(147 days)
No
The summary describes a standard immunoassay kit and automated system for measuring calcitonin levels. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is for in vitro diagnostic use to measure calcitonin as an aid in diagnosis and treatment, not to directly treat a disease.
Yes
The "Intended Use / Indications for Use" states that the assay is for "in vitro diagnostic use" and its "measurement is used as an aid in the diagnosis and treatment of diseases".
No
The device description clearly outlines physical components like reagents, calibrators, and microparticles, indicating it is a hardware-based in vitro diagnostic assay kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use...". This is the most direct indicator.
- Device Description: The description details a kit containing reagents and calibrators used to perform a test on a human sample (serum). This is characteristic of an in vitro diagnostic device.
- Intended User/Care Setting: It specifies "in vitro diagnostic use," reinforcing its purpose.
- Performance Studies: The document describes performance studies conducted to validate the assay's accuracy and reliability for diagnostic purposes, including linearity, precision, method comparison, and expected values in a healthy population. These are standard evaluations for IVD devices.
- Predicate Device(s): The mention of a predicate device (Roche Elecsys/Cobas® Calcitonin) with a K number (K132828) indicates that this device is being compared to a previously cleared IVD device, a common practice in the regulatory pathway for IVDs.
All these elements strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use in the quantitative measurement of calcitonin in human serum using the ADVIA Centaur XP system. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
Product codes
JKR
Device Description
The ADVIA Centaur CALCT Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CALCT Lite Reagent and Solid Phase reagent, and one set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each).
ADVIA Centaur CALCT Calibrator Assigned Value Card and barcode labels and ADVIA Centaur CALCT Master Curve Card are also included in the kit.
The ADVIA Centaur CALCT assay is a fully automated, two-step immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium-ester-labeled recombinant antibody as the Lite Reagent. The Solid phase consists of anti-calcitonin mouse monoclonal antibody-coated paramagnetic microparticles.
The system automatically performs the following steps:
- Dispenses 100 µL of sample into a cuvette.
- Dispenses 120 µL of Solid Phase and incubates the mixture for 18 minutes at 37ºC.
- Separates the Solid Phase from the mixture, aspirates the unbound reagent.
- Washes the cuvettes and resuspends the particles in ADVIA Centaur Wash 1.
- Dispenses 100 µL of Lite Reagent into the cuvette and incubates for 18 minutes at 37°C.
- Separates the Solid Phase from the mixture, aspirates the unbound reagent.
- Washes cuvettes in ADVIA Centaur Wash 1.
- Dispenses 300 µL each of Acid Reagent and Base Reagent to initiate the chemiluminescent reaction.
- Calculates the results from the relative light units (RLU) generated using a stored master, curve, and reports in pg/mL (pmol/L).
A direct relationship exists between the amount of calcitonin present in the patient sample and the amount of relative light units (RLUs) detected by the system. The system washes the reagent probe with ADVIA Centaur APW1 or ADVIA Centaur PW4 to mitigate potential interference between the ADVIA Centaur CALCT assay and other assays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thyroid and parathyroid glands
Indicated Patient Age Range
The age range was 22-79 years.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Performance:
The ADVIA Centaur CALCT assay demonstrated substantially equivalent performance to the Roche Elecsys/Cobas® calcitonin assay.
Linearity:
Linearity was evaluated according to the CLSI protocol EP06-A.
Two samples containing high levels of calcitonin were mixed with analyte-free human serum. The resulting sample mixtures were assayed for calcitonin. The ADVIA Centaur CALCT assay is linear from 1.75-2000.00 pg/mL (0.51-585.20 pmol/L).
Dilution Recovery:
Fourteen samples containing high levels of calcitonin (2002.73 - 206737.95 pg/mL (586.00 - 60491.52 pmol/L)) were diluted 1:100 (1 part sample plus 99 parts diluent) with ADVIA Centaur Multi-Diluent 13 and assayed for recovery correcting the diluted sample by the dilution factor.
In a representative study the observed percent recovery for individual samples ranged from 82.8% to 117.4%.
