POLY-CHEM 90 ISE MODULE

K112408 · Polymedco, Inc. · CEM · Nov 4, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112408
• Device Name: POLY-CHEM 90 ISE MODULE
• Applicant: Polymedco, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Nov 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

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 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.

Device Story

Poly-Chem 90 ISE Module is an ion-selective electrode (ISE) accessory for the Poly-Chem 90 clinical chemistry analyzer; performs quantitative in vitro measurement of sodium, potassium, and chloride in human serum. Device utilizes ISE technology to measure ion concentrations; results are displayed on the analyzer interface for use by clinicians to diagnose and monitor electrolyte and metabolic disorders. System is intended for professional use in clinical laboratory settings. Benefits include rapid, accurate electrolyte quantification to support clinical decision-making for conditions such as cystic fibrosis, diabetic acidosis, and adrenal dysfunction.

Clinical Evidence

Bench testing only. Performance characteristics evaluated included precision (intra-assay CV 0.06-0.54%, inter-assay CV 0.28-1.20%), linearity (r² > 0.998), sensitivity (LOD 33.5-41.0 mmol/L), and interference testing. Method comparison against the predicate device (n=63-74 samples) showed high correlation (r=0.9929-0.9985) across clinical ranges.

Technological Characteristics

Ion-selective electrode (ISE) technology; quantitative measurement of sodium, potassium, and chloride; utilizes Medica Calibrator A and B; standalone module integrated into Poly-Chem 90 clinical chemistry analyzer; serum sample input.

Indications for Use

Indicated for quantitative in vitro measurement of sodium, potassium, and chloride in human serum for patients requiring electrolyte assessment, including those with aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, electrolyte imbalances, or metabolic disorders like cystic fibrosis and diabetic acidosis.

Regulatory Classification

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.

Predicate Devices

• Randox RX Daytona ISE Module (K024014)

Submission Summary (Full Text)

{0}------------------------------------------------

NOV - 4 2011

LYMEDCO inc. Corporate Office

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone] Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone] FAX: [phone]

### 510(k) Summary

| Contact Person: | Helen Landicho |
|-----------------|----------------|
|-----------------|----------------|

Address: Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567

Phone: [phone] [phone] (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 |

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YMEDCO inc. Corporate Office

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone]

Seattle Office

9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone] FAX: [phone]

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<br>measurement of the level of sodium,<br>potassium, and chloride in human<br>serum on the Poly-Chem 90 analyzer. | For the quantitative in vitro<br>measurement of the level of<br>sodium, potassium, and chloride<br>in human serum, plasma, and<br>urine on the RX Daytona<br>analyzer. |
| Indications for Use | Sodium measurements are used in the<br>diagnosis and treatment of<br>aldosteronism (excessive secretion of<br>the hormone aldosterone), diabetes<br>insipidus (chronic excretion of large<br>amounts of dilute urine, accompanied<br>by extreme thirst), adrenal<br>hypertension, Addison's disease<br>(caused by destruction of the adrenal<br>glands), dehydration, inappropriate<br>antidiuretic hormone secretion, or other<br>diseases involving electrolyte<br>imbalance. Potassium measurements<br>are used to monitor electrolyte balance<br>in the diagnosis and treatment of<br>diseases conditions characterized by<br>low or high blood potassium levels.<br>Chloride measurements are used in the<br>diagnosis and treatment of electrolyte<br>and metabolic disorders such as cystic<br>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%<br>Interassay: %CV from 0.28% to 0.94%<br>Samples from 82.9 to 173 mmol/L | Intraassay: %CV from 0.52% to 0.75%<br>Interassay: %CV from 0.90% to 1.28%<br>Samples from 136.9 to 154 mmol/L |
| Precision (K) | Intraassay: %CV from 0.14% to 0.33%<br>Interassay: %CV from 0.43% to 1.08%<br>Samples from 2.41 to 7.3 mmol/L | Intraassay: %CV from 0.39% to 0.54%<br>Interassay: %CV from 1.43% to 1.63%<br>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%<br>Interassay: %CV from 0.33% to 1.20%<br>Samples from 53.8 to 134 mmol/L | Intraassay: %CV from 0.53% to 0.82%<br>Interassay: %CV from 0.97% to 1.02%<br>Samples from 98.1 to 114 mmol/L |
| Measuring range | 33.5 - 191.6 mmol/L (Na)<br>0.5 - 9.98 mmol/L (K)<br>41.0 - 169.8 mmol/L (Cl) | 20 - 200 mmol/L (Na)<br>0.2-20 mmol/L (K)<br>25 - 200 mmol/L (Cl) |
| Comparison with<br>Predicate (Na) | $y = 1.04x - 5.06, r = 0.9929$ ; 63<br>samples from 56.0 – 189.0 mmol/L | $y = 0.91x + 8.60, r^2 = 0.99 N = 91$ |
| Comparison with<br>Predicate (K) | $y = 0.99x + 0.02, r = 0.9982$ ; 74<br>samples from 1.39 - 9.13 mmol/L | $y = 0.97x + 0.09, r^2 = 0.99 N = 73$ |
| Comparison with<br>Predicate (Cl) | $y = 1.01x - 1.64, r = 0.9985$ ; 74<br>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)<br>3.5-5.1 mmol/L (K)<br>97 - 107 mmol/L (Cl) | Same |
| Calibration | Medica Calibrator A and Calibrator B | Same |
| Analyzer | Poly-Chem 90 | RX Daytona |

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# POLYMEDCO inc. Corporate Office i

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone]

Seattle Office

.

9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone] FAX: [phone]

{3}------------------------------------------------

POLYMEDCO inc. Corporate Office i

510 Furnace Dock Road, Cortiandt Manor, NY 10567 Tel: [phone] FAX [phone]

Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone]

FAX: [phone]

### 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<br>(95% CI) | Intercept<br>(95% CI) | r2 |
|-----------|--------------|------------------------|---------------------------|--------|
| Sodium | 30.4 - 191.6 | 0.99<br>(0.97 to 1.00) | 0.09<br>(-1.92 to 2.11) | 0.9989 |
| Potassium | 1.09 – 9.98 | 0.98<br>(0.98 to 0.99) | 0.17<br>(0.13 to 0.21) | 0.9998 |
| Chloride | 31.3 - 169.8 | 1.02<br>(1.00 to 1.04) | -5.35<br>(-7.62 to -3.07) | 0.9989 |

{4}------------------------------------------------

# OLYMEDCO inc. Corporate Office

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone]

Seattle Office

9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone] FAX: [phone]

#### Sensitivity

| Test | Limit of Blank | Limit of Detection | Limit of Quantitiation<br>(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<br>(1.00 to 1.08) | -5.06<br>(-11.47 to -0.30) | 0.9929 |
| Potassium | 74 | 1.39 - 9.13 | 0.99<br>(0.97 to 1.01) | 0.02<br>(-0.04 to 0.11) | 0.9982 |
| Chloride | 74 | 49.0 - 166.0 | 1.01<br>(1.00 to 1.03) | -1.64<br>(-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.

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#### 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.

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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 [phone]. 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 [phone]. 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 [phone] 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

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## 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

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