Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard automated in vitro diagnostic system and assays using established chemical and photometric methods. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.

Therapeutic

No
Explanation: The device is an in vitro diagnostic (IVD) system used for quantitative analysis of substances in patient samples (e.g., TSH, albumin) to aid in diagnosis, not to provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "an automated, integrated system in vitro diagnostic tests on clinical specimens." It further details its use for the "qualitative analysis of various body fluids" and in the "diagnosis of thyroid or pituitary disorders" and "diagnosis and treatment of numerous diseases primarily involving the liver or kidneys."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Atellica® CI Analyzer is an automated, integrated system containing "all the necessary hardware, electronics, and software" to perform in vitro diagnostic tests. This indicates it is a hardware system with integrated software, not a software-only medical device.

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 document explicitly states: "The Atellica® CI Analyzer is an automated, integrated system in vitro diagnostic tests on clinical specimens." and "The Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) assay is for in vitro diagnostic use..." and "The Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use..."
Explicit Statement in Device Description: The document states: "The Atellica® CI Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on clinical specimens."
Purpose of the Tests: The assays performed on the system (TSH and Albumin) are used for the "diagnosis of thyroid or pituitary disorders" and "diagnosis and treatment of numerous diseases primarily involving the liver or kidneys." This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Specimen Type: The system analyzes "clinical specimens" and specifically mentions "human serum and plasma," which are common types of specimens used in in vitro diagnostic testing.
Technology Used: The system utilizes technologies like photometry, turbidimetric, chemiluminescent, and integrated ionselective electrode technology, which are standard methods employed in clinical laboratories for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Atellica® CI Analyzer is an automated, integrated system in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative analysis of various body fluids, using photometry, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

The Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) 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® CI Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use in the quantitative measurement of albumin in human serum and plasma (lithium heparin, potassum EDTA) using the Atellica® CI Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

Product codes

JLW, CJW, JJE

Device Description

The Atellica® CI Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.
The Atellica CI Analyzer with Atellica® Rack Handler supports both clinical chemistry (CH) and Immunoassay (IM) features and contains all the necessary hardware, electronics, and software to automatically process samples and generate results, including sample and reagent dispensing, mixing, and incubating.

The Atellica IM TSH3-UL assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection.

The Atellica CH Albumin BCP (AlbP) assay is an adaptation of the bromocresol purple dy-e binding method reported by Carter and Louderback et al. In the Atellica CH AlbP 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 coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the 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

Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL)
Study Type: Detection Capability & Precision
Detection Capability:

Limit of Blank (LoB) 0.004 µIU/mL (mIU/L)
Limit of Detection (LoD) 0.008 µIU/mL (mIU/L)
Limit of Quantitation (LoQ) 0.008 µIU/mL (mIU/L)
Precision (for TSH3-UL):
Sample size (N): 80 for each sample type (Serum, EDTA Plasma, Heparin Plasma, Controls)
Study design: Samples assayed in duplicate in 2 runs per day for 20 days.
Key results: CV for repeatability ranges from 1.1% to 1.5% for serum samples, 1.2% to 1.5% for EDTA plasma, and 1.1% to 1.5% for heparin plasma, and 1.3% to 1.7% for controls. Within-Laboratory Precision CV ranges from 2.0% to 2.9% for serum samples, 2.2% to 2.4% for EDTA plasma, and 1.9% to 3.3% for heparin plasma, and 2.3% to 2.4% for controls.

Assay Comparison (TSH3-UL):

Study type: Weighted Deming regression model validation (CLSI Document EP09c-ed3)
Sample size (N): 112 (Serum)
Regression Equation: y = 0.96x - 0.001 µIU/mL (mIU/L)
Correlation coefficient (r): 0.996

Interferences (TSH3-UL):

Study type: Interference testing (CLSI Document EP07-ed3)
Key results: Hemoglobin (500 mg/dL), conjugated Bilirubin (40 mg/dL), unconjugated Bilirubin (40 mg/dL), and Lipemia (1000 mg/dL) showed a percent bias of -3% to 3%. Various other substances (e.g., Biotin, Ibuprofen, Cholesterol) did not exceed 10% bias at TSH concentrations of approximately 0.800 µIU/mL and 9.000 µIU/mL.

Specimen Equivalency (TSH3-UL):

Study type: Weighted Deming regression model (CLSI Document EP09c-ed3)
Sample size (N): 64 for each plasma type
Regression Equation:
- Plasma (Lithium heparin) vs Serum: y = 1.00x + 0.001 µIU/mL (mIU/L), r = 1.00
- Plasma (EDTA) vs Serum: y = 1.00x - 0.001 µIU/mL (mIU/L), r = 1.00

High-Dose Hook Effect (TSH3-UL):

Key results: Patient samples with TSH concentrations as high as 3000 µIU/mL (mIU/L) will report > 150.000 µIU/mL (mIU/L).

Cross-Reactivity (TSH3-UL):

Study type: Cross-reactivity testing (CLSI Document EP07-ed3)
Key results: Human Chorionic Gonadotropin (200,000 µIU/mL), Follicle Stimulating Hormone (1,500 µIU/mL), and Luteinizing Hormone (600 µIU/mL) showed a percent difference of -2.1% to 1.7%, not exceeding 5%.

