(32 days)
No
The device description and performance studies focus on the chemical composition and stability of calibration materials, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is described as an in vitro diagnostic product used for the verification of calibration and reportable range of assays, not for therapeutic use in treating patients.
Yes
These materials are explicitly described as "in vitro diagnostic products" and are used for the "verification of calibration and reportable range" of assays that detect specific substances (Vitamin B12, hCG, Testosterone), which are markers used in medical diagnosis. Their use for "bi-annual calibration checks of the assay range and linearity" also indicates their role in ensuring the accuracy of diagnostic tests.
No
The device description clearly states that the product is an in vitro diagnostic product containing various levels of analytes in buffered human serum albumin, equine serum, or human plasma. These are physical materials, not software.
Yes, these devices are IVDs (In Vitro Diagnostics).
The document explicitly states in the "Device Description" section for each product:
- "ADVIA Centaur® Vitamin B12 Master Curve Material is an in vitro diagnostic product..."
- "ADVIA Centaur® ThCG Master Curve Materials is an in vitro diagnostic product..."
- "ADVIA Centaur® TSTO Master Curve Materials is an in vitro diagnostic product..."
Furthermore, the "Intended Use / Indications for Use" describes their use in the verification of calibration and reportable range of ADVIA Centaur assays, which are themselves IVD assays used to measure analytes in biological samples. This function aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the information is about the performance of the diagnostic assay itself.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur VB12 assay.
The ADVIA Centaur® Total hCG (ThCG) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay.
The ADVIA Centaur® Testosterone (TSTO) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur Testosterone assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
ADVIA Centaur® Vitamin B12 Master Curve Material: ADVIA Centaur® Vitamin B12 Master Curve Material is an in vitro diagnostic product containing various levels of vitamin B12 in buffered human serum albumin with sodium azide (0.2%) and preservatives. Each set contains six levels (MCM1-6); with a fill volume of 1.0 mL per level. VB12 MCMs are ready-to-use liquid products. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 100, 250, 500, 1000, and 2200 pg/mL.
ADVIA Centaur® Total hCG Master Curve Material: ADVIA Centaur® ThCG Master Curve Materials is an in vitro diagnostic product containing various levels of ThCG in lyophilized equine serum with preservatives including amphotericin B. Each set contains ten lyophilized levels (MCM1-10); with a reconstituted volume of 1.0 mL each. MCM1 contains no analyte. The ThCG MCMs assigned values are lot specific of target values: 0.0, 5.00, 10.0, 25.0, 50.0, 100, 250, 500, 750, and 1400 mIU/mL.
ADVIA Centaur® Testosterone Master Curve Material: ADVIA Centaur® TSTO Master Curve Materials is an in vitro diagnostic product containing various levels of testosterone spiked in lyophilized human plasma with sodium azide and preservatives. Each set contains seven lyophilized levels (MCM1-7); with a reconstituted volume of 1.0 mL each. MCMI contains no analyte. The TSTO MCMs assigned values are lot specific of target values 0.00, 50.0, 100, 500, 750, 1000, and 1600 ng/dL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ADVIA Centaur® Vitamin B12 Master Curve Material:
- Stability Studies:
- Real Time/Shelf Life (unopened): Test VB12 MCMs were stored unopened at 2-8°C and tested at T=0 and at 6 months, 12 months, and 15 months. Acceptance criteria were met up to 15 months, supporting a shelf-life claim of 14 months.
- On-Board Stability: Pooled aliquots of test VB12 MCMs in sample cups were stored on the ADVIA Centaur system and measured at T=0, 2, 4 and 5 hours. Acceptance criteria were met up to 5 hours, supporting an on-board stability claim of 4 hours.
- Value Assignment:
- MCM1: run in 5 replicates on two separate runs using one reagent kit lot.
- MCM2-MCM6: nested testing run protocol, running alternating samples of reference and new MCM level in the same run. Tested on 20 replicates in total (one run, four sample cups, 5 replicates per cup).
- Performance verification run: 6 replicates of each MCM level using one instrument, one reagent kit lot and Bio-Rad controls.
