LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600

K172232 · Ams Diagnostics · JGS · Jun 12, 2019 · Clinical Chemistry

Device Facts

• Record ID: K172232
• Device Name: LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
• Applicant: Ams Diagnostics
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jun 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease 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. The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

Device Story

LIASYS 600 is a random-access, computer-controlled, standalone clinical chemistry analyzer. It processes human serum samples loaded onto dual carousels (100-sample capacity). Sodium, potassium, and chloride are measured via an Ion Selective Electrode (ISE) module; creatinine is measured via a photometric Jaffe reaction (picric acid/sodium hydroxide). The system translates electrical potential (Nernst equation) or absorbance (510 nm) into analyte concentrations. Operated by laboratory personnel in clinical settings, the device provides quantitative results to assist physicians in diagnosing electrolyte imbalances, renal disease, and metabolic disorders. It supports barcode specimen identification and requires external quality control materials and specific calibrators.

Clinical Evidence

Bench testing only. Performance established via precision studies (CLSI EP05-A3), linearity (CLSI EP06), detection limits (CLSI EP17-A2), and interference testing (CLSI EP07-A2). Method comparison study (N=109-117 samples) against legally marketed comparators showed strong correlation (R=0.990-0.998) and acceptable Deming regression slopes (0.956-1.056). No clinical trials performed.

Technological Characteristics

Random-access clinical chemistry analyzer. ISE module for Na/K/Cl; photometric/colorimetric (Jaffe) for creatinine. Reagents: 10 mM picric acid, 250 mM NaOH. Throughput: 600 tests/hr (absorbance), 120 tests/hr (ISE). Connectivity: Standalone, barcode-enabled, no wireless transmission. Traceable to NIST SRM 919b, 918c, 956d, 914a.

Indications for Use

Indicated for quantitative determination of sodium, potassium, chloride, and creatinine in human serum for patients requiring diagnosis or monitoring of electrolyte imbalances, metabolic disorders (e.g., cystic fibrosis, diabetic acidosis), or renal diseases. No specific age or gender contraindications provided, though icteric samples are contraindicated for sodium and creatinine testing.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k172232

B. Purpose for Submission:
New device

C. Measurand:
Sodium, potassium, chloride, and creatinine

D. Type of Test:
Quantitative, potentiometric, ion selective electrodes for sodium, potassium, and chloride
Quantitative, photometric/colorimetric method for creatinine

E. Applicant:
AMS Diagnostics

F. Proprietary and Established Names:
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600

G. Regulatory Information:

| Regulation | Classification | Product Code | Panel |
| --- | --- | --- | --- |
| 21 CFR 862.1665
Sodium Test System | Class II | JGS | Clinical Chemistry (75) |
| 21 CFR 862.1600
Potassium Test System | Class II | CEM | Clinical Chemistry (75) |
| 21 CFR 862.1170
Chloride Test System | Class II | CGZ | Clinical Chemistry (75) |
| 21CFR 862.1225
Creatinine Test System | Class II | CGX | Clinical Chemistry (75) |
| 21 CFR 862.2160
Discrete photometric chemistry analyzer for clinical use | Class I | JJE | Clinical Chemistry (75) |

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H. Intended Use:

1. Intended use:
See Indications for use.

2. Indications for use:
The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease 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.

The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

3. Special conditions for use statements:
For prescription use only.

4. Special instrument requirements:
LIASYS 600

I. Device Description:

The LIASYS 600 sodium, potassium, and chloride assays are supplied through an ISE (ion specific electrode) module installed onto the LIASYS 600 instrument. Internal solution composition: sodium 140 mmol/L, potassium 4.0 mmol/L, and chloride 125 mmol/L.

The LIASYS 600 creatinine assay is supplied as reagent kit in a single vial with ready to use liquid. Reagent concentrations: 10 mM picric acid, 250 mM sodium hydroxide 250 mM; pH 12.8 to 13.2.

The LIASYS 600 is a fully automated, random access, analyzer for clinical chemistry assays.

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J. Substantial Equivalence Information:

1. Predicate device names:
LIASYS Sodium, potassium, and chloride - k080468
Roche Reagent for Creatinine - k941837
LIASYS 450 SAT 450 - k113131

2. Predicate 510(k) numbers:
See predicate device names above.

3. Comparison with predicate:

| Similarities and Differences for Na/K/Cl | | |
| --- | --- | --- |
| Item | Candidate device k172232 | Predicate device k080468 |
| Intended use | For the quantitative determination of the sodium, potassium, and chloride concentration in serum. | Same |
| Method | Ion Selective Electrode | Same |
| Specimen types | Serum | Same |
| Measuring Range | Na: 53 - 200 mmol/L
K: 1.8 - 10.1 mmol/L
Cl: 50 - 200 mmol/L | Na: 27 - 200 mmol/L
K: 0.4 - 20 mmol/L
Cl: 27 - 200 mmol/L |
| Similarities and Differences for Creatinine | | |
| --- | --- | --- |
| Item | Subject device k172232 | Predicate device k941837 |
| Intended use | For the quantitative determination of the creatinine concentration in serum. | Same |
| Method | Colorimetric – Jaffe reaction. | Same |
| Specimen types | Serum | Serum, plasma, and urine |
| Measuring Range | 0.2 - 20 mg/dL | 0 - 30 mg/dL serum
0 - 200 mg/dL urine |

