(29 days)
No
The document describes calibration and control materials for an immunoassay system, not a device that processes data or makes decisions using AI/ML.
No
The device is an in vitro diagnostic product used for verification of calibration and reportable range of assays, not for treating any condition or directly providing therapy to patients.
No.
The device is described as "Master Curve Material" for in vitro diagnostic use in the verification of calibration and reportable range of specific assays. It is used to verify the performance of other diagnostic devices (the ADVIA Centaur Prolactin and Cortisol assays), rather than directly diagnosing diseases or conditions. The "Key Metrics" section also states "Not Applicable (Quality Control Material)".
No
The device description clearly states it is an in vitro diagnostic product containing biological materials (lyophilized equine serum, human plasma) and chemical components (sodium azide, amphotericin B). This indicates it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The ADVIA Centaur® Prolactin (PRL) Master Curve Material is for in vitro diagnostic use..."
- "The ADVIA Centaur® Cortisol (COR) Master Curve Material is for in vitro diagnostic use..."
The "Device Description" also refers to the materials as "in vitro diagnostic product".
These statements clearly indicate that the device is intended for use in the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition. In this case, the materials are used to verify the performance of assays that measure prolactin and cortisol, which are biomarkers used in clinical diagnosis.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Prolactin (PRL) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Prolactin assay.
The ADVIA Centaur® Cortisol (COR) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Cortisol assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
ADVIA Centaur® Prolactin Master Curve Material is an in vitro diagnostic product containing various levels of prolactin spiked in lyophilized equine serum with sodium azide (0.1%) and preservatives including amphotericin B. Each set contains ten levels (MCM1–10); with a reconstituted volume of 1.0 mL per level. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 2.11, 4.61, 9.21, 26.0, 51.1, 82.9, 113, 161, and 218 ng/mL.
ADVIA Centaur® Cortisol Master Curve Materials is an in vitro diagnostic product containing various levels of cortisol in lyophilized human plasma with sodium azide. Each set contains seven lyophilized levels (MCM1-7); with a reconstituted volume of 1.0 mL each. MCM1 contains no analyte. The COR MCMs assigned values are lot-specific of target values: 0.00, 1.00, 2.00, 6.00, 12.0, 30.0, and 80.0 µg/dL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only
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)
Stability studies were conducted to support the shelf life (unopened) and reconstituted material for the ADVIA Centaur PRL MCMs to ensure that it maintains optimal product performance throughout the established shelf-life. The data supports the stability claims detailed in the ADVIA Centaur PRL MCM Instructions for Use.
Real time shelf-life studies (unopened): Test PRL MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 12 months, and 30 months. Acceptance criteria for the real-time stability study were met up to the 30 months' time point, which supports a shelf-life claim of 29 months.
In-Use Open Vial (Reconstituted): Test PRL MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 7, 14, 21 28, and 29 days. Acceptance criteria for the open vial (reconstituted) stability study were met to the 29 days' time point, which supports the open vial claim of 28 days when properly stored at 2-8°C.
On-board Stability: Pooled aliquots of test PRL MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Stability studies were conducted to support the shelf life unopened and reconstituted material for the ADVIA Centaur COR MCMs to ensure that it maintains optimal product performance throughout the established shelf-life. The data supports the stability claims detailed in the ADVIA Centaur COR MCM Instructions for Use.
Real time shelf-life studies (unopened): Test COR MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 12 months, 18 months, and 23 months. Acceptance criteria for the real-time stability study were met up to the 23 months' time point, which supports a shelf-life claim of 22 months.
In-Use Open Vial (Reconstituted): Test COR MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 2, 4, 7, 11, 14, and 15 days. Acceptance criteria for the open vial (reconstituted) stability study were met to the 15 days' time point, which supports the open vial claim of 14 days when properly stored at 2-8°C.