ADVIA Centaur® Total hCG Master Curve Material:
- Stability Studies:
- Real Time/Shelf Life (unopened): Test ThCG MCMs were stored unopened at 2-8°C and tested at T=0 and at 6 months, 12 months, and 15 months. Acceptance criteria were met up to 15 months, supporting a shelf-life claim of 14 months.
- In-Use Open Vial (Reconstituted): Test ThCG 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 29 days, supporting an open vial claim of 28 days when stored at 2-8°C.
- On-Board Stability: Pooled aliquots of test ThCG MCMs in sample cups were stored on the ADVIA Centaur system and measured at T=0, 2, 4 and 5 hours. Acceptance criteria were met up to 5 hours, supporting an on-board stability claim of 4 hours.
- Value Assignment:
- MCM1: run in 5 replicates on two separate runs using one reagent kit lot.
- MCM2-MCM10: nested testing run protocol, running alternating samples of reference and new MCM level in the same run. Tested on 20 replicates in total (one run, four sample cups, 5 replicates per cup).
- Performance verification run: 6 replicates of each MCM level using one instrument, one reagent kit lot and Bio-Rad controls.
ADVIA Centaur® Testosterone Master Curve Material:
- Stability Studies:
- Real Time/Shelf Life (unopened): Test TSTO MCMs were stored unopened at 2-8°C and tested at T=0 and at 12 months, 18 months, and 21 months. Acceptance criteria were met up to 21 months, supporting a shelf-life claim of 20 months.
- In use open vial (reconstituted) stored at 2-8°C: Test TSTO MCMs were reconstituted, pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 2, 4, 7, 8, 11, 14 and 15 days. Acceptance criteria were met up to the 15 day time point, supporting an open vial claim of 14 days when stored at 2-8°C.
- On-Board Stability: Pooled aliquots of test TSTO MCMs in sample cups were stored on the ADVIA Centaur system and measured at T=0, 2, 4 and 5 hours. Acceptance criteria were met up to 5 hours, supporting an on-board stability claim of 4 hours.
- Value Assignment:
- MCM1: run in 5 replicates on two separate runs using one reagent kit lot.
- MCM2-MCM7: nested testing run protocol, running alternating samples of reference and new MCM level in the same run. Tested on 20 replicates in total (one run, four sample cups, 5 replicates per cup).
- Performance verification run: 6 replicates of each MCM level using one instrument, one reagent kit lot and Bio-Rad controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ADVIA Centaur® Vitamin B12 Master Curve Material:
- Real Time/Shelf life (Unopened) Acceptance Criteria:
- MCM1: ≤ 45 pg/mL dose.
- MCM2: % dose recovery within 75 to 125%.
- MCM3-6: % dose recovery within 85 to 115% calculated back to Day 0 and/or no adverse trends.
- On-Board Acceptance Criteria:
- MCM1: ≤ 45 pg/mL dose.
- MCM2: % dose recovery within 75 to 125%.
- MCM3-6: % dose recovery within 85 to 115% calculated to T=0.
ADVIA Centaur® Total hCG Master Curve Material:
- Real Time/Shelf life (Unopened) Acceptance Criteria:
- MCM1: ≤ 2.0 mIU/mL dose.
- MCM2-3: % dose recovery within 80 to 120%.
- MCM4-10: % dose recovery within 85 to 115% calculated to Day 0 and/or no adverse trends.
- In-Use Open Vial (Reconstituted) Acceptance Criteria:
- MCM1: ≤ 2.0 mIU/mL dose.
- MCM2-3: average dose % dose recovery must be within 80 to 120% versus -80°C MCM2-3.
- MCM4-10: average dose % dose recovery must be within 85 to 115% versus -80°C MCM4-10.
- On-Board Acceptance Criteria:
- MCM1: ≤ 2.0 mIU/mL dose.
- MCM2-3: % dose recovery within 80 to 120%.
- MCM4-10: % dose recovery within 85% to 115% calculated to Time=0.
ADVIA Centaur® Testosterone Master Curve Material:
- Real Time/Shelf life (Unopened) Acceptance Criteria:
- MCM1: ≤ 10.0 ng/dL dose.
- MCM2-3: average % dose recovery within 75 to 125%.
- MCM4-7: average % dose recovery within 85 to 115% calculated to Day 0 and/or no adverse trends.
