Atellica® CH Creatinine_3 (Crea3)

K242685 · Siemens Healthcare Diagnostics, Inc. · CGX · Dec 4, 2024 · Clinical Chemistry

Device Facts

• Record ID: K242685
• Device Name: Atellica® CH Creatinine_3 (Crea3)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Dec 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin, dipotassium EDTA, and sodium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

Device Story

In vitro diagnostic assay for quantitative creatinine measurement in human serum, plasma, and urine; used on Atellica® CH Analyzer. Principle: modified kinetic Jaffe technique; reaction of picrate with creatinine in alkaline medium (sodium hydroxide) forms red chromophore creatinine picrate complex. Rate of complex formation measured photometrically at 505/571 nm; proportional to creatinine concentration. Includes rate blanking to reduce interference from non-specific protein interactions. Operated by laboratory personnel in clinical settings. Output: creatinine concentration (mg/dL). Results assist clinicians in diagnosing/treating renal disease and monitoring dialysis. Reagent kit contains sodium hydroxide and lithium picrate.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP05-A3, EP07-ED3, EP09C-ED3, EP17-A2). Precision studies (n=80 per sample) showed within-lab CVs ≤ 4.0% for serum and ≤ 1.3% for urine. Method comparison against the predicate (n=151 serum, n=113 urine) yielded correlation coefficients (r) of 1.000. Interference testing confirmed bias ≤ 10% for common substances, with specific limitations noted for Cefoxitin and Cephalothin.

Technological Characteristics

Modified kinetic Jaffe methodology; photometric detection at 505/571 nm. Reagents: sodium hydroxide (1.0 mol/L) and lithium picrate (25 mmol/L). Standardization: NIST SRM967. Connectivity: integrated with Atellica® CH Analyzer. Stability: 17-day onboard reagent stability; 180-day lot calibration interval.

Indications for Use

Indicated for quantitative determination of creatinine in human serum, plasma, and urine for diagnosis and treatment of renal diseases and monitoring renal dialysis. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Atellica® CH Creatinine_2 (Crea_2) (K161494)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 4, 2024

Siemens Healthcare Diagnostics Inc. Elisha Caban Regulatory Affairs Professional 511 Benedict Ave Tarrytown, New York 10591

Re: K242685

Trade/Device Name: Atellica® CH Creatinine 3 (Crea3) Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: CGX Dated: September 6, 2024 Received: September 6, 2024

Dear Elisha Caban:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

{2}------------------------------------------------

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Deputy Division 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

{3}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Submission Number (if known)

K242685

Device Name

Atellica® CH Creatinine_3 (Crea3)

| Indications for Use (Describe) |
|--------------------------------|
|--------------------------------|

The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin, dipotassium EDTA, and sodium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

{4}------------------------------------------------

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.

The assigned 510(k) Number is:K242685

### 1. Date Prepared

November 7, 2024

### 2. Applicant Information

| Manufacturer Name: | Siemens Healthcare Diagnostics, Inc. |
|--------------------|--------------------------------------------------------------------------------|
| Contact: | Elisha Caban |
| Address: | Regulatory Affairs Professional<br>511 Benedict Ave<br>Tarrytown, NY 10591 USA |
| Email: | [e-mail] |

### 3. Regulatory Information

| Information | Atellica® CH Creatinine_3<br>(Crea3) |
|---------------------------|----------------------------------------------|
| Trade Name | Atellica® CH Creatinine_3<br>(Crea3) |
| Device | Alkaline Picrate, Colorimetry,<br>Creatinine |
| Regulation Description | Creatinine test system |
| FDA Device Classification | Class II |
| Review Panel | Clinical Chemistry |
| Product Code | CGX |
| Regulation Number | 21 CFR 862.1225 |

### Predicate Device Information 4.

| Candidate Device | Predicate Device | Predicate 510(k) Clearance# |
|--------------------------------------|---------------------------------------|-----------------------------|
| Atellica® CH Creatinine_3<br>(Crea3) | Atellica® CH Creatinine_2<br>(Crea_2) | K161494 |

{5}------------------------------------------------

| Product | Intended Use |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Atellica® CH<br>Creatinine_3<br>(Crea3) | The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic<br>use in the quantitative determination of creatinine in human serum,<br>plasma (lithium heparin, dipotassium EDTA, and sodium heparin), and<br>urine using the Atellica® CH Analyzer. Such measurements are used<br>in the diagnosis and treatment of renal diseases, and in monitoring<br>renal dialysis. |

