Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
Device Facts
| Record ID | K161954 |
|---|---|
| Device Name | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) |
| Applicant | Siemens Healthcare Diagnostics |
| Product Code | JGS · Clinical Chemistry |
| Decision Date | Mar 9, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
Intended Use
The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. The Atellica™ A-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 Atellica™ 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 Atellica™ 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 Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
Device Story
Atellica™ Solution is a configurable, modular in vitro diagnostic system for clinical laboratories. It integrates Atellica™ Sample Handler, Magline™ transport system, and Atellica™ CH (chemistry) and IM (immunoassay) analytical modules. The Sample Handler manages loading/unloading of patient samples, STATs, calibrators, and QC. Magline™ transport moves samples between modules via carriers. The system performs ion-selective electrode (Na, K, Cl), photometric (albumin), turbidimetric (vancomycin), and chemiluminescent (TSH) assays. Operators interface via the workstation, using barcode scanners for sample identification. Data is transmitted to LIS. The system automates sample handling and transport, replacing manual loading, to improve laboratory workflow efficiency and throughput. Results assist clinicians in diagnosing electrolyte imbalances, liver/kidney disease, thyroid disorders, and monitoring therapeutic drug levels.
Clinical Evidence
No clinical trials were performed. Evidence consists of analytical performance verification (precision) and method comparison studies. Precision was evaluated over 5 days (N=25 per specimen) with CVs ranging from 0.2% to 6.3%. Method comparison against predicate systems (N=105-125 samples per analyte) demonstrated high correlation (r=0.992-0.999) and slopes near 1.0, confirming accuracy across the analytical measuring intervals.
Technological Characteristics
Multi-component automated analyzer. Sensing: ISE (Na, K, Cl), photometric (Albumin), turbidimetric (Vancomycin), chemiluminescent (TSH). Energy: 200-240 VAC. Connectivity: LIS/LAS interfaces. Software: Windows 7-based Intel processor, Universal Instrument Workstation GUI. Reagent cooling: 4-12°C (CH), 4-8°C (IM). Cuvettes: reusable plastic, 7 mm optical path. Standards: CLSI EP15-A3, EP09-A3, IEC 61010-1, EN 61326-1.
Indications for Use
Indicated for in vitro diagnostic quantitative analysis of Na, K, Cl, albumin, TSH, and vancomycin in human serum, plasma, and urine. Used for diagnosis/treatment of electrolyte/metabolic disorders, thyroid/pituitary disorders, and monitoring vancomycin therapy. 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
- Trinidad TD-LYTE Integrated Multisensor (Na, K, Cl) (k151767)
- Trinidad IM Thyroid Stimulating Hormone (TSH) Assay (k151792)
- Trinidad CH Vancomycin (Vanc) Assay (k160202)
- Trinidad CH Albumin BCP Reagent (Alb_P) (k151767)
Related Devices
- K112412 — AU5800(R) CHEMISTRY ANALYZER · Beckman Coulter, Inc. · Dec 23, 2011
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
SIEMENS HEALTHCARE DIAGNOSTICS JUSTIN DIVALENTINO REGULATORY AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K161954
Trade/Device Name: Atellica™ Solution, Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl), Atellica™ CH Albumin BCP Reagent (Alb P), Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, Atellica™ CH Vancomycin (Vanc) assay
Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, JJE, CEM, CGZ, LEH, CJW, JLW Dated: February 8, 2017 Received: February 9, 2017
Dear Justin DiValentino:
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 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
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -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) K161954
## Device Name
Atellicated Solution, Atellicand A-LYTE Integrated Multisensor (Na, K, C), Atellica™ CH Albumin BCP Reagent (Alb P)Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, Atellica™ CH Vancomycin (Vanc) assay
