Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a multi-component in vitro diagnostic system and associated reagents/assays using standard analytical technologies (photometric, turbidimetric, chemiluminescent, ion selective electrode). There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
This device is an in vitro diagnostic system used to analyze clinical specimens for diagnostic purposes, not to provide therapy or treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the Siemens Atellica™ Solution is "intended for in vitro diagnostic testing of clinical specimens." It further details how specific components and assays (like the Atellica™ A-L YTE Integrated Multisensor, Atellica™ CH Albumin BCP Reagent, Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, and Atellica™ CH Vancomycin (Vanc) assay) are used for "in vitro diagnostic use" in the quantitative determination of various substances, and how the measurements "are used in the diagnosis and treatment of" specific diseases and conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-component system" consisting of hardware components like the Atellica Sample Handler, Atellica Magline Magnetic Sample Transport system, Atellica IM, and Atellica CH modules, in addition to software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement in Intended Use/Indications for Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens."
Explicit Statement in Device Description: The "Device Description" section also begins with: "The Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens."
Description of Testing Clinical Specimens: The document describes the system as being used for the analysis of "various body fluids" and specifically mentions testing "human serum, plasma, and urine." This is characteristic of in vitro diagnostic testing, which involves analyzing samples taken from the body.
Purpose of Measurements: The intended use for each specific assay (Na, K, Cl, Albumin, TSH, Vancomycin) explicitly states that the measurements are used in the "diagnosis and treatment" of various diseases and conditions. This is the core purpose of an IVD.
Mention of Reagents/Assays: The device description mentions that the submission covers specific "reagents/assays used with the Atellica Solution." Reagents and assays are fundamental components of in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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.

Product codes (comma separated list FDA assigned to the subject device)

JGS, JJE, CEM, CGZ, LEH, CJW, JLW

Device Description

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. 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.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance equivalence of the Atellica Solution was demonstrated by testing precision and running a method comparison of IM/CH assays on IM and CH modules fitted with a Direct Load component.

Precision Study:

Study Type: Precision
Sample Size: n = 5 replicates, one time a day for 5 days with controls and serum pools for each assay.
Key Results:
- Sodium:
  - Sample 4 (Serum, 72.7 mmol/L): Repeatability SD 0.23, CV 0.3%; Within-Lab SD 0.45, CV 0.6%
  - Sample 1 (Serum QC, 114 mmol/L): Repeatability SD 0.62, CV 0.5%; Within-Lab SD 0.62, CV 0.5%
  - Sample 2 (Serum QC, 141 mmol/L): Repeatability SD 0.4, CV 0.3%; Within-Lab SD 0.6, CV 0.4%
  - Sample 3 (Serum QC, 155 mmol/L): Repeatability SD 0.82, CV 0.5%; Within-Lab SD 0.82, CV 0.5%
- Potassium:
  - Sample 1 (Serum QC, 2.72 mmol/L): Repeatability SD 0.01, CV 0.4%; Within-Lab SD 0.01, CV 0.4%
  - Sample 2 (Serum QC, 4.04 mmol/L): Repeatability SD 0.01, CV 0.2%; Within-Lab SD 0.05, CV 1.2%
  - Sample 6 (Serum, 5.86 mmol/L): Repeatability SD 0.02, CV 0.4%; Within-Lab SD 0.03, CV 0.4%
  - Sample 3 (Serum QC, 7.34 mmol/L): Repeatability SD 0.04, CV 0.6%; Within-Lab SD 0.04, CV 0.6%
- Chloride:
  - Sample 1 (Serum QC, 77.2 mmol/L): Repeatability SD 0.14, CV 0.2%; Within-Lab SD 0.31, CV 0.4%
  - Sample 2 (Serum QC, 100 mmol/L): Repeatability SD 0.42, CV 0.4%; Within-Lab SD 0.57, CV 0.6%
  - Sample 3 (Serum QC, 114 mmol/L): Repeatability SD 0.55, CV 0.5%; Within-Lab SD 0.58, CV 0.5%
  - Sample 5 (Serum, 188 mmol/L): Repeatability SD 0.68, CV 0.4%; Within-Lab SD 0.81, CV 0.4%
- Albumin:
  - Sample 1 (Serum QC, 2.3 g/dL): Repeatability SD 0.02, CV 0.9%; Within-Lab SD 0.02, CV 0.9%
  - Sample 2 (Serum, 2.9 g/dL): Repeatability SD 0, CV 0%; Within-Lab SD 0, CV 0%
  - Sample 3 (Serum, 4 g/dL): Repeatability SD 0.05, CV 1.2%; Within-Lab SD 0.05, CV 1.3%
  - Sample 4 (Serum QC, 4.9 g/dL): Repeatability SD 0.03, CV 0.6%; Within-Lab SD 0.03, CV 0.6%
  - Sample 5 (Serum, 6.4 g/dL): Repeatability SD 0.06, CV 0.9%; Within-Lab SD 0.06, CV 0.9%
- Vancomycin:
  - Sample 1 (Serum QC, 6.9 µg/mL): Repeatability SD 0.08, CV 1.1%; Within-Lab SD 0.1, CV 1.5%
  - Sample 2 (Serum, 11.7 µg/mL): Repeatability SD 0.12, CV 1%; Within-Lab SD 0.14, CV 1.2%
  - Sample 3 (Serum QC, 18.4 µg/mL): Repeatability SD 0.13, CV 0.7%; Within-Lab SD 0.24, CV 1.3%
  - Sample 4 (Serum, 34 µg/mL): Repeatability SD 0.32, CV 0.9%; Within-Lab SD 0.38, CV 1.1%
  - Sample 5 (Serum, 43.1 µg/mL): Repeatability SD 0.38, CV 0.9%; Within-Lab SD 0.46, CV 1.1%
- TSH:
  - Sample 8 (Serum QC, 0.067 µIU/mL): Repeatability SD 0.001, CV 2.1%; Within-Lab SD 0.001, CV 2.1%
  - Sample 1 (Serum, 1.124 µIU/mL): Repeatability SD 0.027, CV 2.4%; Within-Lab SD 0.037, CV 3.3%
  - Sample 2 (Serum, 6.285 µIU/mL): Repeatability SD 0.155, CV 2.5%; Within-Lab SD 0.189, CV 3%
  - Sample 3 (Serum, 11.126 µIU/mL): Repeatability SD 0.15, CV 1.3%; Within-Lab SD 0.353, CV 3.2%
  - Sample 4 (Serum, 31.683 µIU/mL): Repeatability SD 0.497, CV 1.6%; Within-Lab SD 1.36, CV 4.3%
  - Sample 5 (Serum, 59.332 µIU/mL): Repeatability SD 0.974, CV 1.6%; Within-Lab SD 3.758, CV 6.3%
  - Sample 7 (Serum, 103.003 µIU/mL): Repeatability SD 1.706, CV 1.7%; Within-Lab SD 5.772, CV 5.6%
  - Sample 6 (Serum, 122.49 µIU/mL): Repeatability SD 2.225, CV 1.8%; Within-Lab SD 6.914, CV 5.6%

Method Comparison Study:

Study Type: Method Comparison
Key Results:
- Sodium:
  - Comparative Assay: DL-CH module (Na) (K151767)
  - Analysis Statistics: Passing & Bablok
  - Specimen Type: serum
  - Slope: 1.00
  - Intercept: 0.00
  - Sample Range: 58.70 to 197.00
  - Correlation: 0.999
  - N: 121
- Potassium:
  - Comparative Assay: DL-CH module (K) (K151767)
  - Analysis Statistics: Passing & Bablok
  - Specimen Type: serum
  - Slope: 1.00
  - Intercept: 0.00
  - Sample Range: 1.30 to 9.66
  - Correlation: 0.999
  - N: 125
- Chloride:
  - Comparative Assay: DL-CH module (Cl) (K151767)
  - Analysis Statistics: Passing & Bablok
  - Specimen Type: serum
  - Slope: 0.99
  - Intercept: 1.030
  - Sample Range: 61.00 to 189.00
  - Correlation: 0.999
  - N: 122
- Albumin:
  - Comparative Assay: DL-CH module (Alb_P) (K151767)
  - Analysis Statistics: Ordinary Least Square
  - Specimen Type: serum
  - Slope: 0.994
  - Intercept: -0.006
  - Sample Range: 0.90 to 5.80
  - Correlation: 0.999
  - N: 105
- Vancomycin:
  - Comparative Assay: DL-CH module (Vanc) (K160202)
  - Analysis Statistics: Deming
  - Specimen Type: serum
  - Slope: 0.988
  - Intercept: -0.063
  - Sample Range: 6.10 to 48.80
  - Correlation: 0.997
  - N: 112
- TSH:
  - Comparative Assay: DL-IM module (TSH) (K151792)
  - Analysis Statistics: Weighted Deming
  - Specimen Type: serum
  - Slope: 1.02
  - Intercept: 0.069
  - Sample Range: 0.008 to 142.907
  - Correlation: 0.992
  - N: 116

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151792, K151767, K160202

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
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.(b)
Classification. Class II.

Summary

0

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 an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

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

1

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

2

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)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

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

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
Chemistry (75)
LEH		21 CFR 862.3950; Vancomycin test system	Toxicology (91)
JJE	Class I,
exempt	21 CFR 862.2160 Discrete Photometric Analyzer
Chemistry For Clinical Use	Clinical
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

5

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:

7

1.1.9.1 System

1.1.9.1.1 Analytical module similarities and differences

| Feature | Predicate Device: (K151767)
Trinidad CH module (K151792) Trinidad
IM module with Direct Load | New Device:
Atellica Solution configured with the
Atellica CH and Atellica IM module |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 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 and
the quantitative measurement of
Vancomycin (Vanc) and Albumin
(Alb_P) in human serum or plasma on
the Trinidad CH module, and thyroid-
stimulating hormone (TSH,
thyrotropin) in serum, heparinized
plasma, and EDTA plasma using the
Trinidad IM system | Same |
| Cleared Assays | Sodium, Potassium, Chloride, Albumin
Vancomycin, and thyroid-
stimulating hormone | Same |
| Type of System | Random continuous access, batch,
discrete processing | Same |
| Types of
Measurements | Electrolyte, Photometric ,
Turbidimetric - CH module
Chemiluminescence using magnetic-
particle solid phase and
chemiluminescent label - IM module | Same |
| Optical system | Water bath and cuvette optical path
length (7 mm) - CH module
PMT used in photon counting mode -
IM module | Same |
| Feature | Predicate Device: (K151767)
Trinidad CH module (K151792) Trinidad
IM module with Direct Load | New Device:
Atellica Solution configured with the
Atellica CH and Atellica IM module |
| Throughput Rate | 1800 tests/hour, 1200 tests/hour
colorimetric, 600 tests/hour ISE - CH
module
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
sample cups | Same |
| Sample Type | Whole blood, serum, plasma, CSF or
urine | Same |
| Sample Tray | Samples identified and delivered by
Direct Load - 60 positions | Samples identified and delivered by
Atellica Sample Handler/Magline |
| Bar Codes | Same with addition of reagent pack
data matrix 2D | Same |
| Dedicated STAT
Positions | All samples can be Stat processed.
(Not dedicated) | Same |
| Universal Rack
Handler (URH) Option | Samples delivered by
Direct load | Samples identified and delivered by
Atellica Sample Handler/Magline |
| Auto-repeat | Automatic repeat testing from the
retained pre-diluted sample. | Same |
| Auto-dilution | Automatic dilution from retained pre-
diluted sample | Same |
| Liquid Level Sensing | Capacitance technology - CH module
Air pressure fluid sensing and
disposable tip sensing; clog detection
mechanism to alert operator to
clogged sample probe – IM module | Same |
| Feature | Predicate Device: (K151767)
Trinidad CH module (K151792) Trinidad
IM module with Direct Load | New Device:
Atellica Solution configured with the
Atellica CH and Atellica IM module |
| Automatic Sample
Pre-dilution | All samples diluted 1:5 (different
dilutions possible) – CH module
Allowed on a per-assay basis;
capability of dilution of samples
requiring pretreatment - IM module | Same |
| Original sample
volume | 2 to 50 µL; system uses an average of
2-3 µL per test – CH module
10 to 100 µl – IM module | Same |
| Sample probes | Dilution probe picks up primary
sample from primary tube or cup, and
dispenses to dilution tray with saline
to dilute sample.
A secondary probe
(Sample Probe) transfers an aliquot of
diluted sample to reaction cuvette.
All probes have liquid surface
verification. | Same |
| Pre-diluted Sample | Retained until results are available | Same |
| Reaction Tray | 221 reusable plastic cuvettes | Same |
| Cuvette Optical Path
Length | 7 mm | Same |
| Reaction Volume | 80-240 µL | Same |
| Reaction Bath | Water bath, 37°C | Same |
| Photometer | 11 fixed wavelengths | Same |
| Turbidimetric
Measurements | Made with photometer | Same |
| Feature | Predicate Device: (K151767)
Trinidad CH module (K151792) Trinidad
IM module with Direct Load | New Device:
Atellica Solution configured with the
Atellica CH and Atellica IM module |
| Light Source | 12 V, 50 W Halogen lamp / cooled by
lamp coolant additive and one LED | Same |
| Assays | Endpoint, rate reaction, 2-point rate,
sample blank correction | Same |
| Reaction Times | 3 to 10 minutes | Same |
| Reagent Handling | | |
| Reagent Tray | 2 refrigerated reagent trays;
70 positions R1
70 Positions R2
Up to 4 of the positions of R2 may be
occupied by wash solutions and/or
diluents. | Same |
| Reagent cooling | CH Module:
4-12° C
IM module:
4-8° C | Same |
| Reagent Container | Approximate maximum wedge size of
50 mL. Packs have two wells with 1 or
2 wells filled (depending on assay) | Same |
| Reagent Capacity On-
board | CH module:
Up to 70 Reagents
and 3 ISE
IM module:
Assay reagent:
Rotating refrigerated tray with 42
positions; Reagent Pack contains both
Solid Phase and Tracer Reagent in
separate wells
Ancillary Reagent:
Rotating refrigerated compartment
with 42 positions | Same |
| Dispensing System | 2 probes with liquid level sensing | Same |
| Reagent Dispense
volume | 10-100 µl per test | Same |
| Feature | Predicate Device: (K151767)
Trinidad CH module (K151792) Trinidad
IM module with Direct Load | New Device:
Atellica Solution configured with the
Atellica CH and Atellica IM module |
| Reagent Inventory
Management | Tracks tests remaining, lot number,
on-board stability and expiration date | Same |
| Reagent Dilutions | Capability to dilute concentrated
reagents on-board | Same |
| Method Principle | Ion Selective Electrode | Same |
| ISE Internal Standard | Internal Standard | Same |
| Sample Volume | CH module:
25 μL | Same |
| | IM module:
10 μL-100 μL | |
| Calibration | | |
| Calibration Frequency | Up to 60 days | Same |
| Auto-Calibration | User-defined time interval or with
new reagent cartridge | Same |
| Calibration/Control
Tray | Calibrators and controls delivered by
Direct Load / manual input. | Same |
| General Specification | | |
| Power Requirements | 200-240 VAC +/-10%, 8 Amp, 50/60
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:
1363.5 (h) x 1452.5 (w) x 1183.3 (d) | Varies based on configuration |
| CH | | |
| Feature | Predicate Device: (K151767)
Trinidad CH module (K151792) Trinidad
IM module with Direct Load | New Device:
Atellica Solution configured with the
Atellica CH and Atellica IM module |
| | Direct Load:
1365 (h) x 425.3 (w) x 1150 (d) mm

