(74 days)
Not Found
No
The document describes a standard clinical chemistry analyzer module using ion-selective electrode technology for quantitative measurements. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic measurements of analytes in human serum, used in the diagnosis and treatment of various conditions. It does not provide therapy or treatment.
Yes
The device is intended for "diagnosis and treatment" of various medical conditions by measuring specific analytes (sodium, potassium, and chloride) in human serum, which directly supports its classification as a diagnostic device.
No
The device description explicitly states it is an "ISE module" and measures using "ion selective electrode technology," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "for the quantitative in vitro measurement of sodium, potassium, and chloride in human serum". The term "in vitro" is a key indicator of an IVD. It also describes how these measurements are used in the "diagnosis and treatment" of various diseases, which is the purpose of an IVD.
- Device Description: The description reiterates that the device is for "quantitative in vitro measurement" of these analytes in "human serum".
- Performance Studies: The performance studies focus on metrics relevant to the analytical performance of a diagnostic test (precision, linearity, sensitivity, interference, method comparison), which are crucial for demonstrating the reliability of an IVD.
- Predicate Device: The mention of a "Predicate device" (Randox RX Daytona ISE Module) with a K number (K024014) strongly suggests this is a submission to a regulatory body (like the FDA in the US) for an IVD device, as predicate devices are used to demonstrate substantial equivalence for new IVDs.
N/A
Intended Use / Indications for Use
The Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of sodium, potassium, and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer.
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 diseases 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.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ
Device Description
Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of the level of sodium, potassium and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. The ISE module measures sodium, potassium and chloride using ion selective electrode technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence, performance characteristics that were tested included precision, linearity, sensitivity, interferences, and method comparison. Results of this testing are summarized below. The results indicate that the Poly-Chem 90 ISE Module is substantially equivalent to currently marketed Sodium, Potassium, and Chloride test systems.
Precision:
Sodium:
Sample 1: Mean 83.54 (Instrument 1), 82.91 (Instrument 2); Within run CV 0.27% (Instrument 1), 0.12% (Instrument 2); Between run CV 0.94% (Instrument 1), 0.71% (Instrument 2).
Sample 2: Mean 139.05 (Instrument 1), 139.70 (Instrument 2); Within run CV 0.18% (Instrument 1), 0.11% (Instrument 2); Between run CV 0.56% (Instrument 1), 0.46% (Instrument 2).
Sample 3: Mean 172.03 (Instrument 1), 172.95 (Instrument 2); Within run CV 0.17% (Instrument 1), 0.06% (Instrument 2); Between run CV 0.45% (Instrument 1), 0.28% (Instrument 2).
Potassium:
Sample 1: Mean 2.43 (Instrument 1), 2.41 (Instrument 2); Within run CV 0.33% (Instrument 1), 0.29% (Instrument 2); Between run CV 1.08% (Instrument 1), 0.90% (Instrument 2).
Sample 2: Mean 3.91 (Instrument 1), 3.89 (Instrument 2); Within run CV 0.18% (Instrument 1), 0.17% (Instrument 2); Between run CV 0.49% (Instrument 1), 0.43% (Instrument 2).
Sample 3: Mean 7.3 (Instrument 1), 7.3 (Instrument 2); Within run CV 0.16% (Instrument 1), 0.14% (Instrument 2); Between run CV 0.63% (Instrument 1), 0.68% (Instrument 2).
Chloride:
Sample 1: Mean 54.4 (Instrument 1), 53.8 (Instrument 2); Within run CV 0.54% (Instrument 1), 0.32% (Instrument 2); Between run CV 1.20% (Instrument 1), 0.98% (Instrument 2).
Sample 2: Mean 101.0 (Instrument 1), 101.0 (Instrument 2); Within run CV 0.14% (Instrument 1), 0.08% (Instrument 2); Between run CV 0.34% (Instrument 1), 0.36% (Instrument 2).
Sample 3: Mean 134.0 (Instrument 1), 133.8 (Instrument 2); Within run CV 0.11% (Instrument 1), 0.10% (Instrument 2); Between run CV 0.34% (Instrument 1), 0.33% (Instrument 2).
Linearity of the test:
Sodium: Range 30.4 - 191.6, Slope 0.99, Intercept 0.09, r2 0.9989.