Onboard Dilution Recovery (TSH3-UL):

Key results: Mean recovery for 1:2 dilution was 99.3% for serum and 100.5% for plasma; for 1:5 dilution, it was 100.1% for serum and 99.3% for plasma.

Linearity (TSH3-UL):

Study type: Linearity studies (CLSI EP06-ED2)
Study design: Dilution series of at least 14 levels (N=5 replicates per level).
Key results: Linear regression for Serum: Y=0.9945*X-0.0011, supporting the claimed linear range of 0.008-150.000 µIU/mL.

Traceability (TSH3-UL):

Traceable to the World Health Organization (WHO) 3rd International Standard for human TSH (IRP 81/565).

Atellica CH Albumin BCP (AlbP)
Study Type: Detection Capability & Precision
Detection Capability:

Limit of Blank (LoB): ≤ 0.1 g/dL (≤ 1 g/L)
Limit of Detection (LoD): ≤ 0.6 g/dL (≤ 6 g/L), determined as 0.5 g/dL (5 g/L) using 486 determinations.
Limit of Quantitation (LoQ): ≤ 0.6 g/dL (≤ 6 g/L), determined as 0.5 g/L.

Precision (for AlbP):

Study design: Samples assayed in duplicate in 2 runs per day for at least 20 days.
Sample size (N): ≥ 80 for each sample.
Key results: CV for repeatability ranges from 0.6% to 1.3%. Within-Laboratory Precision CV ranges from 1.7% to 2.6%.

Reproducibility (for AlbP):

Study design: Samples assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots.
Sample size (N): 225 for each sample.
Key results: Total Reproducibility CV ranges from 1.4% to 1.9%.

Assay Comparison (AlbP):

Study type: Deming linear regression model (CLSI Document EP09c.13)
Sample size (N): 106 (Serum)
Regression Equation: y = 0.98x + 0.0 g/dL
Correlation coefficient (r): 0.999

Specimen Equivalency (AlbP):

Study type: Deming linear regression model (CLSI Document EP09c)
Sample size (N): 76 (Lithium heparin plasma), 55 (Potassium EDTA plasma)
Regression Equation:
- Plasma (Lithium heparin) vs Serum: y = 1.01x + 0.0 g/dL, r = 0.995
- Plasma (Potassium EDTA) vs Serum: y = 0.99x + 0.0 g/dL, r = 0.997

Hemolysis, Icterus, and Lipemia (HIL) (AlbP):

Study type: Interference testing (CLSI Document EP07)
Key results: Hemoglobin (up to 1000 mg/dL), conjugated Bilirubin (up to 30 mg/dL), unconjugated Bilirubin (up to 30 mg/dL), and Lipemia (up to 2000 mg/dL) showed a percent bias within ≤ 10%.

Non-Interfering Substances (AlbP):

Key results: Various substances (e.g., N-Acetylcysteine, Acetaminophen, Biotin, Cholesterol, Immunoglobin G) did not interfere with the assay, with bias ≤ 10%.

Linearity (AlbP):

Study type: Linearity studies (CLSI EP06-ED2)
Study design: Dilution series of at least nine levels (N=5 replicates per level).
Key results: Linear regression for Serum: Y=0.9984*X+0.2891 (g/dL), supporting the claimed linear range of 0.5-8.0 g/dL.

Traceability (AlbP):

Traceable to ERM DA470k Reference Material.

Key Metrics

TSH3-UL:

Limit of Blank (LoB): 0.004 µIU/mL (mIU/L)
Limit of Detection (LoD): 0.008 µIU/mL (mIU/L)
Limit of Quantitation (LoQ): 0.008 µIU/mL (mIU/L)
Precision (CV%) for repeatability: 1.1% to 1.5% (Serum), 1.2% to 1.5% (EDTA Plasma), 1.1% to 1.5% (Heparin Plasma), 1.3% to 1.7% (Controls)
Precision (CV%) for Within-Laboratory Precision: 2.0% to 2.9% (Serum), 2.2% to 2.4% (EDTA Plasma), 1.9% to 3.3% (Heparin Plasma), 2.3% to 2.4% (Controls)
Correlation coefficient (r) for Assay Comparison: 0.996
Percent Bias for Interferences: -3% to 3% for common interferents; ≤ 10% for other substances.
Recovery for Onboard Dilution: 99.3% to 101.6%

AlbP:

Limit of Blank (LoB): ≤ 0.1 g/dL (≤ 1 g/L)
Limit of Detection (LoD): 0.5 g/dL (5 g/L)
Limit of Quantitation (LoQ): 0.5 g/L
Precision (CV%) for repeatability: 0.6% to 1.3%
Precision (CV%) for Within-Laboratory Precision: 1.7% to 2.6%
Reproducibility (Total CV%): 1.4% to 1.9%
Correlation coefficient (r) for Assay Comparison: 0.999
Percent Bias for HIL substances: ≤ 10%
Percent Bias for Non-Interfering Substances: ≤ 10%

Predicate Device(s)

K151792, K151767

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1690 Thyroid stimulating hormone test system.