- In Use Open Vial (reconstituted) Acceptance Criteria:
- MCM1: ≤ 10.0 ng/dL dose (versus fresh).
- MCM2-3: average % dose recovery within 75 to 125% (versus freshly reconstituted -80°C stored MCM2-3 average dose).
- MCM4-7: average % dose recovery within 85 to 115% (versus freshly reconstituted -80°C stored MCM4-7 average dose).
- On-Board Acceptance Criteria:
- MCM1: ≤ 10.0 ng/dL dose.
- MCM2-3: % dose recovery within 75 to 125%.
- MCM4-7: % dose recovery within 85 to 115% calculated to Time=0.
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.
Elecsys Vitamin B12 CalCheck K060755, Elecsys HCG CalCheck 5 K092168, Elecsys Testosterone CalCheck K970146
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
Section 006: 510(k) Summary
510(k) Summary - ADVIA Centaur VB12 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: K140505
| 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: | February 24, 2014 |
| 2. Device Name
Proprietary Name:
Measurand:
Type of Test: | ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material
Quality Control materials for ADVIA Centaur VB12 assay
Master Curve Material (MCM) for ADVIA Centaur VB12 assay
21 CFR 862.1660, Quality Control Material |
| Regulation Section: | Class I Reserved |
| Classification: | JJX - Single (Specified) Analyte Controls (Assayed and |
| Products Code: | Unassayed) |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device Name
Predicate 510(k) No: | Elecsys Vitamin B12 CalCheck
K060755 |
| 4. Device Description: | ADVIA Centaur® Vitamin B12 Master Curve Material is an
in vitro diagnostic product containing various levels of vitamin
B12 in buffered human serum albumin with sodium azide (0.2%)
and preservatives. Each set contains six levels (MCM1-6); with
a fill volume of 1.0 mL per level. VB12 MCMs are ready-to-use |
500, 1000, and 2200 pg/mL.
liquid products. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 100,250,
1
ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| ADVIA Centaur® VB12, tHCG, and ISTO Master Curve Material (MCM) | |
|---|---|
| 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. | |
| 5. Intended Use: | |
| Indication for Use: | See Indications for Use Statement below: |
| The ADVIA Centaur® Vitamin B12 (VB12) Master Curve | |
| Material is for in vitro diagnostic use in the verification of | |
| calibration and reportable range of the ADVIA Centaur VB12 | |
| 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 VB12 MCM | |
| is substantially equivalent to the predicate device as | |
| summarized in Table 1 |
2
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur VB12 MCM | Elecsys Vitamin B12 CalCheck |
| Intended | ||
| Use | The ADVIA Centaur Vitamin B12 | |
| (VB12) Master Curve Material is for in | ||
| vitro diagnostic use in the verification | ||
| of calibration and reportable range of | ||
| the ADVIA Centaur VB12 assay. | For use in the verification of the | |
| calibration established by the Elescys | ||
| Vitamin B12 reagent on the indicated | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | ||
| Analyte | Vitamin B12 | Same |
| Use | Multiple Use | Same |
| Storage | 2–8°C | Same |
| DIFFERENCES | ||
| Form | Liquid | Lyophilized |
| Matrix | Human Serum Albumin | Human Serum |
| Levels | 6 | 3 |
| Stability | Unopened - Stable when stored | |
| unopened at 2-8°C until the expiration | ||
| date on the vial label. | ||
| Opened - Stable on-board for 4 hours. | Unopened - Stable at 2-8°C up to | |
| the expiration date printed on the | ||
| bottle labels. | ||
| Reconstituted - Stable for 4 hours at | ||
| 20-25°C. |
| Table 1: Substantial Equivalence Comparison | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------------------- |
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- 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® VB12, ThCG, and TSTO Master Curve Material (MCM)
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration 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
Stability studies were conducted to support the shelf life (unopened) and on-board (opened) material for the ADVIA Centaur VB12 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 VB12 MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur VB12 MCM:
- Real Time/Shelf Life (unopened) .
- . On-Board
Real time shelf-life studies (unopened): Test VB12 MCMs were stored unopened at 2-8℃ and tested at T=0 and at the following time points: 6 months, 12 months, and 15 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 15 months' time point, which supports a shelf-life claim of 14 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
On-board Stability: Pooled aliquots of test VB12 MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. On-board stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the onboard stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
4
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur VB12 MCM are as follows:
- . Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ≤ 45 pg/mL dose; MCM2, the % dose recovery must be within 75 to 125%; MCM3-6, the % dose recovery must be within 85 to 115% calculated back to Day 0 and/or no adverse trends.
