(168 days)
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.
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.
The cobas 8000 ISE Indirect Na, K, Cl for Gen. 2 device is intended for the in vitro potentiometric determination of chloride, potassium, and sodium in serum, plasma, and urine using ion-selective electrodes. This summary outlines the acceptance criteria and the study results demonstrating the device's performance.
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against a predicate device (COBAS INTEGRA ISE cleared under K963627) and, for method comparison, against reference methods (flame photometer for Sodium and Potassium, coulometry for Chloride). While explicit acceptance criteria (e.g., target CV% or correlation coefficients) are not directly stated as numerical thresholds for substantial equivalence, the reported performance metrics are compared to the predicate device and reference methods to demonstrate analytical validity. The tables below summarize the reported performance for the cobas 8000 Urine ISE.
Sodium Performance
| Parameter | Acceptance Criteria (Implied by Predicate/Reference) | cobas 8000 Urine ISE Performance |
|---|---|---|
| Repeatability (CV%) | Comparable to predicate (Low: 1.0%, High: 0.49%) | Low: 0.6%, Med: 0.5%, High: 0.2%, Liq 1: 0.4%, Liq 2: 0.3% |
| Intermediate Precision (CV%) | Comparable to predicate (Low: 3.0%, High: 1.2%) | Low: 1.6%, Med: 0.6%, High: 0.7%, Liq 1: 1.4%, Liq 2: 0.6% |
| Method Comparison to Reference (Flame Photometer) | High Correlation, Slope ~1, Intercept ~0 | N=59, Days=2, Correlation=0.9997, Slope=0.976, Intercept=4.3548 |
| Method Comparison to Predicate | High Correlation, Slope ~1, Intercept ~0 | N=59, Days=2, Correlation=0.9996, Slope=0.930, Intercept=12.0671 |
| Reportable Range | 20-350 mmol/L (Predicate) | 60-350 mmol/L |
Potassium Performance
| Parameter | Acceptance Criteria (Implied by Predicate/Reference) | cobas 8000 Urine ISE Performance |
|---|---|---|
| Repeatability (CV%) | Comparable to predicate (Low: 0.26%, High: 2.0%) | Low: 1.2%, 0.6%, 0.8%, 0.6%, 0.6% (multiple levels) |
| Intermediate Precision (CV%) | Comparable to predicate (Low: 1.4%, High: 2.0%) | Low: 1.7%, 1.3%, 1.6%, 1.2%, 1.7% (multiple levels) |
| Method Comparison to Reference (Flame Photometry) | High Correlation, Slope ~1, Intercept ~0 | N=59, Days=2, Correlation=0.9993, Slope=0.962, Intercept=1.7605 |
| Method Comparison to Predicate | High Correlation, Slope ~1, Intercept ~0 | N=59, Days=2, Correlation=0.9997, Slope=0.920, Intercept=1.4589 |
| Reportable Range | 1-150 mmol/L (Predicate) | 3-100 mmol/L |
Chloride Performance
| Parameter | Acceptance Criteria (Implied by Predicate/Reference) | cobas 8000 Urine ISE Performance |
|---|---|---|
| Repeatability (CV%) | Comparable to predicate (Low: 0.44%, High: 0.30%) | Low: 0.7%, Med: 0.5%, High: 0.3%, Liq 1: 0.5%, Liq 2: 0.3% |
| Intermediate Precision (CV%) | Comparable to predicate (Low: 1.1%, High: 2.1%) | Low: 1.7%, Med: 0.7%, High: 1.0%, Liq 1: 1.2%, Liq 2: 0.9% |
| Method Comparison to Reference (Coulometry) | High Correlation, Slope ~1, Intercept ~0 | N=59, Days=2, Correlation=0.9985, Slope=1.092, Intercept=-11.2893 |
| Method Comparison to Predicate | High Correlation, Slope ~1, Intercept ~0 | N=59, Days=2, Correlation=0.9997, Slope=0.952, Intercept=0.5078 |
| Reportable Range | 20-350 mmol/L (Predicate) | 60-350 mmol/L |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set:
- Method Comparison (to reference method and predicate): N = 59 unique samples were used for the method comparison studies for Sodium, Potassium, and Chloride. These samples were tested over 2 days.
- Repeatability and Intermediate Precision: The number of unique samples for these studies is not explicitly stated as 'test set' but rather multiple levels of controls/samples were run, e.g., "Low", "Med", "High", "Liq 1", "Liq 2" for the cobas 8000 Urine ISE. The data presented are statistical summaries (mean, SD, CV%) derived from these runs.
- Data Provenance: The document does not explicitly state the country of origin for the data. However, the submitter is Roche Diagnostics (Indianapolis, IN, USA) with establishment registration in Mannheim, Germany, suggesting the studies could have been conducted in either or both locations. The studies appear to be prospective as they detail the evaluation of the new device for urine sample types.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is a submission for an in vitro diagnostic device (analyzing electrolytes) where the 'ground truth' is established by established reference methods (e.g., flame photometry, coulometry) or by comparison to a legally marketed predicate device, not by expert human interpretation of medical images or other subjective data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is established by objective laboratory methods, not by human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an IVD device and does not involve human readers for interpretation, thus an MRMC study is not relevant.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire submission details the performance of the cobas 8000 ISE module as an algorithm-only (device-only) without human-in-the-loop performance measurement. The repeatability, intermediate precision, method comparison, detection limits (LOB, LOD, LOQ), and reportable range data reflect the standalone performance of the device.