(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol that represents the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

July 13, 2023

Siemens Healthcare Diagnostics Inc. Anoop Joy Clinical Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591

Re: K222116

Trade/Device Name: Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW, CJW, JJE Dated: December 31, 2022 Received: January 4, 2023

Dear Anoop Joy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K222116

Device Name

Atellica® CI Analyzer Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Atellica® CH Albumin BCP (AlbP)

Indications for Use (Describe)

The Atellica® CI Analyzer is an automated, integrated system in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative analysis of various body fluids, using photometry, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

The Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) 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® CI Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use in the quantitative measurement of albumin in human serum and plasma (lithium heparin, potassum EDTA) using the Atellica® CI Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

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)

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510(k) Summary of Safetv and Effectiveness

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.

The assigned 510(k) Number: K222116

1. APPLICANT

Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA

Contact: Anoop Jov Regulatory Clinical Affairs Specialist Phone: (516) 232-3307 E-mail: anoop.joy@siemens-healthineers.com

Date Prepared: 06 July 2023

2. Requlatory Information

System: Atellica CI Analyzer

Requlation section: 21 CFR § 862.2160 Classification: Class I Trade Name: Atellica® CI Analyzer Product Code: JJE, Photometric Analyzer for Clinical Use Panel: Clinical Chemistry

Assay: Atellica IM Thvroid Stimulating Hormone 3-Ultra (TSH3-UL)

Regulation section: 21 CFR § 862.1690 Classification: Class II Trade Name: Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Product Code: JLW, Thyroid stimulating hormone test system Panel: Clinical Chemistry

Assay: Atellica CH Albumin BCP (AlbP)

Classification Name: Bromocresol Purple Dye-Binding, Albumin Regulation Section: 21CFR862.1035, Albumin Test system Trade Name: Atellica® CH Albumin BCP (AlbP) Classification: Class II Product Code: CJW Panel: Clinical Chemistry

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3. PREDICATE DEVICE INFORMATION

Candidate Device	Predicate Device	510(k) #	Class	Code
Atellica CI Analyzer	Trinidad Immunoassay (IM)
System	K151792	Class I	JJE
Atellica CI Analyzer	Trinidad CH system	K151767	Class I	JJE
Atellica IM Thyroid Stimulating
Hormone 3-Ultra (TSH3-UL)	Trinidad IM Thyroid Stimulating
Hormone (TSH) Assay	K151792	Class II	JLW
Atellica CH Albumin BCP
(AlbP)	Trinidad CH Albumin BCP
reagent (Alb_P)	K151767	Class II	CJW

4. DEVICE DESCRIPTION

4.1. Atellica Cl Analyzer

The Atellica® CI Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

The Atellica CI Analyzer with Atellica® Rack Handler supports both clinical chemistry (CH) and Immunoassay (IM) features and contains all the necessary hardware, electronics, and software to automatically process samples and generate results, including sample and reagent dispensing, mixing, and incubating.

4.2. Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL)

The Atellica IM TSH3-UL assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection

4.3. Atellica CH Albumin BCP (AlbP)

The Atellica CH Albumin BCP (AlbP) assay is an adaptation of the bromocresol purple dy-e binding method reported by Carter and Louderback et al. In the Atellica CH AlbP 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 coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

5. INTENDED USE

5.1 Atellica CI Analyzer

The Atellica® Cl Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

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5.2 Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL)

The Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) 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® Cl Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

5.3 Atellica CH Albumin BCP (AlbP)

The Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use in the quantitative measurement of albumin in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica® Cl Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

6. INDICATIONS FOR USE

Same as Intended use

7. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following table provides a comparison between the predicate and candidate device.

Feature	Trinidad CH system	Trinidad Immunoassay (IM) System	Atellica Cl Analyzer
			CH side	IM side
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, turbidimetric and ion-selective electrode technology for clinical use.	The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The Trinidad IM system's assay application utilizes chemiluminescents technology for clinical use.	The Atellica® CI Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on 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.
Feature	Trinidad CH
system	Trinidad
Immunoassay
(IM) System	Atellica Cl Analyzer
			CH side	IM side
Operating
Principle	Electrolyte,
Photometric
and Turbidimetric	Chemiluminescenc
e using magnetic-
particle solid
phase and
chemiluminescent
label	Same as CH	Same as IM
Type of
System	Random continuous access, batch,
discrete processing	Same	Same
Analytical
and
Detection
Technology	Electrolyte,
Photometric
and Turbidimetric	Chemiluminescenc
e using magnetic-
particle solid
phase and
chemiluminescent
label	Same as CH	Same as IM
Pack
capacity on-
board	Up to 70 x 2	42 primary and 35
ancillary reagent
packs	70 positions	40 positions (20 in
the primary and 20
in the
ancillary
compartments).
Reagent
Probes	4	3	3	1
Mixing	N/A	Centrifugal	N/A	Rocking
Throughput	1800 tests/hour,
1200 tests/hour
colorimetric, 600
tests/hour ISE	220 to 440 tests/hr.	CH maximum
throughput of up
to 1000
assays/hour: 600
photometric
assays/hour, 400
IMT assays/hour	120 IM Test / hour
Optical
System	Water bath and
cuvette optical
path length
(7 mm)
11 fixed
wavelengths	PMT used in
photon counting
mode	Same as CH	Same as IM
Water
Requirements	Special reagent water (SRW) typically
through direct plumbing.	Same	Same
Water
Consumption	Max 33 L/Hour	1600: Average of 6
L/hour	18 L/hour
Feature	Trinidad CH
system	Trinidad
Immunoassay
(IM) System	Atellica CI Analyzer
			CH side	IM side
Temperature
Control	Water bath, 37°C	Stationary foil
heaters	Same	Same
Liquid Level
Sensing	Capacitance
technology	Air pressure
fluid sensing
and
disposable tip
sensing; clog
detection
mechanism
to alert
operator to
clogged	Same	Same
Dispense
System	Sample Probe
transfers an
aliquot of diluted
sample to
reaction cuvette.

