SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Device Facts
| Record ID | K200544 |
|---|---|
| Device Name | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ |
| Applicant | Diamond Diagnostics, Inc. |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | Oct 1, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1600 |
| Device Class | Class 2 |
Indications for Use
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples. The SmartLyte® Plus Sodium Assay is intended to measure sodium in whole blood, serum, plasma, and urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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. The SmartLyte® Plus Potassium Assay is intended to measure potassium in whole blood, serum, plasma, and urine on the SmartLyte® Plus Electrolyte Analyzer. 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. The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, and urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, and serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The SmartLyte® Plus Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder). For in-vitro diagnostic use only.
Device Story
SmartLyte® Plus is an automated, microprocessor-controlled electrolyte analyzer using ion-selective electrodes (ISE) to measure Na+, K+, Cl-, Ca++, and Li+ in venous whole blood, serum, sodium heparin plasma, and urine. Used in clinical laboratories by trained technicians for in-vitro diagnostic testing. Device self-calibrates using a fluid pack every 4 hours or on demand. Input samples are processed via ISE technology; potential is measured relative to a silver/silver chloride reference electrode. Output is displayed on a touchscreen and can be printed or stored. Modifications from the predicate include faster analysis time (30 seconds), increased sample/QC storage, LAN/WiFi connectivity, and an RFID board for reagent pack monitoring. Results assist clinicians in diagnosing renal, metabolic, and cardiovascular disorders and managing lithium dosage for bipolar disorder.
Clinical Evidence
Bench testing only. Precision evaluated via within-run (n=30) and total precision (n=40) studies across all matrices. Linearity confirmed via regression analysis (R² > 0.99). Method comparison against predicate (GemLyte) performed with >100 samples per matrix, showing high correlation (R² > 0.99). LoB, LoD, and LoQ determined for Ca2+ and Li+ per CLSI EP17-A2. No clinical trials conducted.
Technological Characteristics
Potentiometric ISE technology. Electrodes: glass tube (Na+), neutral carrier ionophore membranes (K+, Ca++, Li+), ionophore-bound substrate (Cl-). Reference: Ag/AgCl electrode. Connectivity: LAN/WiFi. Processor: STM32F407BG. Power: 100-240V 50/60Hz. Form factor: 31.5cm x 33.5cm x 29.5cm, <6kg. Calibration: Automatic/on-demand 2-point (Na, K, Cl, Ca) or 3-point (Li).
Indications for Use
Indicated for patients requiring electrolyte monitoring (Na+, K+, Cl-, Ca2+, Li+) in serum, sodium heparin plasma, venous whole blood, or pre-diluted urine. Used for diagnosis/treatment of electrolyte imbalances, metabolic disorders, parathyroid/bone/renal disease, and lithium therapy management.
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
- SmartLyte® (GEMLYTE) (K082462)
Related Devices
- K121040 — SMARTLYTE ELECTROLYTE ANALYZER · Diamond Diagnostics, Inc. · Aug 30, 2012
- K082462 — GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ · Diamond Diagnostics, Inc. · Feb 6, 2009
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
k200544
B Applicant
Diamond Diagnostics Inc.
C Proprietary and Established Names
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JGS | Class II | 21 CFR 862.1665 - Sodium Test System | CH - Clinical Chemistry |
| CGZ | Class II | 21 CFR 862.1170 - Chloride test system | CH - Clinical Chemistry |
| JFP | Class II | 21 CFR 862.1145 - Calcium test system | CH - Clinical Chemistry |
| JIH | Class II | 21 CFR 862.3560 - Lithium test system | TX - Clinical Toxicology |
| JJE | Class I | 21 CFR 862.2160 - Discrete photometric chemistry analyzer for clinical use | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New Device
B Measurand:
Sodium, Potassium, Chloride, Calcium, Lithium
C Type of Test:
Quantitative, Ion Selective Electrodes
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K200544 - Page 2 of 12
# III Intended Use/Indications for Use:
## A Intended Use(s):
See Indications for Use below.
## B Indication(s) for Use:
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in whole blood, serum, plasma, and urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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.
The SmartLyte® Plus Potassium Assay is intended to measure potassium in whole blood, serum, plasma, and urine on the SmartLyte® Plus Electrolyte Analyzer. 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.