Potassium: Range 1.09 – 9.98, Slope 0.98, Intercept 0.17, r2 0.9998.
Chloride: Range 31.3 - 169.8, Slope 1.02, Intercept -5.35, r2 0.9989.
Sensitivity:
Sodium: Limit of Blank 32.4 mmol/L, Limit of Detection 33.5 mmol/L, Limit of Quantitation (10% CV) 32.5 mmol/L.
Potassium: Limit of Blank 0.35 mmol/L, Limit of Detection 0.393 mmol/L, Limit of Quantitation (10% CV) 0.5 mmol/L.
Chloride: Limit of Blank 40.2 mmol/L, Limit of Detection 41.0 mmol/L, Limit of Quantitation (10% CV) 40.8 mmol/L.
Interference:
Maximum concentration without significant interference.
Sodium: Hemoglobin 800 mg/dL, Bilirubin 7.5 mg/dL, Triglyceride 549 mg/dL.
Potassium: Hemoglobin 800 mg/dL, Bilirubin 25 mg/dL, Triglyceride 663 mg/dL.
Chloride: Hemoglobin 800 mg/dL, Bilirubin 25 mg/dL, Triglyceride 549 mg/dL.
Comparison with predicate device:
Sodium: n=63, Range 56.0 - 189.0, Slope 1.04, Intercept -5.06, r 0.9929.
Potassium: n=74, Range 1.39 - 9.13, Slope 0.99, Intercept 0.02, r 0.9982.
Chloride: n=74, Range 49.0 - 166.0, Slope 1.01, Intercept -1.64, r 0.9985.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
0
NOV - 4 2011
LYMEDCO inc. Corporate Office
510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: 800.431.2123 FAX 914.739.5890 Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: 206.402.6146 FAX: 206.659.4956
510(k) Summary
| Contact Person: | Helen Landicho |
|---|---|
| ----------------- | ---------------- |
Address: Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567
Phone: (206) 402-6146 (206) 659-4956 (fax)
Summary prepared August 15, 2011
| 510(k) number: | |
|---|---|
| Name of the device: | Poly-Chem® 90 ISE Module |
| Device common name: | Ion selective electrode module; test for sodium, potassium, chloride |
| Product code: | JGS, CEM, CGZ |
| Regulation number: | 862.1665, 862.1600, 862.1170 |
| Classification: | Class II |
| Predicate Device: | Randox RX Daytona ISE Module |
| Device common name: | Ion selective electrode module; test for sodium, potassium, chloride |
| 510(k) number: | K024014 |
| Product code: | JGS, CEM, CGZ |
| Regulation number: | 862.1665, 862.1600, 862.1170 |
| Classification: | Class II |
| Device Description: | Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of the level of sodium, potassium and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. The ISE module measures sodium, potassium and chloride using ion selective electrode technology. |
| Intended use: | Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of the level of sodium, potassium and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. 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 |
1
YMEDCO inc. Corporate Office
510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: 800.431.2123 FAX 914.739.5890
Seattle Office
9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: 206.402.6146 FAX: 206.659.4956
diagnosis and treatment of diseases 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.
