(60 days)
Not Found
No
The device description and performance studies focus on a chemical assay based on enzymatic reactions and spectrophotometric measurement. There is no mention of AI, ML, image processing, or any data analysis techniques that would typically involve these technologies.
No.
Explanation: The device is for in vitro diagnostic use, intended to quantitatively determine amylase activity in human samples to aid in the diagnosis and monitoring of acute pancreatitis. It does not provide direct treatment or prevention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use in the quantitative determination of amylase activity" and that "Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas)."
No
The device is an in vitro diagnostic assay (reagent) used with a specific analyzer (Atellica® CH Analyzer), which is a hardware component. The summary describes the chemical reaction and performance characteristics of the assay itself, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states, "The Atellica® CH Amylase_2 (AMY_2) assay is for in vitro diagnostic use..." This is the most direct and definitive indicator.
- Purpose: The assay is designed for the "quantitative determination of amylase activity in human serum, plasma (lithium heparin), and urine." This is a laboratory test performed on biological samples outside of the body.
- Clinical Application: The results of the assay are used "primarily in the diagnosis and monitoring of acute pancreatitis." This demonstrates a clear medical purpose for the test results.
- Device Description: The description details the biochemical method used to measure amylase activity, which is a typical characteristic of an in vitro diagnostic assay.
- Performance Studies: The document describes various performance studies (Detection Limit, LoQ, Linearity, Precision, Interferences, Method Comparison, Matrix Equivalency, Expected Values, Extended Measuring Interval) that are standard for validating the performance of an IVD.
- Predicate Device: The mention of a predicate device (Roche Cobas Amylase Reagent) with a K number (K903309) indicates that this device is being compared to a previously cleared IVD.
All of these factors strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Atellica® CH Amylase_2 (AMY_2) assay is for in vitro diagnostic use in the quantitative determination of amylase activity in human serum, plasma (lithium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas).
Product codes (comma separated list FDA assigned to the subject device)
JFJ
Device Description
The Atellica® CH Amylase_2 (AMY_2) assay is based on the procedure of Jensen and Wydeveld. The Atellica CH AMY 2 assay uses ethylidene blocked p-nitrophenylmaltoheptaoside as substrate. The indicator enzyme a-glucosidase, used to release pnitrophenol (PNP), is also employed in the assay. The terminal glucose of the substrate is chemically blocked, preventing cleavage by the indicator enzymes. The released pnitrophenol is measured at 410/694 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DETECTION LIMIT
The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
Assessment of LoB was the 95th percentile of all values (sorted from lowest to highest), using non-parametric approach.
LoB: 1 U/L Serum/Plasma/Urine (Protocol: 4 samples with no analyte were tested (N=20) for 3 days, one run per day, 3 reagent lots)
LoD: 7 U/L Serum/Plasma; 9 U/L Urine (Protocol: 4 low analyte samples were tested (N=20) for 3 days, one run per day, 3 reagent lots)
LoQ
The Limit of Quantitation (LoQ) for serum/plasma and urine was determined as described in CLSI EP17-A2. For both serum/plasma and urine fluids, 4 low samples were processed on three reagent lots for three days, on one instrument for a total of 120 measurements per lot.
For serum/plasma, the measured LoQ was 18 U/L. For urine, the measured LoQ was 19 U/L.
The LoQ claim of 20 U/L for serum/plasma and urine are each based on a total of 120 determinations with a total error goal of ≤ 30% for serum/plasma specimens and ≤ 30% for urine specimens.
LINEARITY
Linearity was evaluated with 9 samples which spanned the assay measuring interval for serum specimens and 9 samples which spanned the assay measuring interval for urine specimens. Each was prepared by mixing high and low concentration samples across the measurement interval as described in CLSI EP06-A. Five replicates were measured for each sample.
Linearity was demonstrated with both serum and urine specimens to encompass the measuring interval of 20 to 1500 U/L for serum, plasma, and urine specimens.
PRECISION
Precision testing was performed in accordance with CLS/ EP05-A3. Precision was tested using n = 2 replicates, two times per day for at least 20 days for a total of 80 replicates per sample with controls, serum, plasma, and urine pools on one instrument. Analysis of variance (ANOVA) was used to evaluate the data.
