Atellica® CH Creatinine_3 (Crea3)
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 |
Indications for 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)
Related Devices
- K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) · Siemens Healthcare Diagnostics, Inc. · Nov 15, 2016
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K242685
B Applicant
Siemens Healthcare Diagnostics Inc.
C Proprietary and Established Names
Atellica® CH Creatinine_3 (Crea3)
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CGX | Class II | 21 CFR 862.1225 - Creatinine Test System | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Creatinine
C Type of Test:
Quantitative, photometric/colorimetric method
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
K242685 - Page 2 of 12
## B Indication(s) for 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.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## D Special Instrument Requirements:
Atellica® CH Analyzer
## IV Device/System Characteristics:
### A Device Description:
The Atellica® CH Creatinine_3 (Crea3) assay kit has 2 major reagent packs. Reagent pack 1 (P1) contains 21.8 mL of sodium hydroxide (1.0 mol/L), and reagent pack 2 (P) contains 13.26 mL of lithium picrate (25 mmol/L).
The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use with the Atellica® CH Analyzer (previously cleared under K151767).
### B Principle of Operation:
The Atellica® CH Crea3 assay is based on the reaction of picrate with creatinine in an alkaline medium. The technique is based on modified kinetic Jaffe technique with rate blanking and intercept correction. In the presence of a strong base such as sodium hydroxide, picrate reacts with creatinine to form a red chromophore creatinine picrate complex. The rate of complex formation is measured at 505/571 nm and is proportional to the creatinine concentration in the sample. Rate blanking is used to reduce interference from non-specific serum/plasma protein interactions with the reagent.
### V Substantial Equivalence Information:
#### A Predicate Device Name(s):
Atellica® CH Creatinine_2 (Crea_2)
#### B Predicate 510(k) Number(s):
K161494
{2}
K242685 - Page 3 of 12
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K242685 | K161494 |
| --- | --- | --- |
| Device Trade Name | Atellica® CH Creatinine_3 (Crea3) | Atellica® CH Creatinine_2 (Crea_2) |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma, and urine using the Atellica® CH Analyzer. Measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. | Same |
| Device Technology | Modified Jaffe methodology (creatinine alkaline picrate) with photometric detection. | Same |
| Assay Range / Measuring Interval | Serum: 0.15 mg/dL to 30.00 mg/dL Urine: 3.00 mg/dL to 245.00 mg/dL | Same |
| Standardization | NIST SRM967 | Same |
| General Device Characteristic Differences | | |
| Sample Type | Serum, lithium heparin plasma, dipotassium EDTA plasma, sodium heparin plasma, urine | Serum, Plasma (Lithium Heparin), urine |
VI Standards/Guidance Documents Referenced:
CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures, Third Edition.
CLSI EP06-Ed2: Evaluation of the Linearity of Quantitative Measurement Procedures, Second Edition.
{3}
CLSI EP07-Ed3: Interference Testing in Clinical Chemistry, 3rd Edition.
CLSI EP09C-Ed3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition.
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline, Second Edition.
CLSI EP25-Ed2: Evaluation of Stability of In Vitro Diagnostic Medical Laboratory Test Reagents, Second Edition.
CLSI EP28-A3C: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Third Edition.
