(35 days)
No
The device description and intended use clearly define the product as master curve materials for calibrating and verifying assays, which are standard laboratory reagents and do not involve AI/ML technology. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is described as "for in vitro diagnostic use in the verification of calibration and reportable range" for assays, and its descriptions state it is an "in vitro diagnostic product" containing various substances for this purpose. This indicates it is used for testing and calibration of diagnostic tools, not for treating a condition or disease.
No
Explanation: The device is described as "for in vitro diagnostic use in the verification of calibration and reportable range" of an assay, and its function is to serve as "Master Curve Material" for specific assays (TnI-Ultra and Digoxin). This indicates it is a quality control or calibrator material used to ensure the accuracy of other diagnostic tests, rather than a diagnostic device itself that directly diagnoses a condition in a patient.
No
The device description clearly states it is an "in vitro diagnostic product containing various levels of bovine cardiac troponin I in a goat serum matrix" and "various levels of digoxin in defibrinated human plasma". This indicates the device is a physical material (reagents/calibrators) and not software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The ADVIA Centaur® TnI-Ultra® Master Curve Material is for in vitro diagnostic use..." and "The ADVIA Centaur® Digoxin Master Curve Material is for in vitro diagnostic use...". This is the most direct confirmation.
- Device Description: The "Device Description" section also refers to the materials as "in vitro diagnostic product".
- Function: The device is used to verify the calibration and reportable range of other in vitro diagnostic assays (ADVIA Centaur TnI-Ultra assay and ADVIA Centaur Digoxin assay). This function is inherently related to the performance and quality control of IVD tests.
Therefore, the text explicitly and repeatedly identifies this device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® TnI-Ultra® Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur TnI-Ultra assay.
The ADVIA Centaur® Digoxin Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Digoxin assay.
Product codes
JJX
Device Description
ADVIA Centaur® TnI-Ultra® Master Curve Material is an in vitro diagnostic product containing various levels of bovine cardiac troponin I in a goat serum matrix with preservatives. Each set contains five lyophilized levels (MCM1-5); with a reconstituted volume of 1.0 ml each. MCM1 contains no analyte. The TnI-Ultra MCMs assigned values are lot-specific of target values 0.00, 1.00, 3.50, 14.0 and 40.0 ng/mL.
ADVIA Centaur® Digoxin Master Curve Material is an in vitro diagnostic product containing various levels of digoxin in defibrinated human plasma with sodium azide (0.1% after reconstitution) and preservatives. Each set contains six lyophilized levels (MCM1-6); with a reconstituted volume of 1.0 mL each. MCM1 contains no analyte. The Digoxin MCMs assigned values are lot specific of target values 0.0, 0.50, 1.00, 2.00, 3.00, 5.50 ng/mL. CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDA-approved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.
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)
ADVIA Centaur® TnI-Ultra® Master Curve Material:
Stability Studies:
- Real Time/Shelf Life (unopened): Test TnI-Ultra MCMs were stored unopened at 2-8°C and tested at T=0 and at 3 months, and 10 months. Acceptance criteria were met up to the 10 months time point, supporting a shelf-life claim of 9 months.
- In Use (open vial) stored at 2-8℃ (reconstituted): Test TnI-Ultra MCMs were reconstituted, pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 2, 4, 6, 8, 9, 24 and 25 hours. Acceptance criteria were met up to the 9 hour time point, supporting an 8-hour open vial claim when stored at 2-8°C.
- In Use (open vial) stored at -20°C (reconstituted): Test TnI-Ultra MCMs were reconstituted, pooled, aliquotted and stored at -20°C, tested in 5 replicates per level at Day=0, 14, 28, 35, 45, 60 and 63 days. Acceptance criteria were met up to the 63 days time point, supporting a 60-day open vial (reconstituted) claim when stored at -20℃.
- On-Board Stability: Test TnI-Ultra MCMs were reconstituted, pooled, aliquotted into sample cups and stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. Acceptance criteria were met up to 5 hours, supporting a 4-hour on-board stability claim.
Value Assignment:
- For each new TnI-Ultra MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot.