IM:
880 mm (d) x 1350mm (l) x1500 mm
(w) | |
| Weight | CH Module:
437 kg
Direct Load:
150 kg
IM module:
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. | Same |
| Indications for Use | 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. | Same |
| Device Technology | Indirect potentiometric measurements with Integrated
Multisensor Technology (IMT) | Same |
| Sample Type | Serum/plasma/urine | Same |
| Analytical
Measuring Interval | Serum/Plasma
Na: 50.0 to 200 mmol/L
K: 1.0 to 10.0 mmol/L
Cl: 50.0 to 200 mmol/L
Urine
Na: 10 to 300 mmol/L
K: 2 to 300 mmol/L
Cl: 20 to 330 mmol/L | Same |
| 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
Urine | Same |
| | Na: 40 – 220 mmol/day | |
| | K: 25 – 125 mmol/day | |
| | Cl: 110 – 250 mmol/day | |
| Interferences | Na: Bilirubin (Conjugated) – 60 mg/dL
Bilirubin (Unconjugated) – 60 mg/dL
Lipemia (Intralipid®) – 3000 mg/dL
Hemoglobin – 750 mg/dL

K: Bilirubin (Conjugated) – 60 mg/dL
Bilirubin (Unconjugated) – 60 mg/dL
Lipemia (Intralipid®) – 3000 mg/dL

Cl: Bilirubin (Conjugated) – 60 mg/dL
Bilirubin (Unconjugated) – 60 mg/dL
Lipemia (Intralipid®) – 3000 mg/dL
Hemoglobin – 750 mg/dL | Same |
| Standardization | Na: Flame photometric method with NIST reference standards

K: Flame photometric method with NIST reference serum

8

9

10

11

12

13

1.1.9.1.2 Na, K, Cl

14

15

Alb_P

16

Vanc

17

18

TSH

| Feature Trinidad IM System, TSH assay Atellica Solution, TSH assay |
|------------------------ | Intended Use quantitative determination stimulating hormone (TSH,
thyrotropin) in serum, heparinized
plasma, and EDTA plasma using the
Trinidad IM system | Same | Indications for Use hormone produced by the anterior
pituitary are used thyroid or pituitary disorders. | Assay Principle | Device Technology | Sample Type | Detection Antibody antibody BSA conjugate acridinium ester (AE) | Capture Antibody monoclonal mouse anti-TSH
antibody covalently bound to
paramagnetic particles (PMP) | Assay Range | Expected values Children: $0.67 - 4.16 \mu IU/mL$
Adolescent: $0.48- 4.17 \mu IU/mL$
Adult: $0.55 - 4.78 \mu IU/mL$ | Calibration | Calibrators | Number of
Calibrators | Two (2) levels | Use of controls | Standardization and is traceable to the World Health | Calibrators
packaging | Organization (WHO) 3rd
International standard for human
TSH (IRP 81/565)
Provided with reagent kit | Predicate Device:
| New Device:
--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| For in vitro diagnostic use in the
of thyroid-
|
| Measurements of thyroid stimulating
in the diagnosis of
| Same |
| Sandwich immunoassay | |
| Chemiluminescence | Same |
| Serum and Plasma | Same |
| Monoclonal mouse anti-TSH
labeled with
| Same |
| Anti-fluorescein labeled (FITC)
| Same |
| $0.008 - 150 \mu IU/mL$ | Same |
| Infants: $0.87 - 6.15 \mu IU/mL$
| Same |
| 2 point | Same |
| Atellica TSH Calibrators | Same |
| Same |
| Yes (recommended) | Same |
| Standardized to internal standards
| Same |
| Same |

19

1.1.10 Standard/Guidance Document Referenced (if applicable):

CLSI EP15-A3 : User Verification of Precision and Estimation of Bias
CLSI - EP09-A3: Method comparison and bias estimation using patient samples
. IEC 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General Requirements
EN 61326-1:2012, Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1:General requirements
. EN 61326-1:2012, Electrical equipment for measurement, control and laboratory use – Part 2-6: Particular Requirements – In vitro diagnostic (IVD) medical equipment
IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General Requirements
IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Parts 2- 6: Particular Requirements – In vitro diagnostic (IVD) medical equipment
EN ISO 14971:2012, Application of risk management to medical devices

1.1.11 Performance Characteristics

The below studies are submitted on the Atellica Solution to support the use of the Atellica SH with the Atellica CH and IM Systems cleared as the Trinidad CH and IM systems under K151767, K160202 and K151792 respectively. Full assay performance can be found in the assay associated 510(k)s.