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| Similarities and Differences for LIASYS 600 | | |
| --- | --- | --- |
| Item | Candidate device k172232 | Predicate device k113131 |
| Intended use | A random access, computer controlled, standalone clinical analyzer for clinical chemistry intended for the in-vitro determination of analytes in human serum. | Same |
| Measurement Modes | Absorbance and ion selective electrodes. | Same |
| Throughput | Absorbance: 600 tests per hour
Ion selective electrodes: Serum 120 tests/hr | Absorbance: 450 tests per hour
Ion selective electrodes: Serum 120 tests/hr Urine 60 tests/hr |

K. Standard/Guidance Document Referenced:

CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.

CLSI EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.

CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition.

L. Test Principle:

The sodium, potassium, and chloride assays are based on ion selective electrode technologies that are specific for each ion of interest in the sample. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to the internal solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.

The creatinine assay is a photometric assay based on Jaffe reaction, in which creatinine reacts with picric acid under alkaline conditions to form a colored complex with absorbance at 510 nm.

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# M. Performance Characteristics:

# 1. Analytical performance:

# a. Precision/Reproducibility:

The precision performance for sodium, potassium, chloride, and creatinine was established by a within-laboratory study following the recommendations in CLSI EP05-A3 guideline. In the study, serum based control material samples were tested in duplicate per run with 2 runs per day over 20 days for a total of 80 measurements. The results are summarized below.

Sodium

| Mean, mmol/L | Repeatability %CV | Between-Run %CV | Between-Day %CV | Within-laboratory %CV |
| --- | --- | --- | --- | --- |
| 161 | 0.6% | 0.6% | 0.5% | 1.0% |
| 141 | 0.6% | 0.6% | 0.7% | 1.1% |
| 122 | 0.6% | 0.3% | 0.7% | 1.0% |

Potassium

| Mean, mmol/L | Repeatability %CV | Between-Run %CV | Between-Day %CV | Within-laboratory %CV |
| --- | --- | --- | --- | --- |
| 6.13 | 0.9% | 1.3% | 1.3% | 2.0% |
| 4.48 | 1.1% | 1.1% | 1.1% | 1.9% |
| 2.57 | 1.1% | 0.9% | 2.1% | 2.5% |

Chloride

| Mean, mmol/L | Repeatability %CV | Between-Run %CV | Between-Day %CV | Within-laboratory %CV |
| --- | --- | --- | --- | --- |
| 121 | 0.8% | 0.2% | 0.7% | 1.1% |
| 105 | 0.6% | 0.7% | 0.2% | 0.9% |
| 91.9 | 0.7% | 0.5% | 0.9% | 1.2% |

Creatinine

| Mean, mg/dL | Repeatability %CV | Between-Run %CV | Between-Day %CV | Within-laboratory %CV |
| --- | --- | --- | --- | --- |
| 0.48 | 5.7% | 2.3% | 5.8% | 8.5% |
| 1.11 | 1.7% | 1.4% | 4.0% | 4.6% |
| 4.55 | 1.7% | 2.2% | 2.2% | 3.6% |
| 12.48 | 0.9% | 1.8% | 1.0% | 2.3% |
| 16.73 | 0.8% | 0.8% | 0.9% | 1.5% |

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# b. Linearity/assay reportable range:

The linearity performance of the LIASYS 600 for sodium, potassium, chloride, and creatinine was established in a study by testing six samples across the measurement range in replicates of 2. The samples were commercially available standards. The expected values were plotted against the observed values and a linear regression line was fitted with the following regression equations:

| Analyte | Slope | Intercept | Correlation coefficient, R |
| --- | --- | --- | --- |
| Sodium | 0.989 | 0.8 | 0.978 |
| Potassium | 1.000 | 0.14 | 0.999 |
| Chloride | 0.994 | 1.6 | 0.988 |
| Creatinine | 0.990 | 0.13 | 0.980 |

The linearity studies support the following claimed measurement ranges:

| Analyte | Analytical Measurement Range | Sample Range Tested |
| --- | --- | --- |
| Sodium | 53 – 200 mmol/L | 26 – 204 mmol/L |
| Potassium | 1.8 – 10.1 mmol/L | 0.6 – 10.1 mmol/L |
| Chloride | 50 – 200 mmol/L | 26 – 200 mmol/L |
| Creatinine | 0.2 – 20.0 mg/dL | 0.1 – 19.7 mg/dL |

# c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The sodium, potassium, chloride, and creatinine assays on the LIASYS 600 are traceable to commercially available standards whose concentrations were verified against NIST Standard Reference Material (SRM) 919b for sodium, SRM 918c for potassium, SRM 956d for chloride, and SRM 914a for creatinine.