The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, and urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, and serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SmartLyte® Plus Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## D Special Instrument Requirements:
SmartLyte® Plus Electrolyte Analyzer Na⁺/K⁺/Cl⁻/Ca²⁺/Li⁺
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## IV Device/System Characteristics:
### A Device Description:
The SmartLyte® Plus Electrolyte Analyzer Na⁺/K⁺/Cl⁻/Ca²⁺/Li⁺ is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, ionized calcium and lithium in serum, sodium heparin plasma and venous whole blood, as well as measurement of sodium, potassium and chloride in prediluted urine samples. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (k013850) every 4 hours throughout the day or on request.
### B Principle of Operation:
The SmartLyte® Plus Electrolyte Analyzer Na⁺/K⁺/Cl⁻/Ca²⁺/Li⁺ measures sodium, potassium and chloride in whole blood, serum, plasma, and urine and ionized calcium and lithium in whole blood, serum, and plasma, using ion selective electrode technology. The flow-through sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The flow-through potassium, chloride, ionized calcium, and lithium electrodes incorporate a neutral carrier ionophore membrane. The potential of each electrode is measured relative to a fixed, stable voltage established by the silver/silver chloride reference electrode. An ion selective electrode develops a voltage that varies with the concentration of the ion to which it responds. The relationship between the voltage developed and the concentration of the sensed ion is logarithmic.
### C Instrument Description Information:
1. **Instrument Name:**
SmartLyte® Plus Electrolyte Analyzer Na⁺/K⁺/Cl⁻/Ca²⁺/Li⁺
2. **Specimen Identification:**
Specimen (sample type and patient) should be identified by manually entering the information via the touchscreen.
3. **Specimen Sampling and Handling:**
Sodium heparin venous whole blood from syringe, evacuated collection tubes or cup can be aspirated by positioning the sample over a probe for all analytes.
4. **Calibration:**
The SmartLyte® Plus analyzer performs a 2-point calibration (3-point calibration if lithium) every 4 hours. The software also permits calibration on demand. A 1-point calibration is performed automatically with each measurement.
5. **Quality Control:**
Diamond Diagnostics controls (k033063) are the recommended quality control material to be used daily.
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V Substantial Equivalence Information:
A Predicate Device Name(s):
GemLyte Electrolyte Analyzer Na⁺/K⁺/Cl⁻/Ca²⁺/Li⁺
B Predicate 510(k) Number(s):
k082462
C Comparison with Predicate(s):
| Device & Predicate Device(s): | k190947 | k082462 |
| --- | --- | --- |
| Device Trade Name | SmartLyte® Plus Electrolyte Analyzer Na⁺/K⁺/Cl⁻/Ca²⁺/Li⁺ | GemLyte Electrolyte Analyzer |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the measurement of sodium, potassium, chloride, calcium, and lithium | Same |
| Measurement Method | Ion selective electrodes | Same |
| Sample Matrix | Venous whole blood, Sodium Heparin plasma, serum, and urine | Same |
| Calibration | Automatic and on demand. | Same |
| Measurement Range, Blood | Na⁺: 40-200 mmol/L
K⁺: 1.5 -15.0 mmol/L
Cl⁻: 50-200 mmol/L
Ca²⁺: 0.3-5.0 mmol/L
Li⁺: 0.2-5.5 mmol/L | Same |
| Measurement Range, Urine | Na⁺: 3-300 mmol/L
K⁺: 5-120 mmol/L
Cl⁻: 15-300 mmol/L | Same |
| General Device Characteristic Differences | | |
| Analyzer Output | 5" touchscreen color display
4 USB ports | 32-character, 2-line alphanumeric display
2 USB ports |
| USB Ports | Four | Two |
| Analysis time | 30 sec | 57 sec |
| Sample Results Storage | 10000 | 1000 |
| Program Flow | Multi-level menu structure | Single level menu |
K200544 - Page 4 of 12
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VI Standards/Guidance Documents Referenced:
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Procedures; Approved Guideline – Third Edition.
CSLI EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.
CLSI EP07-A3 Interference Testing in Clinical Chemistry; Approved Guideline – Third Edition.
CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Within run precision was evaluated using three sodium heparin venous whole blood, serum, sodium heparin plasma, urine samples, and controls for each analyte. Sample concentrations spanned across the measuring range for each analyte. Each sample was measured 30 times consecutively in one day without calibration between measurements. The results are summarized below.