Dilution probe
picks up primary
sample from
primary tube or
cup, and
dispenses to
dilution cuvette
with diluent to
dilute sample
(except, IMT)

Direct Load
1100 mm D X
1360mm H X
425 mm W | IM
1155.5mm D X
1500mm H X
1491mm W

7.1. Atellica CI Analyzer

6

7

8

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7.2. Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL)

Below is a features comparison for the Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) assay on the Atellica CI Analyzer and the predicate device Trinidad IM system.

| Feature | Predicate Device:
Atellica IM TSH3-UL on Trinidad IM system | New Device:
Atellica IM TSH3-UL on Atellica CI Analyzer |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Trinidad 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 Trinidad | The Atellica® IM Thyroid
Stimulating Hormone 3-Ultra
(TSH3-UL) assay is for in vitro
diagnostic use in the
quantitative determination of
thyroid-stimulating hormone
(TSH, thyrotropin) in
human serum and plasma |
| | IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. | (EDTA and lithium heparin) using the Atellica® CI Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. |
| Indications for Use: | Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders | Same |
| Sample type | Serum and plasma | Same |
| Measurement | Quantitative | Same |
| Assay Principle | Sandwich immunoassay | Same |
| Technology | Chemiluminescence | Same |
| Detection Antibody | Monoclonal murine anti-TSH antibody BSA conjugate labeled with acridinium ester (AE) | Same |
| Capture Antibody | Anti-fluorescein labeled (FITC) monoclonal murine anti-TSH antibody covalently bound to paramagnetic particles (PMP) | Same |
| Assay Range | 0.008—150.000 µIU/mL | Same |
| Calibration | 2 Point | Same |
| Calibrators | Atellica IM TSH3-UL CAL | Same |
| Number of Calibrators | Two (2) levels | Same |
| Use of Controls | Yes (recommended) | Same |
| Traceability | Traceable to the World Health Organization (WHO) 3rd International standard for human TSH (IRP 81/565) | Same |
| Calibrators Packaging | Provided with reagent kit | Same |
| Expected Values | Infants: 0.87 - 6.15 µIU/mL
Children:0.67 - 4.16 µIU/mL
Adolescent: 0.48- 4.17 µIU/mL
Adult: 0.55 - 4.78 µIU/mL | Same |

10

11

7.3. Atellica CH Albumin BCP (AlbP)

Below is a features comparison for the Atellica CH AlbP assay on the Atellica CI Analyzer and the predicate device Trinidad CH System.

| Feature | Predicate Device:
Atellica CH AlbP on Trinidad CH System | New Device:
Atellica CH AlbP on Atellica CI Analyzer |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | 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 Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use in the quantitative measurement of albumin in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica® CI Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. |
| Indications for Use: | Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. | Same |
| Device Technology: | bromocresol purple (BCP) dye-binding method | Same |
| Sample Type: | Serum/plasma | Same |
| Analytical Measuring Interval: | ALBP : 0.5–8.0 g/dL | Same |
| Reference Interval: | 3.4–5.0 g/dL | Same |
| Interferences: | Bilirubin (Conjugated) – 30 mg/dL
Bilirubin (Unconjugated) – 30 mg/dL
Lipemia – 500 mg/dL
Hemoglobin – 600 mg/dL | Bilirubin (Conjugated) – same
Bilirubin (Unconjugated) – same
Lipemia – same
Hemoglobin – 800 mg/dL |
| Traceability: | ERM-DA470k
Reference Material | Same |
| Calibration Frequency: | Every 30 days | Same |
| Calibrators: | Albumin BCP Calibrator | Same |
| Calibrator Matrix: | ALBP: Human Serum | Same |
| Calibrator Form: | Lyophilized | Same |
| Number of Calibrator Levels: | ALBP: One | Same |

12

8. PERFORMANCE CHARACTERISTICS DATA

8.1. Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL)

Detection Capability

Limit of Blank (LoB) 0.004 µIU/mL (mIU/L) Limit of Detection (LoD) 0.008 µIU/mL (mIU/L) Limit of Quantitation (LoQ) 0.008 µIU/mL (mIU/L)

The LoB corresponds to the highest measurement result likely to be observed for a blank sample with a probability of 95%. The LoD corresponds to the lowest concentration of TSH that can be detected with a probability of 95%. The LoQ corresponds to the lowest amount of Atellica IM TSH3-UL in a sample at which the within laboratory CV is ≤ 20%. Detection capability was determined in accordance with CLSI Document EP17-A2.18.