Performance equivalence of the Atellica Solution was demonstrated by testing precision and running a method comparison of IM/CH assays on IM and CH modules fitted with a Direct Load component .

1.1.11.1 Precision

Precision was tested n = 5 replicates, one time a day for 5 days with controls and serum pools for the Na, K, Cl, Alb_P, Vanc and TSH assays on one instrument. This is consistent with the governing standard CLSI EP15-A3: User Verification of Precision and Estimation of Bias with 1 reagent lot.

20

1.1.11.1.1 Sodium

Sample	Specimen	N	Mean	Repeatability		Within-Lab
ID#	Type		(mmol/L)	SD (mmol/L)	CV (%)	SD (mmol/L)	CV (%)
4	Serum	25	72.7	0.23	0.3	0.45	0.6
1	Serum QC	25	114	0.62	0.5	0.62	0.5
2	Serum QC	25	141	0.4	0.3	0.6	0.4
3	Serum QC	25	155	0.82	0.5	0.82	0.5

1.1.11.1.2 Potassium

Sample	Specimen		Mean	Repeatability		Within-Lab
ID#	Type	N	(mmol/L)	SD (mmol/L)	CV (%)	SD (mmol/L)	CV (%)
1	Serum QC	25	2.72	0.01	0.4	0.01	0.4
2	Serum QC	25	4.04	0.01	0.2	0.05	1.2
6	Serum	25	5.86	0.02	0.4	0.03	0.4
3	Serum QC	25	7.34	0.04	0.6	0.04	0.6

1.1.11.1.3 Chloride

Sample	Specimen		Mean	Repeatability		Within-Lab
ID#	Type	N	(mmol/L)	SD (mmol/L)	CV (%)	SD (mmol/L)	CV (%)
1	Serum QC	25	77.2	0.14	0.2	0.31	0.4
2	Serum QC	25	100	0.42	0.4	0.57	0.6
3	Serum QC	25	114	0.55	0.5	0.58	0.5
5	Serum	25	188	0.68	0.4	0.81	0.4

1.1.11.1.4 Albumin

| Sample
ID# | Specimen
Type | N | Mean
(g/dL) | Repeatability | | Within-Lab | |
|---------------|------------------|----|----------------|---------------|--------|------------|--------|
| | | | | SD (g/dL) | CV (%) | SD (g/dL) | CV (%) |
| 1 | Serum QC | 25 | 2.3 | 0.02 | 0.9 | 0.02 | 0.9 |
| 2 | Serum | 25 | 2.9 | 0 | 0 | 0 | 0 |
| 3 | Serum | 25 | 4 | 0.05 | 1.2 | 0.05 | 1.3 |
| 4 | Serum QC | 25 | 4.9 | 0.03 | 0.6 | 0.03 | 0.6 |
| 5 | Serum | 25 | 6.4 | 0.06 | 0.9 | 0.06 | 0.9 |

1.1.11.1.5 Vancomycin

Sample	Specimen	N	Mean	Repeatability	Within-Lab
--------	----------	---	------	---------------	------------

21

ID#	Type		(µg/mL)	SD (µg/mL)	CV (%)	SD (µg/mL)	CV (%)
1	Serum QC	25	6.9	0.08	1.1	0.1	1.5
2	Serum	25	11.7	0.12	1	0.14	1.2
3	Serum QC	25	18.4	0.13	0.7	0.24	1.3
4	Serum	25	34	0.32	0.9	0.38	1.1
5	Serum	25	43.1	0.38	0.9	0.46	1.1