Sample 1 (Serum): Mean 52 U/L, SD 0.6 U/L (Repeatability), CV 1.1% (Repeatability), SD 0.7 U/L (Within-Lab), CV 1.4% (Within-Lab)
Serum QC: Mean 187 U/L, SD 0.8 U/L (Repeatability), CV 0.4% (Repeatability), SD 1.1 U/L (Within-Lab), CV 0.6% (Within-Lab)
Sample 2 (Serum): Mean 1128 U/L, SD 2.2 U/L (Repeatability), CV 0.2% (Repeatability), SD 4.3 U/L (Within-Lab), CV 0.4% (Within-Lab)
Urine QC: Mean 58 U/L, SD 1.0 U/L (Repeatability), CV 1.7% (Repeatability), SD 1.3 U/L (Within-Lab), CV 2.2% (Within-Lab)
Urine 1: Mean 183 U/L, SD 0.8 U/L (Repeatability), CV 0.4% (Repeatability), SD 2.3 U/L (Within-Lab), CV 1.3% (Within-Lab)
Urine 2: Mean 1260 U/L, SD 9.3 U/L (Repeatability), CV 0.7% (Repeatability), SD 21.5 U/L (Within-Lab), CV 1.7% (Within-Lab)
INTERFERENCES
CLSI EP07-A2 was followed. Bias exceeding 10% is considered interference. Dilution studies were conducted to determine the level at which the spiked substance no longer displayed significant interference.
No interference was detected at the following concentrations: Hemoglobin 500 mg/dL, Bilirubin (conjugated & unconjugated) 30 mg/dL, Lipemia (Intralipid®) 650 mg/dL, Acetaminophen 30 mg/dL, Ascorbic Acid 20 mg/dL, Acetylsalicylic Acid 200 mg/dL.
METHOD COMPARISON
Study Type: Split sample method comparison, following CLSI EP09-A3.
N: 118 for serum, 114 for urine.
Data were analyzed using weighted Deming regression.
Serum (Roche Cobas AMYL2 x vs. Atellica CH Amylase 2 y): r = 0.996, Regression Equation y = 1.09x + 0 U/L, Sample Range (on the Roche Cobas) 28-1294 U/L.
Urine (Roche Cobas AMYL2 x vs. Atellica CH Amylase 2 y): r = 0.998, Regression Equation y = 1.11x - 1 U/L, Sample Range (on the Roche Cobas) 20-1194 U/L.
Key Results: Demonstrated good agreement between the Atellica® CH Amylase_2 (AMY_2) and the predicate Roche Cobas Amylase (AMYL2) assay with patient samples.
MATRIX EQUIVALENCY
Matched serum and lithium heparin plasma sets were processed with N= 2 replicates using only the first replicate for analysis.
Plasma (Lithium heparin x vs. Atellica® CH AMY_2 serum y): N = 66, r = 1.000, Regression Equation y = 1.00x + 0 U/L, Sample Range 36 - 1419 U/L.
EXTENDED MEASURING INTERVAL
The Atellica® CH Amylase_2 assay parameters support both serum/plasma and urine extended ranges 3x the upper measuring interval. The serum/plasma and urine extended measuring interval is up to 4500 U/L.
STANDARDIZATION
The Atellica® CH AMY_2) assay is traceable to the IRMM/IFCC-456 reference material and commutable to the IFCC Alpha-Amylase Primary Reference Procedure as established by patient sample correlation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Roche Cobas Amylase Reagent (K903309)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.
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July 30, 2019
Siemens Healthcare Diagnostics Inc. Catherine Daigle Regulatory Technical Specialist 500 GBC Drive P.O. Box 6101, M/S 514 Newark, DE 19714
Re: K191454
Trade/Device Name: Atellica® CH Amylase 2 (AMY 2) Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System Regulatory Class: Class II Product Code: JFJ Dated: May 30, 2019 Received: May 31, 2019
Dear Catherine Daigle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191454
Device Name Atellica® CH Amylase_2 (AMY_2)
Indications for Use (Describe)
The Atellica® CH Amylase_2 (AMY_2) assay is for in vitro diagnostic use in the quantitative determination of amylase activity in human serum, plasma (lithium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots in a circular pattern.
Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514 P.O. Box 6101 Newark, DE 19714-6101
510(k) Summary for Atellica® CH Amylase_2 (AMY_2)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
ASSIGNED 510(K) NUMBER
The assigned 510(k) number is: K191454
APPLICANT AND DATE
Catherine I. Daigle, MS Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: catherine.i.daigle@siemens-healthineers.com Phone: 302-631-7310 Fax: 302-631-6299
May 30, 2019
MANUFACTURER
Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 Registration Number: 2432235
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REGULATORY INFORMATION
| Common Name: | Photometric Method, Amylase |
|---|---|
| Proprietary Name: | Atellica CH Amylase_2 (AMY_2) |
| Classification Name: | Amylase Test System |
| Regulation Number: | 21CFR862.1070 |
| Classification: | Class II |
| Product Code: | JFJ |
| Panel: | Clinical Chemistry |
| Predicate Device: | Roche Cobas Amylase Reagent |
| (K903309) |
Requlatory Submission for the Atellica® CH Amvlase 2 (AMY 2)
DEVICE DESCRIPTION
ATELLICA CH AMYLASE 2 (AMY-2)
The Atellica® CH Amylase_2 (AMY_2) assay is based on the procedure of Jensen and Wydeveld. The Atellica CH AMY 2 assay uses ethylidene blocked p-nitrophenylmaltoheptaoside as substrate. The indicator enzyme a-glucosidase, used to release pnitrophenol (PNP), is also employed in the assay. The terminal glucose of the substrate is chemically blocked, preventing cleavage by the indicator enzymes. The released pnitrophenol is measured at 410/694 nm.