Measuring Interval:
The ADVIA Centaur CALCT assay measures calcitonin concentrations from 1.75-2000.00 pg/mL (0.51-585.20 pmol/L).
Detection Capability:
The limit of blank (LoB), limit of detection (LoD), and the limit of quantitation (LoQ) were determined as described in CLSI Document EP17-A2.28. The ADVIA Centaur CALCT assay is designed to have an LoQ of 0.95, a slope of 0.90–1.10, and an intercept ± 2.00 pg/mL (± 0.59 pmol/L) for alternate tube types (y) versus human serum (x).
A specimen collection study was performed with serum calcitonin values ranging from approximately 2.50-2000.00 pg/mL (0.73-585.20 pmol/L). Passing-Bablok regression and a Pearson coefficient analysis were performed and no significant difference between tube types was observed.
For Human serum (x) vs Serum Separator Tube (y), n=60 samples showed a Slope of 5.99, Intercept (pg/mL) of 0.36, Intercept (pmol/L) of 0.09, and r = 0.99.
Summary of Clinical Performance:
The ADVIA Centaur anti-CCP IgG assay demonstrated substantially equivalent performance to the predicate as indicated by reference intervals (expected values) and a method comparison.
Method Comparison:
The ADVIA Centaur CALCT assay is designed to have a correlation coefficient (r) > 0.95 compared to a comparable method.
A total of 97 human serum samples with calcitonin concentrations in the range of 1.01-1813.00 pg/mL (0.30-530.48 pmol/L) were tested over 4 discrete reagent lots. The relationship of the ADVIA Centaur CALCT assay (y) and a comparable method (x) is described using Passing-Bablok regression and a Pearson coefficient using the ADVIA Centaur XP system.
Representative data from the study: ADVIA Centaur CALCT (y)=0.97 (x)+1.09 pg/mL (intercept), r = 0.98. ADVIA Centaur CALCT (y) = 0.97 (x) + 0.32 pmol/L (intercept), r = 0.98.
Expected Values:
The ADVIA Centaur CALCT assay results were obtained on 240 apparently healthy subjects, males (n = 120) and females (n = 120). The age range was 22-79 years. Reference intervals were determined using the 97.5th percentiles as upper limit of normal according to EP28-A3c.
- Males: ≤ 13.38 pg/mL (≤ 3.91 pmol/L)
- Females: ≤ 9.53 pg/mL (≤ 2.79 pmol/L)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Key metrics reported are:
- Linearity: 1.75-2000.00 pg/mL (0.51-585.20 pmol/L)
- Dilution Recovery: 82.8% to 117.4%
- Measuring Interval: 1.75-2000.00 pg/mL (0.51-585.20 pmol/L)
- LoB: 1.29 pg/mL (0.38 pmol/L)
- LoD: 1.65 pg/mL (0.48 pmol/L)
- LoQ: 1.75 pg/mL (0.51 pmol/L)
- High Dose Hook: no hook effect up to 1,200,000 pg/mL (351,120 pmol/L)
- Within-Laboratory %CV: 0.95 (actual r = 0.98 for method comparison)
- Slope: 0.97 (for method comparison)
- Intercept: 1.09 pg/mL (0.32 pmol/L) (for method comparison)
Predicate Device(s)
Roche Elecsys/Cobas® Calcitonin (K132828)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1140 Calcitonin test system.