### 5. Intended Use / Indications For Use

Special Conditions for Use Statement(s): For Prescription Use Only.

| 6. | Device Description |
|----|--------------------|
|----|--------------------|

| Product | Device Description |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Atellica® CH<br>Creatinine_3<br>(Crea3) | The Atellica CH Crea3 assay is based on the reaction of picrate with<br>creatinine in an alkaline<br><br>The Atellica CH Crea3 assay reacts with picrate in an alkaline medium<br>to produce a red chromophore creatinine picrate complex. The rate of<br>complex formation is measured at 505/571 nm and is proportional to<br>the creatinine concentration. The Atellica CH Crea3 assay is a<br>modification of the Jaffe method, using rate blanking and intercept<br>correction. Rate blanking is used to minimize bilirubin interference.<br>Also, because non-specific serum/plasma protein interactions with this<br>reagent have been found to produce a positive bias of<br>approximately0.3 mg/dL (26.5 $\mu$ mol/L), serum/plasma measurements<br>are automatically corrected by subtracting 0.3 mg/dL (26.5 $\mu$ mol/L)<br>from each result. |

### Purpose of Submission 7.

The purpose of this submission is a premarket notification for the new devices:

- Atellica® CH Creatinine_3 (Crea3) assay .
### 8. Comparison of Candidate Device and Predicate Device

### Atellica® CH Creatinine 3 (Crea3) assay 8.1

The table below describes the similarities and differences between the Atellica® CH Creatinine_3 (Crea3) assay (Candidate Device), and the Atellica® CH Creatinine_2 (Crea_2) assay (Predicate Device).

The performance and accuracy of the Candidate Device are substantially equivalent to those of the Predicate Device. The method comparison of the Candidate Device and the Predicate Device demonstrates acceptable correlation between the two methods.

{6}------------------------------------------------

| Feature | Candidate Device | Predicate Device |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Atellica® CH Creatinine_3 (Crea3) | Atellica® CH Creatinine_2 (Crea_2) |
| Intended Use | The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin, dipotassium EDTA, and sodium heparin), and urine using the Atellica® CH Analyzer. | The Atellica® CH Creatinine_2 (Crea_2) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin), and urine using the Atellica® CH Analyzer. |
| Indications for Use | Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. | Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. |
| Sample Type | Serum, lithium heparin plasma, dipotassium EDTA plasma, sodium heparin plasma, urine | Serum, Plasma (Lithium Heparin), urine. |
| Units of Measure | mg/dL | Same |
| Assay Range / Measuring Interval | Serum 0.15 mg/dL to 30.00 mg/dL<br>Urine 3.00 mg/dL to 245.00 mg/dL | Same |
| Expected Values | Serum/plasma<br>Adult Males: 0.70 – 1.30 mg/dL<br>Adult Females: 0.55 – 1.02 mg/dL<br>Urine<br>Adult Males 950 - 2490 mg/day<br>Adult Female 600 - 1800 mg/day | Same |
| Assay Principle | Enzymatic | Same |
| Standardization | NIST SRM 967 | Same |
| Calibration | Single point | Same |
| Calibrators | Atellica® CH CHEM CAL (CHEM CAL) | Same |

### Table 1: Comparison Table of Candidate Device and Predicate Device

### 9. Standard/Guidance Document References

The following recognized standards from Clinical Laboratory Standards Institute (CLSI) were used as a basis of the study procedures described in this submission for both the Atellica® CH Creatinine 3 (Crea3) assay.

{7}------------------------------------------------

- Evaluation of Precision of Quantitative Measurement Procedures-Third Edition. (CLSI . EP05-A3).
- . Interference Testing in Clinical Chemistry, 3rd Edition (CLSI EP07-ED3).
- Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition (CLSI EP09C-ED3).
- Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; ● Approved Guideline-Second Edition (EP17-A2).
- Evaluation of Stability of In Vitro Diagnostic Medical Laboratory Test Reagents,200 Edition ● (CLSI EP25-ED2).
- Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Third ● Edition. (CLSI EP28-A3C).
- Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and ● Spiking, 1st Edition (CLSI EP34-ED1).
- Evaluation of the Linearity of Quantitative Measurement Procedures, 200 st Edition (CLSI EP06-ED2).
- . EP32-R Metrological Traceability and its Implementation

{8}------------------------------------------------

### Performance Characteristics for Atellica® CH Creatinine 3 (Crea3) 10. Assav

### Detection Capability 10.1

### Atellica® CH Creatinine_3 (Crea3) 10.1.1

The Limit of Blank (LoB) corresponds to the highest measurement result that is likely to be observed for a blank sample. The assay is designed to have an LoB ≤ Limit of Detection (LoD) for serum and urine samples.