## Indications for Use (Describe)
The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
The Atellica™ A-L YTE 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 Atellica™ 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 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 Atellica™ 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 Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;"> <span style="color: black;">☑</span> </span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;"> <span style="color: black;">☐</span> </span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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## 1. 510k Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
### 1.1.1 510(k) Number: K161954
- 1.1.2 Date of original preparation: July 15, 2016 Date of revised preparation: February 23, 2017
### Proprietary and Established Names: 1.1.3
Atellica™ Solution Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl) Atellica™ CH Albumin BCP Reagent (Alb P) Atellica™ IM Thyroid Stimulating Hormone (TSH) assay Atellica™ CH Vancomycin (Vanc) assay
### 1.1.4 Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Justin DiValentino, Regulatory Affairs Specialist and Compliance Office: (914) 524-2280 Fax: (914) 524-3579
### 1.1.5 Regulatory Information:
| Product<br>Code | Classification | Regulation Section | Panel |
|-----------------|--------------------|-----------------------------------------------------------------------------|----------------------------|
| JGS | | 21 CFR 862.1665 Sodium Test System | Clinical |
| CEM | | 21 CFR 862.1600 Potassium Test System | Chemistry (75) |
| CGZ | | 21 CFR 862.1170 Chloride Test System | |
| CJW | | 21 CFR 862.1035 Albumin Test System | |
| JLW | Class II | 21 CFR § 862.1690 Thyroid stimulating hormone test system | Clinical<br>Chemistry (75) |
| LEH | | 21 CFR 862.3950; Vancomycin test system | Toxicology (91) |
| JJE | Class I,<br>exempt | 21 CFR 862.2160 Discrete Photometric Analyzer<br>Chemistry For Clinical Use | Clinical<br>Chemistry (75) |
### 1.1.6 Predicate Devices:
Trinidad IM module with Direct Load cleared under k151792 for TSH Measurement Trinidad CH module with Direct Load cleared under k151767 for Na, K, Cl and Albumin Measurement Trinidad CH module with Direct Load cleared under k160202 for Vancomycin Measurement
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### 1.1.7 Device Description:
## 1.1.7.1 Name change and alignment with prior clearance
The Atellica™ Solution is designed to support the Trinidad immunoassay (IM) analytical module, the Trinidad clinical chemistry (CH) analytical module and reagents cleared under 510(k submission# k151792, k151767 and k160202, respectively. These analytical modules and reagents will be marketed and sold under the name Atellica™ IM and Atellica™ CH.
| Name in prior clearance | Updated name |
|-----------------------------------------------------------------------------|------------------------------------------------------|
| Trinidad Immunoassay (IM) system | Atellica™ IM |
| Trinidad Clinical Chemistry (CC) system | Atellica™ CH |
| Trinidad Clinical Chemistry (CC) Integrated Multisensor (Na, K, Cl) | Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl) |
| Trinidad Clinical Chemistry (CC) Albumin BCP Reagent (Alb_P) | Atellica™ CH Albumin BCP Reagent (Alb_P) |
| Trinidad Clinical Chemistry (CC) IM Thyroid Stimulating Hormone (TSH) assay | Atellica™ IM Thyroid Stimulating Hormone (TSH) assay |
| Trinidad Clinical Chemistry (CC) Vancomycin (Vanc) assay | Atellica™ CH Vancomycin (Vanc) assay |
## 1.1.7.2 Atellica™ Solution
The Atellica™ Solution consists of any combination of Atellica Sample Handler component, an Atellica Magline Magnetic Sample Transport system component, Atellica IM and all software and hardware needed to support a customizable array of analyzers.
# 1.1.7.3 Assays
Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl) Atellica™ CH Albumin BCP Reagent (Alb_P) Atellica™ IM Thyroid Stimulating Hormone (TSH) assay Atellica™ CH Vancomycin (Vanc) assay
### 1.1.8 Intended Use / Indications for Use:
The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selectrode technology for clinical use.