(a)
Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2018
Axis-Shield Diagnostics Limited Claire Dora Regulatory Affairs Manager Luna Place. The Technology Park Dundee, Scotland DD2 1XA UK
Re: K182012
Trade/Device Name: ADVIA Centaur® Calcitonin (CALCT) assay Regulation Number: 21 CFR 862.1140 Regulation Name: Calcitonin test system Regulatory Class: Class II Product Code: JKR Dated: November 29, 2018 Received: December 3, 2018
Dear Claire Dora:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
Courtney H. Lias, Ph.D. for Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182012
Device Name
ADVIA Centaur® Calcitonin (CALCT) assay
Indications for Use (Describe)
The ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use in the quantitative measuremt of calcitonin in human serum using the ADVIA Centaur XP system. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
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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3
ADVIA Centaur Calcitonin (CALCT) Assay 510(k) Summary
Created: 19th December 2018
4
ADVIA Centaur Calcitonin (CALCT) Assay 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K182012
Submission correspondent:
Dr. Claire Dora Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park, Dundee, DD2 1XA, UK Tel: +44(0)1382 422000
Device Name: ADVIA Centaur® Calcitonin assay
Reagents:
Classification Name: Radioimmunoassay, Calcitonin Trade Name: ADVIA Centaur® Calcitonin (CALCT) assay Common Name: Calcitonin Governing Regulation: 862.1140 Device Classification: Class II Classification Panel: Chemistry Product Code: JKR
Legally marketed device to which equivalency is claimed:
Roche Elecsys/Cobas® Calcitonin (K132828)
Intended Use of Device:
The ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use in the quantitative measurement of calcitonin in human serum using the ADVIA Centaur XP system. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
Device Summary:
The ADVIA Centaur CALCT Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CALCT Lite Reagent and Solid Phase reagent, and one set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each).
ADVIA Centaur CALCT Calibrator Assigned Value Card and barcode labels and ADVIA Centaur CALCT Master Curve Card are also included in the kit.
Section_06
5
Principles of the Device:
The ADVIA Centaur CALCT assay is a fully automated, two-step immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium- ester-labeled recombinant antibody as the Lite Reagent. The Solid phase consists of anti-calcitonin mouse monoclonal antibody-coated paramagnetic microparticles.
The system automatically performs the following steps:
- · Dispenses 100 µL of sample into a cuvette.
- · Dispenses 120 µL of Solid Phase and incubates the mixture for 18 minutes at 37ºC.
- · Separates the Solid Phase from the mixture, aspirates the unbound reagent.
- Washes the cuvettes and resuspends the particles in ADVIA Centaur Wash 1.
- Dispenses 100 µL of Lite Reagent into the cuvette and incubates for 18 minutes at 37°C.
- · Separates the Solid Phase from the mixture, aspirates the unbound reagent.
- · Washes cuvettes in ADVIA Centaur Wash 1.
- Dispenses 300 µL each of Acid Reagent and Base Reagent to initiate the chemiluminescent reaction.
- Calculates the results from the relative light units (RLU) generated using a stored master, curve, and reports in pg/mL (pmol/L).
A direct relationship exists between the amount of calcitonin present in the patient sample and the amount of relative light units (RLUs) detected by the system. The system washes the reagent probe with ADVIA Centaur APW1 or ADVIA Centaur PW4 to mitigate potential interference between the ADVIA Centaur CALCT assay and other assays.
6
Comparison of Technological Characteristics:
The ADVIA Centaur CALCT assay and the Roche Elecsys/Cobas® Calcitonin assay are both automated immunoassays for the quantitative measurement of calcitonin in human serum.