The Limit of Detection (LoD) corresponds to the lowest concentration of Creatinine that can be detected with a probability of 95%. The assay is designed to have an LoD ≤ 0.15 mg/dL for serum/plasma and ≤ 3.00 mg/dL for urine.

The Limit of Quantitation (LoQ) corresponds to the lowest concentration of Creatinine in a sample at which the within lab imprecision is ≤ 20%CV for serum and plasma. The assay is designed to have an LoQ ) ≤ 0.15 mg/dL for serum/plasma with ≤ 0.10 mg/dL total analytical error and ≤ 3.00 mg/dL for urine with ≤ 1.50 mg/dL total analytical error.

Detection capability was determined in accordance with CLSI Document EP17-A2.

The following results were obtained:

## Table 2: Crea3 Instructions for Use Detection Capability Claims

| Specimen Type | Detection Capability | Result<br>mg/dL |
|---------------|----------------------|-----------------|
| Serum/plasma | LoB | 0.05 |
| | LoD | 0.10 |
| | LoQ | 0.15 |
| Urine | LoB | 0.50 |
| | LoD | 1.00 |
| | LoQ | 3.00 |

### 10.2 Precision

### Atellica® CH Creatinine 3 (Crea3) 10.2.1

Precision was determined in accordance with CLSI Document EP05-A3. Samples were assayed on the Atellica® CH Analyzer in duplicate in 2 runs per day for 20 davs. The following results were obtained:

{9}------------------------------------------------

| Specimen<br>Type | Na | Repeatability | Within-Lab | | | |
|------------------|----|---------------|--------------|------------|--------------|-----------|
| | | Mean<br>mg/dL | SDb<br>mg/dL | CVc<br>(%) | SD<br>mg/dL) | CV<br>(%) |
| Serum 1 | 80 | 0.38 | 0.006 | 1.6 | 0.012 | 3.2 |
| Serum 2 | 80 | 0.73 | 0.023 | 3.2 | 0.029 | 4.0 |
| Serum 3 | 80 | 0.73 | 0.006 | 0.8 | 0.019 | 2.6 |
| Serum 4 | 80 | 1.18 | 0.007 | 0.6 | 0.019 | 1.6 |
| Serum QC 1 | 80 | 1.85 | 0.007 | 0.4 | 0.024 | 1.3 |
| Serum QC 2 | 80 | 6.21 | 0.011 | 0.2 | 0.067 | 1.1 |
| Serum 5 | 80 | 17.39 | 0.035 | 0.2 | 0.189 | 1.1 |
| Serum 6 | 80 | 28.54 | 0.056 | 0.2 | 0.317 | 1.1 |
| Urine 1 | 80 | 56.74 | 0.102 | 0.2 | 0.746 | 1.3 |
| Urine 2 | 80 | 135.80 | 0.206 | 0.2 | 1.601 | 1.2 |
| Urine QC 1 | 80 | 195.79 | 0.253 | 0.1 | 2.376 | 1.2 |

### Table 3: Crea3 Instructions for Use Precision Claims

ª Number of results.

b Standard deviation.

°Coefficient of variation.

