Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

K151767 · Siemens Healthcare Diagnostics, Inc. · JGS · Dec 11, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151767
• Device Name: Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium 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. Measurements of potassium obtained by this device 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 TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System.

Device Story

Trinidad CH System is a floor-model, fully automated, microprocessor-controlled clinical chemistry analyzer. It processes human serum, plasma, and urine samples using photometric and ion-selective electrode (ISE) technologies. The system includes an analytical module and a Direct Load (DL) sample handler. For electrolytes (Na, K, Cl), the system uses an Integrated Multisensor (IMT) with four electrodes; samples are pre-diluted 1:10 with diluent before analysis. Potentiometric measurements are compared against standard solutions using the Nernst equation. For albumin, the system uses a bromocresol purple (BCP) dye-binding method measured as an endpoint reaction at 596/694 nm. The system performs automated two-point calibrations every 4 hours and one-point checks with each measurement. Results are stored in a database and used by clinicians to diagnose and monitor electrolyte imbalances, metabolic disorders, and hepatic or renal conditions. The system supports random continuous access, batch, or discrete processing.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP17-A2, EP06-A, EP05-A2, EP09-A3). Studies included LoB/LoD/LoQ determination, linearity, precision (n=80 replicates), interference testing, and method comparison against the ADVIA 1800 predicate and reference methods (flame emission spectrophotometry/coulometry). Method comparison showed high correlation (r > 0.99) for Na, K, Cl, and albumin across clinical ranges. Matrix equivalency (serum/plasma/urine) was demonstrated.

Technological Characteristics

Floor-model, automated, microprocessor-controlled analyzer. Uses photometric and indirect potentiometric (ISE) detection. Light source: 12V, 50W halogen lamp and LED. Connectivity: Barcode identification (Interleaved 2 of 5, Code 39, 128, Codabar, 2D data matrix). Software-controlled, automated dilution (1:10 for IMT). Reagents: Prepackaged packs. Calibration: Automated two-point (every 4 hours) and one-point checks.

Indications for Use

Indicated for quantitative determination of Na, K, Cl, and albumin in human serum, plasma, and urine. Used for diagnosis/treatment of electrolyte imbalances (aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, SIADH), electrolyte/metabolic disorders (cystic fibrosis, diabetic acidosis), and liver/kidney diseases. Prescription use only.

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.

Predicate Devices

• Siemens ADVIA 1800 Chemistry System (K990346)
• Siemens ADVIA 1800 Chemistry System (K132664)

Submission Summary (Full Text)

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

A. 510(k) Number:
K151767

B. Purpose for Submission:
New devices

C. Measurand:
Sodium, Potassium, Chloride, Albumin

D. Type of Test:
Quantitative, photometry, and ion selective multisensors for electrolytes

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
Trinidad CH system
TD-LYTE Integrated Multisensor (Na, K, Cl)
TD-LYTE IMT Standard A
TD-LYTE IMT Standard B + Salt Bridge
Trinidad CH Albumin BCP Reagent (Alb_P)
Trinidad CH Albumin BCP Calibrator

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JGS | Class II | 21 CFR 862.1665 Sodium Test System | Clinical Chemistry (75) |
| CEM | | 21 CFR 862.1600 Potassium Test System | |
| CGZ | | 21 CFR 862.1170 Chloride Test System | |
| CJW | | 21 CFR 862.1035 Albumin Test System | |
| JIT | | 21 CFR 862.1150 Calibrator (single analyte) | |
| JIX | | 21 CFR 862.1150 Calibrator (multiple analytes) | |
| JJE | Class I, exempt | 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use | |

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H. Intended Use:

1. Intended use(s):

See Indications for use below

2. Indication(s) for use:

The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform *in vitro* diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.

The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for *in vitro* diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium 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. Measurements of potassium obtained by this device 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 TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.

The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System.

The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for *in vitro* diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Trinidad CH Albumin BCP calibrator is for *in vitro* diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System.

3. Special conditions for use statement(s):

For prescription use only

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4. Special instrument requirements:

Trinidad CH System

I. Device Description:

The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL). The TD-LYTE IMT system consists of the following:

- TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode.
- TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na⁺ at 14 mmol/L, K⁺ at 0.4 mmol/L and Cl⁻ at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na⁺ at 7 mmol/L, K⁺ at 6 mmol/L and Cl⁻ at 16 mmol/L. The target concentrations of the Salt Bridge include: K⁺ at 120.0 mmol/L and Cl⁻ at 120.0 mmol/L.
- TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing.
- TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results.