Within-run precision, sodium heparin venous whole blood (mmol/L)
| Sample 1 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 103.35 | 2.717 | 81.15 | 0.6546 | 0.542 |
| %CV | 0.47 | 1.19 | 0.88 | 0.45 | 0.69 |
| N | 30 | 30 | 30 | 30 | 30 |
| Sample 2 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 139.28 | 3.575 | 105.22 | 1.0644 | 0.9842 |
| %CV | 0.47 | 1.38 | 0.72 | 1.47 | 1.24 |
| N | 30 | 30 | 30 | 30 | 30 |
| Sample 3 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 163.33 | 7.177 | 139.91 | 1.6935 | 1.5573 |
| %CV | 0.59 | 0.35 | 0.61 | 1.16 | 1.83 |
| N | 30 | 30 | 30 | 30 | 30 |
Within-run precision, sodium heparin plasma (mmol/L)
| Sample 1 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 108.63 | 2.533 | 83.20 | 0.5028 | 0.4120 |
| %CV | 0.29 | 0.62 | 0.33 | 0.42 | 0.79 |
| N | 30 | 30 | 30 | 30 | 30 |
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| Sample 2 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 135.42 | 3.327 | 107.73 | 1.3297 | 1.0684 |
| %CV | 0.32 | 0.46 | 0.35 | 0.30 | 1.81 |
| N | 30 | 30 | 30 | 30 | 30 |
| Sample 3 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 167.73 | 6.885 | 140.93 | 1.6685 | 1.7837 |
| %CV | 0.43 | 0.54 | 0.52 | 0.46 | 0.88 |
| N | 30 | 30 | 30 | 30 | 30 |
Within-run precision, serum (mmol/L)
| Sample 1 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 115.13 | 2.610 | 76.24 | 0.4503 | 0.5612 |
| %CV | 0.82 | 1.20 | 0.62 | 0.74 | 0.89 |
| N | 30 | 30 | 30 | 30 | 30 |
| Sample 2 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 132.48 | 4.167 | 103.41 | 1.0923 | 1.1763 |
| %CV | 0.15 | 0.27 | 0.32 | 0.37 | 0.86 |
| N | 30 | 30 | 30 | 30 | 30 |
| Sample 3 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 162.35 | 6.859 | 131.02 | 1.5722 | 2.2646 |
| %CV | 0.27 | 0.51 | 0.29 | 0.43 | 0.97 |
| N | 30 | 30 | 30 | 30 | 30 |
Within-run precision, urine (mmol/L)
| | | Na+ | K+ | Cl- |
| --- | --- | --- | --- | --- |
| Sample 1 | Mean | 62.61 | 28.811 | 90.38 |
| | %CV | 1.64 | 0.51 | 1.06 |
| | N | 30 | 30 | 30 |
| Sample 2 | Mean | 108.92 | 46.644 | 139.83 |
| | %CV | 0.87 | 0.26 | 0.68 |
| | N | 30 | 30 | 30 |
| Sample 3 | Mean | 248.66 | 171.262 | 151.70 |
| | %CV | 0.65 | 0.56 | 0.61 |
| | N | 30 | 30 | 30 |
## Total precision
Total precision was evaluated using three sodium heparin venous whole blood, serum, sodium heparin plasma, urine, and control samples for each analyte. Samples concentrations spanned the measuring range. Samples were measured twice a day in duplicate for ten consecutive days resulting in $n = 40$ replicates per sample using multiple reagents lots. Venous whole blood samples were tested over 2-hour time period since the analytes measured are not stable in sodium heparin venous whole blood for long periods of times. The results are summarized below.
