(89 days)
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.
The Atellica CH Crea3 assay is based on the reaction of picrate with creatinine in an alkaline medium to produce a red chromophore creatinine picrate complex. The rate of complex formation is measured at 505/571 nm and is proportional to the creatinine concentration. The Atellica CH Crea3 assay is a modification of the Jaffe method, using rate blanking and intercept correction. Rate blanking is used to minimize bilirubin interference. Also, because non-specific serum/plasma protein interactions with this reagent have been found to produce a positive bias of approximately 0.3 mg/dL (26.5 µmol/L), serum/plasma measurements are automatically corrected by subtracting 0.3 mg/dL (26.5 µmol/L) from each result.
The provided text describes the performance characteristics and studies for the Atellica® CH Creatinine_3 (Crea3) assay, a new in vitro diagnostic device for quantitative determination of creatinine. It compares this new device to a predicate device, the Atellica® CH Creatinine_2 (Crea_2) assay.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: The document focuses on establishing substantial equivalence for an in vitro diagnostic (IVD) test, which primarily relies on analytical performance characteristics rather than clinical outcome studies or multi-reader multi-case (MRMC) comparative effectiveness studies typically seen with imaging AI devices. Therefore, some of your requested information (like number of experts for ground truth, adjudication methods, MRMC studies, and training set details for an AI model) are not directly applicable or provided in this type of submission.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are established through various analytical performance studies, primarily comparing it to a legally marketed predicate device (Atellica® CH Creatinine_2). The acceptance criteria are implicitly defined by the successful demonstration of equivalence or meeting pre-defined performance goals for each characteristic.
Here's a table summarizing the acceptance criteria (inferred from the "designed to have" or "determined in accordance with" statements and the reported results meeting these) and the reported device performance:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Atellica® CH Creatinine_3 (Crea3)) |
|---|---|---|
| Detection Capability | LoB: $\le$ LoD for serum and urine samples. LoD: $\le$ 0.15 mg/dL for serum/plasma; $\le$ 3.00 mg/dL for urine. LoQ: $\le$ 0.15 mg/dL for serum/plasma with $\le$ 0.10 mg/dL total analytical error; $\le$ 3.00 mg/dL for urine with $\le$ 1.50 mg/dL total analytical error. | Serum/plasma: LoB: 0.05 mg/dL LoD: 0.10 mg/dL LoQ: 0.15 mg/dL Urine: LoB: 0.50 mg/dL LoD: 1.00 mg/dL LoQ: 3.00 mg/dL (All results meet the stated design goals/acceptance criteria). |
| Precision | Determined in accordance with CLSI Document EP05-A3 (indicates adherence to specific statistical targets for repeatability and within-lab precision, implicitly accepted if within CLSI guidelines for the assay's use). | Serum Samples (n=80 each): - Serum 1 (0.38 mg/dL): Repeatability SD 0.006, CV 1.6%; Within-Lab SD 0.012, CV 3.2% - Serum 2 (0.73 mg/dL): Repeatability SD 0.023, CV 3.2%; Within-Lab SD 0.029, CV 4.0% - Serum 3 (0.73 mg/dL): Repeatability SD 0.006, CV 0.8%; Within-Lab SD 0.019, CV 2.6% - Serum 4 (1.18 mg/dL): Repeatability SD 0.007, CV 0.6%; Within-Lab SD 0.019, CV 1.6% - Serum QC 1 (1.85 mg/dL): Repeatability SD 0.007, CV 0.4%; Within-Lab SD 0.024, CV 1.3% - Serum QC 2 (6.21 mg/dL): Repeatability SD 0.011, CV 0.2%; Within-Lab SD 0.067, CV 1.1% - Serum 5 (17.39 mg/dL): Repeatability SD 0.035, CV 0.2%; Within-Lab SD 0.189, CV 1.1% - Serum 6 (28.54 mg/dL): Repeatability SD 0.056, CV 0.2%; Within-Lab SD 0.317, CV 1.1% Urine Samples (n=80 each): - Urine 1 (56.74 mg/dL): Repeatability SD 0.102, CV 0.2%; Within-Lab SD 0.746, CV 1.3% - Urine 2 (135.80 mg/dL): Repeatability SD 0.206, CV 0.2%; Within-Lab SD 1.601, CV 1.2% - Urine QC 1 (195.79 mg/dL): Repeatability SD 0.253, CV 0.1%; Within-Lab SD 2.376, CV 1.2% (All results demonstrate low CVs, indicating good precision). |