1.1.11.1.6 TSH

| Sample
ID# | Specimen
Type | N | Mean
(µIU/mL) | Repeatability | | Within-Lab | |
|---------------|------------------|----|------------------|---------------|-----|------------|-----|
| 8 | Serum QC | 25 | 0.067 | 0.001 | 2.1 | 0.001 | 2.1 |
| 1 | Serum | 25 | 1.124 | 0.027 | 2.4 | 0.037 | 3.3 |
| 2 | Serum | 25 | 6.285 | 0.155 | 2.5 | 0.189 | 3 |
| 3 | Serum | 25 | 11.126 | 0.15 | 1.3 | 0.353 | 3.2 |
| 4 | Serum | 25 | 31.683 | 0.497 | 1.6 | 1.36 | 4.3 |
| 5 | Serum | 25 | 59.332 | 0.974 | 1.6 | 3.758 | 6.3 |
| 7 | Serum | 25 | 103.003 | 1.706 | 1.7 | 5.772 | 5.6 |
| 6 | Serum | 25 | 122.49 | 2.225 | 1.8 | 6.914 | 5.6 |

1.1.11.2 Method Comparison

Method comparison studies were conducted with 1 reagent lot consistent with the governing standard CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples.

1.1.11.2.1 Sodium

| Comparative
Assay | Analysis
Statistics | Specimen
Type | Slope | Intercept | Sample
Range | Correlation | N |
|--------------------------------|------------------------|------------------|-------|-----------|--------------------|-------------|-----|
| DL-CH module (Na)
(K151767) | Passing &
Bablok | serum | 1.00 | 0.00 | 58.70 to
197.00 | 0.999 | 121 |

1.1.11.2.2 Potassium

| Comparative
Assay | Analysis
Statistics | Specimen
Type | Slope | Intercept | Sample
Range | Correlation | N |
|--------------------------------|------------------------|------------------|-------|-----------|-----------------|-------------|-----|
| DL- CH module (K)
(K151767) | Passing &
Bablok | serum | 1.00 | 0.00 | 1.30 to 9.66 | 0.999 | 125 |

22

| Comparative
Assay | Analysis
Statistics | Specimen
Type | Slope | Intercept | Sample
Range | Correlation | N |
|---------------------------------|------------------------|------------------|-------|-----------|--------------------|-------------|-----|
| DL- CH module (Cl)
(K151767) | Passing &
Bablok | serum | 0.99 | 1.030 | 61.00 to
189.00 | 0.999 | 122 |

1.1.11.2.4 Albumin

| Comparative
Assay | Analysis
Statistics | Specimen
Type | Slope | Intercept | Sample
Range | Correlation | N |
|------------------------------------|-----------------------------|------------------|-------|-----------|-----------------|-------------|-----|
| DL- CH module
(Alb_P) (K151767) | Ordinary
Least
Square | serum | 0.994 | -0.006 | 0.90 to 5.80 | 0.999 | 105 |

1.1.11.2.5 Vancomycin

| Comparative
Assay | Analysis
Statistics | Specimen
Type | Slope | Intercept | Sample
Range | Correlation | N |
|----------------------------------|------------------------|------------------|-------|-----------|-----------------|-------------|-----|
| DL-CH module
(Vanc) (K160202) | Deming | serum | 0.988 | -0.063 | 6.10 to 48.80 | 0.997 | 112 |

1.1.11.2.6 TSH

| Comparative
Assay | Analysis
Statistics | Specimen
Type | Slope | Intercept | Sample
Range | Correlation | N |
|----------------------------------|------------------------|------------------|-------|-----------|---------------------|-------------|-----|
| DL- IM module
(TSH) (K151792) | Weighted
Deming | serum | 1.02 | 0.069 | 0.008 to
142.907 | 0.992 | 116 |

1.1.12 Conclusions

Comparative testing of Atellica™ Solution (Atellica™M and Atellica™IM and Atellica™CH analyzers) is substantially equivalent in principle and performance to the Predicate Devices, Trinidad IM immunoassay analyzer (cleared under K151792) and the Trinidad CH clinical chemistry analyzer (cleared under K151767 and K160202).