(205 days)
No
The device description and performance studies focus on the chemical composition and stability of calibration materials for laboratory assays, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is for in vitro diagnostic use to verify calibration and reportable range of assays, not for treating or diagnosing patients directly.
No
The device is described as "in vitro diagnostic product containing various levels of follicle stimulating hormone spiked in lyophilized equine serum" and its intended use is "in the verification of calibration and reportable range of the ADVIA Centaur FSH assay" and other similar assays. It is a master curve material used for verifying the calibration of diagnostic assays, not for directly diagnosing a condition in a patient.
No
The device description explicitly states it is an "in vitro diagnostic product containing various levels of follicle stimulating hormone spiked in lyophilized equine serum" and other biological materials. This indicates a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence for each of the listed materials explicitly states "is for in vitro diagnostic use".
- Device Description: The descriptions for each material also state "is an in vitro diagnostic product".
- Predicate Devices: The listing of predicate devices with K numbers indicates that these materials are being compared to other devices that have been cleared by regulatory bodies as IVDs.
- Intended User/Care Setting: "For prescription use only" suggests use in a clinical or laboratory setting, which is typical for IVDs.
The purpose of these materials is to verify the calibration and reportable range of specific assays performed on the ADVIA Centaur system, which are themselves IVD assays used to measure analytes in biological samples (serum and plasma). This function of verifying the performance of an IVD assay makes the verification material itself an IVD.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Follicle Stimulating Hormone (FSH) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FSH assay.
The ADVIA Centaur® Free thyroxine (FT4) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FT4 assay.
The ADVIA Centaur® Thyroxine (T4) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T4 assay.
The ADVIA Centaur® Triiodothyronine (T3) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T3 assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
ADVIA Centaur® FSH Master Curve Material is an in vitro diagnostic product containing various levels of follicle stimulating hormone spiked in lyophilized equine serum with sodium azide (0.1% after reconstitution) and preservatives. Each set contains eight levels (MCM1–8); 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, 1.50, 4.50, 12.0, 30.0, 62.5, 130, 225 mIU/mL.
ADVIA Centaur® FT4 Master Curve Material is an in vitro diagnostic product containing various levels of thyroxine in human plasma with sodium azide. Each set contains seven levels; with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The FT4 MCMs assigned values are lot-specific of target values: 0.00, 2.00, 5.00, 10.0, 15.0, 22.0, and 35.0 µg/dL which corresponds to FT4 values of 0.00, 0.42, 0.80, 1.70, 3.0, 5.6, and 13.5 ng/dL.
ADVIA Centaur® T4 Master Curve Material is an in vitro diagnostic product containing various levels of levothyroxine in human plasma with sodium azide and preservatives. Each set contains six levels; with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The T4 MCMs assigned values are lot-specific of target values: 0.00, 2.50, 5.00, 10.0, 15.0. and 35.0 µg/dL.
ADVIA Centaur® T3 Master Curve Material is an in vitro diagnostic product containing various levels of liothyronine in human plasma with sodium azide and preservatives. Each se contains seven levels; with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The T3 MCMs assigned values are lot-specific of target values: 0.00, 0.42, 0.69, 1.11, 1.65, 3.87, and 7.00 ng/mL.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
FSH Master Curve Material:
Stability Studies:
Real Time/Shelf Life (unopened) Stability: Test FSH MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 10 months. Real time studies are on-going at T=14 months, 18 months, 24 months, and 25 months. 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) stored at 2-8°C Stability: Test FSH 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. The sponsor's 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 FSH MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. The on-board stability study met the sponsor's acceptance criteria at the 5 hours' time point, which supports the onboard stability claim for 4 hours.
Value Assignment: The new MCM doses must fall within the final value assignment specification for FSH MCMs. 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.
FT4 Master Curve Material:
Stability Studies:
Real Time/Shelf Life (Unopened) Stability: Test FT4 MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 11 months. Real time studies are on-going at T=15 months, 19 months, 24months, 30 months, and 31 months. The sponsor's acceptance criteria for the real-time stability study were met up to the 7 months' time point, which supports a shelflife claim of 6 months.