Reaction Equation
Image /page/4/Figure/7 description: This image shows two chemical reactions. In the first reaction, Ed-G7PNP is converted to Ed-Gn + Gn-PNP by alpha-amylase. In the second reaction, Gn-PNP is converted to PNP + Glucose by alpha-Glucosidase.
Serum, lithium heparin plasma and urine specimens may be used. The reagent is stored unopened at 2 - 8 °C and is stable for use on system for 31 days. Calibration is performed every 62 days for a reagent lot or every 31 days for an individual pack well.
-
- Jenson AP, Wydeveld A. α-(p-nitrophenyl) maltohexaside as a substrate for the assay of amylase. Nature. 1958; 182:525-526.
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INTENDED USE / INDICATIONS FOR USE
ATELLICA CH AMYLASE_2 (AMY-2)
The Atellica® CH Amylase_2 (AMY_2) assay is for in vitro diagnostic use in the quantitative determination of amylase activity in human serum, plasma (lithium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Below is a features comparison for the Atellica® CH Amylase_2 (AMY_2) assay and the predicate device:
| Feature | Predicate Device:
Roche Cobas Amylase Reagent
(K903309) | New Device:
Atellica® CH Amylase_2 (AMY_2) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | In vitro test for the quantitative
determination of α-amylase in
human serum, plasma and urine
on Roche/Hitachi cobas c
systems. | The Atellica® CH Amylase_2
(AMY_2) assay is for in vitro
diagnostic use in the quantitative
determination of amylase activity
in human serum, plasma (lithium
heparin), and urine using the
Atellica® CH Analyzer. Such
measurements are used primarily
in the diagnosis and monitoring of
acute pancreatitis (inflammation of
the pancreas). |
| Device
Technology: | Enzymatic colorimetric assay | Same |
| Sample Type: | Serum, Li-Heparin Plasma and
Urine | Same |
| Expected Values: | Serum/Li-Heparin Plasma:
Men/Women: 28-100 U/L
Spontaneously Voided Urine:
Men: 16-491 U/L
Women: 21-447 U/L | Serum/Li-Heparin Plasma: 30-118 U/L
Urine: ≤ 650 U/L |
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| Feature | Predicate Device:
Roche Cobas Amylase Reagent
(K903309) | New Device:
Atellica® CH Amylase_2 (AMY_2) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Standardization: | This method has been
standardized against Roche
system reagent using calibrated
pipettes together with a manual
photometer providing absolute
values and substrate-specific
absorptivity, ε. | Traceable to IRMM/IFCC-456
Pancreatic Alpha-Amylase
Reference Material and
commutable to the IFCC Alpha-
Amylase Primary Reference
Procedure as established by
patient sample correlation. |
| Calibration
Frequency: | After reagent lot change As required following quality control procedures | 62 days for a reagent lot; 31 days
for an individual pack well |
| Analytical
Measuring
Interval: | Serum/Plasma/Urine:
3-1500 U/L | Serum/Plasma/Urine:
20-1500 U/L |
| Interferences: | No significant interference for:
Bilirubin (Conjugated) at a
concentration of: 60 mg/dL
Bilirubin (Unconjugated) at a
concentration of: 60 mg/dL
Lipemia (Intralipid®) at a
concentration of: 1500 mg/dL
Hemoglobin at a concentration of:
500 mg/dL | No significant interference for:
Bilirubin (Conjugated) at a
concentration of: 30 mg/dL
Bilirubin (Unconjugated) at a
concentration of: 30 mg/dL
Lipemia (Intralipid®) at a
concentration of: 650 mg/dL
Hemoglobin at a concentration of:
500 mg/dL |
SUMMARY OF PERFORMANCE TESTING
Assay performance comparison results for the Atellica® CH Amylase_2 (AMY_2) were obtained by processing the appropriate body fluids. Summary statistics for each are provided. These data demonstrate substantial equivalency of the Atellica® CH Amylase_2 (AMY_2) compared to the predicate device. The following data represent typical assay performance.