# d. Detection limit:

The detection limit of the LIASYS 600 creatinine assay was assessed in a study measuring the limit of quantitation (LoQ) following the recommendation in CLSI EP17-A2 guideline. The low level creatinine samples were measured in 10 replicates per run with 3 runs per day for 3 days. The results support the claimed LoQ for creatinine of $0.19\mathrm{mg / dL}$ using the sponsor definition of LoQ as the lowest concentration with $< 20\%$ CV.

The lower limit of the measurement range, supported by linearity studies above in M.1.b defines the detection limit for the LIASYS 600 sodium, potassium, and chloride assays.

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# e. Analytical specificity:

Interference testing on the LIASYS 600 for sodium, potassium, chloride, and creatinine was evaluated follow the recommendations in CLSI EP07-A2 guideline. The study tested for possible interference from bilirubin, lipemia, and hemolysis. Testing was conducted using samples with the following analyte concentrations: sodium = 138 mmol/L, potassium = 4 mmol/L, chloride = 93 mmol/L, creatinine = 1.1 mg/dL. The samples were divided into two aliquots: control sample with no added interferent and test sample with interferent added. The test samples were serially diluted into a series and measured in duplicates to identify the highest concentration without significant bias (i.e., <10% difference between test and control). The results of the study are given below.

| Sodium – Substances tested | Highest concentration without significant interference |
| --- | --- |
| Hemoglobin | 1000 mg/dL |
| Bilirubin conjugate, ditaurate | 10.7 mg/dL |
| Intralipid | 1130 mg/dL |
| Potassium – Substances tested | Highest concentration without significant interference |
| --- | --- |
| Hemoglobin | 900 mg/dL |
| Bilirubin conjugate, ditaurate | 17.3 mg/dL |
| Intralipid | 1130 mg/dL |
| Chloride – Substances tested | Highest concentration without significant interference |
| --- | --- |
| Hemoglobin | 1000 mg/dL |
| Bilirubin conjugate, ditaurate | 17.3 mg/dL |
| Intralipid | 1130 mg/dL |
| Creatinine – Substances tested | Highest concentration without significant interference |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Bilirubin conjugate, ditaurate | 7.9 mg/dL |
| Intralipid | 538 mg/dL |

The following limitations are identified in the product labeling:

Do not test for sodium in icteric samples.

Do not test for creatinine in icteric samples.

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f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

The accuracy performance of the LIASYS 600 was evaluated in a method comparison study by comparing sodium, potassium, chloride, and creatinine measurements for agreement to legally marketed comparator methods. For the study, serum specimens were tested in singlicate on the subject device and in duplicate on the comparator methods. To cover the measurement range, no more than 10% of the samples were diluted and/or spiked. The results of the method comparison study are summarized as follows.

Deming regression analysis

| Analyte | Slope | Intercept | R | N | Range Tested |
| --- | --- | --- | --- | --- | --- |
| Sodium | 1.019 | -3.2 | 0.990 | 110 | 53 - 197 mmol/L |
| Potassium | 1.056 | -0.3 | 0.998 | 111 | 1.80 - 9.70 mmol/L |
| Chloride | 0.956 | 6.8 | 0.990 | 117 | 50 - 192 mmol/L |
| Creatinine | 1.031 | 0.08 | 0.998 | 109 | 0.2 to 19.8 mg/dL |

b. Matrix comparison:

Not applicable, only human serum samples are indicated.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

c. Other clinical supportive data:

Not applicable.

4. Clinical cut-off:

Not applicable.

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5. Expected values/Reference range:

The product labeling identifies the following reference ranges from the literature:

Sodium¹ 136 – 145 mmol/L
Potassium¹ 3.5 – 5.1 mmol/L
Chloride¹ 98 – 107 mmol/L
Creatinine²
men 0.72 – 1.18 mg/dL
women 0.55 – 1.02 mg/dL

Sources:
1. Tietz, textbook of Clinical Chemistry 2nd ed, Philadelphia, W.B. Saunders, (1994).
2. Henry RJ (Ed). Clin. Chem. Principles and Techniques (2nd Ed). Harper and Row. 1974, 548-551.

N. Instrument Name:

LIASYS 600

O. System Descriptions:

1. Modes of Operation:
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☐ X or No ☐
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?
Yes ☐ or No ☐ X

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐

3. Specimen Identification:
Barcode option for specimen identification.

4. Specimen Sampling and Handling:
Sample specimens are loaded onto the instrument’s two independent carousels which can host a total of 100 samples.

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5. Calibration:
The product labeling recommends for calibration of sodium, potassium, and chloride the use of an appropriate ISE calibrator, and for the creatinine assay the use of AMS Chemistry Calibrator.

6. Quality Control:
The product labeling recommends for quality control the use of two levels of external quality control materials.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Not applicable.

Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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