- A nested testing run protocol is used for MCM2-MCM5 value assignment, consisting of running alternating samples of the reference and new MCM level in the same run.
- MCM2-MCM5 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.
- A performance verification run consisting of 6 replicates of each MCM level is run using one instrument, one reagent kit lot and Bio-Rad Cardiac controls. The mean MCM doses of the new TnI-Ultra MCM lot manufactured must fall within the release range specifications (5% tighter than customer ranges).
ADVIA Centaur® Digoxin Master Curve Material:
Stability Studies:
- Real Time/Shelf Life (unopened): Test Digoxin MCMs were stored unopened at 2-8°C and tested at T=0 and at 12 months, 18 months, and 33 months. Acceptance criteria were met up to the 33 months' time point, supporting a 32-month shelf-life claim.
- In Use (open vial) stored at 2-8℃ (reconstituted): Test Digoxin MCMs were reconstituted, pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 7, 14, 21, 28 and 29 days. Acceptance criteria were met up to the 29 days' time point, supporting a 28-day open vial claim when stored at 2-8℃.
- On-Board Stability: Test Digoxin MCMs were reconstituted, pooled, aliquotted into sample cups and stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. Acceptance criteria were met up to 5 hours, supporting a 4-hour on-board stability claim.
Value Assignment:
- For each new Digoxin MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot.
- A nested testing run protocol is used for MCM2-MCM6 value assignment, consisting of running alternating samples of the reference and new MCM level in the same run.
- MCM2-MCM6 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.
- 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 Digoxin MCM lot manufactured must fall within the release range specifications (5% tighter than customer ranges).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ADVIA Centaur® TnI-Ultra® Master Curve Material:
- Real Time/Shelf life (Unopened) Acceptance Criteria: The dose recovery for MCM1 must be ≤ 0.02 dose and for MCM2-5, the % dose recovery must be within 85 to 115% calculated to Day 0 and/or no adverse trends.
- In Use (Open Vial) storage at 2-8°C (reconstituted) Acceptance Criteria: The dose recovery for MCM1 versus freshly reconstituted -80°C stored MCM1 average dose must be ≤ 0.02 dose and for MCM 2-5 versus freshly reconstituted -80℃ stored MCM2-5 average dose, the % dose recovery must be within 85 to 115%.
- In Use (Open Vial) storage at -20°C (reconstituted) Acceptance Criteria: The dose recovery for MCM1 versus freshly reconstituted -80°C stored MCM1 average dose must be ≤ 0.02 dose and for MCM 2-5 versus freshly reconstituted -80℃ stored MCM2-5 the average % dose recovery must be within 85 to 115%.
- On-Board Acceptance Criteria: The dose recovery for MCM1 must be
§ 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
(Bundled) Abbreviated 510(k) Premarket Notification
ADVIA Centaur® TnI-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
Section 006: 510(k) Summary
510(k) Summary
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.
K140267 The assigned 510(k) Number:
-
- Applicant Information
- Mailing Address:
Contact Person:
Phone Number: Fax Number: E-mail Address: Date Prepared:
-
- Device Name Proprietary Name: Measurand: Type of Test:
Regulation Section: Classification: Products Code:
- Device Name Proprietary Name: Measurand: Type of Test:
Panel:
-
- Predicate Device Name Predicate 510(k) No:
-
- Device Description:
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 USA
Fatima Pacheco Regulatory Clinical Affairs Specialist (914) 524-2450 (914) 524-3579 fatima.pacheco@siemens.com January 29, 2014
ADVIA Centaur® TnI-Ultra® Master Curve Material Quality Control materials for ADVIA Centaur TnI-Ultra assay Master Curve Material (MCM) for ADVIA Centaur TnI-Ultra assav 21 CFR 862.1660. Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassaved)
Clinical Chemistry (75)
Elecsys Troponin I CalCheck 5 k 100594
ADVIA Centaur® TnI-Ultra® Master Curve Material is an in vitro diagnostic product containing various levels of bovine cardiac troponin I in a goat serum matrix with preservatives. Each set contains five Iyophilized levels (MCM1-5); with a reconstituted volume of 1.0 ml_each. MCM1contains no analyte. The Tnl-Ultra MCMs assigned values are lot-specific
1
.