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DETECTION LIMIT
The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
Assessment of LoB was the 95th percentile of all values (sorted from lowest to highest), using non-parametric approach.
| Atellica ® CH Amylase_2 (AMY_2) – Detection Capability | ||
|---|---|---|
| Limit | Protocol | Result |
| LoB | 4 samples with no analyte | |
| were tested (N=20) for 3 | ||
| days, one run per day, 3 | ||
| reagent lots | 1 U/L Serum/Plasma/Urine | |
| LoD | 4 low analyte samples were | |
| tested (N=20) for 3 days, one | ||
| run per day, 3 reagent lots | 7 U/L Serum/Plasma | |
| 9 U/L Urine |
LoB Rank Position = 0.5 +0.95*B, where B=total reps=240; Rank = 228.5
LoQ
The Limit of Quantitation (LoQ) for serum/plasma and urine was determined as described in CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. Total Error is calculated using: TE = |bias| + 2 * SD.
For both serum/plasma and urine fluids, 4 low samples were processed on three reagent lots for three days, on one instrument for a total of 120 measurements per lot. For serum/plasma, the measured LoQ was 18 U/L in support of the low end of the measuring interval of 20 U/L for serum and plasma samples. For urine, the measured LoQ was 19 U/L in support of the low end of the measuring interval of 20 U/L for urine samples. The LoQ claim of 20 U/L for serum/plasma and urine are each based on a total of 120 determinations with a total error goal of ≤ 30% for serum/plasma specimens and ≤ 30% for urine specimens.
LINEARITY
Linearity was evaluated with 9 samples which spanned the assay measuring interval for serum specimens and 9 samples which spanned the assay measuring interval for urine specimens. Each was prepared by mixing high and low concentration samples across the measurement interval as described in CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures. The high sample was prepared by spiking
8
native serum or urine pools with amylase. Low pools were created by diluting serum and urine samples with CH diluent. Five replicates were measured for each sample. The mean of these replicates was used for the calculations.
The assay was considered linear across the measuring interval if the p-values of nonlinear terms in the quadratic and cubic fit equations are nonsignificant (p > 0.05). If any of the aforementioned p-values are ≤ 0.05, then linearity was determined via an allowable bias of ≤ 10% or ≤ 10 U/L, whichever is greater, for the observed values vs. the linear fit. Linearity of the Atellica CH Amylase 2 (AMY 2) was demonstrated with both serum and urine specimens to encompass the measuring interval of 20 to 1500 U/L for serum, plasma, and urine specimens.
PRECISION
Precision testing was performed in accordance with CLS/ EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods. Precision was tested using n = 2 replicates, two times per day for at least 20 days for a total of 80 replicates per sample with controls, serum, plasma, and urine pools on one instrument. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP05-A3. The data are summarized in the following table.
| Repeatability | Within-Lab Precision | |||||
|---|---|---|---|---|---|---|
| Sample Type | n | Mean | ||||
| U/L | SDa | |||||
| U/L | CVb | |||||
| (%) | SDa | |||||
| U/L | CVb | |||||
| (%) | ||||||
| Sample 1 | 80 | 52 | 0.6 | 1.1 | 0.7 | 1.4 |
| Serum QC | 80 | 187 | 0.8 | 0.4 | 1.1 | 0.6 |
| Sample 2 | 80 | 1128 | 2.2 | 0.2 | 4.3 | 0.4 |
| Urine QC | 80 | 58 | 1.0 | 1.7 | 1.3 | 2.2 |
| Urine 1 | 80 | 183 | 0.8 | 0.4 | 2.3 | 1.3 |
| Urine 2 | 80 | 1260 | 9.3 | 0.7 | 21.5 | 1.7 |
ª SD = standard deviation
b CV = coefficient of variation
INTERFERENCES
CLSI EP07-A2, Interference Testing in Clinical Chemistry, was followed for the interference testing. The interference study was conducted using a "paired difference worst case scenario" approach where these compounds were spiked into fresh sample pools containing either low or high levels of measurand in serum and urine pools.