CLSI EP32-R: Metrological Traceability and its Implementation
CLSI EP37-Ed1: Supplemental Tables for Interference Testing in Clinical Chemistry
## VII Performance Characteristics (if/when applicable):
## A Analytical Performance:
1. Precision/Reproducibility:
Precision was determined in accordance with CLSI EP05-A3. Samples were assayed on the Atellica® CH Analyzer in duplicate in 2 runs per day for 20 days for a total of 80 replicates. The results are summarized in the table below:
| Specimen Type | Mean mg/dL | Repeatability | | Within-Lab | |
| --- | --- | --- | --- | --- | --- |
| | | SD mg/dL | CV (%) | SD mg/dL | CV (%) |
| Serum 1 | 0.38 | 0.006 | 1.6 | 0.012 | 3.2 |
| Serum 2 | 0.73 | 0.023 | 3.2 | 0.029 | 4.0 |
| Serum 3 | 0.73 | 0.006 | 0.8 | 0.019 | 2.6 |
| Serum 4 | 1.18 | 0.007 | 0.6 | 0.019 | 1.6 |
| Serum QC 1 | 1.85 | 0.007 | 0.4 | 0.024 | 1.3 |
| Serum QC 2 | 6.21 | 0.011 | 0.2 | 0.067 | 1.1 |
| Serum 5 | 17.39 | 0.035 | 0.2 | 0.189 | 1.1 |
| Serum 6 | 28.54 | 0.056 | 0.2 | 0.317 | 1.1 |
| Urine 1 | 56.74 | 0.102 | 0.2 | 0.746 | 1.3 |
| Urine 2 | 135.80 | 0.206 | 0.2 | 1.601 | 1.2 |
| Urine QC 1 | 195.79 | 0.253 | 0.1 | 2.376 | 1.2 |
Reproducibility was determined in accordance with CLSI EP05-A3. Samples were assayed on the Atellica® CH Analyzer with n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots at three sites (one instrument and three lots of reagents per site) for a total of 225 replicates per sample. The data were analyzed to calculate the following components of
K242685 - Page 4 of 12
{4}
precision: repeatability, between-day, between-lot, between-instrument, and reproducibility (total). The results are summarized as below:
| | Mean mg/dL | Repeatability | | Between-Day | | Between-Lot | | Between-Instrument | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD mg/dL | CV % | SD mg/dL | CV % | SD mg/dL | CV % | SD mg/dL | CV % | SD mg/dL | CV % |
| Sample | | | | | | | | | | | |
| Serum 1 | 0.40 | 0.014 | 3.5 | 0.007 | 1.8 | 0.011 | 2.8 | 0.006 | 1.5 | 0.020 | 5.0 |
| Serum 2 | 0.72 | 0.015 | 2.1 | 0.021 | 2.9 | 0.007 | 1.0 | 0.014 | 1.9 | 0.030 | 4.2 |
| Serum 3 | 1.21 | 0.009 | 0.7 | 0.015 | 1.2 | 0.013 | 1.1 | 0.013 | 1.1 | 0.025 | 2.1 |
| Serum QC 1 | 1.90 | 0.011 | 0.6 | 0.021 | 1.1 | 0.006 | 0.3 | 0.014 | 0.7 | 0.028 | 1.5 |
| Serum QC 2 | 6.31 | 0.030 | 0.5 | 0.052 | 0.8 | 0.023 | 0.4 | 0.040 | 0.6 | 0.076 | 1.2 |
| Serum 4 | 17.62 | 0.048 | 0.3 | 0.113 | 0.6 | 0.000 | 0.0 | 0.090 | 0.5 | 0.152 | 0.9 |
| Serum 5 | 28.76 | 0.105 | 0.4 | 0.192 | 0.7 | 0.079 | 0.3 | 0.153 | 0.5 | 0.278 | 1.0 |
| Urine 1 | 57.23 | 0.213 | 0.4 | 0.475 | 0.8 | 0.177 | 0.3 | 0.681 | 1.2 | 0.875 | 1.5 |
| Urine 2 | 137.89 | 0.511 | 0.4 | 0.842 | 0.6 | 0.385 | 0.3 | 1.577 | 1.1 | 1.898 | 1.4 |
| Urine QC 1 | 199.45 | 0.913 | 0.5 | 1.659 | 0.8 | 0.655 | 0.3 | 2.398 | 1.2 | 3.125 | 1.6 |
# 2. Linearity:
A linearity study was performed in accordance with CLSI EP06-Ed2. Samples were prepared by mixing high and low concentration samples to span the measurement interval; at least 9 samples were used to evaluate the entire measuring interval for serum and urine. Five replicates were tested for each sample and the mean of these replicates was used for the calculation. The concentrations for serum samples ranged from $0.12 - 38\mathrm{mg / dL}$ and the concentrations for urine samples ranged from $1.33 - 264\mathrm{mg / dL}$ . The results showed that the deviation from linearity did not exceed $5\%$ for samples within the measuring range.
