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

Intended 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines representing movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA DUGGAN, REGULATORY TECHNICAL SPECIALIST 500 GBC DRIVE, M/S 514 PO BOX 6101 NEWARK DE 19714-6101

December 11, 2015

Re: K151767 Trade/Device Name: 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. Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, CEM, CGZ, CJW, JIX, JIT, JJE Dated: November 9, 2015 Received: November 10, 2015

Dear Laura Duggan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) k151767

#### Device Name

Trinidad CH System; TD-LYTE Integrated Multisensor (Na, K, Cl); TD-LYTE IMT Standard B + Salt Bridge; Trinidad CH Albumin BCP Reagent (Alb P); Trinidad CH Albumin BCP Calibrator

#### Indications for Use (Describe)

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 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-L YTE IMT 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 Albumin BCP Reagent (Alb) P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### ASSIGNED 510(K) NUMBER

The assigned 510(k) number is: k151767

#### APPLICANT AND DATE

Laura J. Duggan, Ph. D., RAC Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: [e-mail] Phone: [phone] Fax: [phone]

December 7, 2015

#### MANUFACTURER

Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 Registration Number: 2432235

#### PROPRIETARY 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

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Photometric Chemistry Analyzer Sodium Test System Chloride Test System Potassium Test System Albumin Test System Calibrator

### REGULATORY INFORMATION

| Discrete photometric chemistry analyzer for clinical use (Class I) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Classification Name: | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Regulation Section: | 21CFR862.2160 |
| Classification: | Class I |
| Product Code: | JJE |
| Panel: | Clinical Chemistry |
| Sodium, potassium, chloride and Albumin test systems and the associated calibrators (Class II) | |
| Classification Name: | Electrode, Ion Specific, Sodium |
| Regulation Section: | 21CFR862.1665, Sodium Test System |
| Classification: | Class II |
| Product Code: | JGS |
| Panel: | Clinical Chemistry |
| Classification Name: | Electrode, Ion Specific, Chloride |
| Regulation Section: | 21CFR862.1170, Chloride Test System |
| Classification: | Class II |
| Product Code: | CGZ |
| Panel: | Clinical Chemistry |
| Classification Name: | Electrode, Ion Specific, Potassium |
| Regulation Section: | 21CFR862.1600 |
| Classification: | Class II |
| Product Code: | CEM |
| Panel: | Clinical Chemistry |
| Classification Name: | Calibrator, Multi-Analyte Mixture |
| Regulation Section: | 21 CFR 862.1150 |
| Classification: | Class II |
| Product Code: | JIX |
| Panel: | Clinical Chemistry |
| Classification Name: | Bromocresol Purple Dye-Binding, Albumin |
| Regulation Section: | 21CFR862.1035, Albumin Test system |
| Classification: | Class II |
| Product Code: | CJW |
| Panel: | Clinical Chemistry |
| Classification Name: | Calibrator |
| Regulation Section: | 21CFR862.1150, Calibrator |
| Classification: | Class II |
| Product Code: | JIT |
| Panel: | Clinical Chemistry |

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### PREDICATE DEVICE

The following table describes the predicate devices, device classifications, regulations and product codes associated with this pre-market notification:

| New Product | Predicate Device | 510(k) number | Device Class | Regulation | Product Code |
|---------------------------------------------------------------|----------------------------------------------------------------------------|---------------|--------------|----------------------------------------------|-------------------|
| Trinidad CH System | Siemens ADVIA® 1800 Chemistry* | K990346 | I | 862.2160 | JJE |
| TD-LYTE Integrated Multisensor (Na, K, CI) | ADVIA® Sodium (Na)<br>ADVIA® Potassium (K)<br>ADVIA® Chloride (CI) | K990346 | II | (Na)862.1665<br>(K)862.1600<br>(CI) 862.1170 | JGS<br>CEM<br>CGZ |
| TD-LYTE IMT Standard A & TD-LYTE IMT Standard B + Salt Bridge | ADVIA® Chemistry ISE Serum Standard<br>ADVIA® Chemistry ISE Urine Standard | K990346 | II | 862.1150 | JIX |
| Trinidad CH Albumin BCP Reagent (Alb_P) | ADVIA® Chemistry Albumin BCP Assay (ALBP) | K132664 | II | 862.1035 | CJW |
| Trinidad CH Albumin BCP Calibrator | ADVIA® Chemistry Albumin BCP Calibrator | K132664 | II | 862.1150 | JIT |

*The ADVIA 1800 is a family member of the ADVIA 1650 cleared under K990346.

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### TRINIDAD CLINICAL CHEMISTRY (CH) SYSTEM

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 for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).