The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL.

The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling.

Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV).

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J. Substantial Equivalence Information:

1. Predicate device name(s):
Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays

2. Predicate 510(k) number(s):
K990346, K132664

3. Comparison with predicate:
Instrument

| Item | Trinidad CH System
(Candidate Device k151767) | ADVIA 1800 Chemistry System
(Predicate Device K990346) |
| --- | --- | --- |
| Similarities | | |
| Type of System | Random continuous access, batch, discrete processing | Same |
| Types of Measurements | Quantitative, photometry, and ion selective multisensors for electrolytes | Same |
| Throughput Rate | 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE | Same |
| Sample Containers | Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups | Same |
| Sample Type | Whole blood, serum, plasma, CSF or urine | Same |
| Auto-dilution | Automatic dilution from retained pre-diluted sample | Same |
| QC | provide stored control results, Levy-Jennings plotting, and statistics | Same |
| Differences | | |
| Optical system | Water bath and cuvette optical path length (7 mm) | Oil bath and cuvette optical path length (10 mm) |
| Assay Capacity On-board | Up to 70 slots including 3 ISE | 56 slots including 3 ISE |
| Assays | Endpoint, rate reaction, 2-point rate, sample blank correction. | Endpoint, rate reaction, 2-point rate. |
| Reaction Times | 3, 4, 5, 10, 15 and 21 minutes | 3 to 10 minutes |
| Auto-repeat | Automatic repeat testing from the retained pre-diluted sample | Automatic repeat testing from the retained pre-diluted sample or original sample |
| Auto-reflex | Not available | Ability to perform 3 additional tests based on results of first test |
| Photometer | 11 fixed wavelengths | 14 fixed wavelengths (12 utilized) |

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| Item | Trinidad CH System
(Candidate Device k151767) | ADVIA 1800 Chemistry System
(Predicate Device K990346) |
| --- | --- | --- |
| Light Source | 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED | 12V, 50W halogen lamp, cooled by forced water circulation |
| Bar Codes | Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D | Interleaved 2 of 5, code 39, code 128, Codabar (NW7) |
| Power Requirements | 200-240 VAC +/-10%, 8Amp, 50/60 Hz, 3.2 KVA | 200/220/230 V +/-10%, 30Amp, 50/60 Hz, 3 KVA |
| Dimensions | Analytical Module:
136.35 (h) x 145.25 (w) x 118.33 (d) cm

Direct Load:
136.5 (h) x 42.53 (w) x115.0 (d) cm | 113.3 (h) x 148.0 (w) x 87.7 (d) cm |
| Result Database | Stores up to 1 million results. | 7 days of results maintained in a flat file system |

## ISE Assays

| Item | Trinidad CH System
(Candidate Device k151767) | ADVIA 1800 Chemistry System
(Predicate Device K990346) |
| --- | --- | --- |
| Similarities | | |
| Intended Use | For in vitro diagnostic use in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine | Same |
| Method Principle | Ion Selective Electrode with potentiometric method | Same |
| Standardization | Na: Flame photometric with NIST reference standards
K: Flame photometric method with NIST reference serum
Cl: Coulometric method with NIST standards | Same |
| Analytical Measuring Interval: | Serum/Plasma
K: 1.0 – 10.0 mmol/L | Same |
| Reference Interval | Urine
Na: 40 – 220 mmol/day
K: 25 – 125 mmol/day
Cl: 110 – 250 mmol/day | Same |