The regression statistics of the serum linearity study: $\mathrm{Y} = 1.040\mathrm{x} + 0.053$ r: 0.999
The regression statistics of the urine linearity study: $\mathrm{Y} = 1.002\mathrm{x} + 0.160$ $\mathrm{r} = 1.000$
The results of the linearity studies support the claimed analytical measuring range from 0.15 mg/dL to $30.00\mathrm{mg / dL}$ for serum/plasma, and $3.00\mathrm{mg / dL}$ to $245.00\mathrm{mg / dL}$ for urine for the candidate device.
# 3. Analytical Specificity/Interference:
The evaluation of potential interferents followed the recommendations in CLSI EP07-Ed3.
K242685 - Page 5 of 12
{5}
# Serum
Human serum pools were split into control and test pools. The test pools were spiked with the interferents, and the control pools were spiked with an equivalent volume of compound the interferent was prepared in. For serum samples, low-level analyte pool was native serum (creatinine concentration of 0.60 mg/dL), and the high-level analyte pool was native serum spiked with creatinine (creatinine concentration of 2.0 mg/dL). Five replicates were tested per sample. Substances identified with > 10% (at an analyte concentration of 2.00 mg/dL) or ± 0.15 mg/dL (at an analyte concentration of 0.60 mg/dL) bias were considered to have interfered. For any substances identified as an interferent, dose response testing and analysis was conducted to assess the highest concentration limit below which no significant interference was observed.
Hemolysis, Icterus, and Lipemia (HIL) results are summarized as below:
| Substance | Highest concentration tested that showed no interference (mg/dL) |
| --- | --- |
| Hemoglobin | 1000 |
| Conjugated Bilirubin | 40 |
| Unconjugated Bilirubin | 45 |
| Lipemia (from Intralipid®) | 2250 |
| Lipemia (from Triglyceride Fraction) | 3000 |
The table below lists the highest concentrations of each substance at which no significant interference was found in Serum.
| Substance | Highest concentration tested that showed no interference |
| --- | --- |
| Acetylcysteine (N-Acetylcysteine) | 150 mg/L |
| Acetylsalicylic Acid | 30 mg/L |
| Cefoxitin | 23.5 mg/L |
| Glucose | 250 mg/dL |
| Ibuprofen | 220 mg/L |
| Total Protein | 10 g/dL |
| Acetaminophen | 160 mg/L |
| Acetoacetate | 20 mg/dL |
| Acetohexamide | 1.0 mg/dL |
| Ampicillin-Na | 80 mg/L |
| Ascorbic Acid | 60 mg/L |
| Azlocillin | 7 g/L |
| Biotin | 4250 ng/mL |
| Ca-Dobesilate | 60 mg/L |
| Cefotaxime | 53 mg/dL |
| Cephalothin | 11 mg/dL |
| Cyclosporine | 2 mg/L |
| Doxycycline | 20 mg/L |
K242685 - Page 6 of 12
{6}
Interference beyond ±10% or ±0.15 mg/dL for Serum
| Substance | Substance Concentration | Analyte concentration (mg/dL) | Bias |
| --- | --- | --- | --- |
| Acetohexamide | 2.0 mg/dL | 0.59 | 0.22 mg/dL |
| | 2.0 mg/dL | 2.11 | 10.4% |
| Cefoxitin | 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 | 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 | 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% |
| Hydroxocobalamin (Cyanokit) | 500 mg/L | 0.62 | 0.22 mg/dL |
| | 500 mg/L | 2.14 | 14.5% |
| | 2259 mg/L | 0.59 | 1.13 mg/dL |
| | 2259 mg/L | 2.07 | 49.3% |
| Total Protein | 15 g/dL | 0.65 | 0.45 mg/dL |
K242685 - Page 7 of 12
{7}
K242685 - Page 8 of 12
# Urine
Human urine pools were split into control and test pools. The test pools were spiked with the interferents, and the control pools were spiked with an equivalent volume of the compound the interferent was prepared in. For urine samples, the low creatinine concentration (40.00 mg/dL) samples and the high creatinine concentration (180.00 mg/dL) samples were unique native human urine samples. Five replicates were tested per sample. Substances identified with > 10% bias were considered to have interfered. For any substances identified as an interferent, dose response testing and analysis was conducted to assess the highest concentration limit below which no significant interference was observed.