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Total precision, sodium heparin venous whole blood (mmol/L)
| Sample 1 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 103.10 | 2.72 | 81.6 | 0.65 | 0.52 |
| %CV | 0.36 | 0.63 | 1.05 | 1.05 | 1.60 |
| N | 40 | 40 | 40 | 40 | 40 |
| Sample 2 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 139.34 | 4.36 | 106.57 | 1.07 | 0.97 |
| %CV | 0.38 | 0.75 | 0.78 | 1.83 | 1.52 |
| N | 40 | 40 | 40 | 40 | 40 |
| Sample | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 163.16 | 7.14 | 141.33 | 1.66 | 1.51 |
| %CV | 0.38 | 2.44 | 0.82 | 1.57 | 3.33 |
| N | 40 | 40 | 40 | 40 | 40 |
Total precision, sodium heparin plasma (mmol/L)
| Sample 1 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 108.54 | 2.54 | 84.19 | 0.50 | 0.41 |
| %CV | 0.66 | 1.36 | 1.42 | 0.43 | 0.84 |
| N | 40 | 40 | 40 | 40 | 40 |
| Sample 2 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 135.15 | 4.10 | 108.83 | 1.33 | 1.06 |
| %CV | 0.65 | 1.53 | 0.85 | 0.24 | 1.67 |
| N | 40 | 40 | 40 | 40 | 40 |
| Sample 3 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 167.16 | 6.88 | 142.60 | 1.67 | 1.79 |
| %CV | 0.94 | 3.76 | 1.17 | 0.54 | 0.73 |
| N | 40 | 40 | 40 | 40 | 40 |
Total precision, serum (mmol/L)
| Sample 1 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 115.20 | 2.52 | 76.81 | 0.45 | 0.56 |
| %CV | 1.00 | 1.63 | 1.44 | 0.59 | 0.88 |
| N | 40 | 40 | 40 | 40 | 40 |
| Sample 2 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 132.43 | 4.95 | 104.73 | 1.09 | 1.18 |
| %CV | 0.60 | 1.20 | 0.63 | 0.27 | 0.89 |
| N | 40 | 40 | 40 | 40 | 40 |
| Sample 3 | Na+ | K+ | Cl- | Ca2+ | Li+ |
| --- | --- | --- | --- | --- | --- |
| Mean | 161.91 | 6.82 | 132.18 | 1.57 | 2.27 |
| %CV | 0.87 | 2.69 | 1.07 | 0.33 | 0.88 |
| N | 40 | 40 | 40 | 40 | 40 |
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Total precision, urine (mmol/L)
| | | Na+ | K+ | Cl- |
| --- | --- | --- | --- | --- |
| Sample 1 | Mean | 67.87 | 31.01 | 90.97 |
| | % CV | 3.97 | 3.23 | 2.68 |
| | N | 40 | 40 | 40 |
| Sample 2 | Mean | 108.77 | 46.30 | 137.34 |
| | % CV | 1.70 | 1.66 | 1.49 |
| | N | 40 | 40 | 40 |
| Sample 3 | Mean | 250.10 | 169.93 | 152.85 |
| | % CV | 0.87 | 0.85 | 1.22 |
| | N | 40 | 40 | 40 |
# 2. Linearity:
Linearity was evaluated by preparing stock solutions with high concentrations of Na, K, Cl in sodium heparin venous whole blood, serum, sodium heparin plasma, and urine. Linearity for Li and Ca was assessed in pooled sodium heparin venous whole blood, serum, sodium heparin plasma. Linear regression was performed.
The results are summarized below.
Sodium heparin venous whole blood
| Parameter | Slope | Intercept | R² | Sample range tested (mmol/L) | Claimed measuring range (mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Sodium | 1.02 | -4.52 | 0.9986 | 34.3-205.7 | 40-200 |
| Potassium | 1.02 | -0.15 | 0.9990 | 1.6-16.3 | 1.7-15.0 |
| Chloride | 0.97 | 12.07 | 0.9974 | 55.0-216.7 | 50-200 |
| ionized Calcium | 1.00 | -0.09 | 0.9983 | 0.4-5.8 | 0.3-5.0 |
| Lithium | 0.97 | 0.13 | 0.9977 | 0.3-4.9 | 0.2 -5.5 |
Sodium heparin plasma
| Parameter | Slope | Intercept | R² | Sample range tested (mmol/L) | Claimed measuring range (mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Sodium | 1.00 | 5.29 | 0.9988 | 16.8-211.0 | 40-200 |
| Potassium | 1.01 | 0.07 | 0.9993 | 1.4-17.4 | 1.7-15.0 |
| Chloride | 0.97 | 6.29 | 0.9997 | 53.8-190.4 | 50-200 |
| ionized Calcium | 1.01 | 0.06 | 0.9970 | 0.3-5.1 | 0.3-5.0 |
| Lithium | 1.00 | -0.08 | 0.9983 | 0.3-5.1 | 0.2 -5.5 |
Serum
| Parameter | Slope | Intercept | R² | Sample range tested (mmol/L) | Claimed measuring range (mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Sodium | 1.01 | 2.60 | 0.9990 | 18.1-207.2 | 40-200 |
| Potassium | 1.02 | 0.03 | 0.9992 | 1.3-16.3 | 1.7-15.0 |
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| Parameter | Slope | Intercept | R² | Sample range tested (mmol/L) | Claimed measuring range (mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Chloride | 1.00 | 1.89 | 0.9991 | 20.9-203.0 | 50-200 |
| ionized Calcium | 0.98 | -0.22 | 0.9939 | 0.1-5.3 | 0.3-5.0 |
| Lithium | 1.03 | -0.05 | 0.9995 | 0.2-6.7 | 0.2 -5.5 |
Urine
| Parameter | Slope | Intercept | R² | Sample range tested (mmol/L) | Claimed measuring range(mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Sodium | 1.00 | 2.83 | 0.9988 | 1.2-307.9 | 3-300 |
| Potassium | 1.00 | -0.48 | 0.9984 | 0.5-132.9 | 5-120 |
| Chloride | 1.03 | -7.24 | 0.9987 | 1.4-353.5 | 15-300 |
3. Analytical Specificity/Interference:
The sponsor submitted information to support the interference results included in the labeling which was found to be acceptable.