| Similarities and Differences with Predicate Device | ||
|---|---|---|
| ---------------------------------------------------- | -- | -- |
| Item | Poly-Chem 90 ISE Module | RX Daytona ISE Module |
|---|---|---|
| Intended Use | For the quantitative in vitro | |
| measurement of the level of sodium, | ||
| potassium, and chloride in human | ||
| serum on the Poly-Chem 90 analyzer. | For the quantitative in vitro | |
| measurement of the level of | ||
| sodium, potassium, and chloride | ||
| in human serum, plasma, and | ||
| urine on the RX Daytona | ||
| analyzer. | ||
| Indications for Use | 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 | ||
| diseases 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. | Same | |
| Sample type | Serum | Serum, plasma, urine |
| Methodology | Ion selective electrode | Same |
| Precision (Na) | Intraassay: %CV from 0.06% to 0.27% | |
| Interassay: %CV from 0.28% to 0.94% | ||
| Samples from 82.9 to 173 mmol/L | Intraassay: %CV from 0.52% to 0.75% | |
| Interassay: %CV from 0.90% to 1.28% | ||
| Samples from 136.9 to 154 mmol/L | ||
| Precision (K) | Intraassay: %CV from 0.14% to 0.33% | |
| Interassay: %CV from 0.43% to 1.08% | ||
| Samples from 2.41 to 7.3 mmol/L | Intraassay: %CV from 0.39% to 0.54% | |
| Interassay: %CV from 1.43% to 1.63% | ||
| Samples from 3.96 to 5.96 mmol/L | ||
| Similarities and Differences ISE Module | ||
| Item | Poly-Chem 90 ISE Module | RX Daytona ISE Module |
| Precision (Cl) | Intraassay: %CV from 0.08% to 0.54% | |
| Interassay: %CV from 0.33% to 1.20% | ||
| Samples from 53.8 to 134 mmol/L | Intraassay: %CV from 0.53% to 0.82% | |
| Interassay: %CV from 0.97% to 1.02% | ||
| Samples from 98.1 to 114 mmol/L | ||
| Measuring range | 33.5 - 191.6 mmol/L (Na) | |
| 0.5 - 9.98 mmol/L (K) | ||
| 41.0 - 169.8 mmol/L (Cl) | 20 - 200 mmol/L (Na) | |
| 0.2-20 mmol/L (K) | ||
| 25 - 200 mmol/L (Cl) | ||
| Comparison with | ||
| Predicate (Na) | $y = 1.04x - 5.06, r = 0.9929$ ; 63 | |
| samples from 56.0 – 189.0 mmol/L | $y = 0.91x + 8.60, r^2 = 0.99 N = 91$ | |
| Comparison with | ||
| Predicate (K) | $y = 0.99x + 0.02, r = 0.9982$ ; 74 | |
| samples from 1.39 - 9.13 mmol/L | $y = 0.97x + 0.09, r^2 = 0.99 N = 73$ | |
| Comparison with | ||
| Predicate (Cl) | $y = 1.01x - 1.64, r = 0.9985$ ; 74 | |
| samples from 49.0 - 166.0mmol/L | $y = 0.98x - 0.27, r^2 = 0.99 N = 84$ | |
| Expected values | 136 - 146 mmol/L (Na) | |
| 3.5-5.1 mmol/L (K) | ||
| 97 - 107 mmol/L (Cl) | Same | |
| Calibration | Medica Calibrator A and Calibrator B | Same |
| Analyzer | Poly-Chem 90 | RX Daytona |
2
POLYMEDCO inc. Corporate Office i
510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: 800.431.2123 FAX 914.739.5890
Seattle Office
.
9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: 206.402.6146 FAX: 206.659.4956
3
POLYMEDCO inc. Corporate Office i
510 Furnace Dock Road, Cortiandt Manor, NY 10567 Tel: 800.431.2123 FAX 914.739.5890
Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: 206.402.6146
FAX: 206.659.4956
Summary of performance testing
To demonstrate substantial equivalence, performance characteristics that were tested included precision, linearity, sensitivity, interferences, and method comparison. Results of this testing are summarized below. The results indicate that the Poly-Chem 90 ISE Module is substantially equivalent to currently marketed Sodium, Potassium, and Chloride test systems.