- . On-Board: The dose recovery for MCM1 must be ≤ 45 pg/mL dose: MCM2. the % dose recovery must be within 75 to 125%; MCM3-6, the % dose recovery must be within 85 to 115% calculated to T=0.
9.2.2 Value Assignment
The ADVIA Centaur VB12 MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) VB12 stock and are traceable to USP internal material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new VB12 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. 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 VB12 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. The quality control specifications and final value assignment limits for VB12 MCM ensure that MCM1 measures at or below the VB12 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 determined per % interval on page 6.
5
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 50% |
| MCM3 | 25% |
| MCM4 | 25% |
| MCM5 | 25% |
| MCM6 | 20% |
Lot-specific assigned values and ranges are provided in the ADVIA Centaur VB12 MCM lot-specific value sheet in the example provided in Table 2.
| MCM Level | Target Values
(pg/mL) | Assigned Values
(pg/mL) |
|-------------|--------------------------------|----------------------------|
| MCM1 | 0 | 0.00 |
| MCM2 | 100 | 99.7 |
| MCM3 | 250 | 218 |
| MCM4 | 500 | 469 |
| MCM5 | 1000 | 1099 |
| MCM6 | 2200 | 2309 |
| Assay Range | 45-2000 pg/mL (33-1476 pmol/L) | |
Table 2: Example Lot-specific VB12 MCM Target and Assigned Values
9.2.4 Traceability
The ADVIA Centaur VB12 assay is traceable to an internal standard manufactured using U.S.P. (United States Pharmacopeia) material. Assigned values for calibrators and MCMs are traceable to this standardization. The VB12 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 VB12 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 Vitamin B12 CalCheck. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur VB12 Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
6
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
510(k) Summary - ADVIA Centaur ThCG 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: K140505
| 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: | February 24, 2014 |
| 2. Device Name
Proprietary Name: | ADVIA Centaur® Total hCG Master Curve Material
Quality Control materials for ADVIA Centaur Total hCG assay |
| Measurand:
Type of Test: | Master Curve Material (MCM) for ADVIA Centaur Total hCG
assay |
| Regulation Section:
Classification: | 21 CFR 862.1660, Quality Control Material
Class I Reserved |
| Products Code: | JJX - Single (Specified) Analyte Controls (Assayed and
Unassayed) |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device Name
Predicate 510(k) No: | Elecsys HCG CalCheck 5
K092168 |
| 4. Device Description: | ADVIA Centaur® ThCG Master Curve Materials is an in vitro
diagnostic product containing various levels of ThCG in
lyophilized equine serum with preservatives including
amphotericin B. Each set contains ten lyophilized levels
(MCM1-10); with a reconstituted volume of 1.0 mL each.
MCM1 contains no analyte. The ThCG MCMs assigned values
are lot specific of target values: 0.0, 5.00, 10.0, 25.0, 50.0, 100,
250, 500, 750, and 1400 mIU/mL. |
| 5. Intended Use:
Indication for Use: | See Indications for Use Statement below:
The ADVIA Centaur® Total hCG (ThCG) Master Curve |
The ADVIA Centaur® Total hCG (ThCG) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay.
Section 006, Page 7 of 19
7
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| 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 | A comparison of the device features, intended use, and other |
| information demonstrates that the ADVIA Centaur ThCG MCM |
-
- and Substantial Equivalence Comparison with Predicate:
er information demonstrates that the ADVIA Centaur ThCG MCM is substantially equivalent to the predicate device as summarized in Table 1.