{10}------------------------------------------------

#### 10.3 Reproducibility

#### Atellica® CH Creatinine_3 (Crea3) 10.3.1

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, betweenday, between-lot, between-instrument, and reproducibility (total). The following results were obtained:

### Table 4: Atellica® CH Creatinine 3 (Crea3) Instructions for Use Reproducibility Claims

| Mean | | Repeatability | | | Between-DAY | | | Between-LOT | | | Between-SYSTEM | | | Reproducibility | | | | |
|------------|-----|---------------|--------|-------|-------------|------|-------|-------------|-----|-------|----------------|-----|-------|-----------------|-----|-------|--------|-----|
| | Na | mg/dL | µmol/L | mg/dL | µmol/L | %CVc | mg/dL | µmol/L | %CV | mg/dL | µmol/L | %CV | mg/dL | µmol/L | %CV | mg/dL | µmol/L | %CV |
| Sample | | | | | | | | | | | | | | | | | | |
| Serum 1 | 225 | 0.40 | 35 | 0.014 | 1.2 | 3.5 | 0.007 | 0.6 | 1.8 | 0.011 | 1.0 | 2.8 | 0.006 | 0.5 | 1.5 | 0.020 | 1.8 | 5.0 |
| Serum 2 | 225 | 0.72 | 64 | 0.015 | 1.3 | 2.1 | 0.021 | 1.9 | 2.9 | 0.007 | 0.6 | 1.0 | 0.014 | 1.2 | 1.9 | 0.030 | 2.7 | 4.2 |
| Serum 3 | 225 | 1.21 | 107 | 0.009 | 0.8 | 0.7 | 0.015 | 1.3 | 1.2 | 0.013 | 1.1 | 1.1 | 0.013 | 1.1 | 1.1 | 0.025 | 2.2 | 2.1 |
| Serum QC 1 | 225 | 1.90 | 168 | 0.011 | 1.0 | 0.6 | 0.021 | 1.9 | 1.1 | 0.006 | 0.5 | 0.3 | 0.014 | 1.2 | 0.7 | 0.028 | 2.5 | 1.5 |
| Serum QC 2 | 225 | 6.31 | 558 | 0.030 | 2.7 | 0.5 | 0.052 | 4.6 | 0.8 | 0.023 | 2.0 | 0.4 | 0.040 | 3.5 | 0.6 | 0.076 | 6.7 | 1.2 |
| Serum 4 | 225 | 17.62 | 1558 | 0.048 | 4.2 | 0.3 | 0.113 | 10.0 | 0.6 | 0.000 | 0.0 | 0.0 | 0.090 | 8.0 | 0.5 | 0.152 | 13.4 | 0.9 |
| Serum 5 | 225 | 28.76 | 2542 | 0.105 | 9.3 | 0.4 | 0.192 | 17.0 | 0.7 | 0.079 | 7.0 | 0.3 | 0.153 | 13.5 | 0.5 | 0.278 | 24.6 | 1.0 |
| Urine 1 | 225 | 57.23 | 5059 | 0.213 | 18.8 | 0.4 | 0.475 | 42.0 | 0.8 | 0.177 | 15.6 | 0.3 | 0.681 | 60.2 | 1.2 | 0.875 | 77.4 | 1.5 |
| Urine 2 | 225 | 137.89 | 12189 | 0.511 | 45.2 | 0.4 | 0.842 | 74.4 | 0.6 | 0.385 | 34.0 | 0.3 | 1.577 | 139.4 | 1.1 | 1.898 | 167.8 | 1.4 |
| Urine QC 1 | 225 | 199.45 | 17631 | 0.913 | 80.7 | 0.5 | 1.659 | 146.7 | 0.8 | 0.655 | 57.9 | 0.3 | 2.398 | 212.0 | 1.2 | 3.125 | 276.3 | 1.6 |

a Number of results.

b Standard deviation.

° Coefficient of variation.

{11}------------------------------------------------

### 10.4 Assay Comparison

# Atellica® CH Creatinine_3 (Crea3)

The Atellica® CH Creatinine 3 (Crea3) assay (y) was designed to have a correlation coefficient of ≥ 0.950 and a slope of 1.00 ± 0.05 for serum samples and correlation coefficient of ≥ 0.950 and a slope of 0.000 ± 3.00 for urine samples, compared to the Atellica CH Creatinine 2 (Crea_2) assay on the Atellica CH analyzer. Assay comparison was determined using the Weighted Deming regression model in accordance with CLSI Document EP09C-ED3. The following results were obtained:

| Specimen<br>Type | Comparison<br>Assay (x) | Regression Equation | Sample Range mg/dL | Na | rb |
|------------------|-----------------------------------------|------------------------|--------------------|-----|-------|
| Serum | Atellica CH<br>Creatinine_2<br>(Crea_2) | y = 1.00x - 0.04 mg/dL | 0.44 to<br>28.64 | 151 | 1.000 |
| Urine | Atellica CH<br>Creatinine_2<br>(Crea_2) | y = 1.00x + 0.14 mg/dL | 12.60 to 237.06 | 113 | 1.000 |

### Table 5: Atellica® CH Creatinine_3 (Crea3) Instructions for Use Method Comparison Claims

a Number of samples tested.

b Correlation coefficient.