The Atellica™ A-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 Atellica™ 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
{6}------------------------------------------------
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 Atellica™ 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 Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the guantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
### 1.1.9 Substantial Equivalence Information:
The Atellica Solution (New Device) and the Trinidad IM analyzer (Predicate Device cleared under k151792 for chemiluminescence technology) as well as the Trinidad CH analyzer (Predicate Device cleared under k151767 for ion selective electrode and photometric technology, and k160202 for turbidimetric technology) employ the same prepackaged reagents for use on automated test systems. The Intended Use / Indications for Use, Assay Principle and reagent formulations are the same. The major differences between the New and Predicate Devices are the sample loading and transport system as well as the ability to configure multiple analyzers. The New Device sample loading and transport system delivers the sample to the analytical module and does not pipet the sample to the analytical module nor perform any analytical pipetting. A comparison of the important similarities and differences of these systems are shown in the following tables:
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## 1.1.9.1 System
# 1.1.9.1.1 Analytical module similarities and differences
| Feature | Predicate Device: (k151767)<br>Trinidad CH module (k151792) Trinidad<br>IM module with Direct Load | New Device:<br>Atellica Solution configured with the<br>Atellica CH and Atellica IM module |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the<br>quantitative determination of sodium,<br>potassium and chloride (Na, K, Cl) in<br>human serum, plasma and urine and<br>the quantitative measurement of<br>Vancomycin (Vanc) and Albumin<br>(Alb_P) in human serum or plasma on<br>the Trinidad CH module, and thyroid-<br>stimulating hormone (TSH,<br>thyrotropin) in serum, heparinized<br>plasma, and EDTA plasma using the<br>Trinidad IM system | Same |
| Cleared Assays | Sodium, Potassium, Chloride, Albumin<br>Vancomycin, and thyroid-<br>stimulating hormone | Same |
| Type of System | Random continuous access, batch,<br>discrete processing | Same |
| Types of<br>Measurements | Electrolyte, Photometric ,<br>Turbidimetric - CH module<br>Chemiluminescence using magnetic-<br>particle solid phase and<br>chemiluminescent label - IM module | Same |
| Optical system | Water bath and cuvette optical path<br>length (7 mm) - CH module<br>PMT used in photon counting mode -<br>IM module | Same |
| Feature | Predicate Device: (k151767)<br>Trinidad CH module (k151792) Trinidad<br>IM module with Direct Load | New Device:<br>Atellica Solution configured with the<br>Atellica CH and Atellica IM module |
| Throughput Rate | 1800 tests/hour, 1200 tests/hour<br>colorimetric, 600 tests/hour ISE - CH<br>module<br>250 to 450 tests/hr - IM module | Same |
| Assay Capacity On-board | Up to 70 slots including 3 ISE | Same |
| Sample Handling | | |
| Sample Containers | Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL<br>sample cups | Same |
| Sample Type | Whole blood, serum, plasma, CSF or<br>urine | Same |
| Sample Tray | Samples identified and delivered by<br>Direct Load - 60 positions | Samples identified and delivered by<br>Atellica Sample Handler/Magline |
| Bar Codes | Same with addition of reagent pack<br>data matrix 2D | Same |
| Dedicated STAT<br>Positions | All samples can be Stat processed.<br>(Not dedicated) | Same |
| Universal Rack<br>Handler (URH) Option | Samples delivered by<br>Direct load | Samples identified and delivered by<br>Atellica Sample Handler/Magline |
| Auto-repeat | Automatic repeat testing from the<br>retained pre-diluted sample. | Same |
| Auto-dilution | Automatic dilution from retained pre-<br>diluted sample | Same |
| Liquid Level Sensing | Capacitance technology - CH module<br>Air pressure fluid sensing and<br>disposable tip sensing; clog detection<br>mechanism to alert operator to<br>clogged sample probe – IM module | Same |