Precision

Precision was determined in accordance with CLSI Document EP05-A3. Samples were assayed in duplicate in 2 runs per day for 20 days. The study was performed using calibrations before the first day and before the eleventh day of testing. The following results are representative of the performance of the assay:

			Repeatability		Within-Laboratory Precision
Sample Type	Na	Mean
µIU/mL (mIU/L)	SDb
µIU/mL (mIU/L)	CVc
(%)	SD
µIU/mL (mIU/L)	CV
(%)
Serum A	80	0.017	0.0009	N/Ad	0.0015	N/A
Serum B	80	0.156	0.0018	1.2	0.0047	3.0
Serum C	80	1.129	0.0152	1.3	0.0262	2.3
Serum D	80	9.848	0.1213	1.2	0.1996	2.0
Serum E	80	58.362	0.6498	1.1	1.4346	2.5
Serum F	80	120.833	1.6610	1.4	3.5474	2.9
EDTA Plasma A	80	1.408	0.0170	1.2	0.0311	2.2
EDTA Plasma B	80	39.662	0.6028	1.5	0.9500	2.4
EDTA Plasma C	80	97.894	1.2965	1.3	2.8148	2.9
Heparin Plasma A	80	1.706	0.0230	1.3	0.0321	1.9
Heparin Plasma B	80	40.719	0.4539	1.1	0.8526	2.1
Heparin Plasma C	80	97.533	1.4809	1.5	3.1898	3.3

13

			Repeatability		Within-Laboratory Precision
Sample Type	Na	Mean
μIU/mL (mIU/L)	SDb
μIU/mL (mIU/L)	CVc
(%)	SD
μIU/mL (mIU/L)	CV
(%)
Control 1	80	0.387	0.0057	1.5	0.0091	2.4
Control 2	80	4.745	0.0812	1.7	0.1136	2.4
Control 3	80	32.012	0.4122	1.3	0.7244	2.3

a Number of samples tested.

b Standard deviation.

Coefficient of variation.

d Not applicable.

Assay Comparison

Assay comparison was determined with the weighted Deming regression model in accordance with CLSI Document EP09c-ed3. Agreement of the assays may vary depending on the study design, comparative assay, and population tested.

| Specimen

Type	Comparative Assay (x)	Regression Equation	Sample Interval	Na	rb
Serum	Atellica IM TSH3-UL on
Atellica IM Analyzer	$y = 0.96x - 0.001 \muIU/mL (mIU/L)$	0.013-144.030 $\muIU/mL (mIU/L)$	112	0.996

a Number of samples tested.

b Correlation coefficient.

Interferences

Interference testing was performed in accordance with CLSI Document EP07-ed3.

| Substance | Substance Test Concentration
Common Units (SI Units) | Analyte Concentration
ulU/mL (mIU/L) | Percent Bias |
|-------------------------|---------------------------------------------------------|-----------------------------------------|--------------|
| Hemoglobin | 500 mg/dL (5.00 g/L) | 0.820 | -2 |
| | 500 mg/dL (5.00 g/L) | 8.329 | -3 |
| Bilirubin, conjugated | 40 mg/dL (474 umol/L) | 0.817 | -0.1 |
| | 40 mg/dL (474 umol/L) | 8.361 | -0.3 |
| Bilirubin, unconjugated | 40 mg/dL (684 umol/L) | 0.821 | -1 |
| | 40 mg/dL (684 umol/L) | 8.363 | 0.3 |
| Lipemia (Intralipid®) | 1000 mg/dL (11.3 mmol/L) | 0.816 | -3 |
| | 1000 mg/dL (11.3 mmol/L) | 8.258 | -2 |

Hemolysis, Icterus, and Lipemia (HIL)

14

Other Substances

Interference testing was performed using the Atellica CI Analyzer in accordance with CLSI Document EP07-ed3 and EP37-ed1. The following substances do not interfere with the assay when present at the concentrations indicated. Bias due to these substances does not exceed 10% at TSH concentrations of approximately 0.800 µIU/mL(mIU/L) and 9.000 ulU/mL(mIU/L).

Substance	Substance Test Concentration	Substance	Substance Test Concentration
Biotin	0.35 mg/dL (14.3 µmol/L)	Ibuprofen	21.9 mg/dL (1,062 µmol/L)
Cholesterol	400 mg/dL (10.3 mmol/L)	Levodopa	0.75 mg/dL (38.0 µmol/L)
Protein	15 g/dL (150 g/L)	Levothyroxine	0.0429 mg/dL (0.552 µmol/L)
Rheumatoid Factor	1,500 IU/mL	Liothyronine	0.0075 mg/dL (0.116 µmol/L)
Acetaminophen	15.6 mg/dL (1,033 µmol/L)	Methimazole	8.0 mg/dL (701 µmol/L)
N-Acetylcysteine	15.0 mg/dL (920 µmol/L)	Methyldopa	2.25 mg/dL (107 µmol/L)
Acetylsalicylic acid	3.0 mg/dL (167 µmol/L)	Metronidazole	12.3 mg/dL (719 µmol/L)
Ampicillin	7.5 mg/dL (215 µmol/L)	Octreotide	0.03 mg/dL (0.294 µmol/L)
Ascorbic Acid	5.25 mg/dL (298 µmol/L)	Phenylbutazone	32.1 mg/dL (1,040 µmol/L)
Carbimazole	3.0 mg/dL (161 µmol/L)	Propranolol	24 mg/dL (926 µmol/L)
Cefoxitin	495 mg/dL (11,583 µmol/L)	Propylthiouracil	30 mg/dL (1,762 µmol/L)
Cyclosporine	0.18 mg/dL (1.50 µmol/L)	Rifampicin	4.8 mg/dL (58.6 µmol/L)
Doxycycline	1.8 mg/dL (40.5 µmol/L)	Theophylline	6.0 mg/dL (333 µmol/L)
Heparin	7,500 U/dL