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| Item | Trinidad CH System (Candidate Device k151767) | ADVIA 1800 Chemistry System (Predicate Device K990346) |
| --- | --- | --- |
| Differences | | |
| ISE Internal Standard | built-in reference electrode | None |
| Sample Volume | 25 μL for all three tests | 22 μL total for all three tests |
| Calibration/Control Tray | Calibrators and controls delivered by Direct Load / manual input. | 61 refrigerated positions for calibrators, controls and diluents |
| Technology | Indirect potentiometric measurements with Integrated Multisensor Technology (IMT) | Indirect potentiometric measurements with ion selective electrodes |
| Analytical Measuring Interval: | Serum/Plasma Na: 50 – 200 mmol/L Cl: 50 – 200 mmol/L Urine Na: 10 – 300 mmol/L K: 2.0 – 300 mmol/L Cl: 20 – 330 mmol/L | Serum/Plasma Na: 100 – 200 mmol/L Cl: 15 – 200 mmol/L Urine Na: 10 – 400 mmol/L K: 3.0 – 300 mmol/L Cl: 15 – 400 mmol/L |
| Reference Interval | Serum/Plasma Na: 136–145 mmol/L K (serum): 3.5–5.1 mmol/L K (plasma): 3.4–4.5 mmol/L Cl: 98–107 mmol/L | Serum/Plasma Na: 132 – 146 mmol/L K (Serum): 3.5 – 5.5 mmol/L K (Plasma/males): 3.5 – 4.5 mmol/L K (Plasma/females): 3.4 – 4.4 mmol/L Cl: 99 – 109 mmol/L |
| Calibration Frequency | Every 4 hours | Daily |
| Calibrator | TD-LYTE IMT Standard A and IMT Standard B + Salt Bridge | ADVIA Chemistry ISE Serum Standard & ADVIA Chemistry ISE Urine Standard Set |
| Calibrator Levels | Two for both serum and urine | Two for serum and Two for Urine |

Albumin Assay

| Item | Trinidad CH System (Candidate Device k151767) | ADVIA 1800 Chemistry System (Predicate Device K132664) |
| --- | --- | --- |
| Similarities | | |
| Intended Use | For in vitro diagnostic use in the quantitative determination of albumin in human serum or plasma | Same |
| Technology | bromocresol purple (BCP) dye-binding method | Same |
| Reference Interval | 3.4–5.0 g/dL | Same |

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| Item | Trinidad CH System (Candidate Device k151767) | ADVIA 1800 Chemistry System (Predicate Device K132664) |
| --- | --- | --- |
| Standardization | ERM-DA470k Reference Material | Same |
| Calibrator Levels | One | Same |
| Differences | | |
| Analytical Measuring Interval: | 0.5 - 8.0 g/dL | 0.6-8.0 g/dL |
| Interferences | Bilirubin (Conjugated) - 30 mg/dL Bilirubin (Unconjugated) - 30 mg/dL Lipemia - 500 mg/dL Hemoglobin - 600 mg/dL | Bilirubin (Conjugated) - 60 mg/dL Bilirubin (Unconjugated) - 60 mg/dL Lipemia - 500 mg/dL Hemoglobin - 500 mg/dL |
| Calibration Frequency | Every 30 days | Every 60 days |
| Calibrator | Albumin BCP Calibrator | ADVIA Chemistry Albumin BCP Calibrator |

# K. Standard/Guidance Document Referenced (if applicable):

CLSI - EP05-A2 Evaluation of precision performance of Clinical Chemistry Devices.

CLSI - EP06-A Evaluation of linearity of Quantitative analytical methods.

CLSI - EP07-A2. Interference testing in Clinical Chemistry

CLSI - EP09-A3 Method comparison and bias estimation using patient samples

CLSI - EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures

CLSI - EP28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory

CLSI - EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents

# L. Test Principle:

The TD-LYTE Integrated Multisensor (Na, K, Cl) uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.

A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and $\mathrm{Na^{+}}$ , $\mathrm{K^{+}}$ or $\mathrm{Cl^-}$ ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.

The Trinidad CH IMT system performs a two point automatic calibration in duplicate every 4

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hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power on, with the changing of standards A, B, or a sensor and when the system software is reset.

The Trinidad CH Albumin BCP Regent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at $596 / 694\mathrm{nm}$ .

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Precision testing was performed in accordance with CLSI EP05-A2 guidance. Precision for the Na, K and Cl were evaluated by testing controls, serum pools and urine pools in two replicates per run, two runs per day for 20 days on one instrument. The data are summarized in the following tables:

Sodium

| Specimen | N | Mean (mmol/L) | Repeatability | | Within Lab | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| Serum Pool | 80 | 71.6 | 0.36 | 0.5 | 0.60 | 0.8 |
| Serum QC 1 | 80 | 114 | 0.69 | 0.6 | 1.19 | 1.0 |
| Serum QC 2 | 80 | 141 | 0.84 | 0.6 | 1.41 | 1.0 |
| Serum QC 3 | 80 | 154 | 0.82 | 0.5 | 1.36 | 0.9 |
| Urine Pool 1 | 80 | 32.2 | 0.33 | 1.0 | 0.50 | 1.5 |
| Urine QC 1 | 80 | 80.3 | 0.52 | 0.6 | 0.83 | 1.0 |
| Urine QC 2 | 80 | 177 | 1.23 | 0.7 | 1.85 | 1.0 |
| Urine Pool 2 | 80 | 284 | 1.7 | 0.6 | 3.17 | 1.1 |