In Use Open Vial (reconstituted) stored at 2-8°C Stability: Test FT4 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. The sponsor's acceptance criteria for the open vial (reconstituted) data supports the open vial claim of 14 days when properly stored at 2–8°C.
On-Board Stability: Pooled aliquots of test FT4 MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. The 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.
Value Assignment: For each new FT4 MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot on the ADVIA Centaur system. A nested testing run protocol is used for MCM2-7 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-7 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. The new MCM doses must fall within the final value assignment specification for FT4 MCMs. 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.
T4 Master Curve Material:
Stability Studies:
Real time shelf-life studies (unopened): Test T4 MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 11 months. Real time studies are on-going at T=15 months, 19 months, 24 months. 30 months, and 31 months. Acceptance criteria for the real-time stability study were met up to the 11 months' time point, which supports a shelf-life claim of 10 months.
Value Assignment: For each new T4 MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot on the ADVIA Centaur system. A nested testing run protocol is used for MCM2-6 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-6 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. The new MCM doses must fall within the final value assignment specification for T4 MCMs. MCM6 is expected to read above the assay range of 30.0 ug/dL, therefore the MCM6 level is also diluted 1:4 before testing. 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.
T3 Master Curve Material:
Stability Studies:
Real Time/Shelf Life (Unopened) Stability: Test T3 MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 11 months. Real time studies are on-going at T=15 months, 19 months, 24months, 30 months, and 31 months. The sponsor's acceptance criteria for the real-time stability study were met up to the 11 months' time point, which supports a shelflife claim of 10 months.
In Use Open Vial (reconstituted) stored at 2-8°C Stability: Test T3 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. The sponsor's acceptance criteria for the open vial (reconstituted) stability study were met to the 22 days' time point, which supports the open vial claim of 21 days when properly stored at 2-8°C.
On-Board Stability: Pooled aliquots of test T3 MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0. 2, 4 and 5 hours. The 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.
Value Assignment: For each new T3 MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot on the ADVIA Centaur system. A nested testing run protocol is used for MCM2-7 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-7 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. The new MCM doses must fall within the final value assignment specification for T3 MCMs. 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.
IMMULITE 2000 FSH Calibration Verification Material (CVM) K133124, IMMULITE 2000 FT4 Calibration Verification Material (CVM) K140818, Elecsys T4 Calcheck 5 K112528, Elecsys T3 Calcheck 5 K111552
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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, rendered in a dark color.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2015
SIEMENS HEALTHCARE DIAGNOSTICS, INC. FATIMA PACHECO REGULATORY CLINICAL AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K143687
Trade/Device Name: ADVIA Centaur® Follicle Stimulating Hormone (FSH) Master Curve Material. ADVIA Centaur® FT4 Master Curve Material, ADVIA Centaur® T4 Master Curve Material, ADVIA Centaur® T3 Master Curve Material Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: June 01, 2015 Received: June 02, 2015
Dear 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
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,
Courtney Lias -S
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
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510(k) Number (if known) K143687
Device Name
ADVIA Centaur® Follicle Stimulating Hormone (FSH) Master Curve Material
Indications for Use (Describe)
The ADVIA Centaur® Follicle Stimulating Hormone (FSH) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FSH 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
3
510(k) Number (if known) K143687
Device Name
ADVIA Centaur® FT4 Master Curve Material
Indications for Use (Describe)
The ADVIA Centaur® Free thyroxine (FT4) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FT4 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
4
510(k) Number (if known) K143687
Device Name ADVIA Centaur® T4 Master Curve Material
Indications for Use (Describe)
The ADVIA Centaur® Thyroxine (T4) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T4 assay.