| Feature | Predicate Device: (k151767)<br>Trinidad CH module (k151792) Trinidad<br>IM module with Direct Load | New Device:<br>Atellica Solution configured with the<br>Atellica CH and Atellica IM module |
| Automatic Sample<br>Pre-dilution | All samples diluted 1:5 (different<br>dilutions possible) – CH module<br>Allowed on a per-assay basis;<br>capability of dilution of samples<br>requiring pretreatment - IM module | Same |
| Original sample<br>volume | 2 to 50 µL; system uses an average of<br>2-3 µL per test – CH module<br>10 to 100 µl – IM module | Same |
| Sample probes | Dilution probe picks up primary<br>sample from primary tube or cup, and<br>dispenses to dilution tray with saline<br>to dilute sample.<br>A secondary probe<br>(Sample Probe) transfers an aliquot of<br>diluted sample to reaction cuvette.<br>All probes have liquid surface<br>verification. | Same |
| Pre-diluted Sample | Retained until results are available | Same |
| Reaction Tray | 221 reusable plastic cuvettes | Same |
| Cuvette Optical Path<br>Length | 7 mm | Same |
| Reaction Volume | 80-240 µL | Same |
| Reaction Bath | Water bath, 37°C | Same |
| Photometer | 11 fixed wavelengths | Same |
| Turbidimetric<br>Measurements | Made with photometer | Same |
| Feature | Predicate Device: (k151767)<br>Trinidad CH module (k151792) Trinidad<br>IM module with Direct Load | New Device:<br>Atellica Solution configured with the<br>Atellica CH and Atellica IM module |
| Light Source | 12 V, 50 W Halogen lamp / cooled by<br>lamp coolant additive and one LED | Same |
| Assays | Endpoint, rate reaction, 2-point rate,<br>sample blank correction | Same |
| Reaction Times | 3 to 10 minutes | Same |
| Reagent Handling | | |
| Reagent Tray | 2 refrigerated reagent trays;<br>70 positions R1<br>70 Positions R2<br>Up to 4 of the positions of R2 may be<br>occupied by wash solutions and/or<br>diluents. | Same |
| Reagent cooling | CH Module:<br>4-12° C<br>IM module:<br>4-8° C | Same |
| Reagent Container | Approximate maximum wedge size of<br>50 mL. Packs have two wells with 1 or<br>2 wells filled (depending on assay) | Same |
| Reagent Capacity On-<br>board | CH module:<br>Up to 70 Reagents<br>and 3 ISE<br>IM module:<br>Assay reagent:<br>Rotating refrigerated tray with 42<br>positions; Reagent Pack contains both<br>Solid Phase and Tracer Reagent in<br>separate wells<br>Ancillary Reagent:<br>Rotating refrigerated compartment<br>with 42 positions | Same |
| Dispensing System | 2 probes with liquid level sensing | Same |
| Reagent Dispense<br>volume | 10-100 µl per test | Same |
| Feature | Predicate Device: (k151767)<br>Trinidad CH module (k151792) Trinidad<br>IM module with Direct Load | New Device:<br>Atellica Solution configured with the<br>Atellica CH and Atellica IM module |
| Reagent Inventory<br>Management | Tracks tests remaining, lot number,<br>on-board stability and expiration date | Same |
| Reagent Dilutions | Capability to dilute concentrated<br>reagents on-board | Same |
| Method Principle | Ion Selective Electrode | Same |
| ISE Internal Standard | Internal Standard | Same |
| Sample Volume | CH module:<br>25 μL | Same |
| | IM module:<br>10 μL-100 μL | |
| Calibration | | |
| Calibration Frequency | Up to 60 days | Same |
| Auto-Calibration | User-defined time interval or with<br>new reagent cartridge | Same |
| Calibration/Control<br>Tray | Calibrators and controls delivered by<br>Direct Load / manual input. | Same |
| General Specification | | |
| Power Requirements | 200-240 VAC +/-10%, 8 Amp, 50/60<br>Hz, 3.2 KVA | Varies based on configuration |
| Water Requirements | Direct plumb – Lab Grade Type 1 only | Same |
| Water Consumption | 33 liters per hour (maximum) | Varies based on configuration |
| Dimensions | Analytical Module:<br>1363.5 (h) x 1452.5 (w) x 1183.3 (d) | Varies based on configuration |
| CH | | |
| Feature | Predicate Device: (k151767)<br>Trinidad CH module (k151792) Trinidad<br>IM module with Direct Load | New Device:<br>Atellica Solution configured with the<br>Atellica CH and Atellica IM module |
| | Direct Load:<br>1365 (h) x 425.3 (w) x 1150 (d) mm<br><br>IM:<br>880 mm (d) x 1350mm (l) x1500 mm<br>(w) | |
| Weight | CH Module:<br>437 kg<br>Direct Load:<br>150 kg<br>IM module:<br><750 kg | Varies based on configuration |
| Electrical Compliance | UL, cUL, CE | UL, cUL, CE |
| CPU | Intel processor using Windows 7 | Same |
| Display/Monitor…
