(28 days)
Not Found
No
The summary describes calibration verification materials for laboratory assays, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
Explanation: The device is for in vitro diagnostic use, specifically for verifying the calibration and reportable range of assays, not for treating or preventing disease.
No
This device is described as "Master Curve Material" for "verification of calibration and reportable range" of assays. It is used to check the performance of other diagnostic assays, rather than directly diagnosing a patient condition itself. It's a quality control material, not a diagnostic device.
No
The device description clearly states that the product is an "in vitro diagnostic product containing various levels of progesterone spiked in lyophilized human plasma" and "various levels of ferritin in human serum". These are physical materials, not software. The device is a control material used with an instrument, not software itself.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use/Indications for Use: The text clearly states: "The ADVIA Centaur® Progesterone (PRGE) Master Curve Material is for in vitro diagnostic use..." and "The ADVIA Centaur® Ferritin (FER) Master Curve Material is for in vitro diagnostic use...".
- Explicit Statement in Device Description: The text also states: "ADVIA Centaur® Progesterone Master Curve Material is an in vitro diagnostic product..." and "ADVIA Centaur® Ferritin Master Curve Material is an in vitro diagnostic product...".
- Function: The device is used to verify the calibration and reportable range of diagnostic assays (Progesterone and Ferritin assays), which are themselves IVDs. This function is directly related to ensuring the accuracy and reliability of in vitro diagnostic testing.
Therefore, the device is explicitly identified and described as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Progesterone (PRGE) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Progesterone assay.
The ADVIA Centaur® Ferritin (FER) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Ferritin assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
ADVIA Centaur® Progesterone Master Curve Material is an in vitro diagnostic product containing various levels of progesterone spiked in lyophilized human plasma with sodium azide (0.1%) and preservatives. Each set contains nine levels (MCM1-9); with a reconstituted volume of 1.0 mL/vial per level. MCM1contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 1.20, 2.50, 5.00, 10.0, 20.0, 30.0, 42.0, and 65.0 ng/mL.
ADVIA Centaur® Ferritin Master Curve Material is an in vitro diagnostic product containing various levels of ferritin in human serum with sodium azide. Each set contains eight levels; ready to use (MCM1-8); with a volume of 1.0 mL/vial per level. MCM1 contains no analyte. The FER MCMs assigned values are lot-specific of target values: 0.00, 5.00, 10.5, 47.0, 150, 470, 800, and 1750 ng/mL.
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
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)
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
9.2.1 Stability Studies (for Progesterone MCM):
Stability studies were conducted on the ADVIA Centaur XP system to support the shelf life (unopened) and reconstituted material for the ADVIA Centaur PRGE 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 PRGE MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur PRGE MCM:
- Real Time/Shelf Life (unopened) Stability
- In Use Open Vial (reconstituted) stored at 2-8℃ Stability
- On-Board Stability
Real time shelf-life studies (unopened): Test PRGE MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 10 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 -80°C reference MCMs. Current testing meets the sponsor's acceptance criteria for the real-time stability study up to the 7 months' time point, which supports a shelf-life claim of 6 months.
In-Use Open Vial (Reconstituted): Test PRGE 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. Sponsor's 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 PRGE MCMs in sample cups were stored on the ADVIA Centaur XP 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. Sponsor's acceptance criteria for the on-board stability study were met up to 5 hours, which supports the onboard stability claim for 4 hours.
Stability Acceptance Criteria (for Progesterone MCM):
The stability specifications acceptance criteria for the ADVIA Centaur PRGE MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ≤ 0.15 ng/mL dose; MCM2-9, the % dose recovery met the sponsor's required acceptance criteria.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 must be ≤ 0.15 ng/mL dose; MCM2-9, the % dose recovery met the sponsor's required acceptance criteria.
- On-Board: The dose recovery for MCM1 must be ≤ 0.15 ng/mL dose; MCM2-9, the % dose recovery met the sponsor's required acceptance criteria.
9.2.1 Stability Studies (for Ferritin MCM):
Stability studies were conducted on the ADVIA Centaur XP system to support the shelf life unopened and open material for the ADVIA Centaur FER 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 FER MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur FER MCM:
- Real Time/Shelf Life (Unopened) Stability
- On-Board Stability
Real time shelf-life studies (unopened): Test FER MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 3 months, 7 months, 8 months, and 9 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 -80°C stored reference MCM. Sponsor's acceptance criteria for the real-time stability study were met up to the 9 months' time point, which supports a shelflife claim of 8 months.
On-board Stability: Pooled aliquots of test FER MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. Sponsor's 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 (for Ferritin MCM):
The sponsor's stability specifications acceptance criteria for the ADVIA Centaur FER MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ≤ 0.5 ng/mL dose; MCM2-8, the % dose recovery met the sponsor's required acceptance criteria.