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
5
510(k) Number (if known) K143687
Device Name
ADVIA Centaur® T3 Master Curve Material
Indications for Use (Describe)
The ADVIA Centaur® Triiodothyronine (T3) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T3 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
6
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Section 006: 510(k) Summary
510(k) Summary - ADVIA Centaur FSH 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: K143687
| 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: | July 13, 2015 |
| 2. Device Name | |
| Proprietary Name: | ADVIA Centaur® Follicle Stimulating Hormone (FSH)
Master Curve Material |
| Measurand: | Master Curve Material |
| Type of Test: | Quality Control materials for ADVIA Centaur FSH assay
Master Curve Material (MCM) for ADVIA Centaur FSH 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 | IMMULITE 2000 FSH Calibration Verification Material
(CVM) |
| Predicate 510(k) No: | K133124 |
| 4. Device Description: | ADVIA Centaur® FSH Master Curve Material is an
in vitro diagnostic product containing various levels of follicle
stimulating hormone spiked in lyophilized equine serum with
sodium azide (0.1% after reconstitution) and preservatives.
Each set contains eight levels (MCM1–8); with a reconstituted |
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| (Bundled) Abbreviated 510(k) Premarket Notification |
|---|
| ADVIA Centaur® FSH, FT4, T4, and T3 Master Curve Material (MCM) |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
volume of 1.0 mL/vial per level. MCM1contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 1.50, 4.50, 12.0, 30.0, 62.5, 130, 225 mIU/mL.
-
- Intended Use: See Indications for Use Statement below: The ADVIA Centaur® Follicle Stimulating Hormone (FSH) Indication for Use: Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FSH assay. Special Conditions for For prescription use only Use Statement(s):
- A comparison of the device features, intended use, and other 6. Technological Characteristics information demonstrates that the ADVIA Centaur FSH MCM and Substantial Equivalence Comparison with Predicate: is substantially equivalent to the predicate device as summarized in Table 1.
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| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur FSH MCM | IMMULITE 2000 FSH Calibration |
| Verification Material (CVM) | ||
| Intended | ||
| Use | The ADVIA Centaur Follicle | |
| Stimulating Hormone (FSH) Master | ||
| Curve Material is for in vitro | ||
| diagnostic use in the verification of | ||
| calibration and reportable range of the | ||
| ADVIA Centaur FSH assay. | The IMMULITE FSH Calibration | |
| Verification Material (CVM) is for | ||
| in vitro diagnostic use in the | ||
| verification of calibration of the | ||
| IMMULITE FSH assay on the | ||
| IMMULITE 2000systems. | ||
| Analyte | Follicle stimulating Hormone | Same |
| Matrix | Equine serum | Bovine serum |
| DIFFERENCES | ||
| Use | Multiple Use | Single Use |
| Form | Lyophilized | Liquid |
| Storage | 2–8°C | ≤ -20°C |
| Levels | 8 | 4 |
| Stability | Unopened – Stable when stored | |
| unopened at 2-8°C for 6 months. | ||
| Opened (Reconstituted) – Stable | ||
| when stored at 2–8°C for 28 days; or | ||
| on-board for 4 hours. | Unopened - Stable at ≤ -20°C up to | |
| the expiration date. |
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
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SIEMENS
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 FSH 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 FSH MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur FSH 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 FSH MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 10 months. Real time studies are on-going at T=14 months, 18 months, 24 months, and 25 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 FSH 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. The sponsor's 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.
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Image /page/10/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 word is presented in all capital letters and is centered in the image.
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® FSH, FT4, T4, and T3 Master Curve Material (MCM)
On-board Stability: Pooled aliquots of test FSH 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. The on-board stability study met the sponsor's acceptance criteria at the 5 hours' time point, which supports the onboard stability claim for 4 hours.
Stability Acceptance Criteria
The sponsor's stability specifications acceptance criteria for the ADVIA Centaur FSH MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 and the ● % dose recoveries for MCM2-8 met the sponsor's required acceptance criteria.
- . In-Use Open Vial (Reconstituted): The dose recovery for MCM1 and the % dose recoveries for MCM2-8 met the sponsor's required acceptance criteria.
- On-Board: The dose recovery for MCM1 and the % dose recoveries for . MCM2-8 met the sponsor's required acceptance criteria.
9.2.2 Value Assignment
The ADVIA Centaur FSH MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using follicle-stimulating hormone stock and are traceable to internal material which is standardized against World Health Organization (WHO) 2nd International Standard for human FSH (IS 94/632) reference material. The MCMs are manufactured using qualified materials and measurement procedures.