On-board Stability: Pooled aliquots of test COR MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a wavy line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
SIEMENS HEALTHCARE DIAGNOSTICS, INC. FATIMA PACHECO REGULATORY CLINICAL AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K143194
Trade/Device Name: ADVIA Centaur® Prolactin Master Curve Material (MCM), ADVIA Centaur® Cortisol Master Curve Material (MCM) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: October 31, 2014 Received: November 6, 2014
Dear Ms. Fatima Pacheco:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Stayce Beck -S
For : Courtney H. Lias, Ph.D. 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) K143194
Device Name
ADVIA Centaur® Prolactin Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® Prolactin (PRL) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Prolactin assay.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K143194
Device Name
ADVIA Centaur® Cortisol Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® Cortisol (COR) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Cortisol assay.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
Section 006: 510(k) Summary
510(k) Summary – ADVIA Centaur Prolactin Master Curve Material
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K143194
| 1. Applicant Information
Mailing Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 USA |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fatima Pacheco
Regulatory Clinical Affairs Specialist |
| Phone Number: | (914) 524-2450 |
| Fax Number: | (914) 524-3579 |
| E-mail Address: | fatima.pacheco@siemens.com |
| Date Prepared: | November 25, 2014 |
| 2. Device Name | ADVIA Centaur® Prolactin (PRL) Master Curve Material |
| Proprietary Name: | Quality Control materials for ADVIA Centaur PRL assay |
| Measurand: | Master Curve Material (MCM) for ADVIA Centaur PRL assay |
| Type of Test: | 21 CFR 862.1660, Quality Control Material |
| Regulation Section: | Class I Reserved |
| Classification: | JJX – Single (Specified) Analyte Controls (Assayed and
Unassayed) |
| Products Code: | Clinical Chemistry (75) |
| Panel: | Elecsys Prolactin II CalCheck 5
K110613 |
| 3. Predicate Device Name
Predicate 510(k) No: | ADVIA Centaur® Prolactin Master Curve Material is an
in vitro diagnostic product containing various levels of prolactin
spiked in lyophilized equine serum with sodium azide (0.1%)
and preservatives including amphotericin B. Each set contains
ten levels (MCM1–10); with a reconstituted volume of 1.0 mL
per level. MCM1contains no analyte. The MCMs assigned
values are lot-specific of target values: 0.00, 2.11, 4.61, 9.21,
26.0, 51.1, 82.9, 113, 161, and 218 ng/mL. |
| 4. Device Description: | |
5
(Bundled) Abbreviated 510(k) Premarket Notification
ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
| 5. Intended Use:
Indication for Use: | See Indications for Use Statement below:
The ADVIA Centaur® Prolactin (PRL) Master Curve Material is
for in vitro diagnostic use in the verification of calibration and
reportable range of the ADVIA Centaur Prolactin assay. |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Special Conditions for
Use Statement(s): | For prescription use only |
| Special Instrument
Requirements: | ADVIA Centaur® Systems
A description of the ADVIA Centaur system is documented
in K971418. Subsequent modifications to the instrument have
been reviewed and cleared in K032525 and K041133. |
| 6. Technological Characteristics
and Substantial Equivalence
Comparison with Predicate: | A comparison of the device features, intended use, and other
information demonstrates that the ADVIA Centaur PRL MCM
is substantially equivalent to the predicate device as
summarized in Table 1. |
6
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur PRL MCM | Elecsys Prolactin II CalCheck 5 |
| Intended | ||
| Use | The ADVIA Centaur Prolactin (PRL) | |
| Master Curve Material is for in vitro | ||
| diagnostic use in the verification of | ||
| calibration and reportable range of the | ||
| ADVIA Centaur Prolactin assay. | The Elecsys Prolactin II CalCheck 5 | |
| is an assayed control for use | ||
| in calibration verification and for use | ||
| in the verification of the assay | ||
| range established by the Elecsys | ||
| Prolactin II reagent on the indicated | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | ||
| Analyte | Prolactin | Same |
| Use | Multiple Use | Same |
| Storage | 2–8°C | Same |
| Form | Lyophilized | Same |
| Matrix | Equine serum | Same |
| DIFFERENCES | ||
| Levels | 10 | 5 |
| Stability | Unopened – Stable when stored | |
| unopened at 2-8°C for 29 months. | ||
| Opened (Reconstituted) – Stable | ||
| when stored at 2–8°C for 28 days; or | ||
| on-board for 4 hours. | Unopened - Stable at 2-8°C up to | |
| the expiration date printed on the | ||
| bottle labels. | ||
| Reconstituted – Stable for 4 hours at | ||
| 20-25°C. |
Table 1: Substantial Equivalence Comparison
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic ● Calibrators
- . Guidance for Industry and FDA Staff – Assayed and Unassayed Quality Control Material
7
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration verification checks of the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
9. Performance Characteristics
9.1 Analytical performance:
The following studies are not applicable for the purpose of this submission:
- Precision/Reproducibility ●
- . Linearity/Assay Reportable Range
- Detection limit ●
- Analytical Specificity
- Assay cut-off
- . Method Comparison Studies
- Clinical Studies (Sensitivity, Specificity, and cut-off) ●
9.2 Non-Clinical Performance Testing
The following studies were conducted on the ADVIA Centaur XP system.