Specimen Equivalency

Specimen equivalency was determined using the weighted Deming regression model in accordance with CLSI Document EP09c-ed3. The following results were obtained:

| Specimen (y) | Reference
Specimen (x) | Regression Equation | Sample Interval | Na | rb |
|-----------------------------|---------------------------|--------------------------------------|----------------------------------|----|------|
| Plasma (Lithium
heparin) | Serum | $y = 1.00x + 0.001 \muIU/mL (mIU/L)$ | 0.023-134.942 $\muIU/mL$ (mIU/L) | 64 | 1.00 |
| Plasma (EDTA) | Serum | $y = 1.00x - 0.001 \muIU/mL (mIU/L)$ | 0.023-134.942 $\muIU/mL$ (mIU/L) | 64 | 1.00 |

a Number of samples tested.

b Correlation coefficient.

High-Dose Hook Effect

High TSH concentrations can cause a paradoxical decrease in the RLUs (high-dose hook effect). In this assay, patient samples with TSH concentrations as high as 3000 µIU/mL (mIU/L) will report > 150.000 µIU/mL (mIU/L).

15

Cross-Reactivity

Cross-reactivity was determined using the Atellica CI Analyzer in accordance with with CLSI Document EP07-ed3. The following substances do not interfere with the assay when present in serum at the concentrations indicated. Bias due to these substances does not exceed 5%.

| Substance | Substance Test Concentration
µIU/mL (mIU/L) | TSH Concentration
µIU/mL (mIU/L) | Percent Difference
(%) |
|------------------------------|------------------------------------------------|-------------------------------------|---------------------------|
| Human Chorinic Gonadotropin | 200,000 | 0.323 | 0.3 |
| | | 3.637 | -2.1 |
| | | 51.156 | 1.4 |
| | | 114.932 | 1.6 |
| Follicle Stimulating Hormone | 1,500 | 0.323 | -1.5 |
| | | 3.637 | 0.1 |
| | | 51.156 | 0.5 |
| | | 114.932 | 1.7 |
| Luteinizing Hormone | 600 | 0.323 | 0.9 |
| | | 3.637 | -0.6 |
| | | 51.156 | 0.3 |
| | | 114.932 | 1.1 |

Onboard Dilution Recovery

Serum and plasma samples were diluted onboard the Atellica CI Analyzer with Atellica CI Multi-Diluent 15. The following results are representative of the performance of the assay:

| Sample
(Serum) | Dilution | Observed
µIU/mL (mIU/L) | Expected
µIU/mL (mIU/L) | Recovery
(%) |
|-------------------|----------|----------------------------|----------------------------|-----------------|
| 1 | 1:2 | 279.994 | 277.025 | 101.1 |
| 2 | 1:2 | 282.326 | 286.927 | 98.4 |
| 3 | 1:2 | 250.056 | 253.858 | 98.5 |
| Mean | | | | 99.3 |
| 1 | 1:5 | 281.490 | 277.025 | 101.6 |
| 2 | 1:5 | 284.370 | 286.927 | 99.1 |
| 3 | 1:5 | 252.720 | 253.858 | 99.6 |
| Mean | | | | 100.1 |

16

| Sample
(Plasma) | Dilution | Observed
µIU/mL (mIU/L) | Expected
µIU/mL (mIU/L) | Recovery
(%) |
|--------------------|----------|----------------------------|----------------------------|-----------------|
| 1 | 1:2 | 231.502 | 234.614 | 98.7 |
| 2 | 1:2 | 224.044 | 217.294 | 103.1 |
| 3 | 1:2 | 180.004 | 180.317 | 99.8 |
| Mean | | | | 100.5 |
| 1 | 1:5 | 233.170 | 234.614 | 99.4 |
| 2 | 1:5 | 220.400 | 217.294 | 101.4 |
| 3 | 1:5 | 175.125 | 180.317 | 97.1 |
| Mean | | | | 99.3 |

Linearity

Linearity studies were performed following CLSI EP06-ED2. Dilution series composed of at least 14 levels created by mixing the high and low serum samples. Measurements were made with N=5 replicates per level. The results of the linear regression analysis are summarized in the table below.

Sample	Linear Regression	Claimed Linear Range
Serum	$Y=0.9945*X-0.0011$	0.008-150.000 µIU/mL

The results demonstrated linearity of the claimed measuring range.

Traceability

The Atellica IM TSH3-UL assay and assigned values for calibrators are traceable to the World Health Organization (WHO) 3rd International Standard for human TSH (IRP 81/565).

17

8.2. Atellica CH Albumin BCP (AlbP)

Detection Capability

Detection capability was determined in accordance with CLSI Document EP17-A2. The assay is designed to have a limit of blank (LoB) ≤ 0.1 g/dL (≤ 1 g/L), a limit of detection (LoD) ≤ 0.6 g/dL (≤ 6 g/L), and a limit of quantitation (LoQ) ≤ 0.6 g/dL (≤ 6 g/L).

The LoD corresponds to the lowest concentration of albumin that can be detected with a probability of 95%. The LoD for the Atellica CH AlbP assay is 0.5 g/dL (5 g/L), and was determined using 486 determinations, with 270 blank and 216 low level replicates, and a LoB of value 0.1 g/dL (1 g/L).