The new MCM doses must fall within the final value assignment specification for FSH 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 FSH MCM ensure that MCM1 measures at or below the FSH assay sensitivity limit. MCM8 targeted greater than the assay range is diluted with the MCM1 to meet the reportable range of the assay.
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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 FSH MCM.
ADVIA Centaur FSH MCM levels and target values are provided in Table 2.
| MCM level | Target Values
(mIU/mL) |
|-------------|---------------------------|
| MCM1 | 0.00 |
| MCM2 | 1.50 |
| MCM3 | 4.50 |
| MCM4 | 12.0 |
| MCM5 | 30.0 |
| MCM6 | 62.5 |
| MCM7 | 130 |
| MCM8 | 225 |
| Assay Range | 0.3—200 mIU/mL |
Table 2: Example FSH MCM Levels and Target Values
Traceability 9.2.4
The ADVIA Centaur FSH assay is standardized against World Health Organization (WHO) 2nd International Standard for human FSH (IS 94/632) reference material based on the following correlation: ADVIA Centaur FSH = 0.91 (WHO) - 0.18 mIU/mL
r = 0.999
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 FSH 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 2000 FSH Calibration Verification Material (CVM). Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur FSH Master Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
12
SIEMENS
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® FSH, FT4, T4, and T3 Master Curve Material (MCM)
510(k) Summary – ADVIA Centaur FT4 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: K143687
| 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: | July 13, 2015 |
| 2. Device Name | |
| Proprietary Name: | ADVIA Centaur® FT4 Master Curve Material |
| Measurand: | Quality Control materials for ADVIA Centaur FT4 assay |
| Type of Test: | Master Curve Material (MCM) for ADVIA Centaur FT4 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: | IMMULITE 2000 FT4 Calibration Verification Material (CVM)
K140818 |
| 4. Device Description: | ADVIA Centaur® FT4 Master Curve Material is an in vitro
diagnostic product containing various levels of thyroxine in
human plasma with sodium azide. Each set contains seven
levels; with a reconstituted volume of 1.0 mL/vial per level.
MCM1 contains no analyte. The FT4 MCMs assigned values
are lot-specific of target values: 0.00, 2.00, 5.00, 10.0, 15.0,
22.0, and 35.0 µg/dL which corresponds to FT4 values of 0.00,
0.42, 0.80, 1.70, 3.0, 5.6, and 13.5 ng/dL. |
| 5. Intended Use: | |
| Indication for Use: | See Indications for Use Statement below:
The ADVIA Centaur® Free thyroxine (FT4) Master Curve
Material is for in vitro diagnostic use in the verification of
calibration and reportable range of the ADVIA Centaur FT4
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 FT4 MCM
is substantially equivalent to the predicate device as
summarized in Table 1 |
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14
| SIMILARITIES | ||||
|---|---|---|---|---|
| Candidate Device | Predicate Device | |||
| Item | ADVIA Centaur FT4 MCM | IMMULITE 2000 FT4 Calibration | ||
| Verification Material (CVM) | ||||
| Intended | ||||
| Use | The ADVIA Centaur Free thyroxine | |||
| (FT4) MCM is for in vitro diagnostic | ||||
| use in the verification of calibration | ||||
| and reportable range of the ADVIA | ||||
| Centaur FT4 assay. | The IMMULITE Free T4 Calibration | |||
| Verification Material (CVM) is for | ||||
| in vitro diagnostic use in the verification | ||||
| of calibration of the IMMULITE Free T4 | ||||
| assay on the IMMULITE 2000 systems. | ||||
| Analyte | Free thyroxine | Same | ||
| Form | Lyophilized | Same | ||
| Matrix | Human plasma | Human serum | ||
| DIFFERENCES | ||||
| Use | Multiple Use | Single Use | ||
| Storage | 2–8°C | $\leq$ -20°C | ||
| Levels | 7 | 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 - Stored at $\leq$ -20°C until the | |||
| expiration date. | ||||
| Opened (Reconstituted) – Stable for 8 | ||||
| hours at 15-25°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.