- and Substantial Equivalence Comparison with Predicate:
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur ThCG MCM | Elecsys HCG CalCheck 5 |
| Intended | ||
| Use | The ADVIA Centaur Total hCG | |
| (ThCG) MCM is for in vitro | ||
| diagnostic use in the verification of | ||
| calibration and reportable range of | ||
| the ADVIA Centaur ThCG assay. | The Elecsys HCG 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 HCG+β reagent and Elecsys | ||
| HCG STAT reagent on the indicated | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | ||
| Analyte | HCG | Same |
| Use | Multiple Use | Same |
| Storage | 2-8°C | Same |
| Form | Lyophilized | Same |
| DIFFERENCES | ||
| Matrix | Equine Serum | Human Serum |
| Levels | 10 | 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 (Reconstituted) - Stable for | ||
| 4 hours at 20-25°C. |
Table 1: Substantial Equivalence Comparison
8
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
-
- 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
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
9.2.1 Stability Studies
Stability studies were conducted to support the shelf life unopened and reconstituted material for the ADVIA Centaur ThCG 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 ThCG MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur ThCG MCM:
- Real Time/Shelf Life (unopened) .
- . In Use Open Vial (Reconstituted)
- . On-Board
Real time shelf-life studies (unopened): Test ThCG MCMs were stored unopened at 2-8℃ and tested at T=0 and at the following time points: 6 months, 12 months, and 15 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 15 months' time point, which supports a shelf-life claim of 14 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
9
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
In-Use Open Vial (Reconstituted): Test ThCG MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 7, 14, 21 28, and 29 days. Acceptance criteria for the open vial (reconstituted) stability study were met to the 29 days' time point, which supports the open vial claim of 28 days when properly stored at 2-8°C.
On-board Stability: Pooled aliquots of test ThCG MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. Acceptance criteria for the on-board stability study were met up to 5 hours. which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur ThCG MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ● ≤ 2.0 mIU/mL dose; MCM2-3, the % dose recovery must be within 80 to 120%; MCM4-10, the % dose recovery must be within 85 to 115% calculated to Day 0 and/or no adverse trends.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 must be . ≤ 2.0 mIU/mL dose; MCM2-3, versus -80℃ MCM2-3 the average dose % dose recovery must be within 80 to 120%; MCM4-10, versus -80℃ MCM4-10 the average dose % dose recovery must be within 85 to 115%.
- On-Board: The dose recovery for MCM1 must be ≤ 2.0 mIU/mL dose; . MCM2-3, the % dose recovery must be within 80 to 120%; MCM4-10, the % dose recovery must be within 85% to 115% calculated to Time=0.
9.2.2 Value Assignment
The ADVIA Centaur ThCG MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using hCG stock and are traceable to internal material which is standardized against World Health Organization (WHO) 4" IS 75/589 reference material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new ThCG MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing run protocol is used for MCM2-MCM10 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-MCM10 were tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot. This protocol is designed to remove system and run variation. The new MCM doses must fall within the final value assignment specification for ThCG 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
10
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
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. The quality control specifications and final value assignment limits for ThCG MCM ensure that MCM1 measures at or below the ThCG assay sensitivity limit. MCM10 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 determined per % interval as below.
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 35 |
| MCM3 | 25 |
| MCM4 | 25 |
| MCM5 | 25 |
| MCM6 | 25 |
| MCM7 | 25 |
| MCM8 | 25 |
| MCM9 | 25 |
| MCM10 | 25 |
Lot-specific assigned values and ranges are provided in the ADVIA Centaur ThCG MCM lot-specific value sheet in the example provided in Table 2.
| MCM Level | Target Values
(mIU/mL) | Assigned Values
(mIU/mL) |
|-------------|---------------------------|-----------------------------|
| MCM1 | 0.00 | 0 |
| MCM2 | 5.00 | 4.39 |
| MCM3 | 10.0 | 9.82 |
| MCM4 | 25.0 | 21.5 |
| MCM5 | 50.0 | 45.0 |
| MCM6 | 100 | 94.3 |
| MCM7 | 250 | 270 |
| MCM8 | 500 | 557 |
| MCM9 | 750 | 791 |
| MCM10 | 1400 | 1393 |
| Assay Range | 2.0-1000 mIU/mL | |
Table 2: Example Lot-specific ThCG MCM Target and Assigned Values
11
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
9.2.4 Traceability
The ADVIA Centaur ThCG assay is standardized against the WHO 4" IS 75/589 reference material. Assigned values for calibrators and MCMs are traceable to this standardization. The ThCG 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 ThCG 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 HCG CalCheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur ThCG Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
12
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
510(k) Summary - ADVIA Centaur TSTO 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: K140505
| 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: | February 24, 2014 |
| 2. Device Name | ADVIA Centaur® Testosterone (TSTO) Master Curve Material |
| Proprietary Name: | Quality Control materials for ADVIA Centaur TSTO assay |
| Measurand: | Master Curve Material (MCM) for ADVIA Centaur TSTO |
| Type of Test: | 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 Testosterone CalCheck |
| Predicate 510(k) No: | K970146 |
| 4. Device Description: | ADVIA Centaur® TSTO Master Curve Materials is an in vitro
diagnostic product containing various levels of testosterone |
spiked in lyophilized human plasma with sodium azide and preservatives. Each set contains seven lyophilized levels (MCM1-7); with a reconstituted volume of 1.0 mL each. MCMI contains no analyte. The TSTO MCMs assigned values are lot specific of target values 0.00, 50.0, 100, 500, 750, 1000, and 1600 ng/dL.