4. Assay Reportable Range:
| Measuring range in sodium heparin venous whole blood, sodium heparin plasma and serum | Na⁺: 40-200 mmol/L
K⁺: 1.7-15.0 mmol/L
Cl⁻: 50-200 mmol/L
Ca²⁺: 0.3-5.0 mmol/L
Li⁺: 0.2-5.5 mmol/L |
| --- | --- |
| Measuring range urine | Na⁺: 3-300 mmol/L
K⁺: 5-120 mmol/L
Cl⁻: 15-300 mmol/L |
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The SmartLyte® Plus Sodium assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the National Institute of Standards and Technology (NIST).
The SmartLyte® Plus Potassium assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the NIST.
The SmartLyte® Plus Chloride assay is traceable to a coulometric reference method, which uses reference materials from the NIST.
The SmartLyte® Plus Calcium assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the NIST.
The SmartLyte® Plus Lithium assay is traceable flame emission spectrophotometry reference method, which uses reference materials from the NIST.
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6. Detection Limit:
Reportable ranges were determined based on the linearity studies for Na⁺, K⁺, and Cl⁻ (see Section VII.A.2 above).
The limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) were determined for ionized calcium and lithium according to CLSI EP17-A2 guideline.
For LoB studies, blank samples were tested on one analyzer with two different reagent lots. Five different blank samples were run in replicates of five on each day for three days for a total of 75 replicates per lot. The LoB was calculated using the non-parametric method.
For LoD studies, samples with low levels of ionized calcium or lithium were prepared and run five times on one analyzer with two different reagent lots. Five different low-level samples were tested in replicates of five on each day for three days for a total of 75 replicates per lot. The results were pooled to calculate the total standard deviation (SDL) per lot. The LoD was calculated using the equation: $\mathrm{LoD} = \mathrm{LoB} + \mathrm{CpSDL}$. The maximum value of the LoDs obtained for the two lots was reported as the LoD of the device.
For LoQ studies, five pooled samples with low levels of ionized calcium or lithium were prepared and measured in replicates of five on each day for three days using two different reagent lots on one analyzer giving a total of 75 replicates per lot. The mean, SD, and bias relative to a reference value was calculated for each sample. These values were used to calculate TE using the equation $\mathrm{TE} = |\mathrm{Bias}| + 2s$ for each sample and expressed as concentrations relative to the respective reference value for each sample. The LoQ was defined as a Total Error (TE) of $21.6\%$.
The overall results of LoB, LoD, and LoQ for each matrix are summarized below:
| Sodium heparin venous whole blood | | | |
| --- | --- | --- | --- |
| Analyte | LoB | LoD | LoQ |
| Ca²⁺ (mmol/L) | 0.043 | 0.094 | 0.295 |
| Li⁺ (mmol/L) | 0.029 | 0.077 | 0.204 |
| Sodium heparin plasma | | | |
| --- | --- | --- | --- |
| Analyte | LoB | LoD | LoQ |
| Ca²⁺ (mmol/L) | 0.035 | 0.072 | 0.302 |
| Li⁺ (mmol/L) | 0.040 | 0.053 | 0.174 |
| Serum | | | |
| --- | --- | --- | --- |
| Analyte | LoB | LoD | LoQ |
| Ca²⁺ (mmol/L) | 0.047 | 0.089 | 0.299 |
| Li⁺ (mmol/L) | 0.041 | 0.079 | 0.199 |
7. Assay Cut-Off:
Not applicable.