9.2.1 Stability Studies
Stability studies were conducted to support the shelf life (unopened) and reconstituted material for the ADVIA Centaur PRL MCMs to ensure that it maintains optimal product performance throughout the established shelf-life. The data supports the stability claims detailed in the ADVIA Centaur PRL MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur PRL MCM:
- Real Time/Shelf Life (unopened) Stability ●
- In Use Open Vial (reconstituted) stored at 2-8°C Stability ●
- On-Board Stability .
Real time shelf-life studies (unopened): Test PRL MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 12 months, and 30 months. Shelf life claims are based upon real time stability carried out one month after the duration claimed. Real time shelf-life stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the real-time stability study were met up to the 30 months' time point, which supports a shelf-life claim of 29 months. Storage shelflife (unopened) at 2-8°C is indicated by the expiration date on the vial label.
In-Use Open Vial (Reconstituted): Test PRL MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 7, 14, 21 28, and 29 days. Acceptance criteria for the open vial (reconstituted) stability study were met to the 29 days' time point, which supports the open vial claim of 28 days when properly stored at 2-8°C.
8
On-board Stability: Pooled aliquots of test PRL MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. On-board stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur PRL MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 and . % dose recovery for MCM2-10 met the requirements of the acceptance criteria and no adverse trends.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 and the % dose recovery MCM2-10 met the requirements of the acceptance criteria.
- . On-Board: The dose recovery for MCM1 and the % dose recovery for MCM2-10 met the requirements of the acceptance criteria.
9.2.2 Value Assignment
The ADVIA Centaur PRL MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using Prolactin stock and are traceable to internal material which is standardized against World Health Organization (WHO) 3td IRP for human Prolactin 84/500 reference material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new PRL MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing run protocol is used for MCM2-MCM10 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-MCM10 were tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot. This protocol is designed to remove system and run variation. The new MCM doses must fall within the final value assignment specification for PRL MCMs. The MCMs dose values are generated using the two-point calibration. The new MCM dose is calculated based on the relationship between the observed reference MCM dose and its assigned value. A performance verification run consisting of 6 replicates of each MCM level is run using one instrument, one reagent kit lot and Bio-Rad controls. The mean MCM doses of the new MCM lot manufactured must fall within the customer range specifications.
The target for MCM1 is assigned a 0.0 dose. MCM1 is analyte-free basepool comprising of only the matrix and preservatives. The quality control specifications and final value assignment limits for PRL MCM ensure that MCM1 measures at or below the PRL assay sensitivity limit. MCM10 targeted greater
9
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
than the assay range is diluted with the MCM1 to meet the reportable range of the assay.
9.2.3 Expected Values
The expected values are the lot-specific assigned values obtained at value assignment and the lot-specific assigned ranges are the lot-specific customer ranges are established per % interval as below.
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 40% |
| MCM3 | 25% |
| MCM4 | 25% |
| MCM5 | 25% |
| MCM6 | 25% |
| MCM7 | 25% |
| MCM8 | 25% |
| MCM9 | 25% |
| MCM10 | 20% |
Example Lot-specific target and assigned values are provided in the ADVIA Centaur PRL MCM lot-specific value sheet in the example provided in Table 2.
| MCM level | Target Values
(ng/mL) | Assigned Values
(ng/mL) |
|-------------|--------------------------|----------------------------|
| MCM1 | 0.00 | 0.00 |
| MCM2 | 2.11 | 2.02 |
| MCM3 | 4.61 | 5.21 |
| MCM4 | 9.21 | 9.09 |
| MCM5 | 26.0 | 25.9 |
| MCM6 | 51.1 | 52.0 |
| MCM7 | 82.9 | 87.4 |
| MCM8 | 113 | 124 |
| MCM9 | 161 | 148 |
| MCM10 | 218 | 243 |
| Assay Range | 0.3–200 ng/mL | |
Table 2: Example Lot-specific PRL MCM Target and Assigned Values
9.2.4 Traceability
The ADVIA Centaur Prolactin assay is traceable to World Health Organization (WHO) 3te IRP for Prolactin (84/500). Assigned values for calibrators and MCMs are traceable to this standardization. The PRL MCMs are manufactured using qualified materials and measurement procedures.