- On-Board: The dose recovery for MCM1 must be ≤ 0.5 ng/mL dose; MCM2-8, the % dose recovery met the sponsor's required acceptance criteria.
9.2.2 Value Assignment (for Progesterone MCM):
The ADVIA Centaur PRGE MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using progesterone stock and are traceable to analytically prepared internal material which are traceable to gas-chromatography-mass spectroscopy (GC-MS). The MCMs are manufactured using qualified materials and measurement procedures. Value assignment testing was conducted per the sponsor's value assignment procedure on the ADVIA Centaur XP system. The testing met the pre-defined sponsor's acceptance criteria. The new MCM doses must fall within the final value assignment specification for PRGE 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.
9.2.2 Value Assignment (for Ferritin MCM):
The ADVIA Centaur FER MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using ferritin stock and are traceable to internal material that is standardized against World Health Organization (WHO) 2nd International Standard (WHO 80/578) reference material. The MCMs are manufactured using qualified materials and measurement procedures. Value assignment testing was conducted per the sponsor's value assignment procedure on the ADVIA Centaur XP system. The testing met the pre-defined sponsor's acceptance criteria. The new MCM doses must fall within the final value assignment specification for FER 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.
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.
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
§ 862.1660 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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figures, with three distinct profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
Siemens Healthcare Diagnostics Inc. c/o Ms. Fatima Pacheco 511 Benedict Avenue Tarrytown, NY 10591 USA
Re: K143376
Trade/Device Name: ADVIA Centaur® Progesterone (PRGE) Master Curve Material ADVIA Centaur® FER Master Curve Material Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Codes: JJX Dated: November 24, 2014 Received: November 25, 2014
Dear Ms. 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
1
as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
Elizabeth A. Stafford -S
for Maria M. Chan, Ph. D. Director Division of Immunology and Hematology 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) K143376
Device Name
ADVIA Centaur® Progesterone Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® Progesterone (PRGE) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Progesterone assay.
| 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)
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) K143376
Device Name
ADVIA Centaur® Ferritin Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® Ferritin (FER) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur Ferritin assay.
| 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)
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
510(k) Summary
510(k) Summary – ADVIA Centaur Progesterone 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: K143376
| 1. Applicant Information
Mailing Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 USA |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Phone Number:
Fax Number:
E-mail Address:
Date Prepared: | Fatima Pacheco
Regulatory Clinical Affairs Specialist
(914) 524-2450
(914) 524-3579
fatima.pacheco@siemens.com
December 23, 2014 |
| 2. Device Name
Proprietary Name:
Measurand:
Type of Test: | ADVIA Centaur® Progesterone (PRGE) Master Curve
Material
Quality Control materials for ADVIA Centaur PRGE assay
Master Curve Material (MCM) for ADVIA Centaur PRGE
assay |
| Regulation Section:
Classification:
Products Code:
Panel: | 21 CFR 862.1660, Quality Control Material
Class I Reserved
JJX - Single (Specified) Analyte Controls (Assayed and
Unassayed)
Immunology (82) |
| 3. Predicate Device Name
Predicate 510(k) No: | IMMULITE/IMMULITE 1000 Progesterone Calibration
Verification Material (CVM)
K103683 |
| 4. Device
Description: | ADVIA Centaur® Progesterone Master Curve Material is an
in vitro diagnostic product containing various levels of
progesterone spiked in lyophilized human plasma with sodium
azide (0.1%) and preservatives. Each set contains nine levels
(MCM1-9); with a reconstituted volume of 1.0 mL/vial per |
5
level. MCM1contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 1.20, 2.50, 5.00, 10.0, 20.0, 30.0, 42.0, and 65.0 ng/mL.
- See Indications for Use Statement below: 5. Intended Use: The ADVIA Centaur® Progesterone (PRGE) Master Curve Indication for Use: Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Progesterone assay.
Special Conditions for Use Statement(s):
ARUKA® g
For prescription use only
Special Instrument Requirements:
ADVIA Centaur® Systems
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the ADVIA Centaur PRGE MCM is substantially equivalent to the predicate device as summarized in Table 1.