The table below lists the highest concentrations of each substance at which no significant interference was found in Urine.
| Substance | Highest concentration tested that showed no interference |
| --- | --- |
| Ascorbate | 3.0 mg/dL |
| Conjugated Bilirubin | 50 mg/dL |
| Gamma Globulin | 0.5 g/dL |
| Glucose | 2000 mg/dL |
| Hemoglobin | 100 mg/dL |
| Human Serum Albumin | 0.5 g/dL |
| N-Acetyl Cysteine | 2 mg/dL |
| 6N HCL | 0.01% |
| 6N Nitric Acid | 0.60% |
| Acetaminophen | 200 mg/dL |
| Acetic Acid | 25 mL/24-hr collection |
| Boric Acid | 1% w/v |
| Ethanol | 1 g/dL |
| Ibuprofen | 500 mg/dL |
| Oxalic Acid | 0.1 g/dL |
| pH 4 | pH 4 |
| pH 9 | pH 9 |
| Sodium Carbonate | 5 g/24-hr collection |
| Cefoxitin | 3300 mg/L |
| Levodopa | 700 mg/L |
Interference beyond ±10% for Urine
| Substance | Substance Concentration | Analyte concentration (mg/dL) | Bias |
| --- | --- | --- | --- |
| Cefoxitin | 4950 mg/L | 42.55 | 11.3% |
| | 6600 mg/L | 42.55 | 15.4% |
{8}
K242685 - Page 9 of 12
# Limitations:
The sponsor included the following limitation statements in their instructions for use:
- Use of assay is not recommended for patients taking Cefoxitin. Cefoxitin may produce falsely increased results.
- The Atellica CH Crea3 assay is susceptible to interference from cephalosporin class antibiotics at therapeutically relevant interferent concentrations.
## 4. Assay Reportable Range:
The Atellica® CH Creatinine_3 (Crea3) assay reportable range on the Atellica® CH Analyzer is 0.15 mg/dL to 30.00 mg/dL for serum/plasma, and 3.00 mg/dL to 245.00 mg/dL for urine.
## 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
### Traceability:
The Atellica® CH Chemistry Calibrator (CHEM CAL) is traceable to NIST SRM 967.
### On-board Reagent Stability:
An open bottle stability study was conducted to ensure the reagent performed consistently throughout the claimed in use/onboard stability. The study results support the claim of onboard stability of 17 days. All protocols and results were reviewed and found to be acceptable.
### Sample Stability
A sample stability study was conducted to establish the recommendations for the handling of patient samples specified in the Atellica® CH Creatinine_3 (Crea3) assay Instructions for Use. Study protocols and results for serum and urine sample stability were reviewed and found to be acceptable.
### Calibration Interval:
The calibration interval study completed confirmed the lot calibration interval (defines the time the Atellica® CH Analyzer can store a fresh pack calibration) of 180 days and pack calibration interval (defines the time before re-calibration is required within an opened reagent pack chamber (well-set)) of 10 days. The protocol and acceptance criteria were reviewed and found to be acceptable.