The LoQ corresponds to the lowest amount of analyte in a sample at which the within laboratory precision is ≤ 10%. The LoQ of the AlbP assay is 0.5 g/L). All samples were assayed n = 5 using 3 reagent lots, over a period of 5 days.

Precision

Precision was determined in accordance with CLSI Document EP05-A3. Samples were assaved on an Atellica Cl Analyzer in duplicate in 2 runs per day for at least 20 days (N ≥ 80 for each sample). The following results were obtained:

			Repeatability		Within-Laboratory Precision
Sample Type	N	Mean
g/dL (g/L)	SDa
g/dL (g/L)	CVb
(%)	SDa
g/dL (g/L)	CVb
(%)
Serum 1	80	2.7 (27)	0.03 (0.3)	1.1	0.06 (0.6)	2.2
Serum QC 1	80	3.1 (31)	0.04 (0.4)	1.3	0.08 (0.8)	2.6
Serum 2	80	3.6 (36)	0.03 (0.3)	0.8	0.09 (0.9)	2.5
Serum 3	80	7.1 (71)	0.04 (0.4)	0.6	0.12 (1.2)	1.7

Standard deviation.

b Coefficient of variation.

Reproducibility

Reproducibility was determined in accordance with CLSI Document EP05-A3. Samples were assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots. The data were analyzed to calculate the following components of precision: repeatability, between-day, between-lot, between-instrument, and reproducibility (total). The following results were obtained:

18


Sample	N a	Mean
g/dL
(g/L)	SD b
g/dL
(g/L)	CV c
(%)	SD
g/dL
(g/L)	CV
(%)	SD
g/dL
(g/L)	CV
(%)	SD
g/dL
(g/L)	CV
(%)	SD
g/dL
(g/L)	CV
(%)
Serum 1	225	2.7
(27)	0.03
(0.3)	1.2	0.03
(0.3)	1.3	0.02
(0.2)	0.7	0.01
(0.1)	0.2	0.05
(0.5)	1.9
Serum 2	225	3.7
(37)	0.03
(0.3)	0.9	0.03
(0.3)	0.9	0.01
(0.1)	0.4	0.01
(0.1)	0.3	0.05
(0.5)	1.4
Serum 3	225	7.1
(71)	0.04
(0.4)	0.6	0.06
(0.6)	0.9	0.00
(0.0)	0.0	0.07
(0.7)	1.1	0.11
(1.1)	1.5

a Number of results.

b Standard deviation.

Coefficient of variation.

Assay Comparison

The performance of the Atellica CH AlbP assay on the Atellica CI Analyzer (y) was compared with the performance of the comparison assay on the indicated system (x) and is designed to have a correlation coefficient of > 0.960 and a slope of 1.00 ± 0.10. Assay comparison was determined using the Deming linear regression model in accordance with CLSI Document EP09c.13 The following results were obtained:

Specimen	Comparative Assay (x)	Regression Equation
Serum	Atellica CH AlbP on Atellica CH Analyzer	y = 0.98x + 0.0 g/dL
(y = 0.98x + 0 g/L)	0.6–7.5 g/dL
(6–75 g/L)	106	0.999

Number of samples tested. a

b Correlation coefficient.

Specimen Equivalency

Specimen equivalency was determined using the Deming linear regression model in accordance with CLSI Document EP09c. The following results were obtained:

Specimen (y)	Reference Specimen (x)	Regression Equation
Plasma (Lithium heparin)	Serum	$y = 1.01x + 0.0 g/dL$
( $y = 1.01x + 0 g/L$ )	0.5-7.9 g/dL
(5-79 g/L)	76	0.995
Plasma (Potassium EDTA)	Serum	$y = 0.99x + 0.0 g/dL$
( $y = 0.99x + 0 g/L$ )	0.5-7.9 g/dL
(5-79 g/L)	55	0.997

a Number of samples tested.

b Correlation coefficient.

Hemolysis, Icterus, and Lipemia (HIL)

The Atellica CH AlbP assay is designed to have ≤ 10% interference from hemoglobin, bilirubin, and lipemia. Interfering substances at the levels indicated in the table below were tested in accordance with CLSI Document EP07 using the Atellica CH AlbP assay.

19

Bias is the difference in the results between the control sample (does not contain the interferent) and the test sample (contains the interferent) expressed in percent. Bias > 10% is considered interference. Analyte results should not be corrected based on this bias.

| Substance | Substance Test Concentration
Common Units (SI Units) | Analyte Concentration
g/dL (g/L) | Percent Biasa |
|-------------------------|---------------------------------------------------------|-------------------------------------|---------------|
| Hemoglobin | 800 mg/dL (8 g/L) | 3.4 (34) | 9 |
| | 1000 mg/dL (10 g/L) | 5.0 (50) | 6 |
| Bilirubin, conjugated | 30 mg/dL (513 µmol/L) | 3.4 (34) | -3 |
| | 30 mg/dL (513 µmol/L) | 5.0 (50) | -4 |
| Bilirubin, unconjugated | 30 mg/dL (513 µmol/L) | 3.6 (36) | -3 |
| | 30 mg/dL (513 µmol/L) | 5.3 (53) | -2 |
| Lipemia (Trig Fraction) | 2000 mg/dL (20 g/L) | 3.3 (33) | 6 |
| | 2000 mg/dL (20 g/L) | 4.8 (48) | 6 |
| Lipemia (Intralipid®) | 500 mg/dL (5 g/L) | 3.6 (36) | 8 |
| | 500 mg/dL (5 g/L) | 5.3 (53) | 4 |

a Analyte results should not be corrected based on this bias.

