(74 days)
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.
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.
Here's an analysis of the Poly-Chem 90 ISE Module's acceptance criteria and the study proving it meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Poly-Chem 90 ISE Module appear to be established by demonstrating substantial equivalence to the predicate device (Randox RX Daytona ISE Module) across various performance characteristics. While explicit numerical "acceptance criteria" are not stated as pass/fail thresholds independent of the predicate, the comparison implicitly sets the predicate's performance as the benchmark.
| Performance Characteristic | Acceptance Criteria (Implicit by Predicate Performance) | Poly-Chem 90 ISE Module Performance |
|---|---|---|
| Precision (Sodium) | Intraassay %CV: 0.52-0.75% Interassay %CV: 0.90-1.28% | Intraassay %CV: 0.06-0.27% Interassay %CV: 0.28-0.94% |
| Precision (Potassium) | Intraassay %CV: 0.39-0.54% Interassay %CV: 1.43-1.63% | Intraassay %CV: 0.14-0.33% Interassay %CV: 0.43-1.08% |
| Precision (Chloride) | Intraassay %CV: 0.53-0.82% Interassay %CV: 0.97-1.02% | Intraassay %CV: 0.08-0.54% Interassay %CV: 0.33-1.20% |
| Measuring Range (Na) | 20 - 200 mmol/L | 33.5 - 191.6 mmol/L |
| Measuring Range (K) | 0.2 - 20 mmol/L | 0.5 - 9.98 mmol/L |
| Measuring Range (Cl) | 25 - 200 mmol/L | 41.0 - 169.8 mmol/L |
| Method Comparison (Na) | $y = 0.91x + 8.60, r^2 = 0.99$ | $y = 1.04x - 5.06, r = 0.9929$ |
| Method Comparison (K) | $y = 0.97x + 0.09, r^2 = 0.99$ | $y = 0.99x + 0.02, r = 0.9982$ |
| Method Comparison (Cl) | $y = 0.98x - 0.27, r^2 = 0.99$ | $y = 1.01x - 1.64, r = 0.9985$ |
| Linearity (Na) | Not explicitly stated as acceptance criteria, but demonstrated for predicate. | Slope: 0.99 (0.97 to 1.00), Intercept: 0.09 (-1.92 to 2.11), r2: 0.9989 (Range: 30.4 - 191.6 mmol/L) |
| Linearity (K) | Not explicitly stated as acceptance criteria, but demonstrated for predicate. | Slope: 0.98 (0.98 to 0.99), Intercept: 0.17 (0.13 to 0.21), r2: 0.9998 (Range: 1.09 – 9.98 mmol/L) |
| Linearity (Cl) | Not explicitly stated as acceptance criteria, but demonstrated for predicate. | Slope: 1.02 (1.00 to 1.04), Intercept: -5.35 (-7.62 to -3.07), r2: 0.9989 (Range: 31.3 - 169.8 mmol/L) |
| Sensitivity | Not explicitly stated in comparison table for predicate. | LoB: Na 32.4, K 0.35, Cl 40.2 mmol/L LoD: Na 33.5, K 0.393, Cl 41.0 mmol/L LoQ: Na 32.5, K 0.5, Cl 40.8 mmol/L |
| Interference | Not explicitly stated in comparison table for predicate. | Up to: Hemoglobin 800 mg/dL, Bilirubin 7.5-25 mg/dL, Triglyceride 549-663 mg/dL |
| Intended Use | For quantitative in vitro measurement of Na, K, Cl in human serum, plasma, and urine on RX Daytona analyzer. | For quantitative in vitro measurement of Na, K, Cl in human serum on Poly-Chem 90 analyzer. |
| Indications for Use | Same as Poly-Chem 90 ISE Module (detailed list for Na, K, Cl). | Same as Predicate. |
| Sample Type | Serum, plasma, urine | Serum |
| Methodology | Ion selective electrode | Ion selective electrode |
2. Sample Sizes Used for the Test Set and Data Provenance
The document provides sample sizes for the method comparison studies (where the device is compared to the predicate), which can be considered part of the test set:
- Sodium (Na): 63 samples
- Potassium (K): 74 samples
- Chloride (Cl): 74 samples
The precision, linearity, and sensitivity tests also involved samples, but the exact number of unique patient samples isn't specified in detail beyond "Samples from [range] mmol/L" for precision.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions the measurement of levels in "human serum."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" would typically refer to the reference method (the predicate device in this case, or a gold standard method) rather than expert interpretation of images or clinical data. There is no mention of human experts being involved in establishing the "ground truth" for the performance characteristics of this chemical analyzer.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established by chemical measurement, not through expert review and adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable to this type of device (in vitro diagnostic for chemical analysis). This study design is typically used for imaging diagnostics where human readers interpret results, often with and without AI assistance.
6. Standalone Performance
Yes, a standalone performance evaluation was done. The precision, linearity, and sensitivity studies presented in the "Summary of performance testing" section (pages 3-4) directly demonstrate the performance of the Poly-Chem 90 ISE Module itself, without comparison to the predicate. The method comparison studies (page 4) also provide the device's measurements, which are then compared to the predicate, implicitly showing its standalone output.
7. Type of Ground Truth Used
The "ground truth" for evaluating this device's performance appears to be primarily:
- Reference measurements/Method comparison: The predicate device (Randox RX Daytona ISE Module) serves as the comparator for method comparison studies, implying that its measurements are considered the "truth" for this comparison.
- Established analytical methods: For precision, linearity, and sensitivity, the ground truth is based on the inherent principles of analytical chemistry and expected performance characteristics for such assays. For example, linearity is assessed against a theoretical linear response, and precision against statistical variability.
8. Sample Size for the Training Set
The document does not provide information about a specific "training set" or its sample size. This device is an in vitro diagnostic analyzer, not an AI/ML algorithm that typically undergoes a distinct training phase on a dataset. Its performance is characterized through analytical validation studies (precision, linearity, etc.), not a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's operational parameters and calibration are established through standard analytical chemistry principles and calibration procedures (e.g., using Medica Calibrator A and B, as mentioned) during its manufacturing and setup, not through a data-driven training process.
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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 vitromeasurement of the level of sodium,potassium, and chloride in humanserum on the Poly-Chem 90 analyzer. | For the quantitative in vitromeasurement of the level ofsodium, potassium, and chloridein human serum, plasma, andurine on the RX Daytonaanalyzer. |
| Indications for Use | 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, or otherdiseases involving electrolyteimbalance. Potassium measurementsare used to monitor electrolyte balancein the diagnosis and treatment ofdiseases 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. | 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 withPredicate (Na) | $y = 1.04x - 5.06, r = 0.9929$ ; 63samples from 56.0 – 189.0 mmol/L | $y = 0.91x + 8.60, r^2 = 0.99 N = 91$ |
| Comparison withPredicate (K) | $y = 0.99x + 0.02, r = 0.9982$ ; 74samples from 1.39 - 9.13 mmol/L | $y = 0.97x + 0.09, r^2 = 0.99 N = 73$ |
| Comparison withPredicate (Cl) | $y = 1.01x - 1.64, r = 0.9985$ ; 74samples 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.
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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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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
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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
Page 1 of 1
§ 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.