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 FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody
Section 006, Page 13 of 19
13
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| ADVIA Centaur® VBI2, ThCG, and TSTO Master Curve Material (MCM) | |
|---|---|
| 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: |
| Indication for Use: | The ADVIA Centaur® Testosterone (TSTO) Master Curve |
| Material is for in vitro diagnostic use in the verification of | |
| calibration and reportable range of the ADVIA Centaur | |
| Testosterone assay. | |
| Special Conditions for | |
| Use Statement(s): | For prescription use only |
| Special Instrument | ADVIA Centaur® Systems |
| 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 | |
| and Substantial Equivalence | |
| Comparison with Predicate: | A comparison of the device features, intended use, and other |
| information demonstrates that the ADVIA Centaur TSTO MCM | |
| is substantially equivalent to the predicate device as | |
| summarized in Table 1. |
,
.
14
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
Table 1: Substantial Equivalence Comparison
| Table 1: Substantial Equivalence Comparison | ||
|---|---|---|
| SIMILARITIES | ||
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur TSTO MCM | Elecsys Testosterone CalCheck |
| Intended | ||
| Use | The ADVIA Centaur Testosterone | |
| (TSTO) MCM is for in vitro | ||
| diagnostic use in the verification of | ||
| calibration and reportable range of | ||
| the ADVIA Centaur TSTO assay. | For use in the verification of the | |
| calibration established by the Elecsys | ||
| Testosterone reagent on the indicated | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | ||
| Analyte | Testosterone | Same |
| Use | Multiple Use | Same |
| Storage | 2–8°C | Same |
| Form | Lyophilized | Same |
| DIFFERENCES | ||
| Candidate Device | Predicate Device | |
| Matrix | Human Plasma | Human Serum |
| Levels | 7 | 3 |
| 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 14 days; or | ||
| on-board for 4 hours. | Unopened - Stable at 2-8°C up to the | |
| expiration date printed on the bottle | ||
| labels. | ||
| Opened (Reconstituted) - Stable for | ||
| 4 hours at 15-25°C. |
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
15
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration verification checks of the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
9. Performance Characteristics
9.1 Analytical performance:
The following studies are not applicable for the purpose of this submission:
- Precision/Reproducibility .
- Linearity/Assay Reportable Range .
- Detection limit .
- Analytical Specificity .
- Assay cut-off .
- . Method Comparison Studies
- . Clinical Studies (Sensitivity, Specificity, and cut-off)
9.2 Non-Clinical Performance Testing
9.2.1 Stability Studies
Stability studies were conducted to support the shelf life unopened and reconstituted material for the ADVIA Centaur TSTO 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 TSTO MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur TSTO MCM:
- . Real Time/Shelf Life (unopened)
- . In Use Open Vial (reconstituted)
- . On-Board
Real time shelf-life studies (unopened): Test TSTO MCMs were stored unopened at 2-8ºC and tested at T=0 and at the following time points: 12 months. 18 months, and 21 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 21 months' time point, which supports a shelf-life claim of 20 months. Unopened storage shelf-life is indicated by expiration date on the vial label.
In use open vial (reconstituted) stored at 2-88°C: Test TSTO MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8℃, tested in 5 replicates per level at T=0, 2, 4, 7, 8, 11, 14 and 15 days. Acceptance criteria for the open vial (reconstituted) stability study were met up to the 15 day time point, which supports the open vial claim of 14 days when stored at 2-8°C.