Non-Interfering Substances

The following substances do not interfere with the Atellica CH AlbP assay when present in serum, potassium EDTA plasma, and lithium heparin plasma at the concentrations indicated in the table below. Bias due to these substances is ≤ 10%.

| Substance | Substance Test Concentration
Conventional Units (SI Units) | Analyte Concentration
Conventional Units (SI Units) | Bias
% |
|----------------------|---------------------------------------------------------------|--------------------------------------------------------|-----------|
| N-Acetylcysteine | 15 mg/dL (0.9 mmol/L) | 3.5 g/dL (35 g/L) | -6 |
| | 15 mg/dL (0.9 mmol/L) | 5 g/dL (50 g/L) | -4 |
| Acetaminophen | 15.6 mg/dL (1032 $\mu$ mol/L) | 3.4 g/dL (34 g/L) | 3 |
| | 15.6 mg/dL (1032 $\mu$ mol/L) | 5 g/dL (50 g/L) | 0 |
| Acetylsalicylic acid | 3 mg/dL (166.7 $\mu$ mol/L) | 3.5 g/dL (35 g/L) | 0 |
| | 3 mg/dL (166.7 $\mu$ mol/L) | 5 g/dL (50 g/L) | 0 |
| Ampicillin | 7.5 mg/dL (214.9 $\mu$ mol/L) | 3.4 g/dL (34 g/L) | 3 |
| | 7.5 mg/dL (214.9 $\mu$ mol/L) | 5 g/dL (50 g/L) | 0 |
| Ascorbic acid | 5.25 mg/dL (298.3 $\mu$ mol/L) | 3.5 g/dL (35 g/L) | -3 |
| | 5.25 mg/dL (298.3 $\mu$ mol/L) | 5 g/dL (50 g/L) | 0 |
| Biotin | 0.351 ng/mL (1.4 nmol/L) | 3.6 g/dL (36 g/L) | 0 |
| | 0.351 ng/mL (1.4 nmol/L) | 5.1 g/dL (51 g/L) | -2 |
| Cefoxitin | 75 mg/dL (1756.4 $\mu$ mol/L) | 3.3 g/dL (33 g/L) | 3 |
| | 75 mg/dL (1756.4 $\mu$ mol/L) | 4.7 g/dL (47 g/L) | 0 |

20

| Substance | Substance Test Conventional Units (SI Units) | Analyte Conventional Units (SI Units) | Bias
% |
|-------------------|------------------------ | Cholestrol | 400 mg/dL (10.3 mmol/L) | | 400 mg/dL (10.3 mmol/L) | Cyclosporine | 0.18 mg/dL (1.5 µmol/L) | | 0.18 mg/dL (1.5 µmol/L) | Heparin | 3300 IU/L | | 3300 IU/L | Ibuprofen | 21.9 mg/dL (1063.1 µmol/L) | | 21.9 mg/dL (1063.1 µmol/L) | Immunoglobin G | 5 g/dL (50 g/L) | | 5 g/dL (50 g/L) | Levodopa | 0.75 mg/dL (38.1 µmol/L) | | 0.75 mg/dL (38.1 µmol/L) | Rheumatoid Factor | 1500 IU/mL | | 1500 IU/mL | Rifampicin | 4.8 mg/dL (58.3 µmol/L) | | 4.8 mg/dL (58.3 µmol/L) | Theophylline | 6 mg/dL (333.3 µmol/L) | | 6 mg/dL (333.3 µmol/L) Concentration
Concentration
---------------------------------------|--------------------------------------------------------|-----------|
| 3 g/dL (30 g/L) | 7 |
| 4.3 g/dL (43 g/L) | 2 |
| 3.6 g/dL (36 g/L) | 3 |
| 5.1 g/dL (51 g/L) | 2 |
| 3.5 g/dL (35 g/L) | 0 |
| 5 g/dL (50 g/L) | 0 |
| 3.5 g/dL (35 g/L) | 3 |
| 5 g/dL (50 g/L) | 2 |
| 3.7 g/dL (37 g/L) | -3 |
| 5.2 g/dL (52 g/L) | -4 |
| 3.5 g/dL (35 g/L) | 0 |
| 5 g/dL (50 g/L) | 0 |
| 3 g/dL (30 g/L) | 10 |
| 4.3 g/dL (43 g/L) | 7 |
| 3.5 g/dL (35 g/L) | 0 |
| 5 g/dL (50 g/L) | 2 |
| 3.5 g/dL (35 g/L) | -3 |
| 5 g/dL (50 g/L) | 0 |

Linearity

Linearity studies were performed following CLSI EP06-ED2. Dilution series composed of at least nine levels created by mixing the high and low pools of serum. Measurements were made with N=5 replicates per level. The results of the linear regression analysis are summarized in the table below.

Sample	Linear Regression	Claimed Linear Range
Serum	Y=0.9984*X+0.2891 (g/dL)	0.5-8.0 g/dL

The results demonstrated linearity of the claimed measuring range.

Traceability

The Atellica CH AlbP assay and assigned values for calibrators are traceable to ERM DA470k Reference Material.

9. CONCLUSION

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