| Reproducibility | Determined in accordance with CLSI Document EP05-A3 (implies meeting specific statistical targets for variability components across different days, lots, and instruments). | Serum Samples (n=225 each): Overall CV (%) for reproducibility ranges from 1.0% to 5.0%. Urine Samples (n=225 each): Overall CV (%) for reproducibility ranges from 1.4% to 1.6%. (All results demonstrate good reproducibility across conditions). |
| Assay Comparison | Serum: Correlation coefficient $\ge$ 0.950 and slope of 1.00 $\pm$ 0.05, compared to predicate (Atellica CH Creatinine 2), using Weighted Deming regression. Urine: Correlation coefficient $\ge$ 0.950 and slope of 0.000 $\pm$ 3.00, compared to predicate (Atellica CH Creatinine 2), using Weighted Deming regression. | Serum (n=151): Regression equation y = 1.00x - 0.04 mg/dL, correlation coefficient (r) = 1.000. Sample range 0.44 to 28.64 mg/dL. Urine (n=113): Regression equation y = 1.00x + 0.14 mg/dL, correlation coefficient (r) = 1.000. Sample range 12.60 to 237.06 mg/dL. (Both serum and urine results meet the acceptance criteria for correlation and slope). |
| Specimen Equivalence | Determined using Weighted Deming regression (implicitly, the regression line should demonstrate equivalence, i.e., close to y=x, with high correlation coefficient). | Sodium Heparin (n=50): y = 1.00x + 0.00 mg/dL, r=0.999. Lithium Heparin (n=50): y = 0.99x + 0.06 mg/dL, r=0.999. Dipotassium EDTA (n=50): y = 0.98x + 0.04 mg/dL, r=0.998. (All demonstrate strong equivalence to serum reference). |
| Interferences (HIL) | $\le$ 10% interference from hemoglobin, bilirubin, and lipemia. Bias > 10% or 0.15 mg/dL (whichever is greater for serum/plasma) is considered interference. | Reported biases for Hemoglobin (1000 mg/dL), Conjugated Bilirubin (40-45 mg/dL), Unconjugated Bilirubin (45-60 mg/dL), and Lipemia (2250-3000 mg/dL) are all within the $\pm$10% or $\pm$0.15 mg/dL threshold for the tested analyte concentrations, demonstrating acceptable interference profiles. |
| Interfering Substances | Bias $\le$ 10% or $\pm$0.15 mg/dL for Serum/plasma samples. Bias $\le$ 10% for Urine samples (for listed substances). | Most tested substances (e.g., Acetaminophen, Ascorbic Acid, etc.) show negligible bias, meeting the criteria. Substances showing bias beyond acceptance criteria for Serum: - Cefoxitin: Significant interference (e.g., 243.6% and 947.9% bias at high concentrations). - Cephalothin: Shows significant bias (e.g., 44.0% bias at 180 mg/dL). - Glucose: Shows bias beyond 10% at higher concentrations (e.g., 11.5% at 500 mg/dL and 22.5% at 1000 mg/dL). - Total Protein: Shows bias beyond 0.15 mg/dL at 15 g/dL (0.45 mg/dL). - Acetohexamide: Shows bias beyond 10% at 2.0 mg/dL (10.4%). - Hydroxocobalamin (Cyanokit): Shows significant bias (e.g., 14.5% and 49.3% at higher concentrations). Substances showing bias beyond acceptance criteria for Urine: - Cefoxitin: Shows bias beyond 10% at higher concentrations (e.g., 11.3% and 15.4%). (The document explicitly lists these substances under "Interference beyond $\pm$10% for Serum" and "Interference beyond $\pm$10% for Urine," indicating that they failed the non-interference criteria at the tested concentrations. This is typical for IVD submissions, where known interferences are identified for labeling purposes). |
| Standardization | The assay shall be traceable to the reference material SRM967, from the National Institute of Standards and Technology (NIST). | Statement confirms the assay is traceable to NIST SRM967. |
Study Details:
-
Sample Size and Data Provenance:
- Test Set Sample Sizes:
- Detection Capability: Not explicitly stated as "sample size" but data points obtained according to CLSI EP17-A2.