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Tinl-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
| 5. Intended Use:
Indication for Use: | See Indications for Use Statement below:
The ADVIA Centaur TnI-Ultra Master Curve Material is for
in vitro diagnostic use in the verification of calibration and
reportable range of the ADVIA Centaur TnI-Ultra 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 TnI-Ultra
MCM is substantially equivalent to the predicate device as
summarized in Table 1. |
of target values 0.00, 1.00, 3.50, 14.0 and 40.0 ng/mL
2
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® TnI-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur Tnl-Ultra MCM | Elecsys Troponin I CalCheck 5 |
| Intended | ||
| Use | The ADVIA Centaur Tnl-Ultra | |
| Master Curve Material is for in vitro | ||
| diagnostic use in the verification of | ||
| calibration and reportable range of the | ||
| ADVIA Centaur Tnl-Ultra assay. | The Elecsys Troponin I 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 Troponin I | ||
| reagent on the indicated Elecsys and | ||
| cobas e immunoassay analyzers. | ||
| Analyte | Troponin I | Same |
| Form | Lyophilized | Same |
| Use | Multiple Use | Same |
| Levels | 5 | Same |
| Storage | 2–8°C | Same |
| DIFFERENCES | ||
| Matrix | Goat Serum | Human Serum |
| Stability | Unopened - Stable when stored | |
| unopened at 2-8°C until the expiration | ||
| date on the vial label. | ||
| Opened (Reconstituted) - Stable | ||
| when stored at 2-8°C for 8 hours; or | ||
| on-board for 4 hours; or when stored | Unopened - Stable at 2-8°C up to the | |
| expiration date printed on the bottle | ||
| labels. | ||
| Reconstituted - Stable for 4 hours at | ||
| 20-25°C. |
Table I: Substantial Equivalence Comparison
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- CEN 13640 Stability Testing of In Vitro Diagnostic Reagents .
- . Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
- Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control . Material
3
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® TnI-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers use MCMs for bi-annual calibration verification checks of the assav 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 cul-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 to support the shelf life unopened and reconstituted material for the ADVIA Centaur TnI-Ultra 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 Thl-Ultra MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur Thi-Ultra MCM:
- . Real Time/Shelf Life (unopened)
- . In Use (open vial) storage at 2-8℃ (reconstituted)
- . In Use (open vial) storage at -20℃ (reconstituted)
- . On-Board
Real time shelf-life studies (unopened): Test Tnl-Ultra MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 3 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 the T=0 dose recovery results. Acceptance criteria for the real-time stability study were met up to the 10 months time point, which supports a shelf-life claim of 9 months. Unopened storage shelf-life is indicated by expiration date on the vial label.
In use open vial (reconstituted) stored at 2-8℃: Test Tnl-Ultra MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 2, 4, 6, 8, 9, 24 and 25 hours. Acceptance criteria for the open vial (reconstituted) stability study were met up to the 9 hour time point, which supports the open vial claim of 8 hours when stored at 2-8°C.
4
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Tol-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
In use open vial (reconstituted) stored at -20°C: Test TnI-Ultra MCMs were reconstituted, each level pooled, aliquotted and stored at -20°C. tested in 5 replicates per level at Day=0, 14, 28, 35,45. 60 and 63days. Acceptance criteria for the open vial (reconstituted) stability study were met up to the 63days time point, which supports the open vial (reconstituted) claim stored -20℃ for 60 days.
On-board Stability: Test TnI-Ultra MCMs were reconstituted, each level pooled. aliquotted into sample cups and stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Cenatur Tnl-Ultra MCM are as follows:
- · Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ≤ 0.02 dose and for MCM2-5, the % dose recovery must be within 85 to 115% calculated to Day 0 and/or no adverse trends.
- · In Use (Open Vial) storage at 2-8°C (reconstituted): The dose recovery for MCM1 versus freshly reconstituted -80°C stored MCM1 average dose must be ≤ 0.02 dose and for MCM 2-5 versus freshly reconstituted -80℃ stored MCM2-5 average dose, the % dose recovery must be within 85 to 115%.