16
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
On-board Stability: Pooled aliquots of test TSTO MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur TSTO MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be . ≤ 10.0 ng/dL dose; MCM2-3, the average % dose recovery must be within 75 to 125%; MCM4-7, the average % dose recovery must be within 85 to 115% calculated to Day 0 and/or no adverse trends.
- . In Use Open Vial (reconstituted): The dose recovery for MCM1 versus fresh) v reconstituted -80℃ stored MCM1 average dose must be ≤ 10.0 ng/dL dose; for MCM2-3 versus freshly reconstituted -80°C stored MCM2-3 average dose, the average % dose recovery must be within 75 to 125%: MCM4-7 versus freshly reconstituted -80°C stored MCM4-7 average dose, the average % dose recovery must be within 85 to 115%.
- . On-Board: The dose recovery for MCM1 must be ≤ 10.0 ng/dL dose; MCM2-3, the % dose recovery must be within 75 to 125%; MCM4-7, the % dose recovery must be within 85 to 115% calculated to Time=0.
9.2.2 Value Assignment
The ADVIA Centaur TSTO MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) testosterone stock and are traceable to analytically prepared internal material which are traceable to gas-chromatography-mass spectroscopy (GCMS). The MCMs are manufactured using qualified materials and measurement procedures.
For each new TSTO MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing run protocol is used for MCM2-MCM7 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-MCM7 were tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot. This protocol is designed to remove system and run variation. The new MCM doses must fall within the final value assignment specification for TSTO 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.
17
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
The target for MCM1 is assigned a 0.0 dose. The quality control specifications and final value assignment limits for TSTO MCM ensure that MCM1 measures at or below the TSTO 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 ranges as determined per % interval as below.
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 25 |
| MCM3 | 25 |
| MCM4 | 25 |
| MCM5 | 25 |
| MCM6 | 25 |
| MCM7 | 20 |
Lot-specific assigned values and ranges are provided in the ADVIA Centaur TSTO MCM lot-specific value sheet in the example provided in Table 2.
| MCM Level | Target Values
(ng/dL) | Assigned Values
(ng/dL) |
|-------------|----------------------------------|----------------------------|
| MCM1 | 0 | 0.00 |
| MCM2 | 50.0 | 65.2 |
| MCM3 | 100 | 109 |
| MCM4 | 500 | 557 |
| MCM5 | 750 | 807 |
| MCM6 | 1000 | 1004 |
| MCM7 | 1600 | 1575 |
| Assay Range | 10-1500 ng/dL (0.35-52.1 nmol/L) | |
Table 2: Example Lot-specific TSTO MCM Target and Assigned Values
9.2.4 Traceability
The ADVIA Centaur TSTO assay is traceable to an internal standard manufactured analytically which is traceable to gas chromatography-mass spectroscopy (GC-MS). The following equation describes the relationship between the testosterone standards and GCMS analysis throughout the assay range.
ADVIA Centaur Testosterone = 1.00 (GCMS) + 1.35 ng/dL, r = 1.00
Assigned values for calibrators and MCMs are traceable to this standardization. The TSTO MCMs are manufactured using qualified materials and measurement procedures.
18
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur TSTO 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 Testosterone CalCheck. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur TSTO Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
19
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2014
SIEMENS HEALTHCARE DIAGNOSTICS INC. FATIMA PACHECO 511 BENEDICT AVENUE TARRYTOWN NY 10591-5097
Re: K140505
Trade/Device Name: ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material ADVIA Centaur® Total Hcg (ThCG) Master Curve Material ADVIA Centaur® Testosterone (TSTO) Master Curve Material Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: February 24, 2014 Received: February 27, 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 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.
20
Page 2-Ms. Pacheco
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/ReportalProblem/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
21
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) K140505
Device Name
ADVIA Centaur Vitamin B12 Master Curve Material, Total hCG Master Curve Material, and Testosterone Material
Indications for Use (Describe)
The ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur VB12 assay.
The ADVIA Centaur® Total hCG (ThCG) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay.
The ADVIA Centaur® Testosterone (TSTO) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur Testosterone 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)
22
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