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
6
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur PRGE MCM | IMMULITE/IMMULITE 1000 |
| Progesterone Calibration Verification | ||
| Material (CVM) | ||
| Intended | ||
| Use | The ADVIA Centaur Progesterone | |
| (PGRE) Master Curve Material is for | ||
| in vitro diagnostic use in the | ||
| verification of calibration and | ||
| reportable range of the ADVIA | ||
| Centaur Progesterone assay. | For in vitro diagnostic use, for the | |
| calibration verification of | ||
| IMMULITE/IMMULITE 1000 | ||
| Progesterone assay (LKPW). | ||
| Analyte | Progesterone | Same |
| Storage | 2–8°C | Same |
| DIFFERENCES | ||
| Use | Multiple Use | Single Use |
| Form | Lyophilized | Liquid |
| Matrix | Human plasma | Human serum |
| Levels | 9 | 4 |
| Stability | Unopened – Stable when stored | |
| unopened at 2-8°C for 6 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 vial | ||
| label. | ||
| Opened - Stable at 2-8°C for 30 | ||
| days. |
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
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
Stability Studies 9.2.1
Stability studies were conducted on the ADVIA Centaur XP system to support the shelf life (unopened) and reconstituted material for the ADVIA Centaur PRGE 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 PRGE MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur PRGE MCM:
- Real Time/Shelf Life (unopened) Stability ●
- In Use Open Vial (reconstituted) stored at 2-8℃ Stability
- On-Board Stability
Real time shelf-life studies (unopened): Test PRGE MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 10 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 -80°C reference MCMs. Current testing meets the sponsor's acceptance criteria for the real-time stability study up to the 7 months' time point, which supports a shelf-life claim of 6 months. Storage shelf-life (unopened) at 2-8°C is indicated by the expiration date on the vial label.
In-Use Open Vial (Reconstituted): Test PRGE 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. Sponsor's 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.
8
On-board Stability: Pooled aliquots of test PRGE MCMs in sample cups were stored on the ADVIA Centaur XP 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. Sponsor's acceptance criteria for the on-board stability study were met up to 5 hours, which supports the onboard stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur PRGE MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be . ≤ 0.15 ng/mL dose; MCM2-9, the % dose recovery met the sponsor's required acceptance criteria.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 must be ● ≤ 0.15 ng/mL dose; MCM2-9, the % dose recovery met the sponsor's required acceptance criteria.
- . On-Board: The dose recovery for MCM1 must be ≤ 0.15 ng/mL dose; MCM2-9, the % dose recovery met the sponsor's required acceptance criteria.
9.2.2 Value Assignment
The ADVIA Centaur PRGE MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using progesterone stock and are traceable to analytically prepared internal material which are traceable to gas-chromatography-mass spectroscopy (GC-MS). The MCMs are manufactured using qualified materials and measurement procedures.
Value assignment testing was conducted per the sponsor's value assignment procedure on the ADVIA Centaur XP system. The testing met the pre-defined sponsor's acceptance criteria. The new MCM doses must fall within the final value assignment specification for PRGE 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 ng/mL dose. MCM1 is analyte-free basepool comprising of only the matrix and preservatives. The quality control specifications and final value assignment limits for PRGE MCM ensure that MCM1 measures at or below the PRGE assay sensitivity limit. MCM9 targeted greater than the assay range is diluted with the MCM1 to meet the reportable range of the assay.
9
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 established per the sponsor's internal procedural specifications for PRGE MCM.
ADVIA Centaur PRGE MCM levels and target values are provided in Table 2.
| MCM level | Target Values
(ng/mL) |
|-------------|--------------------------|
| MCM1 | 0.00 |
| MCM2 | 1.20 |
| MCM3 | 2.50 |
| MCM4 | 5.00 |
| MCM5 | 10.0 |
| MCM6 | 20.0 |
| MCM7 | 30.0 |
| MCM8 | 42.0 |
| MCM9 | 65.0 |
| Assay Range | 0.21-60 ng/mL |
Table 2: PRGE MCM Levels and Target Values
9.2.4 Traceability
The ADVIA Centaur PRGE assay is standardized to an internal standard manufactured using Progesterone USP and traceable to gas chromatography-mass spectroscopy (GCMS). Assigned values for calibrators and MCMs are traceable to this standardization. The PRGE 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 PRGE 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 IMMULITE/IMMULITE 1000 Progesterone Calibration Verification Material (CVM). Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur PRGE Master Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
10
510(k) Summary – ADVIA Centaur Ferritin 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: K143376
| 1. Applicant Information
Mailing Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 USA |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Phone Number:
Fax Number:
E-mail Address:
Date Prepared: | Fatima Pacheco
Regulatory Clinical Affairs Specialist
(914) 524-2450
(914) 524-3579
fatima.pacheco@siemens.com
December 23, 2014 |
| 2. Device Name
Proprietary Name:
Measurand:
Type of Test: | ADVIA Centaur® FER Master Curve Material
Quality Control materials for ADVIA Centaur FER assay
Master Curve Material (MCM) for ADVIA Centaur FER assay |
| Regulation Section:
Classification:
Products Code:
Panel: | 21 CFR 862.1660, Quality Control Material
Class I Reserved
JJX - Single (Specified) Analyte Controls (Assayed and
Unassayed)
Immunology (82) |
| 3. Predicate Device Name
Predicate 510(k) No: | Elecsys Ferritin CalCheck 5
K102267 |
| 4. Device Description: | ADVIA Centaur® Ferritin Master Curve Material is an in vitro
diagnostic product containing various levels of ferritin in human
serum with sodium azide. Each set contains eight levels; ready
to use (MCM1-8); with a volume of 1.0 mL/vial per level.
