationdateISE Diluent and ISE InternalReference, 6 weeks on board. |
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| Feature | Predicate device: originalISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,K, Cl for Gen.2 | ||
|---|---|---|---|---|
| Labeled performance characteristics | ||||
| Precision | Total Imprecision, SerumSodium (mmol/L), n=63: | Between day Imprecision, PlasmaSodium (mmol/L), n=21: | ||
| Mean | 151.6128.0 | Mean | 143.0128.5 | |
| Total SD | 0.890.79 | SD | 0.510.52 | |
| Total CV | 0.6%0.6% | CV | 0.4%0.4% | |
| Potassium (mmol/L), n=63: | Potassium (mmol/L), n=21: | |||
| Mean | 6.323.50 | Mean | 6.954.27 | |
| Total SD | 0.050.03 | SD | 0.020.01 | |
| Total CV | 0.8%0.8% | CV | 0.3%0.3% | |
| Chloride (mmol/L), n=63: | Chloride (mmol/L), n=21: | |||
| Mean | 120.498.7 | Mean | 118.892.7 | |
| Total SD | 1.390.71 | SD | 0.420.42 | |
| Total CV | 1.2%0.7% | CV | 0.4%0.5% | |
| Total Imprecision, UrineSodium (mmol/L): | Between day Imprecision, UrineSodium (mmol/L), n=21: | |||
| N | 6063 | Mean | 23.7160.5 | |
| Mean | 59.4163.3 | SD | 0.770.64 | |
| Total SD | 0.930.91 | CV | 3.3%0.4% | |
| Total CV | 1.6%0.6% | |||
| Potassium (mmol/L): | Potassium (mmol/L), n=21: | |||
| N | 6063 | Mean | 19.8659.67 | |
| Mean | 23.5852.64 | SD | 0.150.68 | |
| Total SD | 0.220.70 | CV | 0.8%1.1% | |
| Total CV | 0.9%1.3% | |||
| Chloride (mmol/L): | Chloride (mmol/L), n=21: | |||
| N | 6063 | Mean | 21.4154.5 | |
| Mean | 52.7144.7 | SD | 0.511.00 | |
| Total SD | 0.921.50 | CV | 2.4%0.6% | |
| Total CV | 1.7%1.0% |
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| Feature | Predicate device: originalISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,K, Cl for Gen.2 |
|---|---|---|
| Labeled performance characteristics | ||
| Linearity | Sodium (serum): 59.8–199.6mmol/L with deviation of less than2.0 mmol/L or 3%Potassium (serum): 0.52-12.20mmol/L with deviation of less than0.1 mmol/L or 1%Chloride (serum): 43.4-164.5mmol/L with deviation of less than0.4 mmol/L or 1% | Sodium:Serum = 80-180 mmol/LUrine = 10-250 mmol/LDeviation ± 5% from 40.0-250mmol/L or ± 3 mmol/L atconcentrations < 40.0 mmol/LPotassium:Serum = 1.5-10 mmol/LUrine = 10-100 mmol/LDeviation ± 10 % from 10.0-100.0mmol/L, ± 5% from 1.0-10.0mmol/LChloride:Serum = 60.0-140.0 mmol/LUrine = 10.0 to 250.0 mmol/LDeviation ± 5 % from 45.0-250.0mmol/L, ± 8 mmol/L from < 45.0mmol/L |
| Feature | Predicate device: originalISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,K, Cl for Gen.2 |
| Labeled performance characteristics | ||
| MethodComparison | Sodium (serum), Passing-Bablok:x method = Hitachi 717y method = Hitachi 917n = 99y= 1.013x - 2.21, r = 0.998 | Sodium (plasma), Passing-Bablok:x method = Hitachi 911 (predicatereagent)y method = Hitachi 917 (modifiedreagent) n = 58y= 1.000x - 1.300, r = 0.988 |
| Potassium (serum), Passing-Bablok:x method = Hitachi 717y method = Hitachi 917n = 94y= 0.980x + 0.087, r = 1.000 | Potassium (plasma), Passing-Bablok:x method = Hitachi 911 (predicatereagent)y method = Hitachi 917 (modifiedreagent) n = 58y= 1.000x - 0.070, r = 0.999 | |
| Chloride (serum), Passing-Bablok:x method = Hitachi 717y method = Hitachi 917n = 99y= 1.004x + 0.65, r = 0.997 | Chloride (plasma), Passing-Bablok:x method = Hitachi 911 (predicatereagent)y method = Hitachi 917 (modifiedreagent) n = 58y= 0.993x - 0.664, r = 0.994 | |
| Endogenousinterferences | Reference Literature | Hemolysis:Sodium and Chloride, no significantinterference up to 1000 mg/dLhemoglobinPotassium, hemoglobin >100 mg/dLincrease apparent potassium levelssignificantlyIcterus:No significant interference fromconjugated and unconjugated bilirubinup to 60 mg/dLLipemia:No significant interference up to 2000 mg/dL |
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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).
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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
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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
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§ 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.