### TD-LYTE INTEGRATED MULTISENSOR (NA, K, CL)

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 Na*, K* or 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.

Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.

### TD-LYTE IMT STANDARD A & TD-LYTE IMT STANDARD B + SALT BRIDGE

The Trinidad CH System TD-LYTE Integrated Multisensor 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.

The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.

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ALBUMIN BCP REAGENT

The Trinidad CH System Albumin BCP Reagent (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 , the 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 nm.

Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.

Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.

#### ALBUMIN BCP CALIBRATOR

The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.

The target concentration of the albumin is 4.3 g/dL.

## INTENDED USE

The Intended uses for the system and representative assays are described below.

TRINIDAD CLINICAL CHEMISTRY (CH) SYSTEM

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.

TD-LYTE INTEGRATED MULTISENSOR (NA, K, CL)

For in vitro diagnostic use in the quantitative determination of sodium, potassium and chloride (Na, K, CI) 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

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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.

TD-LYTE IMT STANDARD A & TD-LYTE IMT STANDARD B + SALT BRIDGE

The TD-LYTE IMT 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.

#### ALBUMIN BCP REAGENT

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

#### ALBUMIN BCP CALIBRATOR

The 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.

### INDICATION(S) FOR USE

See Intended Use above.

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### SUBSTANTIAL EQUIVALENCE INFORMATION

Both the Trinidad CH system and the predicate ADVIA 1800 Chemistry system employ prepackaged reagents in plastic, Siemens Healthcare Diagnostics reagent packs. Both systems automatically process and analyze clinical samples using a variety of in vitro diagnostic test assays. Both systems utilize indirect potentiometric technology for analysis of sodium, potassium and chloride electrolytes. A comparison of the important similarities and differences of these two automated analyzer systems is provided in the following table:

Technological and Features Comparison of Trinidad CH System vs. ADVIA 1800 Chemistry System