MCM1 contains no analyte. The FER MCMs assigned values
are lot-specific of target values: 0.00, 5.00, 10.5, 47.0, 150, 470,
800, and 1750 ng/mL. |
| 5. Intended Use:
Indication for Use: | See Indications for Use Statement below:
The ADVIA Centaur® Ferritin (FER) Master Curve Material is
for in vitro diagnostic use in the verification of calibration and
reportable range of the ADVIA Centaur Ferritin assay. |
| Special Conditions for
Use Statement(s): | For prescription use only |
11
Image /page/11/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented.
Special Instrument Requirements:
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
ADVIA Centaur® Systems
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the ADVIA Centaur FER MCM is substantially equivalent to the predicate device as summarized in Table 1.
12
SIEMEI
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur Ferritin MCM | Elecsys Ferritin CalCheck 5 |
| Intended | ||
| Use | The ADVIA Centaur Ferritin (FER) | |
| MCM is for in vitro diagnostic use in | ||
| the verification of calibration and | ||
| reportable range of the ADVIA | ||
| Centaur Ferritin assay. | The Elecsys Ferritin CalCheck5 is an | |
| assayed control for use in calibration | ||
| verification and for use in the verification | ||
| of the assay range established by the | ||
| Elecsys Ferritin reagent on the indicated | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | ||
| Analyte | Ferritin | Same |
| Storage | 2–8°C | Same |
| Form | Liquid | Same |
| Matrix | Human Serum | Same |
| DIFFERENCES | ||
| Use | Single Use | Multiple Use |
| Levels | 8 | 5 |
| Stability | Unopened – Stable when stored | |
| unopened at 2–8°C for 8 months. | ||
| Opened – Stable when stored on- | ||
| board for 4 hours. | Unopened – Stored at 2–8°C until the | |
| expiration date. | ||
| Opened – 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 the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
13
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
9.2.1 Stability Studies
Stability studies were conducted on the ADVIA Centaur XP system to support the shelf life unopened and open material for the ADVIA Centaur FER 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 FER MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur FER MCM:
- Real Time/Shelf Life (Unopened) Stability .
- On-Board Stability
Real time shelf-life studies (unopened): Test FER MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 3 months, 7 months, 8 months, and 9 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 -80°C stored reference MCM. Sponsor's acceptance criteria for the real-time stability study were met up to the 9 months' time point, which supports a shelflife claim of 8 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
On-board Stability: Pooled aliquots of test FER MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. Sponsor's 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 sponsor's stability specifications acceptance criteria for the ADVIA Centaur FER MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be . ≤ 0.5 ng/mL dose; MCM2-8, the % dose recovery met the sponsor's required acceptance criteria.
- On-Board: The dose recovery for MCM1 must be ≤ 0.5 ng/mL dose; MCM2-8, the % dose recovery met the sponsor's required acceptance criteria.
14
Image /page/14/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The background is plain white, which makes the text stand out.
9.2.2 Value Assignment
The ADVIA Centaur FER MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using ferritin stock and are traceable to internal material that is standardized against World Health Organization (WHO) 2nd International Standard (WHO 80/578) reference material. The MCMs are manufactured using qualified materials and measurement procedures.
Value assignment testing was conducted per the sponsor's value assignment procedure on the ADVIA Centaur XP system. The testing met the pre-defined sponsor's acceptance criteria. The new MCM doses must fall within the final value assignment specification for FER 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 ng/mL dose. MCM1 is analyte-free basepool comprising of only the matrix and preservatives. The quality control specifications and final value assignment limits for FER MCM ensure that MCM1 measures at or below the Ferritin assay sensitivity limit. MCM8 targeted greater 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 established per the sponsor's internal procedural specifications for FER MCM.
ADVIA Centaur FER MCM levels and target values are provided in Table 2.
| MCM Level | Target Values
(ng/mL) |
|-------------|--------------------------|
| MCM1 | 0.00 |
| MCM2 | 5.00 |
| MCM3 | 10.5 |
| MCM4 | 47.0 |
| MCM5 | 150 |
| MCM6 | 470 |
| MCM7 | 800 |
| MCM8 | 1750 |
| Assay Range | 0.5–1650 ng/mL |
Table 2: FER MCM Levels and Target Values
15
9.2.4 Traceability
The ADVIA Centaur Ferritin assay is standardized against the World Health Organization (WHO) 2nd International Standard (WHO 80/578) based on the following correlation:
WHO = 0.97 (ADVIA Centaur Ferritin) - 1.8 ng/mL, r=0.9
Assigned values for calibrators and MCMs are traceable to this standardization.
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur FER 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 Ferritin CalCheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur FER Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.