Precision
| Within run | Between run | ||||||
|---|---|---|---|---|---|---|---|
| Sample | Instrument | Mean | SD | CV | SD | CV | |
| Sodium | 1 | 1 | 83.54 | 0.222 | 0.27 | 0.781 | 0.94 |
| 2 | 82.91 | 0.101 | 0.12 | 0.589 | 0.71 | ||
| 2 | 1 | 139.05 | 0.254 | 0.18 | 0.783 | 0.56 | |
| 2 | 139.70 | 0.160 | 0.11 | 0.646 | 0.46 | ||
| 3 | 1 | 172.03 | 0.285 | 0.17 | 0.768 | 0.45 | |
| 2 | 172.95 | 0.099 | 0.06 | 0.481 | 0.28 | ||
| Potassium | 1 | 1 | 2.43 | 0.008 | 0.33 | 0.026 | 1.08 |
| 2 | 2.41 | 0.007 | 0.29 | 0.022 | 0.90 | ||
| 2 | 1 | 3.91 | 0.007 | 0.18 | 0.019 | 0.49 | |
| 2 | 3.89 | 0.007 | 0.17 | 0.017 | 0.43 | ||
| 3 | 1 | 7.3 | 0.012 | 0.16 | 0.046 | 0.63 | |
| 2 | 7.3 | 0.010 | 0.14 | 0.049 | 0.68 | ||
| Chloride | 1 | 1 | 54.4 | 0.29 | 0.54 | 0.66 | 1.20 |
| 2 | 53.8 | 0.17 | 0.32 | 0.53 | 0.98 | ||
| 2 | 1 | 101.0 | 0.15 | 0.14 | 0.35 | 0.34 | |
| 2 | 101.0 | 0.08 | 0.08 | 0.37 | 0.36 | ||
| 3 | 1 | 134.0 | 0.15 | 0.11 | 0.45 | 0.34 | |
| 2 | 133.8 | 0.13 | 0.10 | 0.44 | 0.33 |
Linearity of the test
| | Range | Slope
(95% CI) | Intercept
(95% CI) | r2 |
|-----------|--------------|------------------------|---------------------------|--------|
| Sodium | 30.4 - 191.6 | 0.99
(0.97 to 1.00) | 0.09
(-1.92 to 2.11) | 0.9989 |
| Potassium | 1.09 – 9.98 | 0.98
(0.98 to 0.99) | 0.17
(0.13 to 0.21) | 0.9998 |
| Chloride | 31.3 - 169.8 | 1.02
(1.00 to 1.04) | -5.35
(-7.62 to -3.07) | 0.9989 |
4
OLYMEDCO inc. Corporate Office
510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: 800.431.2123 FAX 914.739.5890
Seattle Office
9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: 206.402.6146 FAX: 206.659.4956
Sensitivity
| Test | Limit of Blank | Limit of Detection | Limit of Quantitiation
(10% CV) |
|-----------|----------------|--------------------|------------------------------------|
| Sodium | 32.4 mmol/L | 33.5 mmol/L | 32.5 mmol/L |
| Potassium | 0.35 mmol/L | 0.393 mmol/L | 0.5 mmol/L |
| Chloride | 40.2 mmol/L | 41.0 mmol/L | 40.8 mmol/L |
Interference
| Test | Hemoglobin | Bilirubin | Triglyceride |
|---|---|---|---|
| Sodium | 800 mg/dL | 7.5 mg/dL | 549 mg/dL |
| Potassium | 800 mg/dL | 25 mg/dL | 663 mg/dL |
| Chloride | 800 mg/dL | 25 mg/dL | 549 mg/dL |
Comparison with predicate device
| Test | n | Range of samples | Slope (95% CI) | Intercept (95% CI) | r |
|---|---|---|---|---|---|
| Sodium | 63 | 56.0 - 189.0 | 1.04 | ||
| (1.00 to 1.08) | -5.06 | ||||
| (-11.47 to -0.30) | 0.9929 | ||||
| Potassium | 74 | 1.39 - 9.13 | 0.99 | ||
| (0.97 to 1.01) | 0.02 | ||||
| (-0.04 to 0.11) | 0.9982 | ||||
| Chloride | 74 | 49.0 - 166.0 | 1.01 | ||
| (1.00 to 1.03) | -1.64 | ||||
| (-2.91 to -0.10) | 0.9985 |
Conclusions
Poly-Chem 90 ISE Module is substantially equivalent to currently marketed Sodium, Potassium, and Chloride test systems.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV. 04 2011
Polymedco, Inc. c/o Helen Landicho Vice President of Regulatory Affairs 510 Furnace Dock Rd., Cortlandt Manor, NY 10567
Re: K112408
Trade/Device Name: Poly-Chem 90 ISE Module Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system. Regulatory Class: II Product Code: CEM, CGZ, JGS Dated: August 16, 2011 Received: August 22, 2011
Dear Ms. Landicho:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
Image /page/5/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
6
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also please con the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 800 97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's s (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/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 1801 01 1796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K 112 408
Device Name: Poly-Chem 90 ISE Module
Indications For Use:
The Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of sodium, potassium, and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer.
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 diseases 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Dus
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112408
Page 1 of 1