### Specimen Equivalence 10.5

### Atellica® CH Creatinine_3 (Crea3) 10.5.1

The specimen equivalency was determined using the Weighted Deming regression model in accordance with CLSI Document EP09-A3. The following results were obtained:

| | | Table 6: Atellica® CH Creatinine 3 (Crea3) Instructions for Use Specimen Equivalence Claims | | |
|--|--|---------------------------------------------------------------------------------------------|--|--|
| | | | | |
| | | | | |

| Specimen (y) | Reference Specimen (x) | Regression Equation | Sample Range mg/dL (µmol/L) | | Na | rb | |
|------------------|------------------------|-------------------------------------------------|-----------------------------|----------|-----------------|----|-------|
| Sodium Heparin | Serum | $y = 1.00x + 0.00 mg/dL$ $y = 1.00x + 0 µmol/L$ | 0.60<br>(53) | to<br>to | 27.26<br>(2410) | 50 | 0.999 |
| Lithium Heparin | Serum | $y = 0.99x + 0.06 mg/dL$ $y = 0.99x + 5 µmol/L$ | 0.60<br>(53) | to<br>to | 27.26<br>(2410) | 50 | 0.999 |
| Dipotassium EDTA | Serum | $y = 0.98x + 0.04 mg/dL$ $y = 0.98x + 4 µmol/L$ | 0.60<br>(53) | to<br>to | 27.26<br>(2410) | 50 | 0.998 |

ª Number of samples tested.

b Correlation Coefficient.

{12}------------------------------------------------

#### 10.6 Interferences

#### 10.6.1.1 Atellica® CH Creatinine_3 (Crea3)

#### 10.6.1.2 Hemolysis, Icterus, and Lipemia (HIL)

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. The Atellica® CH Crea3 assay is designed to have ≤ 10% interference from hemoglobin, billirubin, and lipemia. Bias > 10% or 0.15 mg/dL whichever is greater for serum/plasma is considered interference. Analyte results should not be corrected based on this bias.

Interference testing was performed in accordance with CLSI Document EP07-ED3. The following results were obtained:

| Substance | Substance<br>Concentration<br>(mg/dL) | Analyte<br>Concentration<br>(mg/dL) | Bias |
|-----------------------------------------|---------------------------------------|-------------------------------------|-------------|
| Hemoglobin | 1000 | 0.65 | 0.14 mg/dL |
| Hemoglobin | 1000 | 2.05 | 6.3% |
| Conjugated Bilirubin | 45 | 0.59 | -0.14 mg/dL |
| Conjugated Bilirubin | 40 | 2.03 | -8.5% |
| Unconjugated Bilirubin | 45 | 0.59 | -0.07 mg/dL |
| Unconjugated Bilirubin | 60 | 2.07 | -6.8% |
| Lipemia (from<br>Intralipid®) | 2250 | 0.62 | -0.06 mg/dL |
| Lipemia (from<br>Intralipid®) | 3000 | 1.92 | 8.3% |
| Lipemia (from<br>Triglyceride Fraction) | 3000 | 0.54 | 0.00 mg/dL |
| Lipemia (from<br>Triglyceride Fraction) | 3000 | 1.79 | 0.0% |
| Substance | Substance<br>Concentration | Analyte Concentration (mg/dL) | Bias (%) |
| Acetaminophen | 160 mg/L | 0.60 | 0.00 mg/dL |
| Acetaminophen | 160 mg/L | 2.08 | -0.5% |
| Acetoacetate | 20 mg/dL | 0.63 | 0.01 mg/dL |
| Acetoacetate | 20 mg/dL | 2.13 | -0.5% |
| Acetylcysteine (N-Acetylcysteine) | 150 mg/L | 0.60 | 0.00 mg/dL |
| Acetylcysteine (N-Acetylcysteine) | 150 mg/L | 2.05 | 0.5% |
| Acetylsalicylic Acid | 30 mg/L | 0.60 | 0.01 mg/dL |
| Acetylsalicylic Acid | 30 mg/L | 2.08 | 0.5% |
| Ampicillin-Na | 80 mg/L | 0.60 | 0.01 mg/dL |
| Ampicillin-Na | 80 mg/L | 2.03 | -0.5% |
| Ascorbic Acid | 60 mg/L | 0.60 | 0.01 mg/dL |
| Ascorbic Acid | 60 mg/L | 2.08 | 0.0% |
| Azlocillin | 7 g/L | 0.55 | 0.00 mg/dL |
| Azlocillin | 7 g/L | 1.98 | -1.0% |
| Biotin | 4250 ng/mL | 0.63 | -0.01 mg/dL |
| Biotin | 4250 ng/mL | 2.12 | -0.5% |
| Ca-Dobesilate | 60 mg/L | 0.60 | 0.01 mg/dL |
| Ca-Dobesilate | 60 mg/L | 2.03 | -0.5% |
| Cefotaxime | 53 mg/dL | 0.63 | 0.01 mg/dL |
| Cefotaxime | 53 mg/dL | 2.13 | 0.0% |
| Cyclosporine | 2 mg/L | 0.64 | 0.02 mg/dL |
| Cyclosporine | 2 mg/L | 2.04 | 1.5% |
| Doxycycline | 20 mg/L | 0.62 | -0.01 mg/dL |
| Doxycycline | 20 mg/L | 2.13 | 0.5% |
| Eltrombopag | 300 mg/L | 0.59 | 0.15 mg/dL |
| Eltrombopag | 300 mg/L | 2.08 | 1.4% |
| Ibuprofen | 220 mg/L | 0.64 | 0.00 mg/dL |
| Ibuprofen | 220 mg/L | 2.14 | 0.0% |
| Levodopa | 700 mg/L | 42.01 | -1.4% |
| Levodopa | 700 mg/L | 186.99 | -1.6% |
| Methyldopa | 100 mg/L | 0.63 | 0.03 mg/dL |
| Methyldopa | 100 mg/L | 2.09 | -2.9% |
| Metronidazole | 130 mg/L | 0.60 | 0.02 mg/dL |
| Metronidazole | 130 mg/L | 2.03 | 1.0% |
| Nitrofurantoin | 0.3 mg/dL | 0.64 | 0.01 mg/dL |
| Nitrofurantoin | 0.3 mg/dL | 2.04 | 1.0% |
| Nitroglycerin | 0.015 mg/L | 0.65 | 0.01 mg/dL |
| Substance | Substance<br>Concentration | Analyte Concentration (mg/dL) | Bias (%) |
| Nitroglycerin | 0.015 mg/L | 2.13 | 0.0% |
| Norfenefrine | 4 mg/L | 0.63 | -0.02% |
| Norfenefrine | 4 mg/L | 2.13 | 0.5% |
| Phenylbutazone | 330 mg/L | 0.64 | 0.03% |
| Phenylbutazone | 330 mg/L | 2.14 | 0.0% |
| Rifampicin | 50 mg/L | 0.60 | 0.01% |
| Rifampicin | 50 mg/L | 2.05 | 1.5% |
| Sodium Heparin | 4 U/mL | 0.65 | -0.04% |
| Sodium Heparin | 4 U/mL | 2.13 | 0.0% |
| Sulbactam | 240 mg/L | 0.60 | 0.05% |
| Sulbactam | 240 mg/L | 2.03 | 1.5% |
| Sulfamethoxazole | 40 mg/dL | 0.64 | 0.00% |
| Sulfamethoxazole | 40 mg/dL | 2.14 | -0.5% |
| Sulfapyridine | 30 mg/dL | 0.63 | -0.04% |
| Sulfapyridine | 30 mg/dL | 2.12 | 0.0% |
| Sulfasalazine | 500 mg/L | 0.64 | -0.07% |
| Sulfasalazine | 500 mg/L | 2.14 | -7.9% |
| Theophylline (1.3-dimethylxanthine) | 60 mg/L | 0.60 | 0.02% |
| Theophylline (1.3-dimethylxanthine) | 60 mg/L | 2.03 | -0.5% |
| Trimethoprim | 5 mg/dL | 0.64 | 0.00% |
| Trimethoprim | 5 mg/dL | 2.14 | 0.0% |

### Table 7: Atellica® CH Creatinine_3 (Crea3) Instructions for Use Interference HIL Claims

### 10.6.1.3 Non-Interfering Substances

The following substances do not interfere with the Atellica® CH Creatinine 3 (Crea3) assay when present in serum, plasma and urine at the concentrations indicated in the tables below. Bias due to these substances is ≤ 10% or ±0.15 mg/dL for Serum and plasma and ≤ 10% for Urine.