7. Type of Ground Truth Used
The ground truth used for performance evaluation includes:
- Reference Methods:
- For Sodium and Potassium: Flame Photometer
- For Chloride: Coulometry
- Comparison to a Predicate Device: COBAS INTEGRA ISE (K963627)
8. Sample Size for the Training Set
Not applicable. This device is a diagnostic instrument using ion-selective electrodes, not a machine learning or AI algorithm that requires a "training set" in the context of supervised learning. The device's calibration and controls would be analogous to continuous internal checks, but there isn't a "training set" in the traditional AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set in the context of an AI algorithm. The device's operational parameters and calibration are established through physical and chemical principles of ion-selective electrodes, and validated through the performance studies described.
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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 SystemPotassium Test SystemChloride Test System |
| Classification: | Ion-Specific Electrode SodiumIon-Specific Electrode PotassiumIon-Specific Electrode Chloride |
Establishment registration
For the cobas 8000 ISE module, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126. The establishment registration number for Roche Diagnostics, United States is 1823260.
Continued on next page
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Type, Continued
The FDA has classified the Sodium, Potassium, and Chloride Test Systems as Classification Class II devices.
| Panel | Product Code | Classification Name | Regulation |
|---|---|---|---|
| ClinicalChemistry (75) | JGS | Ion Specific Electrode, Sodium | 21 CFR862.1665 |
| ClinicalChemistry (75) | CEM | Ion Specific Electrode,Potassium | 21 CFR862.1600 |
| ClinicalChemistry (75) | CGZ | Ion Specific Electrode, Chloride | 21 CFR862.1170 |
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
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Type, Continued
| Devicedescription | The cobas 8000 ISE module is an Ion-Selective Electrode (ISE) system forthe determination of sodium, potassium, and chloride in serum, plasma, andurine. The cobas 8000 ISE module and the ISE Gen 2 reagents werepreviously cleared for serum and plasma sample types under K100853. Thispremarket notification seeks to obtain FDA review and clearance for the urinesample 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 todevelop an electrical potential (electromotive force, EMF) for themeasurements of ions in solution. The electrode has a selective membrane incontact with both the test solution and an internal filling solution. The internalfilling solution contains the test ion at a fixed concentration. Because of theparticular nature of the membrane, the test ions will closely associate with themembrane on each side. The membrane EMF is determined by the differencein concentration of the test ion in the test solution and the internal fillingsolution. The EMF develops according to the Nernst equation for a specificion in solution (see package insert for further explanation). Please refer toK100853 for detailed hardware and software information relating to the cobas8000 modular analyzer series. | |
| Commercially available controls are recommended for the urine sample type.Aqueous ISE standard calibrators (S1, S2, and S3) were cleared underK053165 and ISE Compensator under K052193. | |
| Intended use | The ISE module of the Roche/Hitachi cobas c system is intended for thequantitative determination of sodium, potassium and chloride in serum,plasma or urine using ion-selective electrodes. |
| Continued on next page |
.
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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
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Type, Continued
| Comparison ofSystems - | System Comparison | |||||
|---|---|---|---|---|---|---|
| similarities anddifferences | Parameter, 标 | PredicateCOBAS INTEGRA ISE ->>>K963627 | cobas 8000 ISE Module,Urine Sample Type | |||
| Intended use | The COBAS INTEGRA ISEmodule applications are intendedfor use for the quantitativedetermination of sodium,potassium, chloride, and lithium inserum, plasma or urine using ion-selective electrodes. | The ISE module of theRoche/Hitachi cobas c systems isintended for the quantitativedetermination of sodium, potassiumand chloride in serum, plasma orurine using ion-selective electrodes. | ||||
| SpecimenType | Serum, Plasma, Urine | Same(this submission only applies to theurine sample type) | ||||
| Measurementprinciple | ISE Potentiometry | Same | ||||
| Reagentcontainer | Plastic bottles closed via screwcaps | Same | ||||
| Onboardstoragetemperature | Room Temperature | Same | ||||
| ISE Module | Integrated into Integra analyzer | Separate ISE module connected toCore cobas 8000 module | ||||
| Ion Selectiveelectrodes(ISEs) | Potentiometric chloride, potassium,sodium and reference electrodes | Same | ||||
| SampleDilution | 1:6 | 1:46 | ||||
| Throughput | Max 600 tests/hour | Max 1800 tests/hour |
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Type, Continued
Comparison of assays similarities and . differences (Sodium)
| Assay Comparison | ||
|---|---|---|
| Sodium | ||
| Parameter | PredicateCobas 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 | ||
| Intermediateprecision(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 | ||
| MethodComparisonto reference(flamephotometer) | Not provided in labeling | N = 59Days = 2Correlation = 0.9997Slope (Bablok) = 0.976Intercept (Bablok) = 4.3548Range (X) = 65.7 - 327.7 |
| Methodcomparisonto predicate | N = 174Correlation = 0.996Slope = 0.95Intercept = 3.4 | N = 59Days = 2Correlation = 0.9996Slope (Bablok) = 0.930Intercept (Bablok) = 12.0671Range (X) = 63.8-339.2 |
| DetectionLimits | Not determined | LOB = 7.55 mmol/LLOD = 8.88 mmol/LLOQ = 49.53 mmol/L |
| Reportablerange | 20-350 mmol/L | 60-350 mmol/L |
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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
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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 | |||||
| Comparisonto reference | Days = 2 | ||||||
| (coulometry) | Correlation = 0.981 | Correlation = 0.9985 | |||||
| Slope = 0.95 | Slope (Bablok) = 1.092 | ||||||
| Intercept = 11.0 | Intercept (Bablok) = - 11.2893Range (X) = 66.0 - 324.0 | ||||||
| Method | |||||||
| comparison | Not provided in labeling | N = 59Days = 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 |
·
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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.
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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
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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
§ 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.