10
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur PRL Master Curve Material (MCM) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys Prolactin II CalCheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur PRL Master Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
11
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
510(k) Summary – ADVIA Centaur COR Master Curve Material
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K143194
| 1. Applicant Information
Mailing Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 USA |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fatima Pacheco
Regulatory Clinical Affairs Specialist |
| Phone Number: | (914) 524-2450 |
| Fax Number: | (914) 524-3579 |
| E-mail Address: | fatima.pacheco@siemens.com |
| Date Prepared: | November 25, 2014 |
| 2. Device Name | ADVIA Centaur® COR Master Curve Material |
| Proprietary Name:
Measurand:
Type of Test: | Quality Control materials for ADVIA Centaur COR assay
Master Curve Material (MCM) for ADVIA Centaur COR assay |
| Regulation Section: | 21 CFR 862.1660, Quality Control Material |
| Classification: | Class I Reserved |
| Products Code: | JJX - Single (Specified) Analyte Controls (Assayed and
Unassayed) |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device Name
Predicate 510(k) No: | Elecsys Cortisol CalCheck
K000576 |
| 4. Device Description: | ADVIA Centaur® Cortisol Master Curve Materials is an in vitro
diagnostic product containing various levels of cortisol in
lyophilized human plasma with sodium azide. Each set contains
seven lyophilized levels (MCM1-7); with a reconstituted
volume of 1.0 mL each. MCM1 contains no analyte. The COR
MCMs assigned values are lot-specific of target values: 0.00,
1.00, 2.00, 6.00, 12.0, 30.0, and 80.0 µg/dL. |
| 5. Intended Use:
Indication for Use: | See Indications for Use Statement below:
The ADVIA Centaur® Cortisol (COR) Master Curve Material is
for in vitro diagnostic use in the verification of calibration and
reportable range of the ADVIA Centaur Cortisol assay. |
| Special Conditions for
Use Statement(s): | For prescription use only |
| Special Instrument
Requirements: | ADVIA Centaur® Systems
A description of the ADVIA Centaur system is documented in
K971418. Subsequent modifications to the instrument have
been reviewed and cleared in K032525 and K041133. |
Section 006, Page 8 of 13
12
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the ADVIA Centaur COR MCM substantially equivalent to the predicate device as is summarized in Table 1.
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
13
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur COR MCM | Elecsys Cortisol CalCheck |
| Intended | ||
| Use | The ADVIA Centaur Cortisol (COR) | |
| MCM is for in vitro diagnostic use in | ||
| the verification of calibration and | ||
| reportable range of the ADVIA | ||
| Centaur Cortisol assay. | For use in the verification of the | |
| calibration established by the Elecsys | ||
| Cortisol reagent on the indicated Elecsys | ||
| and cobas e immunoassay analyzers. | ||
| Analyte | Cortisol | Same |
| Use | Multiple Use | Same |
| Storage | 2–8°C | Same |
| Form | Lyophilized | Same |
| DIFFERENCES | ||
| Matrix | Human Plasma | Human Serum |
| Levels | 7 | 3 |
| Stability | Unopened – Stable when stored | |
| unopened at 2-8°C for 22 months; | ||
| Opened (Reconstituted) – Stable | ||
| when stored at 2–8°C for 14 days; or | ||
| on-board for 4 hours | Unopened - Stable at 2-8°C up to the | |
| expiration date printed on the bottle | ||
| labels. | ||
| Opened (Reconstituted) - Stable for | ||
| 4 hours at 20-25°C |
Table 1: Substantial Equivalence Comparison
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic ● Calibrators
- . Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration verification checks of
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
9. Performance Characteristics
9.1 Analytical performance:
The following studies are not applicable for the purpose of this submission:
- Precision/Reproducibility ●
- Linearity/Assay Reportable Range ●
- Detection limit
- Analytical Specificity ●
- Assav cut-off ●
- Method Comparison Studies ●
- Clinical Studies (Sensitivity, Specificity, and cut-off)
9.2 Non-Clinical Performance Testing
The following studies were conducted on the ADVIA Centaur XP system.