Potassium

| Specimen | N | Mean (mmol/L) | Repeatability | | Within Lab | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| Serum QC 1 | 80 | 2.7 | 0.01 | 0.4 | 0.03 | 1.0 |
| Serum QC 2 | 80 | 3.97 | 0.02 | 0.5 | 0.03 | 0.9 |
| Serum Pool | 80 | 5.88 | 0.03 | 0.4 | 0.04 | 0.7 |
| Serum QC 3 | 80 | 7.31 | 0.04 | 0.5 | 0.06 | 0.8 |
| Urine QC 1 | 80 | 31.2 | 0.15 | 0.5 | 0.30 | 0.9 |
| Urine QC 2 | 80 | 73.7 | 0.39 | 0.5 | 0.69 | 0.9 |
| Urine Pool | 80 | 258 | 2.01 | 0.8 | 2.95 | 1.1 |

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Chloride

| Specimen | N | Mean (mmol/L) | Repeatability | | Within Lab | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| Serum QC 1 | 80 | 78.1 | 0.73 | 0.9 | 1.15 | 1.5 |
| Serum QC 2 | 80 | 102 | 0.83 | 0.8 | 1.05 | 1.0 |
| Serum QC 3 | 80 | 114 | 0.78 | 0.7 | 0.99 | 0.9 |
| Serum Pool | 80 | 189 | 1.01 | 0.5 | 1.30 | 0.7 |
| Urine Pool 1 | 80 | 42.7 | 0.26 | 0.5 | 0.71 | 1.7 |
| Urine QC 1 | 80 | 99.7 | 0.65 | 0.6 | 0.97 | 1.0 |
| Urine QC 2 | 80 | 194 | 0.99 | 0.5 | 1.76 | 0.9 |
| Urine Pool 2 | 80 | 280 | 1.23 | 0.4 | 2.16 | 0.8 |

Precision for the albumin was evaluated by testing controls and a serum pool in two replicates per run, two runs per day for 21 days on one instrument. The data are summarized in the following tables:

Albumin

| Specimen | N | Mean (g/dL) | Repeatability | | Within Lab | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (g/dL) | CV (%) | SD (g/dL) | CV (%) |
| Serum QC 1 | 84 | 2.7 | 0.03 | 1.2 | 0.03 | 1.2 |
| Serum QC 2 | 80* | 3.6 | 0.04 | 1.1 | 0.05 | 1.4 |
| Serum QC 3 | 84 | 7.1 | 0.05 | 0.7 | 0.07 | 1.0 |
| Serum Pool | 80** | 3.3 | 0.04 | 1.4 | 0.06 | 1.8 |

*four data points from one day were not included due to an instrument error (failed assay with foam error).
** four data points from one day were not included due to an operator error (wrong sample was tested).

# b. Linearity/assay reportable range:

The linearity studies were performed followed the CLSI EP06-A guidance. For the three electrolytes, nine equally spaced samples covering the measurement range were prepared by mixing high and low concentration samples. Three replicates were measured for each sample. The mean of these replicates was compared to the expected values and the results of weighted linear regressions are summarized in the table below:

| Analyte in Serum | Claimed Measuring Range | Sample Range Tested | Slope | Intercept |
| --- | --- | --- | --- | --- |
| Sodium | 50.0 to 200 mmol/L | 47.4 to 208 mmol/L | 0.98 | 0.19 |
| Potassium | 1.0 to 10.0 mmol/L | 0.98 to 10.0 mmol/L | 0.98 | 0.00 |
| Chloride | 50.0 to 200 mmol/L | 45.9 to 205 mmol/L | 1.01 | -0.22 |

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| Analyte in Urine | Claimed Measuring Range | Sample Range Tested | Slope | Intercept |
| --- | --- | --- | --- | --- |
| Sodium | 10 to 300 mmol/L | 7.87 to 337 mmol/L | 0.94 | 0.35 |
| Potassium | 2 to 300 mmol/L | 0.24 to 314 mmol/L | 1.00 | -0.38 |
| Chloride | 20 to 330 mmol/L | 10.3 to 397 mmol/L | 1.04 | -0.35 |