The ADVIA Centaur System and Roche Elecsys/Cobas® share similar detection methods both utilizing chemiluminescent microparticle immunoassay (CMIA) technology. Both assays also demonstrated substantial equivalence as described in the table below:
| Similarities | ||
|---|---|---|
| Parameter | New submission device | |
| ADVIA Centaur® CALCT | Submission device | |
| Elecsys/Cobas® CALCT | ||
| Intended use | The ADVIA Centaur® Calcitonin (CALCT) | |
| assay is for in vitro diagnostic use in the | ||
| quantitative measurement of calcitonin in | ||
| human serum using the ADVIA Centaur XP | ||
| system. Calcitonin measurement is used as an | ||
| aid in the diagnosis and treatment of diseases | ||
| involving the thyroid and parathyroid glands, | ||
| including | ||
| carcinoma | ||
| and | ||
| hyperparathyroidism. | The Calcitonin immunoassay is intended for | |
| the in vitro quantitative determination of | ||
| human calcitonin (thyrocalcitonin) in serum | ||
| and plasma. The calcitonin determination is | ||
| intended to be used as an aid in the diagnosis | ||
| and treatment of diseases involving the | ||
| thyroid and parathyroid glands, including | ||
| carcinoma and hyperparathyroidism in | ||
| conjunction with other clinical and laboratory | ||
| findings. | ||
| Assay | ||
| Technology | Automated. Chemiluminescent Microparticle | |
| Immunoassay (CMIA) | Automated. Chemiluminescent Microparticle | |
| Immunoassay (CMIA) | ||
| Standardization | WHO 2nd IRP 89/620 | WHO 2nd IRP 89/620 |
| Specimen type | Human serum and serum separator tubes. | Human serum and serum separator tubes. |
| Test principle | Sandwich principle | Sandwich principle |
| Reagent storage | Intended Storage of 2-8 °C | Intended Storage of 2-8 °C |
| Reagent stability | unopened: stabile until expiry | unopened: stabile until expiry |
| Calibration | 2-point calibration & | |
| master curve (via reagent barcode) | 2-point calibration & | |
| master curve (via reagent barcode) | ||
| Measuring | ||
| interval | 1.75 - 2000.00 pg/mL | 1.0-2000 pg/mL |
| Linear range | 1.75 –2000.00 pg/mL | LOQ-2000.00 pg/mL |
| Dilution | ||
| Capabilities | 1:100 | |
| (auto only) | 1:100 | |
| (auto and manual) | ||
| On-system | ||
| reagent stability | 28 days | 28 days |
| Differences | ||
| Parameter | New submission device | |
| ADVIA Centaur® CALCT | Submission device | |
| Elecsys/Cobas® CALCT | ||
| Calibration | 14 -days lot-specific | 7 -days lot-specific |
| Expected Values in | ||
| Asymptomatic | ||
| Population | Reference ranges for 240 apparently | |
| healthy subjects, males (n = 120) and | ||
| females (n = 120). | ||
| The age range was 22-79 years. | ||
| Reference intervals were determined using | ||
| the 97.5th percentiles as upper limit of | ||
| normal. | ||
| Males: ≤ 13.38 pg/mL (≤ 3.91 pmol/L) | ||
| Females: ≤ 9.53 pg/mL (≤ 2.79 pmol/L) | Reference ranges for apparently health | |
| males (n=184) and apparently healthy | ||
| females (n=180) were determined using the | ||
| 97.5th percentiles as upper limit of normal. | ||
| Females: 7.63 pg/mL (95% CI 6.1-12.7 | ||
| pg/mL) | ||
| Males: 14.3 pg/mL (95%CI 10.4-18.0 pg/mL) | ||
| High Dose hook | no high-dose hook effect at concentrations | |
| up to 1,200,000 pg/mL | no high-dose hook effect at concentrations | |
| up to 1 µg/mL | ||
| Detection | ||
| Capability | Limit of Quantitation = 1.75 pg/mL | Limit of Quantitation = 1 pg/mL |
| Specimen | ||
| Stability | Separated specimens are stable for up to: 4 | |
| hours at room temperature | ||
| 1 day at 2-8 °C. 3 weeks at -20°C | ||
| 11 weeks at -70°C | ||
| Specimens may undergo 1 freeze-thaw | ||
| cycle. | Specimens may be stored for up to: 4 hours | |
| at 20-25 °C | ||
| 1 day at 2-8 °C. | ||
| 3 months at -20°C | ||
| Specimens may undergo 1 freeze-thaw | ||
| cycle. | ||
| Specimen type | Human serum. | Human Serum and plasma (K2-EDTA, K3- |
| EDTA, Lithium Heparin with and without | ||
| gel) |
Comparison of the subject device with the predicate device:
7
8
Summary of Non-Clinical Performance:
The ADVIA Centaur CALCT assay demonstrated substantially equivalent performance to the Roche Elecsys/Cobas® calcitonin assay. A summary of the nonclinical performance data included in this 510(k) submission has been presented.
Linearity
Linearity was evaluated according to the CLSI protocol EP06-A.
Two samples containing high levels of calcitonin were mixed with analyte-free human serum. The resulting sample mixtures were assayed for calcitonin. The ADVIA Centaur CALCT assay is linear from 1.75-2000.00 pg/mL (0.51-585.20 pmol/L).