- · In Use (Open Vial) storage at -20°C (reconstituted): The dose recovery for MCM1 versus freshly reconstituted -80°C stored MCM1 average dose must be ≤ 0.02 dose and for MCM 2-5 versus freshly reconstituted -80℃ stored MCM2-5 the average % dose recovery must be within 85 to 115%.
- · On-Board: The dose recovery for MCM1 must be 26.0 |
| Assay Range | 0.006-50 ng/mL | | |
Table 2: Example Lot-specific Assigned Values and Ranges for Tnl-Ultra MCM
9.2.4 Traceability
The ADVIA Centaur TnI-Ultra assay is traceable to NIST SRM 2921. The ADVIA Centaur Til-Ultra assay is standardized to an internal standard manufactured using highly purified material. Assigned values for callbrators and MCMs are traceable to this standardization. The Tnl-Ultra 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 ThI-Ultra Master Curve Material (MCM) is substantially cquivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys Troponin I CalCheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur Tinl-Ultra Maser Curve Material does not raise any new questions on safety and effectivencss and the results support a determination of substantial equivalence.
6
KI40267
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® TnI-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
510(k) Summary
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.
K140267 The assigned 510(k) Number: _
| 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: | January 29, 2014 |
| 2. Device Name | |
| Proprietary Name: | ADVIA Centaur® Digoxin Master Curve Material |
| Measurand: | Quality Control materials for ADVIA Centaur Digoxin assay |
| Type of Test: | Master Curve Material (MCM) for ADVIA Centaur Digoxin |
| 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 Dogixin CalCheck 5 |
| Predicate 510(k) No: | K102044 |
| 4. Device Description: | ADVIA Centaur® Digoxin Master Curve Materials is an |
| in vitro diagnostic product containing various levels of digoxin | |
| in defibrinated human plasma with sodium azide (0.1% after | |
| reconstitution) and preservatives. Each set contains six | |
| lyophilized levels (MCM1-6); with a reconstituted volume of | |
| 1.0 mL each. MCM1 contains no analyte. The Digoxin MCMs | |
| assigned values are lot specific of target values 0.0, 0.50, | |
| 1.00, 2.00, 3.00, 5.50 ng/mL. | |
| CAUTION! POTENTIAL BIOHAZARD: Contains human | |
| source material. While each human serum or plasma donor uni |
Section 006, Page 7 of 12
7
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® TnI-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM) used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses. HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices. 5. Intended Use: See Indications for Use Statement below: The ADVIA Centaur® Digoxin Master Curve Material is for Indication for Use: in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Digoxin assay. Special Conditions for For prescription use only Use Statement(s): ADVIA Centaur® Systems Special Instrument Requirements: 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 A comparison of the device features, intended use, and other and Substantial Equivalence information demonstrates that the ADVIA Centaur Digoxin Comparison with Predicate: MCM is substantially equivalent to the predicate device as summarized in Table 1.
8
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Tol-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur Digoxin MCM | Elecsys Digoxin CalCheck 5 |
| Intended | ||
| Use | The ADVIA Centaur Digoxin MCM is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Digoxin assay. | The Elecsys Digoxin 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 Digoxin reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Analyte | Digoxin | Same |
| Use | Multiple Use | Same |
| Storage | 2-8°C | Same |
| DIFFERENCES | ||
| Form | Lyophilized | Liquid |
| Matrix | Defibrinated human plasma | Bovine Serum |
| Levels | 6 | 5 |
| Stability | Unopened - Stable when stored unopened at 2-8°C until the expiration date on the vial label. | |
| Opened (Reconstituted) - Stable when stored at 2-8°C for 28 days; or on-board for 4 hours. | Unopened - Stable at 2-8°C up to the expiration date printed on the bottle labels. | |
| Opened - Stable for 5 hours at 20-25°C. |
Table 1: Substantial Equivalence Comparison
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- CEN 13640 Stability Testing of In Vitro Diagnostic Reagents .