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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 reconstituted material for the ADVIA Centaur FT4 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 FT4 MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur FT4 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 FT4 MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 11 months. Real time studies are on-going at T=15 months, 19 months, 24months, 30 months, and 31 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. The sponsor's acceptance criteria for the real-time stability study were met up to the 7 months' time point, which supports a shelflife claim of 6 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
In-Use Open Vial (Reconstituted): Test FT4 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. The sponsor's acceptance criteria for the open vial (reconstituted) data supports the open vial claim of 14 days when properly stored at 2–8°C.
On-board Stability: Pooled aliquots of test FT4 MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. The 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.
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Stability Acceptance Criteria
The sponsor's stability specifications acceptance criteria for the ADVIA Centaur FT4 MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 and the ● % dose recoveries for MCM2-7 met the sponsor's required acceptance criteria.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 and the ● % dose recoveries for MCM2-7 met the sponsor's required acceptance criteria.
- On-Board: The dose recovery for MCM1 and the % dose recoveries for ● MCM2-7 met the sponsor's required acceptance criteria.
9.2.2 Value Assignment
The ADVIA Centaur FT4 MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) T4 stock and are traceable to USP internal material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new FT4 MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot on the ADVIA Centaur system. A nested testing run protocol is used for MCM2-7 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-7 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 FT4 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 FT4 MCM ensure that MCM1 measures at or below the FT4 assay sensitivity limit. MCM7 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
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ranges are established per the sponsor's internal procedural specifications for FT4 MCM.
ADVIA Centaur FT4 MCM levels and target values are provided in Table 2.
| MCM Level | Target Values (ng/dL) |
|---|---|
| MCM1 | 0.00 |
| MCM2 | 0.42 |
| MCM3 | 0.80 |
| MCM4 | 1.70 |
| MCM5 | 3.0 |
| MCM6 | 5.6 |
| MCM7 | 13.5 |
| Assay Range | 0.1-12.0 ng/dL |
Table 2: Example FT4 MCM Levels and Target Values
9.2.4 Traceability
The ADVIA Centaur FT4 assay is standardized to an internal standard manufactured using USP (United States Pharmacopeia) material. 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 FT4 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 2000 FT4 CVM. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur FT4 Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
18
SIEMENS
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® FSH, FT4, T4, and T3 Master Curve Material (MCM)
510(k) Summary – ADVIA Centaur T4 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: K143687
| 1. Applicant Information | Siemens Healthcare Diagnostics Inc. | |
|---|---|---|
| Mailing Address: | 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: | July 13, 2015 | |
| 2. Device Name | ||
| Proprietary Name: | ADVIA Centaur® T4 Master Curve Material | |
| Measurand: | Quality Control materials for ADVIA Centaur T4 assay | |
| Type of Test: | Master Curve Material (MCM) for ADVIA Centaur T4 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 | Elecsys T4 Calcheck 5 | |
| Predicate 510(k) No: | K112528 | |
| 4. Device Description: | ADVIA Centaur® T4 Master Curve Material is an in vitro | |
| diagnostic product containing various levels of levothyroxine in | ||
| human plasma with sodium azide and preservatives. Each set | ||
| contains six levels; with a reconstituted volume of 1.0 mL/vial | ||
| per level. MCM1 contains no analyte. The T4 MCMs assigned | ||
| values are lot-specific of target values: 0.00, 2.50, 5.00, 10.0, | ||
| 15.0. and 35.0 µg/dL. | ||
| 5. Intended Use: | ||
| Indication for Use: | See Indications for Use Statement below: | |
| The ADVIA Centaur® Thyroxine (T4) Master Curve Material is | ||
| for in vitro diagnostic use in the verification of calibration and | ||
| reportable range of the ADVIA Centaur T4 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 T4 MCM is | ||
| substantially equivalent to the predicate device as summarized | ||
| in Table 1. |
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20
| SIMILARITIES | ||||
|---|---|---|---|---|
| Candidate Device | Predicate Device | |||
| Item | ADVIA Centaur T4 MCM | Elecsys T4 Calcheck 5 | ||
| Intended | ||||
| Use | The ADVIA Centaur Thyroxine (T4) | |||
| MCM is for in vitro diagnostic use in | ||||
| the verification of calibration and | ||||
| reportable range of the ADVIA | ||||
| Centaur T4 assay. | The Elecsys T4 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 T4 | ||||
| reagent on the indicated Elecsys and | ||||
| cobas e immunoassay analyzers. | ||||
| Analyte | Thyroxine | Same | ||
| Form | Lyophilized | Same | ||
| Matrix | Human plasma | Human serum | ||
| Storage | 2–8°C | 2–8°C | ||
| DIFFERENCES | ||||
| Levels | 6 | 5 | ||
| Stability | Unopened - Stable when stored | |||
| unopened at 2-8°C for 10 months. | Unopened - Stored at 2-8°C until the | |||
| expiration date printed on the bottle | ||||
| labels. | ||||
| Opened (Reconstituted) - Stable for | ||||
| 4 hours at 20-25°C. | ||||
| Use | Single Use Only | Multiple Use |
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.