- Precision: 80 data points per serum/urine sample type (duplicate runs for 20 days, 2 runs/day).
- Reproducibility: 225 data points per serum/urine sample type (n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots).
- Assay Comparison: 151 serum samples and 113 urine samples.
- Specimen Equivalence: 50 samples for each plasma type (Sodium Heparin, Lithium Heparin, Dipotassium EDTA) compared to serum.
- Interference (HIL & Non-Interfering Substances): Not explicitly stated as a total sample size, but experiments are designed to test specific analyte concentrations with and without interferents, following CLSI EP07-ED3.
- Data Provenance: Not explicitly stated in terms of country of origin. Given the manufacturer (Siemens Healthcare Diagnostics Inc. in Tarrytown, New York, USA) and FDA submission, it's highly probable the studies were conducted in the US or in compliance with US regulatory standards. The studies described are retrospective in the sense that they use pre-collected or prepared samples to assess the analytical performance of the device under controlled conditions, not prospective in tracking patient outcomes in a clinical trial.
- Test Set Sample Sizes:
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- For an in vitro diagnostic (IVD) device measuring a quantitative analyte like creatinine, "ground truth" is typically established by reference methods or established laboratory standards and calibrators, not by human expert consensus or labeling of medical images.
- The "ground truth" for creatinine concentration in this context is based on traceable reference materials (NIST SRM 967) and established laboratory measurement principles, and the performance is compared against a legally marketed predicate device.
- Therefore, this question (relevant for AI/imaging devices) does not directly apply to this type of IVD submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical trials or image labeling pipelines where there's human interpretation involved and a need to resolve disagreements among multiple readers; this is an analytical performance study of an IVD assay.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/imaging device. It's an in vitro diagnostic assay.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is an automated IVD assay performed on the Atellica® CH Analyzer. Its intended use is quantitative determination of creatinine. Therefore, the performance described (precision, accuracy, interference, etc.) is its standalone performance without a human in the loop for the analytical measurement itself, though a human still interacts with the instrument and interprets the results in a clinical context.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary "ground truth" for the Atellica® CH Creatinine_3 assay's performance is traceability to NIST SRM 967 (a certified reference material for creatinine) and comparison to a legally marketed predicate device (Atellica® CH Creatinine_2) using method comparison validated against CLSI guidelines. This is a form of analytical reference standard and comparative performance to an established method.
-
The sample size for the training set:
- This device is an analytical chemistry assay, not a machine learning/AI algorithm that requires a "training set" in the computational sense. The "development" or "optimization" of the assay would involve various experimental data, but it's not codified as a "training set" for an algorithm.
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the AI/ML context for this type of device. The assay development would rely on scientific principles of analytical chemistry, reagent formulation, and instrument calibration against known standards.