For the albumin, nine equally spaced samples covering the measurement range were prepared by mixing a high serum pool spiked with purified albumin and sample diluent. Five replicates were measured for each sample. The mean of these replicates was compared to the expected values and the results of a simple linear regression are summarized in the table below:

| Analyte in Serum | Claimed Measuring Range | Sample Range Tested | Slope | Intercept |
| --- | --- | --- | --- | --- |
| Albumin | 0.5 to 8.0 g/dL | 0.2 to 9.2 g/dL | 1.00 | 0.06 |

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

# Traceability

The Trinidad CH Na assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the National Institute of Standards and Technology (NIST), via patient sample correlation and is verified using NIST Reference Serum.

The Trinidad CH K assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the National Institute of Standards and Technology (NIST), via patient sample correlation and is verified using NIST Reference Serum.

The Trinidad CH Cl assay is traceable to a coulometric reference method, which uses reference materials from the National Institute of Standards and Technology (NIST), via patient sample correlation and is verified using NIST Reference Serum.

The Trinidad CH Albumin BCP assay is traceable to the SI unit through the use of IRMM ERM® DA470k reference material. Assigned values for calibrators are traceable to this standardization.

# Stability

Shelf life stability studies were performed with assay reagents, standards and calibrator, and demonstrated that they are stable for a year when stored unopened as instructed. Once opened, the TD-LYTE Integrated Multisensor (Na, K, Cl) is stable for 14 days on board. The TD-LYTE IMT Standard A & TD-LYTE IMT Standard B + Salt Bridge are stable for 30 days on board. The Trinidad CH System Albumin BCP Reagents (Alb_P) are stable for 20 days on board. The reconstituted Trinidad

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CH System Albumin BCP calibrators are stable for 8 hours on board. The protocols for stability and acceptance criteria were reviewed and found to be adequate.

## Value assignment

Concentrations of the TD-LYTE IMT Standard A & TD-LYTE IMT Standard B Salt Bridge are assigned through an internal procedure. Production lots are gravimetrically prepared and value assigned from master lots. The master lots are traceable to the reference methods via serum anchor pools (secondary reference materials). The serum anchor pools were value assigned through the primary reference procedures and then used to calibrate the instruments used to assign values for the master lots.

The target values for the Standard A and Standard B solutions are stated in the following table:

| | Standard A | Standard B |
| --- | --- | --- |
| Sodium | 14.0 mmol/L | 7.0 mmol/L |
| Potassium | 0.4 mmol/L | 6.0 mmol/L |
| Chloride | 10.4 mmol/L | 16.0 mmol/L |

Values assigned to the Trinidad CH Albumin BCP Calibrator are traceable to the SI unit through the use of IRMM ERM® 470 reference material. ERM® 470 is used to calibrate a nephelometric immunochemical method and assign values to a master pool. The master pool is then used to calibrate the instruments used to assign values for the product calibrators using a standard value assignment process. The target value for Trinidad CH Albumin BCP Calibrator is 4.3 g/dL.

The protocols for value assignment and acceptance criteria were reviewed and found to be adequate.

## d. Detection limit:

The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) were evaluated in accordance with CLSI EP17-A2 Guideline.

For the three electrolytes, LoB was determined by running 4 blank samples of each sample matrix type in 5 replicates per day for 3 days using 2 reagent lots. LoD was determined by running 4 low or diluted patient samples of each sample matrix type in 5 replicates per day for 3 days using 2 reagent lots. LoQ was determined by running 4 low samples of each sample matrix type in 5 replicates per day for 3 days using 2 reagent lots. The results are summarized in the table below:

| Sodium | LoB (mmol/L) | LoD (mmol/L) | LoQ (mmol/L) | Observed Total Error at LoQ level |
| --- | --- | --- | --- | --- |
| serum | 10.2 | 11.9 | 40.4 | 4.8% |
| urine | 4.72 | 5.30 | 5.35 | 1.78 mmol/L |