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic . Calibrators
- . Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material
9
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® TnI-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers 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
9.2.1 Stability Studies
The stability studies were conducted to support the shelf life (unopened) and opened reconstituted material for the ADVIA Centaur Digoxin MCMs. The data supports the stability claims detailed in the ADVIA Centaur Digoxin MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur Digoxin MCM:
- Real Time/Shelf Life (unopened) .
- . In Use (open vial) storage at 2-8℃ (reconstituted)
- . On-Board Stability
Real time shelf-life studies (unopened): Test Digoxin MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 12 months, 18 months, and 33 months. Shelf life claims are based upon real time stability carried out one month after the duration claimed. Real time shelf-life stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the real-time stability study were met up to the 33 months' time point, which supports a shelf-life claim of 32 months. Unopened storage shelf-life is indicated by expiration date on the vial label.
In use open vial (reconstituted)_stored an 2-8℃: Test Digoxin 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 davs. Acceptance criteria for the open vial (reconstituted) stability study were met up to the 29 days' time point, which supports the open vial claim of 28 davs when stored at 2-8℃.
On-board Stability: Test Digoxin MCMs were reconstituted, each level pooled, aliquotted into sample cups and stored on the ADVIA Centaur system and
10
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® Til-Ultra® and ADVIA Centaur® Digoxin Master Curve Material (MCM)
measured at time point T= 0, 2, 4 and 5 hours. Acceptance criteria for the onboard stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur Digoxin MCM are as follows:
- . Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ≤ 0.10 dose, for MCM2 the % dose recovery must be within 82 to 118% and for MCM3-6 the % dose recovery must be within 85 to 115% calculated to Day 0 and/or no adverse trends.
- In Use (Open Vial) storage at 2-8°C (reconstituted): The dose recovery for . MCM1 versus -80°C stored MCM1 average dose must be ≤0.10 dose, for
- . MCM2 versus -80°C stored MCM2 average dose the % dose recovery must be within 82 to 118% and for MCM 3-6 versus -80°C MCMs 3-6 average dose the % dose recovery must be within 85 to 115%.
- On-Board Stability: The dose recovery for MCM1 must be ≤ 0.10 dose, for . MCM2 the % dose recovery must be within 82 to 118% and for MCM3-6 the % dose recovery must be within 85 to 115% calculated to T=0.
9.2.2 Value Assignment
The ADVIA Centaur Digoxin MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) Digoxin stock and are traccable to USP internal material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new Digoxin MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing rum protocol is used for MCM2-MCM6 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run, MCM2-MCM6 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 Digoxin 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 Digoxin MCM lot manufactured must fall within the release range specifications. The release ranges are 5% tighter than the customer range specifications.
The target for MCM1 is assigned a 0.0 dose. There is no statistical method used to assign the 0.0 dose. MCM1 range is claimed as " 4.42 |
| Assay Range | 0.1-5.0 ng/mL | | |
Tuble 2: Example Lot-specific Assigned Values and Ranges for Digoxin MCM
9.2.4 Traceability
The ADVIA Centaur Digoxin 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.
1 (). Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur Digoxin 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 Digoxin CalCheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur Digoxin Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 10, 2014
SIEMENS HEALTHCARE DIAGNOSTICS INC. FATIMA PACHECO REGULATORY CLINICAL AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591-5097
Re: K140267
Trade/Device Name: ADVIA Centaur TnI-Ultra® Master Curve Material (MCM), ADVIA Centaur® Digoxin Master Curve Material (MCM)
Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJX Dated: February 04, 2014 Received: February 7, 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 as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 H. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
Indications for Use
510(k) Number (if known)
Device Name
ADVIA Centaur® TnI-Ultra® Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® Thi-Ultra® Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur TnI-Ultra 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)
.
.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
. .
Ruth A. Chesler -S
FORM FDA 3881 (1/14)
Section 005, Page 1 of 4
15
. 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."
:
16
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration .. .
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
ADVIA Centaur® Digoxin Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur@ Digoxin Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur Digoxin 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ruth A. Chesler -S
FORM FDA 3881 (1/14)
17
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 Chiaf Information Officer Paperwork Reduction Act (PRA) Staff PRAStam@da.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."
. .....