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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"
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(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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
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)
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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 Professional511 Benedict AveTarrytown, NY 10591 USA |
| Email: | elisha.caban@Siemens-Healthineers.com |
3. Regulatory Information
| Information | Atellica® CH Creatinine_3(Crea3) |
|---|---|
| Trade Name | Atellica® CH Creatinine_3(Crea3) |
| Device | Alkaline Picrate, Colorimetry,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(Crea3) | Atellica® CH Creatinine_2(Crea_2) | K161494 |
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| Product | Intended Use |
|---|---|
| Atellica® CHCreatinine_3(Crea3) | The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnosticuse in the quantitative determination of creatinine in human serum,plasma (lithium heparin, dipotassium EDTA, and sodium heparin), andurine using the Atellica® CH Analyzer. Such measurements are usedin the diagnosis and treatment of renal diseases, and in monitoringrenal dialysis. |
5. Intended Use / Indications For Use
Special Conditions for Use Statement(s): For Prescription Use Only.
| 6. | Device Description |
|---|---|
| ---- | -------------------- |
| Product | Device Description |
|---|---|
| Atellica® CHCreatinine_3(Crea3) | The Atellica CH Crea3 assay is based on the reaction of picrate withcreatinine in an alkalineThe Atellica CH Crea3 assay reacts with picrate in an alkaline mediumto produce a red chromophore creatinine picrate complex. The rate ofcomplex formation is measured at 505/571 nm and is proportional tothe creatinine concentration. The Atellica CH Crea3 assay is amodification of the Jaffe method, using rate blanking and interceptcorrection. Rate blanking is used to minimize bilirubin interference.Also, because non-specific serum/plasma protein interactions with thisreagent have been found to produce a positive bias ofapproximately0.3 mg/dL (26.5 $\mu$ mol/L), serum/plasma measurementsare automatically corrected by subtracting 0.3 mg/dL (26.5 $\mu$ mol/L)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.
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| 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/dLUrine 3.00 mg/dL to 245.00 mg/dL | Same |
| Expected Values | Serum/plasmaAdult Males: 0.70 – 1.30 mg/dLAdult Females: 0.55 – 1.02 mg/dLUrineAdult Males 950 - 2490 mg/dayAdult 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.
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- 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
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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 | Resultmg/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:
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| SpecimenType | Na | Repeatability | Within-Lab | |||
|---|---|---|---|---|---|---|
| Meanmg/dL | SDbmg/dL | CVc(%) | SDmg/dL) | CV(%) | ||
| 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.
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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.
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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:
| SpecimenType | ComparisonAssay (x) | Regression Equation | Sample Range mg/dL | Na | rb |
|---|---|---|---|---|---|
| Serum | Atellica CHCreatinine_2(Crea_2) | y = 1.00x - 0.04 mg/dL | 0.44 to28.64 | 151 | 1.000 |
| Urine | Atellica CHCreatinine_2(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(53) | toto | 27.26(2410) | 50 | 0.999 |
| Lithium Heparin | Serum | $y = 0.99x + 0.06 mg/dL$ $y = 0.99x + 5 µmol/L$ | 0.60(53) | toto | 27.26(2410) | 50 | 0.999 |
| Dipotassium EDTA | Serum | $y = 0.98x + 0.04 mg/dL$ $y = 0.98x + 4 µmol/L$ | 0.60(53) | toto | 27.26(2410) | 50 | 0.998 |
ª Number of samples tested.
b Correlation Coefficient.
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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 | SubstanceConcentration(mg/dL) | AnalyteConcentration(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 (fromIntralipid®) | 2250 | 0.62 | -0.06 mg/dL |
| Lipemia (fromIntralipid®) | 3000 | 1.92 | 8.3% |
| Lipemia (fromTriglyceride Fraction) | 3000 | 0.54 | 0.00 mg/dL |
| Lipemia (fromTriglyceride Fraction) | 3000 | 1.79 | 0.0% |
| Substance | SubstanceConcentration | 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 | SubstanceConcentration | 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.
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Table 8: Atellica® CH Creatinine_3 (Crea3) Non-Interfering Substance for Serum
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510(k) Summary of Safety and Effectiveness
{15}------------------------------------------------
| Interference beyond ±10% for Serum | ||||
|---|---|---|---|---|
| Substance | SubstanceConcentration | AnalyteConcentration(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(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 | SubstanceConcentration | AnalyteConcentration(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% |
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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.
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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).
§ 862.1225 Creatinine test system.
(a)
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.(b)
Classification. Class II.