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| Feature | Predicate Device:<br>ADVIA 1800 Chemistry<br>System | New Device:<br>Trinidad CH System |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental | | |
| Type of System | Random continuous access,<br>batch, discrete processing | Same |
| Types of Measurements | Electrolyte, Photometric<br>and Turbidimetric | Electrolyte, Photometric |
| Optical system | Oil bath and cuvette optical<br>path length (10 mm) | Water bath and cuvette<br>optical path length<br>(7 mm) |
| Throughput Rate | 1800 tests/hour, 1200<br>tests/hour colorimetric, 600<br>tests/hour ISE | Same |
| Assay Capacity On-board | 56 slots including 3 ISE | Up to 70 slots including 3<br>ISE |
| Sample Handling | | |
| Sample Containers | Tubes - 5 mL, 7 mL, 10 mL<br>Cups - 2 mL sample cups | Same |
| Sample Type | Whole blood, serum,<br>plasma, CSF or urine | Same |
| Sample Tray | 84 samples, positive sample<br>identification | Samples identified and<br>delivered by Direct Load -<br>60 positions |
| Bar Codes | Interleaved 2 of 5, code 39,<br>code<br>128, Codabar (NW7) | Same with addition of<br>reagent pack data matrix 2D |
| Dedicated STAT<br>Positions | 84 positions/ Universal Rack<br>Handler available | All samples can be Stat<br>processed.<br>(Not dedicated) |
| Universal Rack Handler<br>(URH) Option | 5-position rack handler, 425<br>total<br>capacity, continuous feed | Samples delivered by<br>Direct load |
| Auto-repeat | Automatic repeat testing<br>from the retained pre-diluted<br>sample or original sample | Automatic repeat testing<br>from the retained pre-diluted<br>sample. |
| Auto-dilution | Automatic dilution from<br>retained pre-diluted sample | Same |
| Auto-reflex | Ability to perform 3 additional<br>tests based on results of first<br>test | Not available. |
| Liquid Level Sensing | Capacitance technology | Same |
| Automatic Sample Pre-<br>dilution | All samples diluted 1:5<br>(different<br>dilutions possible) | Same |
| Original sample volume | 2 to 30 µL; system uses an<br>average of 2-3 µL per test | 2 to 50 µL; system uses an<br>average of 2-3 uL per test. |
| Sample probes | Primary probe picks up<br>sample from primary tube or<br>cup, dispenses to<br>dilution tray;<br>secondary probe<br>dispenses saline into tray<br>to dilute sample – only<br>primary probe has clot<br>detect, crash protect & liquid<br>surface verification | Dilution probe picks up<br>primary sample from primary<br>tube or cup, and dispenses<br>to dilution tray with saline to<br>dilute sample.<br>A secondary probe<br>(Sample Probe) transfers an<br>aliquot of diluted sample to<br>reaction cuvette.<br>All probes have liquid<br>surface verification. |
| Pre-diluted Sample | Retained until results are<br>available | Same |
| Reaction Area | | |
| Reaction Tray | 221 reusable plastic cuvettes | Same |
| Cuvette Optical Path Length | 10 mm | 7 mm |
| Reaction Volume | 80-300 $µL$ | 80-240 $µL$ |
| Reaction Bath | Inert fluorocarbon oil<br>circulation system, 37°C | Water bath, 37°C |
| Photometer | 14 fixed wavelengths (12<br>utilized) | 11 fixed wavelengths |
| Turbidimetric Measurements | Made with photometer | Same |
| Light Source | 12V, 50W halogen lamp,<br>cooled by forced water<br>circulation | 12 V, 50 W Halogen lamp /<br>cooled by lamp coolant<br>additive and one LED |
| Assays | Endpoint, rate reaction, 2-<br>point rate. | Endpoint, rate reaction, 2-<br>point rate, sample blank<br>correction |
| Reaction Times | 3, 4, 5, 10, 15 and 21 minutes | 3 to 10 minutes |
| Reagent Handling | | |
| Reagent Tray | 2 refrigerated reagent trays,<br>56 positions each; 4 of these<br>positions may be occupied<br>by wash solutions and/or<br>diluents | 2 refrigerated reagent trays;<br>70 positions R1<br>70 Positions R2<br>Up to 4 of the positions of<br>R2 may be occupied by<br>wash solutions and/or<br>diluents. |
| Reagent cooling | 6-14° C | 4-12° C |
| Reagent Container | 20, 40, 70 mL wedges | Approximate maximum<br>wedge size of 50 mL. Packs<br>have two wells with 1 or 2<br>wells filled (depending on<br>assay) |
| Reagent Capacity On- board | 52 assay Reagents | Up to 70 Reagents<br>and 3 ISE |
| Dispensing System | 2 probes with liquid level<br>sensing | Same |
| Reagent Dispense volume | 10-100 µl per test | Same |
| Reagent Inventory<br>Management | Tracks tests remaining, lot<br>number, on-board stability<br>and expiration date | Same |
| Reagent Dilutions | Capability to dilute<br>concentrated reagents on-<br>board | Same |
| <b>Electrolyte Measurement</b> | | |
| Method Principle | Ion Selective Electrode | Same |
| ISE Internal Standard | None | Internal Standard |
| Sample Volume | 22 µL total for all three tests | 25 µL for all three tests |
| Throughput Rate | 600 tests/hour | Same |
| <b>Calibration</b> | | |
| Calibration Frequency | Up to 60 days | Up to 60 days |
| Auto-Calibration | User-defined time interval<br>or with new reagent cartridge | User-defined time interval or<br>with new reagent cartridge |
| Calibration/Control Tray | 61 refrigerated positions for<br>calibrators, controls and<br>diluents | Calibrators and controls<br>delivered by Direct Load /<br>manual input. |
| <b>General Specifications</b> | | |
| Power Requirements | 200/220/230 V +/-10%, 30<br>A, 50/60 Hz, 3 KVA | 200-240 VAC +/-10%, 8<br>Amp, 50/60 Hz, 3.2 KVA |
| Water Requirements | Direct plumb - Deionized<br>water Type I at the source<br>Type II at the system | Direct plumb - Lab Grade<br>Type 1 only |
| Water Consumption | 30 liters per hour | 33 liters per hour (maximum) |
| Dimensions | 113.3 (h) x 148.0 (w) x 87.7<br>(d) cm | Analytical Module:<br>1363.5 (h) x 1452.5 (w) x<br>1183.3 (d) mm<br>Direct Load:<br>1365 (h) x 425.3 (w) x 1150<br>(d) mm |
| Weight | 1,323 lbs. (540 kg) | CC Module:<br>962 lbs. (437 kg)<br>Direct Load<br>331 lbs. (150 kg) |
| Electrical Compliance | UL, cUL, CE | Same |
| Computers/OS | | |
| CPU | Single Intel Processor<br>running<br>Windows XP Pro | Intel processor using Windows<br>7 |
| Display/Monitor | 19" display (Touch screen<br>is optional) | 22" display with touch screen |
| Software | | |
| GUI Application | User interface unique to<br>ADVIA Chemistry systems | Universal Instrument<br>Workstation, which will be<br>common to new Siemens IVD<br>systems |
| Result Database<br>Capacity | 7 days of results<br>maintained in a flat file<br>system | Stores up to 1MM results. |
| On-Line Help | Separate for System<br>application<br>and ADVIA QC | Not available at this time |
| QC | ADVIA QC V3.2x<br>application<br>provides stored control<br>results, Levy-Jennings<br>plotting, and statistics | Same |
| LIS Interfaces | LIS ASTM standards<br>1394/1381,<br>and J-ASTM, LIS HL7<br>standards | Not available at this time |
| LAS Interfaces | Siemens URAP LAS<br>Interface | Utilize pick and place sampling<br>rather than point in space |
| Real-Time Solutions<br>(RTS) support | Interface to RTS via<br>LabCom protocol and RTS<br>via i2i protocol | Not available at this time |
| External printers | Parallel port and USB<br>interfaced printers | Not available at this time |