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Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference. Dilution studies were conducted to determine the level at which the spiked substance no longer displayed significant interference. Dilution studies were conducted at two analyte concentrations, if both sample pools show significant interference. This study was conducted as needed for both serum pools.
| Approximate Concentration (within 15%) of Analytes in Test Pools | |||
|---|---|---|---|
| Analyte | Matrix | Low | High |
| Amylase | Serum | 100 U/L | 400 U/L |
| Amylase | Urine | 100 U/L | 400 U/L |
No interference was detected a the following analyte concentrations.
| Substance | Substance Test Concentration
Common Unit |
|-------------------------|---------------------------------------------|
| Hemoglobin | 500 mg/dL |
| Bilirubin, conjugated | 30 mg/dL |
| Bilirubin, unconjugated | 30 mg/dL |
| Lipemia (Intralipid®) | 650 mg/dL |
| Acetaminophen | 30 mg/dL |
| Ascorbic Acid | 20 mg/dL |
| Acetylsalicylic Acid | 200 mg/dL |
Interference Testing for Serum and Urine
METHOD COMPARISON
The predicate device selected for the method comparison study was the Roche Cobas Amylase (AMYL2) Reagent. Remnant de-identified samples were tested. No patient history information was obtained on these samples. Inclusion/exclusion data criteria are not applicable. The study included native and spiked samples to properly span the assay measuring interval.
These studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel, and externally by a contracted laboratory. The personnel conducting the study were laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting. They were trained on the operation of both the device and the predicate device. A split sample method comparison, following CLSI EP09-A3, Measurement Procedure Comparision and Bias Estimation Using Patient Samples, demonstrated good agreement between the Atellica® CH Amylase_2 (AMY_2) and the predicate Roche Cobas Amylase (AMYL2) assay with patient samples.
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The results across the full assay intervals were analyzed using weighted Deming regression. For the serum method comparison, one replicate was processed on the Cobas while two replicates were processed on the Atellica. For the urine method comparison two replicates were processed for each sample on both systems. Only the first replicate results were used in statistical analysis. Indicated samples were spiked with pancreatic amylase to span the assay measuring interval.
| Specimen
Type | Comparison
Assay (x) | N | r | Regression
Equation | Sample Range (on the
Roche Cobas) |
|------------------|-------------------------|-----|-------|------------------------|--------------------------------------|
| Serum | Roche Cobas
AMYL2 | 118 | 0.996 | y = 1.09x + 0 U/L | 28-1294 U/L |
| Urine | Roche Cobas
AMYL2 | 114 | 0.998 | y = 1.11x - 1 U/L | 20-1194 U/L |
MATRIX EQUIVALENCY
Matched serum and lithium heparin plasma sets were processed with N= 2 replicates using only the first replicate for analysis on the Atellica® CH Amylase 2 (AMY 2) assay. Some samples were spiked with amylase to obtain samples spanning the assay measuring interval. The table below summarizes the Deming linear regression statistics.
| Specimen Type | Comparison Assay (x) | N | r | Regression Equation | Sample Range |
|---|---|---|---|---|---|
| Plasma (Lithium heparin) | Atellica® CH AMY_2 serum | 66 | 1.000 | y = 1.00x + 0 U/L | 36 - 1419 U/L |
EXPECTED VALUES
Reference intervals for healthy adults were verified on the Atellica® CH Analyzer in accordance with CLSI EP28-A3, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory. As with all in vitro diagnostic assays, each laboratory should determine its own reference interval for the diagnostic evaluation of patient results. Consider these values as guidance only.
| Group | Specimen type | Reference Interval
common unit (SI unit) |
|--------|---------------|---------------------------------------------|
| Adults | Serum/plasma1 | 30 to 118 U/L |
| Adults | Urine2 | ≤ 650 U/L |
- Data on file at Siemens Healthcare Diagnostics. (Evidence-based Medicine and Test Utilization Developing Reference Intervals for Clinical Chemistry Systems Using the CLSI C28-A2 Guideline)
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- Wu AHB. Tietz Clinical Guide to Laboratory Tests. 4th ed. Philadelphia, PA: WB Saunders Co; 2006:104.
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EXTENDED MEASURING INTERVAL
The Atellica® CH Amylase_2 assay parameters support both serum/plasma and urine extended ranges 3x the upper measuring interval.
Using CH Diluent, 3-fold manual dilutions of 5 serum and 5 urine pools were made. Both the undiluted and diluted pools were processed with N=4 replicates; where the undiluted samples were auto-diluted on the Atellica CH system.
The serum/plasma and urine extended measuring interval is up to 4500 U/L.
STANDARDIZATION
The Atellica® CH AMY_2) assay is traceable to the IRMM/IFCC-456 reference material and commutable to the IFCC Alpha-Amylase Primary Reference Procedure as established by patient sample correlation.
Assigned values for calibrators are traceable to this standardization.
CONCLUSION
The Atellica® CH Amylase_2 (AMY_2) is substantially equivalent to the Roche Cobas Amylase Reagent in principle and performance based on the similarity of device designs and function demonstrated through method comparison and other performance attributes.