21
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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 reconstituted material for the ADVIA Centaur T4 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 T4 MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur T4 MCM:
Real time shelf-life studies (unopened): Test T4 MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 11 months. Real time studies are on-going at T=15 months, 19 months, 24 months. 30 months, and 31 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. Acceptance criteria for the real-time stability study were met up to the 11 months' time point, which supports a shelf-life claim of 10 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
Stability Acceptance Criteria
The sponsor's stability specifications acceptance criteria for the ADVIA Centaur T4 MCM are as follows:
Real Time/Shelf life (Unopened): The dose recovery for MCM1 and the % dose recoveries for MCM2-6 met the sponsor's required acceptance criteria.
9.2.2 Value Assignment
The ADVIA Centaur T4 MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) T4 stock and are traceable to USP internal material. The MCMs are manufactured using qualified materials and measurement procedures.
22
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® FSH, FT4, T4, and T3 Master Curve Material (MCM)
For each new T4 MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot on the ADVIA Centaur system. A nested testing run protocol is used for MCM2-6 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-6 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 T4 MCMs. MCM6 is expected to read above the assay range of 30.0 ug/dL, therefore the MCM6 level is also diluted 1:4 before testing. 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 ug/dL dose. MCM1 is analyte-free basepool comprising of only the matrix and preservatives. The quality control specifications and final value assignment limits for T4 MCM ensure that MCM1 measures at or below the T4 assay sensitivity limit. MCM6 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 are established per the sponsor's internal procedural specifications for T4 MCM.
ADVIA Centaur T4 MCM levels and target values are provided in Table 2.
| MCM Level | Target Values
(µg/dL) |
|-------------|--------------------------|
| MCM1 | 0.00 |
| MCM2 | 2.50 |
| MCM3 | 5.00 |
| MCM4 | 10.0 |
| MCM5 | 15.0 |
| MCM6 | 35.0 |
| Assay Range | 0.3–30.0 µg/dL |
Table 2: Example T4 MCM Levels and Target Values
9.2.4 Traceability
The ADVIA Centaur T4 assay is standardized to an internal standard manufactured using USP (United States Pharmacopeia) material. Assigned values for calibrators and MCMs are traceable to this standardization.