## 6. Detection Limit:
The Limit of Blank (LoB), Limit of Detection (LoD) and the Limit of Quantitation (LoQ) of the Atellica® CH Creatinine_3 (Crea_3) on the Atellica® CH Analyzer were evaluated in accordance with CLSI EP17-A2. The LoQ was defined as the lowest concentration of creatinine at which the total analytical error is ≤ 0.10 mg/dL for serum and plasma and ≤ 1.50 mg/dL for urine. A brief protocol and the results are summarized in the tables below:
{9}
| Atellica® CH Creatinine_3 (Crea_3) - Limit of Detection Results (Serum/Plasma) | | |
| --- | --- | --- |
| Limit | Protocol | Value obtained |
| LoB | 4 samples with no analyte were tested in 5 replicates per sample, one run per day for 3 days, 3 reagent lots | 0.05 mg/dL |
| LoD | 5 low analyte samples were tested in 5 replicates per sample one run per day for 3 days, 3 reagent lots | 0.10 mg/dL |
| LoQ | 5 low samples were tested in 5 replicates per sample one run per day for 3 days, 3 reagent lots | 0.15 mg/dL |
| Atellica® CH Creatinine_3 (Crea_3) - Limit of Detection Results (Urine) | | |
| --- | --- | --- |
| Limit | Protocol | Value obtained |
| LoB | 4 samples with no analyte were tested in 5 replicates per sample, one run per day for 3 days, 3 reagent lots | 0.50 mg/dL |
| LoD | 5 low analyte samples were tested in 5 replicates per sample one run per day for 3 days, 3 reagent lots | 1.0 mg/dL |
| LoQ | 5 low samples were tested in 5 replicates per sample one run per day for 3 days, 3 reagent lots | 3.00 mg/dL |
7. Assay Cut-Off:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
The accuracy of the Atellica® CH Creatinine_3 (Crea3) assay on the Atellica® CH analyzer for serum and urine was evaluated for agreement with the predicate device by a method comparison study. The method comparison study was performed following the recommendations in CLSI EP09c-Ed3. A total of 151 serum samples (13 of the 151 samples were spiked) and 113 native urine samples were tested on the predicate device and on the candidate device. These samples were tested on one Atellica® CH Analyzer in silicate for both assays. Weighted Deming statistics were used to calculate the regression equations below:
K242685 - Page 10 of 12
{10}
| Specimen Type | Comparison Assay (x) | Regression Equation | Sample Range as determined by comparator device (mg/dL) | N | r |
| --- | --- | --- | --- | --- | --- |
| Serum | Atellica CH Creatinine_2 (Crea_2) | y = 1.00x - 0.04 mg/dL | 0.44 - 28.64 | 151 | 1.000 |
| Urine | Atellica CH Creatinine_2 (Crea_2) | y = 1.00x + 0.14 mg/dL | 12.60 - 237.06 | 113 | 1.000 |
2. Matrix Comparison:
The specimen equivalency was determined using the Weighted Deming regression. A total of 50 four-way matched sample sets (serum, lithium heparin plasma, sodium heparin plasma and EDTA plasma) were processed and tested with $N = 1$ replicate. The following results were obtained:
| Specimen (y) | N | Reference Specimen (x) | Regression Equation | Sample Range mg/dL | r |
| --- | --- | --- | --- | --- | --- |
| Sodium Heparin | 50 | Serum | y = 1.00x + 0.00 mg/dL | 0.60 – 27.26 | 0.999 |
| Lithium Heparin | 50 | Serum | y = 0.99x + 0.06 mg/dL | 0.60 - 27.26 | 0.999 |
| Dipotassium EDTA | 50 | Serum | y = 0.98x + 0.04 mg/dL | 0.60 - 27.26 | 0.998 |
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D Clinical Cut-Off:
Not applicable.
K242685 - Page 11 of 12
{11}
K242685 - Page 12 of 12
# E Expected Values/Reference Range:
The sponsor provided the following information for the reference ranges in serum and urine for the Atellica® CH Creatinine_3 (Crea3) assay:
| Group | Sample Type | Reference Interval |
| --- | --- | --- |
| Males | Serum | 0.70 - 1.30 mg/dL (62 – 115 μmol/L) |
| Females | Serum | 0.55 - 1.02 mg/dL (49 – 90 μmol/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) |
Junge W, Wilke B, Halabi A, Klein G. Determination of reference intervals for serum creatinine, creatinine excretion and creatinine clearance with an enzymatic and a modified Jaffé method. Clin Chim Acta. 2004;344(1-2):137-48.
Burtis CA, Ashwood ER, eds. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia, PA: WB Saunders Co; 1999:1809. Conclusions.
# VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
# IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