9.2.1 Stability Studies
Stability studies were conducted to support the shelf life unopened and reconstituted material for the ADVIA Centaur COR MCMs to ensure that it maintains optimal product performance throughout the established shelf-life. The data supports the stability claims detailed in the ADVIA Centaur COR MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur COR MCM:
- Real Time/Shelf Life (Unopened) Stability ●
- In Use Open Vial (Reconstituted) stored at 2-8°C Stability ●
- On-Board Stability ●
Real time shelf-life studies (unopened): Test COR MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 12 months, 18 months, and 23 months. Shelf life claims are based upon real time stability carried out one month after the duration claimed. Real time shelf-life stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the real-time stability study were met up to the 23 months' time point, which supports a shelf-life claim of 22 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
In-Use Open Vial (Reconstituted): Test COR MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 2, 4, 7, 11, 14, and 15 days. Acceptance criteria for the open vial (reconstituted) stability study were met to the 15 days' time point, which supports the open vial claim of 14 days when properly stored at 2-8°C.
On-board Stability: Pooled aliquots of test COR MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
hours. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur COR MCM are as follows:
- . Real Time/Shelf life (Unopened): The dose recovery for MCM1 and % dose recovery for MCM2-7 met the requirements of the acceptance criteria and no adverse trends.
- . In-Use Open Vial (Reconstituted): The dose recovery for MCM1 and % dose recovery for MCM2-7 met the requirements of the acceptance criteria.
- On-Board: The dose recovery for MCM1 and % dose recovery for MCM2-7 ● met the requirements of the acceptance criteria.
9.2.2 Value Assignment
The ADVIA Centaur COR MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using cortisol stock traceable analytically prepared internal material which is traceable gas-chromatography-mass spectroscopy (GCMS). The MCMs to are manufactured using qualified materials and measurement procedures.
For each new COR MCM lot manufactured. MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing run protocol is used for MCM2-MCM7 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-MCM7 were tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot. This protocol is designed to remove system and run variation. The new MCM doses must fall within the final value assignment specification for COR MCMs. The MCMs dose values are generated using the two-point calibration. The new MCM dose is calculated based on the relationship between the observed reference MCM dose and its assigned value. A performance verification run consisting of 6 replicates of each MCM level is run using one instrument, one reagent kit lot and Bio-Rad controls. The mean MCM doses of the new MCM lot manufactured must fall within the customer range specifications.
The target for MCM1 is assigned a 0.0 dose. MCM1 is analyte-free basepool comprising of only the matrix and preservatives. The quality control specifications and final value assignment limits for COR MCM ensure that MCM1 measures at or below the Cortisol assay sensitivity limit. MCM7 targeted greater than the assay range is diluted with the MCM1 to meet the reportable range of the assay.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Prolactin and Cortisol Master Curve Material (MCM)
9.2.3 Expected Values
The expected values are the lot-specific assigned values obtained at value assignment and the lot-specific assigned ranges are the lot-specific customer ranges are established per % interval as below.
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 35 |
| MCM3 | 30 |
| MCM4 | 30 |
| MCM5 | 30 |
| MCM6 | 30 |
| MCM7 | 20 |
Example Lot-specific target and assigned values are provided in the ADVIA Centaur COR MCM lot-specific value sheet in the example provided in Table 2.
| MCM Level | Target Values
(µg/dL) | Assigned Values
(µg/dL) |
|-------------|--------------------------|----------------------------|
| MCM1 | 0.00 | 0.0 |
| MCM2 | 1.00 | 1.17 |
| MCM3 | 2.00 | 1.96 |
| MCM4 | 6.00 | 6.99 |
| MCM5 | 12.0 | 12.5 |
| MCM6 | 30.0 | 27.1 |
| MCM7 | 80.0 | 80.3 |
| Assay Range | 0.20–75 µg/dL | |
Table 2: Example Lot-specific COR MCM Target and Assigned Values
9.2.4 Traceability
The ADVIA Centaur Cortisol assay is standardized using internal standards manufactured analytically which are traceable to gas chromatography-mass spectroscopy (GCMS). Assigned values for calibrators and MCMs are traceable to this standardization. The COR MCMs are manufactured using qualified materials and measurement procedures.
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur COR Master Curve Material (MCM) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys Cortisol CalCheck. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur COR Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.