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| Potassium | LoB (mmol/L) | LoD (mmol/L) | LoQ (mmol/L) | Observed Total Error at LoQ level |
| --- | --- | --- | --- | --- |
| serum | 0.244 | 0.279 | 0.792 | 16.3% |
| urine | 0.00 | 0.079 | 1.03 | 0.20 mmol/L |
| Chloride | LoB (mmol/L) | LoD (mmol/L) | LoQ (mmol/L) | Observed Total Error at LoQ level |
| --- | --- | --- | --- | --- |
| serum | 2.23 | 4.43 | 38.3 | 10.3% |
| urine | 4.86 | 5.47 | 15.8 | 2.41 mmol/L |

For albumin, LoB was determined by running 6 blank samples in 5 replicates per day for 3 days using 3 reagent lots. LoD was determined by running 5 low or diluted patient samples in 5 replicates per day for 3 days using 3 reagent lots. LoQ was determined by running 5 low samples type in 5 replicates per day for 3 days using 3 reagent lots. LoQ is defined as the lowest concentration for which the inter-assay precision is $< 10\%$ . The results are summarized in the table below:

| Albumin | LoB (g/dL) | LoD (g/dL) | LoQ (g/dL) |
| --- | --- | --- | --- |
| serum | 0.1 | 0.2 | 0.4 |

The claimed measuring range of the assays is summarized in the tables below:

| Analyte in Serum | Claimed Measuring Range |
| --- | --- |
| Sodium | 50.0 to 200 mmol/L |
| Potassium | 1.0 to 10.0 mmol/L |
| Chloride | 50.0 to 200 mmol/L |
| Albumin | 0.5 to 8.0 g/dL |
| Analyte in Urine | Claimed Measuring Range |
| --- | --- |
| Sodium | 10 to 300 mmol/L |
| Potassium | 2 to 300 mmol/L |
| Chloride | 20 to 330 mmol/L |

# e. Analytical specificity:

Interference studies were performed according to CLSI EP-7A guidance to determine the effects from potential interferents on the ISE and albumin assays. Various concentrations of interferents were spiked into two levels (low and high) of each analyte in serum or urine. Testing was performed in either three replicates (for the electrolytes) or five replicates (for albumin) per level using one reagent lot on one

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instrument. The sponsor states that interference is considered to be non-significant if the bias between the tested and control samples are within $+/-10\%$ .

The highest concentration tested that shows non-significant interference are summarized below:

Sodium (serum)

| Interferent | Tested Concentration |
| --- | --- |
| Hemoglobin | 750 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 3000 mg/dL |
| Potassium | 10 mM |
| Magnesium | 20 mg/dL |
| Calcium | 20 mg/dL |
| Lithium | 3.5 mg/dL |
| Borate | 2.5 mg/dL |
| Acetate | 20 mg/dL |
| Benzoate | 10 mg/dL |
| Citrate | 1 g/dL |
| Ammonium | 0.5 mmol/L |
| Thiopental | 14 mg/dL |

Sodium (urine)

| Interferent | Tested Concentration |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 2000 mg/dL |
| Acetaminophen | 200 mg/dL |
| N-Acetyl cysteine | 2 mg/dL |
| Ascorbic Acid | 60 mg/dL |
| Sodium Cefoxitin | 660 mg/dL |
| Gentamycin Sulfate | 10 mg/dL |
| Ibuprofen | 500 mg/dL |
| Levodopa | 100 mg/dL |
| Ofloxacin | 90 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Tetracycline | 15 mg/dL |
| Low pH | pH 4 |
| High pH | pH 8 |

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Potassium (serum)

| Interferent | Tested Concentration |
| --- | --- |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 3000 mg/dL |
| Magnesium | 20 mg/dL |
| Calcium | 20 mg/dL |
| Lithium | 3.5 mg/dL |
| Borate | 2.5 mg/dL |
| Acetate | 20 mg/dL |
| Benzoate | 10 mg/dL |
| Citrate | 1 g/dL |
| Ammonium | 0.5 mmol/L |
| Iron | 250 mg/dL |

Potassium (urine)

| Interferent | Tested Concentration |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 2000 mg/dL |
| Acetaminophen | 200 mg/dL |
| N-Acetyl cysteine | 2 mg/dL |
| Ascorbic Acid | 60 mg/dL |
| Sodium Cefoxitin | 660 mg/dL |
| Gentamycin Sulfate | 10 mg/dL |
| Ibuprofen | 500 mg/dL |
| Levodopa | 100 mg/dL |
| Ofloxacin | 90 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Tetracycline | 15 mg/dL |
| Low pH | pH 4 |
| High pH | pH 8 |