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Below is a features comparison for the Trinidad CH system assays vs. their predicates:

| Feature | Predicate Device:<br>ADVIA 1800 Chemistry<br>System | New Device:<br>Trinidad CH System |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use :<br>Na, K, Cl | For in vitro diagnostic use in<br>the quantitative determination<br>of sodium in human serum,<br>plasma (lithium heparin), and<br>urine on the ADVIA<br>Chemistry systems.<br><br>For in vitro diagnostic use in<br>the quantitative determination<br>of potassium in human<br>serum, plasma (lithium<br>heparin), and urine on the<br>ADVIA Chemistry systems. | For in vitro diagnostic use<br>in the quantitative<br>determination of sodium,<br>potassium and chloride<br>(Na, K, Cl)<br>in human serum, plasma<br>and urine using the<br>Trinidad CH System. |
| | For <i>in vitro</i> diagnostic use in<br>the quantitative determination<br>of chloride in human serum,<br>plasma, and urine on the<br>ADVIA Chemistry systems. | |
| Albumin BCP | For <i>in vitro</i> diagnostic use in<br>the quantitative measurement<br>of albumin in human serum<br>or plasma on ADVIA®<br>Chemistry systems. | For <i>in vitro</i> diagnostic use<br>in the quantitative<br>measurement of albumin<br>in human serum or<br>plasma on Trinidad CH<br>System. |
| Indications for Use:<br>Na, K, Cl | Sodium measurements are<br>used in the diagnosis and<br>treatment of gross changes in<br>water and salt balance,<br>aldosteronism, diabetes<br>insipidus, adrenal<br>hypertension, Addison's<br>disease, dehydration,<br>inappropriate antidiuretic<br>hormone secretion, diabetic<br>acidosis, severe diarrhea, or<br>other diseases involving<br>electrolyte imbalance.<br>Potassium measurements<br>are used to monitor<br>electrolyte balance in the<br>diagnosis and treatment of<br>primary aldosteronism,<br>metabolic alkalosis, diarrhea,<br>severe vomiting, diuretic<br>administration, diabetic<br>ketoacidosis, and other<br>diseases.<br>Chloride measurements are<br>used for their inferential value<br>and are helpful in diagnosing<br>disorders of acid-base and<br>water balance. It is especially | Measurements of sodium<br>obtained by<br>this device are used in the<br>diagnosis and treatment<br>of aldosteronism<br>(excessive secretion of<br>the hormone<br>aldosterone), diabetes<br>insipidus (chronic<br>excretion of large<br>amounts of dilute urine,<br>accompanied by<br>extreme thirst), adrenal<br>hypertension, Addison's<br>disease (caused by<br>destruction of the adrenal<br>glands),<br>dehydration, inappropriate<br>antidiuretic hormone<br>secretion, or other<br>diseases involving<br>electrolyte<br>imbalance.<br>Measurements of<br>potassium obtained by<br>this device are used to<br>monitor electrolyte<br>balance in<br>the diagnosis and<br>treatment of disease<br>conditions characterized |
| | chloride during the correction<br>of hypokalemic alkalosis and<br>also during severe, prolonged<br>vomiting, which can lower the<br>serum chloride level. | by low or high blood<br>potassium levels.<br>Chloride measurements<br>are used in the diagnosis<br>and treatment of<br>electrolyte and metabolic<br>disorders<br>such as cystic fibrosis and<br>diabetic acidosis. |
| Albumin BCP | Albumin measurements are<br>used in the diagnosis and<br>treatment of numerous<br>diseases primarily involving<br>the liver or kidneys. | Albumin measurements<br>are used in the diagnosis and<br>treatment of<br>numerous diseases<br>primarily involving the<br>liver or kidneys. |
| Device Technology:<br>Na, K, CI | Indirect potentiometric<br>measurements with ion<br>selective electrodes | Indirect potentiometric<br>measurements with<br>Integrated Multisensor<br>Technology (IMT)…