Dilution Recovery
Fourteen samples containing high levels of calcitonin (2002.73 - 206737.95 pg/mL (586.00 - 60491.52 pmol/L)) were diluted 1:100 (1 part sample plus 99 parts diluent) with ADVIA Centaur Multi-Diluent 13 and assayed for recovery correcting the diluted sample by the dilution factor.
In a representative study the observed percent recovery for individual samples ranged from 82.8% to 117.4%.
Measuring Interval
The ADVIA Centaur CALCT assay measures calcitonin concentrations from 1.75-2000.00 pg/mL (0.51-585.20 pmol/L).
Detection Capability
The limit of blank (LoB), limit of detection (LoD), and the limit of quantitation (LoQ) were determined as described in CLSI Document EP17-A2.28 The ADVIA Centaur CALCT assay is designed to have an LoQ of 0.95, a slope of 0.90–1.10, and an intercept ± 2.00 pg/mL (± 0.59 pmol/L) for alternate tube types (y) versus human serum (x). A specimen collection study was performed with serum calcitonin values ranging from approximately 2.50-2000.00 pg/mL (0.73-585.20 pmol/L). Passing-Bablok regression and a Pearson coefficient analysis were performed and no significant difference between tube types was observed. The following results were obtained:
| Intercept | |||||
|---|---|---|---|---|---|
| Human serum (x) vs | n | Slope | (pg/mL) | (pmol/L) | r |
| Serum Separator Tube (y) | 60 | 5.99 | 0.36 | 0.09 | 0.99 |
13
Summary of Clinical Performance:
The ADVIA Centaur anti-CCP IgG assay demonstrated substantially equivalent performance to the predicate as indicated by reference intervals (expected values) and a method comparison.
Method Comparison
The ADVIA Centaur CALCT assay is designed to have a correlation coefficient (r) > 0.95 compared to a comparable method.
A total of 97 human serum samples with calcitonin concentrations in the range of 1.01-1813.00 pg/mL (0.30-530.48 pmol/L) were tested over 4 discrete reagent lots. The relationship of the ADVIA Centaur CALCT assay (y) and a comparable method (x) is described using Passing-Bablok regression and a Pearson coefficient using the ADVIA Centaur XP system.
Representative data from the study is shown below: ADVIA Centaur CALCT (y)=0.97 (x)+1.09 pg/mL (intercept), r = 0.98. ADVIA Centaur CALCT (y) = 0.97 (x) + 0.32 pmol/L (intercept), r = 0.98.
The correlation of the assay may vary depending on the study design, comparable method, and sample population according to EP09-A3. Assay results obtained at individual laboratories may vary from the data presented.
Expected Values
The ADVIA Centaur CALCT assay results were obtained on 240 apparently healthy subjects, males (n = 120) and females (n = 120). The age range was 22-79 years. Reference intervals were determined using the 97.5th percentiles as upper limit of normal according to EP28-A3c.
- Males: ≤ 13.38 pg/mL (≤ 3.91 pmol/L)
- · Females: ≤ 9.53 pg/mL (≤ 2.79 pmol/L)
As with all in vitro diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results. Consider these values as guidelines only.
14
Stability
ADVIA Centaur CALCT Reagents are stable at 2–8°C until the expiration date on the product.
ADVIA Centaur CALCT Calibrators are stable at 2–8°C until the expiration date on the product.
On-System Stability
The ADVIA Centaur CALCT assay reagents are stable unopened until the expiration date on the product or onboard the system for 28 days.
The ADVIA Centaur CALCT calibrators are stable unopened until the expiration date on the product or onboard the system for 4 hours.
Standardization
The ADVIA Centaur CALCT assay is traceable to the World Health Organization (WHO) 2nd International Reference Preparation for Calcitonin (Human); NIBSC code: 89/620. Assigned values for calibrators are traceable to this standard.
Conclusion:
Based on the performance characteristics the ADVIA Centaur CALCT assay is substantially equivalent to the predicate device.