Chloride (serum)

| Interferent | Tested Concentration |
| --- | --- |
| Hemoglobin | 750 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 3000 mg/dL |
| Borate | 2.5 mg/dL |
| Acetate | 20 mg/dL |
| Benzoate | 150 mg/dL |
| Citrate | 0.5 g/dL |
| Sulfate | 2 mmol/L |

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| Salicylate | 50 mg/dL |
| --- | --- |
| Oxalate | 0.5 mmol/L |
| Fluoride | 250 mg/dL |
| Iodine | 25 mg/dL |
| Bromide | 50 mg/dL |

Chloride (urine)

| Interferent | Tested Concentration |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 2000 mg/dL |
| Acetaminophen | 200 mg/dL |
| N-Acetyl cysteine | 2 mg/dL |
| Ascorbic Acid | 60 mg/dL |
| Sodium Cefoxitin | 660 mg/dL |
| Gentamycin Sulfate | 10 mg/dL |
| Ibuprofen | 400 mg/dL |
| Levodopa | 100 mg/dL |
| Ofloxacin | 80 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Tetracycline | 15 mg/dL |
| Low pH | pH 4 |
| High pH | pH 8 |

Albumin (serum)

| Interferent | Tested Concentration |
| --- | --- |
| Hemoglobin | 600 mg/dL |
| Conjugated Bilirubin | 30 mg/dL |
| Unconjugated Bilirubin | 30 mg/dL |
| Lipemia (Intralipid) | 500 mg/dL |

The sponsor added the following limitations to their labeling:

- Avoid Hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium. Intracellular potassium concentration is 30-50 fold greater than that of extracellular serum or plasma.
- Samples exposed to Benzalkonium salts present in certain blood catheter devices will cause falsely elevated sodium and potassium measurements.*
- Citrate at 1 g/dL decreases the chloride result in serum at 82.4 mmol/L by -11.9%.
- Fluoride at 1 g/dL increases the chloride result in serum at 81.7 mmol/L by 40.0% and 101 mmol/L by 55.4%.
- Iodine at 50 mg/dL increases the chloride result in serum at 82.2 mmol/L by 15.7%.

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- Bromide at 200 mg/dL increases the chloride result in serum at 82.1 mmol/L by 54.7% and 101 mmol/L by 36.4%.
- Iron at 1 g/dL increases the potassium result in serum at 2.75 mmol/L by 16.4% and 4.54 mmol/L by 11.1%.
- Ibuprofen at 500 mg/dL increases the chloride result in urine at 47.2 mmol/L by 18.5%.
- Ofloxacin at 90 mg/dL decreases the chloride result in urine at 55.8 mmol/L by -11.3%.

* Koch TR, Cook JD. Benzalkonium interference with test methods for potassium and sodium. Clin Chem. 1990;36:807-8.

f. Assay cut-off:

Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

Method comparison studies were performed following CLSI EP9-A3. Patient samples for each sample matrix type were run in singlet on one Trinidad CH System and the results were compared to those obtained on the predicate device (ADVIA 1800 Chemistry System). Less than 10% of the samples were spiked or diluted to fully span the claimed measuring range of each analyte. The Passing-Bablok regression analysis for the three electrolytes and the simple linear regression analysis for the albumin results are summarized below:

| Analyte | Specimen Type | Slope | Intercept | Correlation Coefficient (r) | N | Concentration range tested (mmol/L) |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | Serum | 1.00 | -4.00 | 0.995 | 106 | 97.5–197 |
| Sodium | Urine | 1.01 | 0.97 | 1.000 | 101 | 15.6–285 |
| Potassium | Serum | 0.96 | 0.10 | 0.998 | 103 | 1.49–9.59 |
| Potassium | Urine | 1.03 | -0.67 | 0.998 | 105 | 3.7–280.9 |
| Chloride | Serum | 1.00 | 0.00 | 0.998 | 108 | 59–196 |
| Chloride | Urine | 0.99 | -0.28 | 0.999 | 102 | 19–321 |
| Albumin | Serum | 0.99 | 0.01 | 0.996 | 130 | 0.9–7.9 g/dL |

b. Matrix comparison:

Serum and lithium heparin plasma equivalency was demonstrated for the Sodium, Potassium and Chloride assays on the Trinidad CH Instrument System by testing 50 matched samples. Less than 10% of total samples were samples diluted with water or spiked with NaCl or KCl to span the assay ranges. One replicate of each sample was collected and used for the analyses. The table below summarizes the Deming linear