{13}------------------------------------------------

### Table 8: Atellica® CH Creatinine_3 (Crea3) Non-Interfering Substance for Serum

{14}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness

{15}------------------------------------------------

| | | Interference beyond ±10% for Serum | | |
|--|--|------------------------------------|--|--|
| | | | | |

| Substance | Substance<br>Concentration | Analyte<br>Concentration<br>(mg/dL) | Bias |
|--------------------------------|----------------------------|-------------------------------------|-------------|
| Cefoxitin | 23.5 mg/L | 0.62 | 0.07 mg/dL |
| | 47 mg/L | 2.13 | 7.5% |
| | 1650 mg/L | 0.58 | 5.37 mg/dL |
| | 1650 mg/L | 2.11 | 243.6% |
| | 6600 mg/L | 0.58 | 20.85 mg/dL |
| | 6600 mg/L | 2.11 | 947.9% |
| Cephalothin | 135 mg/dL | 0.60 | 0.64 mg/dL |
| | 11 mg/dL | 2.13 | 2.3% |
| | 45 mg/dL | 0.60 | 0.20 mg/dL |
| | 45 mg/dL | 2.07 | 11.1% |
| | 180 mg/dL | 0.60 | 0.87 mg/dL |
| | 180 mg/dL | 2.07 | 44.0% |
| Glucose | 250 mg/dL | 0.59 | 0.14 mg/dL |
| | 250 mg/dL | 2.09 | 5.7% |
| | 500 mg/dL | 0.59 | 0.27 mg/dL |
| | 500 mg/dL | 2.09 | 11.5% |
| | 1000 mg/dL | 0.59 | 0.51 mg/dL |
| | 1000 mg/dL | 2.09 | 22.5% |
| Total Protein | 10 g/dL | 0.68 | 0.13 mg/dL |
| | 10 g/dL | 2.23 | 2.2% |
| | 15 g/dL | 2.30 | 5.7% |
| | 15 g/dL | 0.65 | 0.45 mg/dL |
| Acetohexamide | 1.0 mg/dL | 0.59 | 0.11 mg/dL |
| | 1.5 mg/dL | 2.11 | 7.6% |
| | 2.0 mg/dL | 0.59 | 0.22 mg/dL |
| | 2.0 mg/dL | 2.11 | 10.4% |
| Hydroxocobalamin<br>(Cyanokit) | 250 mg/L | 0.62 | 0.11 mg/dL |
| | 250 mg/L | 2.14 | 7.9% |
| | 500 mg/L | 0.62 | 0.22 mg/dL |
| | 2259 mg/L | 0.59 | 1.13 mg/dL |
| | 500 mg/L | 2.14 | 14.5% |
| | 2259 mg/L | 2.07 | 49.3% |