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10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur T4 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 Elescys T4 Calcheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur T4 Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
24
SIEMENS
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® FSH, FT4, T4, and T3 Master Curve Material (MCM)
510(k) Summary – ADVIA Centaur T3 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: K143687
| 1. Applicant Information | Siemens Healthcare Diagnostics Inc. |
|---|---|
| Mailing Address: | 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: | July 13, 2015 |
| 2. Device Name | |
| Proprietary Name: | ADVIA Centaur® T3 Master Curve Material |
| Measurand: | Quality Control materials for ADVIA Centaur T3 assay |
| Type of Test: | Master Curve Material (MCM) for ADVIA Centaur T3 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 | Elecsys T3 Calcheck 5 |
| Predicate 510(k) No: | K111552 |
| 4. Device Description: | ADVIA Centaur® T3 Master Curve Material is an in vitro |
| diagnostic product containing various levels of liothyronine in | |
| human plasma with sodium azide and preservatives. Each se | |
| contains seven levels; with a reconstituted volume of | |
| 1.0 mL/vial per level. MCM1 contains no analyte. The T3 | |
| MCMs assigned values are lot-specific of target values: 0.00, | |
| 0.42, 0.69, 1.11, 1.65, 3.87, and 7.00 ng/mL. | |
| 5. Intended Use: | |
| Indication for Use: | See Indications for Use Statement below: |
| The ADVIA Centaur® Triiodothyronine (T3) Master Curve | |
| Material is for in vitro diagnostic use in the verification o | |
| calibration and reportable range of the ADVIA Centaur T3 | |
| 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 T3 MCM is | |
| substantially equivalent to the predicate device as summarized | |
| in Table 1. |
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| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur T3 MCM | Elecsys T3 Calcheck 5 |
| Intended | ||
| Use | The ADVIA Centaur | |
| Triiodothyronine (T3) MCM is for in | ||
| vitro diagnostic use in the | ||
| verification of calibration and | ||
| reportable range of the ADVIA | ||
| Centaur T3 assay. | The Elecsys T3 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 T3 | ||
| reagent on the indicated Elecsys and | ||
| cobas e immunoassay analyzers. | ||
| Analyte | Triiodothyronine | Same |
| Form | Lyophilized | Same |
| Matrix | Human plasma | Human serum |
| Use | Multiple Use | Same |
| Storage | 2–8°C | 2–8°C |
| DIFFERENCES | ||
| Levels | 7 | 5 |
| Stability | Unopened – Stable when stored | |
| unopened at 2–8°C for 10 months. | ||
| Opened (Reconstituted) – Stable | ||
| when stored at 2–8°C for 21days; or | ||
| on-board for 4 hours. | Unopened - Stored at 2–8°C until 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® FSH, FT4, T4, and T3 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 ●
- 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 reconstituted material for the ADVIA Centaur T3 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 T3 MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur T3 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 T3 MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months and 11 months. Real time studies are on-going at T=15 months, 19 months, 24months, 30 months, and 31 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. The sponsor's acceptance criteria for the real-time stability study were met up to the 11 months' time point, which supports a shelflife claim of 10 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
In-Use Open Vial (Reconstituted): Test T3 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. The sponsor's acceptance criteria for the open vial (reconstituted) stability study were met to the 22 days' time point, which supports the open vial claim of 21 days when properly stored at 2-8°C.
On-board Stability: Pooled aliquots of test T3 MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0. 2, 4 and 5 hours. The 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.
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Stability Acceptance Criteria
The sponsor's stability specifications acceptance criteria for the ADVIA Centaur T3 MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 and the . % dose recoveries for MCM2-7 met the sponsor's required acceptance criteria.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 and the ● % dose recoveries for MCM2-7 met the sponsor's required acceptance criteria.
- On-Board: The dose recovery for MCM1 and the % dose recoveries for . MCM2-7 met the sponsor's required acceptance criteria.
9.2.2 Value Assignment
The ADVIA Centaur T3 MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) T3 stock and are traceable to USP internal material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new T3 MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot on the ADVIA Centaur system. A nested testing run protocol is used for MCM2-7 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-7 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 T3 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 T3 MCM ensure that MCM1 measures at or below the T3 assay sensitivity limit.
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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 the sponsor's internal procedural specifications for T3 MCM.
ADVIA Centaur T3 MCM levels and target values are provided in Table 2.
| MCM Level | Target Values
(ng/mL) |
|-------------|--------------------------|
| MCM1 | 0.00 |
| MCM2 | 0.42 |
| MCM3 | 0.69 |
| MCM4 | 1.11 |
| MCM5 | 1.65 |
| MCM6 | 3.87 |
| MCM7 | 7.00 |
| Assay Range | 0.1-8 ng/mL |
Table 2: Example T3 MCM Levels and Target Values
9.2.4 Traceability
The ADVIA Centaur T3 assay is standardized to an internal standard manufactured using USP (United States Pharmacopeia) material. 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 T3 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 Elescys T3 Calcheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur T3 Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.