8. Accuracy (Instrument):
Not applicable.
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9. Carry-Over:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Method comparison studies were conducted to demonstrate the correlation of Diamond Diagnostics SmartLyte® Plus Analyzer to the predicate device (GemLyte Electrolyte Analyzer) operated by trained personnel. Contrived samples were less than 10% of all samples tested and were limited to the extreme ends of claimed assay ranges. Slope, intercept, and R² were calculated from a linear regression analysis. Results are summarized below.
| Sodium Heparin Venous Whole Blood | | | | | |
| --- | --- | --- | --- | --- | --- |
| | Slope | Intercept | R² | n | Concentrations tested (mmol/L) |
| Sodium | 1.00 | 0.77 | 0.9987 | 109 | 43.7-198.6 |
| Potassium | 0.97 | -0.08 | 0.9953 | 109 | 2.1-14.9 |
| Chloride | 1.03 | -5.35 | 0.9952 | 108 | 51.4-197.8 |
| ionized Calcium | 1.00 | 0.03 | 0.9983 | 112 | 0.3-5.0 |
| Lithium | 1.01 | 0.09 | 0.9960 | 110 | 0.2-5.4 |
| Sodium Heparin Plasma | | | | | |
| --- | --- | --- | --- | --- | --- |
| | Slope | Intercept | R² | n | Concentrations tested (mmol/L) |
| Sodium | 1.02 | -3.04 | 0.9962 | 110 | 40.6-198.5 |
| Potassium | 1.00 | -0.13 | 0.9945 | 125 | 1.8-14.8 |
| Chloride | 0.99 | 0.33 | 0.9954 | 118 | 52.7-200.1 |
| ionized Calcium | 1.03 | -0.04 | 0.9982 | 113 | 0.3-4.6 |
| Lithium | 0.98 | 0.12 | 0.9940 | 122 | 0.2-5.3 |
| Serum | | | | | |
| --- | --- | --- | --- | --- | --- |
| | Slope | Intercept | R² | n | Concentrations tested (mmol/L) |
| Sodium | 1.01 | -0.98 | 0.9959 | 117 | 42.5-200.7 |
| Potassium | 1.02 | -0.23 | 0.9972 | 118 | 1.7-14.85 |
| Chloride | 1.01 | -1.60 | 0.9958 | 125 | 50.1-198.5 |
| ionized Calcium | 1.01 | -0.02 | 0.9963 | 117 | 0.3-4.9 |
| Lithium | 1.00 | 0.08 | 0.9939 | 109 | 0.1-5.3 |
| Urine | | | | | |
| --- | --- | --- | --- | --- | --- |
| | Slope | intercept | R² | n | Concentrations tested (mmol/L) |
| Sodium | 1.01 | -2.48 | 0.9985 | 117 | 5.0-290.0 |
| Potassium | 1.03 | -0.49 | 0.9984 | 115 | 5.4-119.5 |
| Chloride | 1.00 | 2.42 | 0.9977 | 118 | 17.0-297.2 |
K200544 - Page 11 of 12
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2. **Matrix Comparison:**
Not applicable since the performance studies described above were performed using each matrix for which the device is intended to be used.
**C Clinical Studies:**
1. **Clinical Sensitivity:**
Not applicable.
2. **Clinical Specificity:**
Not applicable.
3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Not applicable.
**D Clinical Cut-Off:**
Not applicable.
**E Expected Values/Reference Range:**
The values given in the tables below are from published literature*. Each laboratory or testing site should establish its own range for normal values.
Whole Blood, Serum and Plasma (mmol/L):
Na⁺: 136 - 145 mmol/L
K⁺: 3.5 - 5.1 mmol/L
Cl⁻: 97 - 111 mmol/L
Ca²⁺: 1.0 - 1.30 mmol/L
Li⁺: 0.6 - 1.2 mmol/L
Urine (mmol/L):
Na⁺: 40 - 220 mmol/L
K⁺: 25 - 120 mmol/L
Cl⁻: 110 - 250 mmol/L
*Reference: Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B. Saunders, Co., 1994) pp.1354-1360,2180-2206.
**F Other Supportive Instrument Performance Characteristics Data:**
Not applicable.
**VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
**IX Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K200544 - Page 12 of 12