Table 9: Atellica® CH Creatinine_3 (Crea3) Non-Interfering Substance for Urine

| Substance | Substance Concentration | Analyte Concentration (mg/dL) | Bias (%) |
|----------------------|----------------------------|-------------------------------------|----------|
| 6N HCL | 0.01% | 42.42 | -0.4 |
| 6N HCL | 0.01% | 169.55 | -0.1 |
| 6N Nitric Acid | 0.60% | 42.42 | -0.5 |
| 6N Nitric Acid | 0.60% | 169.55 | -0.1 |
| Acetaminophen | 200 mg/dL | 42.48 | 0.0 |
| Acetaminophen | 200 mg/dL | 170.03 | -0.8 |
| Acetic Acid | 25 mL/24-hr collection | 45.85 | -0.8 |
| Substance | Substance Concentration | Analyte Concentration (mg/dL) | Bias (%) |
| Acetic Acid | 25 mL/24-hr collection | 182.56 | -0.2 |
| Ascorbate | 3.0 mg/dL | 42.52 | -0.4 |
| Ascorbate | 3.0 mg/dL | 170.02 | -1.0 |
| Boric Acid | 1% w/v | 44.86 | -1.5 |
| Boric Acid | 1% w/v | 177.59 | -1.0 |
| Conjugated Bilirubin | 50 mg/dL | 42.52 | -0.5 |
| Conjugated Bilirubin | 50 mg/dL | 170.02 | -1.1 |
| Ethanol | 1 g/dL | 39.18 | 2.7 |
| Ethanol | 1 g/dL | 160.56 | -1.2 |
| Gamma Globulin | 0.5 g/dL | 41.29 | -0.1 |
| Gamma Globulin | 0.5 g/dL | 163.63 | 0.2 |
| Glucose | 2000 mg/dL | 42.52 | 0.8 |
| Glucose | 2000 mg/dL | 170.02 | -1.3 |
| Hemoglobin | 100 mg/dL | 42.39 | 0.1 |
| Hemoglobin | 100 mg/dL | 169.04 | 0.2 |
| Human Serum Albumin | 0.5 g/dL | 41.29 | -0.5 |
| Human Serum Albumin | 0.5 g/dL | 163.63 | 0.2 |
| Ibuprofen | 500 mg/dL | 42.44 | -0.3 |
| Ibuprofen | 500 mg/dL | 164.10 | -0.1 |
| Levodopa | 700 mg/L | 42.81 | -1.4 |
| Levodopa | 700 mg/L | 186.99 | -1.6 |
| N-Acetyl-Cysteine | 2 mg/dL | 42.42 | -0.5 |
| N-Acetyl Cysteine | 2 mg/dL | 169.55 | 0.0 |
| Oxalic Acid | 0.1 g/dL | 42.52 | -0.4 |
| Oxalic Acid | 0.1 g/dL | 170.02 | -1.3 |
| pH 4 | pH 4 | 43.89 | -3.3 |
| pH 4 | pH 4 | 176.86 | -0.2 |
| pH 9 | pH 9 | 43.89 | 0.0 |
| pH 9 | pH 9 | 176.86 | -0.6 |
| Sodium Carbonate | 5 g/24-hr collection | 44.44 | -0.4 |
| Sodium Carbonate | 5 g/24-hr collection | 177.50 | 0.1 |
| Substance | Substance<br>Concentration | Analyte<br>Concentration<br>(mg/dL) | Bias % |
| Cefoxitin | 3300 mg/L | 42.55 | 7.3% |
| | 6600 mg/L | 188.03 | 7.7% |
| | 4950 mg/L | 42.55 | 11.3% |
| | 6600 mg/L | 42.55 | 15.4% |

{16}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness

{17}------------------------------------------------

### Interference beyond ±10% for Urine

### Clinical Study 11.

#### Atellica® CH Creatinine_3 (Crea3) 11.1.1

Not applicable.

#### 11.2 Expected Values

#### 11.2.1 Atellica® CH Creatinine 3 (Crea3)

### Table 10: Atellica® CH Creatinine_3 (Crea3) Instructions for Use for Expected Values

| Group | Sample Type | Reference Interval |
|---------|--------------|-----------------------------------------|
| Males | Serum/Plasma | 0.70 - 1.30 mg/dL (62 - 115 µmol/L) |
| Females | Serum/Plasma | 0.55 - 1.02 mg/dL (49 - 90 umol/L) |
| Males | Urine | 950 - 2490 mg/day (8.4 - 22.0 mmol/day) |
| Females | Urine | 600-1800 mg/day (5.3 - 15.9 mmol/day) |

### 12. Standardization

### Atellica® CH Creatinine_3 (Crea3) Atellica® CH Crea3 12.1.1

The assay shall be traceable to the reference material SRM967, from the National Institute of Standards and Technology (NIST).

### Clinical Cut-off 13.

#### Atellica® CH Creatinine_3 (Crea3) 13.1.1

Not applicable.

{18}------------------------------------------------

### Conclusion 14.

### Atellica® CH Creatinine_3 (Crea3) 14.1

The results from the performance studies support that the Candidate Device, Atellica® CH Creatinine_3 (Crea3) assay, is substantially equivalent to the Predicate Device, Atellica CH Creatinine_2 (Crea_2) assay (K161494).