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regression results statistics when comparing lithium heparin plasma sample results (Y) to serum sample results (X):

| Assay | N | Range of Samples (mmol/L) | Slope | Y-Intercept |
| --- | --- | --- | --- | --- |
| Sodium | 50 | 92.6 to 196 | 0.99 | 0.51 |
| Potassium* | 50 | 1.47 to 9.79 | 0.93 | 0.02 |
| Chloride | 50 | 64.4 to 163 | 0.99 | 0.52 |

*the sponsor displayed the following statement in labeling:

It is documented in the literature that potassium concentrations in plasma specimens can be lower than in serum specimens as a consequence of platelet rupture during coagulation. The extent of the potential difference is dependent on the platelet count in the specimen. The lower potassium reference intervals for plasma specimens compared to serum specimens reflect this known occurrence.

The sponsor performed an additional method comparison study with 59 lithium heparin plasma samples on the potassium assays of the Trinidad CH Analyzer and the ADVIA Chemistry 1800. The study collected one replicate on each instrument for each sample. Deming regression was used to analyze the data and the results are summarized below.

| Specimen Type | Comparison Assay | N | Slope | Intercept | r | Concentration range tested (mmol/L) |
| --- | --- | --- | --- | --- | --- | --- |
| lithium heparin plasma | ADVIA Chemistry 1800 | 59 | 0.96 | 0.18 | 0.999 | 0.88 – 9.94 |

# 3. Clinical studies:

a. Clinical Sensitivity:

Not Applicable

b. Clinical specificity:

Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not Applicable

# 4. Clinical cut-off:

Not Applicable

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5. Expected values/Reference range:

Reference ranges of Na, K, and Cl are cited from literature:
Serum/Plasma Sodium: 136 – 145 mmol/L
Serum Potassium: 3.5 – 5.1 mmol/L
Plasma Potassium: 3.4 – 4.5 mmol/L
Serum/Plasma Chloride, 98 – 107 mmol/L
Urine Sodium: 40 – 220 mmol/24 hrs
Urine Potassium: 25 – 125 mmol/24 hrs
Urine Chloride: 110 – 250 mmol/24 hrs

Tietz Fundamentals of Clinical Chemistry, 5th ed, Philadelphia, PA; WB Saunders Company (2001), ISBN 0-7216-8634-6.

Reference range for albumin is cited from literature:

Albumin: 3.4 – 5.0 g/dL for adults

Willey DA, Savory J, Lasky F. An Evaluation of a Revised Albumin Method for the aca® discrete clinical analyzer, Du Pont Company, Wilmington, DE, August 1982.

N. Instrument Name:

Trinidad CH system

O. System Descriptions:

1. Modes of Operation:

Random continuous access, batch, or discrete processing

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:

The software for the Trinidad CH system is determined to have a moderate level of concern.

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FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ X ☐ or No ☐

3. Specimen Identification:

Manual entry or barcode identification

4. Specimen Sampling and Handling:

Samples are identified and delivered by the sample handler (Direct Load), which is part of the Trinidad CH system.

5. Calibration:

The Trinidad CH System IMT system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power on, with the changing of standards A, B, or a sensor and when the system software is reset. In addition, a new calibration is required under the following conditions:

- After major maintenance or service, if indicated by quality control results
- As indicated in laboratory quality control procedures
- When required by government regulations

The Trinidad CH Albumin BCP assay should be calibrated if one or more of the following conditions exist:

- At the end of the 8-day (per well) pack calibration interval, for calibrated reagent packs on the system
- At the end of the 30-day lot calibration interval, for a specified lot of calibrated reagent on the system
- When replacing system components
- When the reagent lot number changes
- After replacing critical optical or hydraulic components
- When indicated by quality control procedures

6. Quality Control:

The sponsor recommends on their labeling that “Follow government regulations or accreditation requirements for quality control frequency. At least once each day of use, analyze 2 levels (low and high) of commercially available quality control (QC) material with known Na, K, Cl, albumin concentrations.”

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

A urine dilution recovery study was performed to extend the reportable ranges up to 600 mmol/L for Na, 600 mmol/L for K, and 660 mmol/L for Cl by manually diluting 1 part urine with 1 part reagent grade water.

A carry-over study has been performed and found to be acceptable.

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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