(28 days)
No
The device description and performance studies focus on the chemical composition and stability of calibration materials for an immunoassay system. There is no mention of AI or ML in the provided text.
No
This device is an in vitro diagnostic product used for the verification of calibration and reportable range of an assay, not for treating any medical condition.
No
Explanation: The device, ADVIA Centaur® C-peptide Master Curve Material and Insulin Master Curve Material, is an "in vitro diagnostic product" used for the verification of calibration and reportable range of assays, not for diagnosing patients.
No
The device description clearly states it is an "in vitro diagnostic product containing various levels of C-peptide spiked in citric acid buffer" and "an in vitro diagnostic product containing various levels of insulin in buffered saline". These are physical materials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The ADVIA Centaur® C-peptide (CpS) Master Curve Material is for in vitro diagnostic use..."
- "The ADVIA Centaur® Insulin (IRI) Master Curve Material is for in vitro diagnostic use..."
This statement directly identifies the intended use of the device as being for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® C-peptide (CpS) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur C-peptide assay.
The ADVIA Centaur® Insulin (IRI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur insulin assay.
Product codes
JJX
Device Description
ADVIA Centaur® C-peptide Master Curve Material is an in vitro diagnostic product containing various levels of C-peptide spiked in citric acid buffer with casein and preservatives. Each set contains ten levels (MCM1–10); ready-to-use 1.0 mL per level. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values 0.0 0.14, 0.25, 0.55, 1.05, 2.05, 4.00, 8.00, 16.0, 32.5 ng/mL.
ADVIA Centaur® Insulin Master Curve Materials is an in vitro diagnostic product containing various levels of insulin in buffered saline with casein, potassium thiocyanate (3.89%), sodium azide (
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2014
SIEMENS HEALTHCARE DIAGNOSTICS, INC. FATIMA PACHECO REGULATORY CLINICAL AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K142864
Trade/Device Name: ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM) ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) Regulation Number: 21 CFR 862.1660 Regulation Name: Single (Specified) Analyte Controls (Assayed and Unassayed) Regulatory Class: Class I, Reserved Product Code: JJX Dated: September 30, 2014 Received: October 01, 2014
Dear Ms. Fátima 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 Part 801); medical device reporting (reporting of medical
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney 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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Indications for Use
510(k) Number (if known) K142864
Device Name
ADVIA Centaur® C-peptide Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® C-peptide (CpS) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur C-peptide assay.
Type of Use (Select one or both, as applicable)
ك 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K142864
Device Name
ADVIA Centaur® Insulin Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® Insulin (IRI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur insulin assay.
Type of Use (Select one or both, as applicable)
ك 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)
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
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.
The assigned 510(k) Number: K142864
| 1. Applicant Information | 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: | October 23, 2014 |
| 2. Device Name | |
| Proprietary Name: | ADVIA Centaur® C-peptide (CpS) Master Curve Material |
| Measurand: | Quality Control materials for ADVIA Centaur CpS assay |
| Type of Test: | Master Curve Material (MCM) for ADVIA Centaur CpS 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 C-Peptide CalCheck 5 |
| Predicate 510(k) No: | K100810 |
| 4. Device Description: | ADVIA Centaur® C-peptide Master Curve Material is an
in vitro diagnostic product containing various levels of
C-peptide spiked in citric acid buffer with casein and
preservatives. Each set contains ten levels (MCM1–10);
ready-to-use 1.0 mL per level. MCM1 contains no analyte.
The MCMs assigned values are lot-specific of target values 0.0
0.14, 0.25, 0.55, 1.05, 2.05, 4.00, 8.00, 16.0, 32.5 ng/mL. |
| 5. Intended Use: | See Indications for Use Statement below: |
| Indication for Use: | The ADVIA Centaur® C-peptide (CpS) Master Curve Material
is for in vitro diagnostic use in the verification of calibration
and reportable range of the ADVIA Centaur C-peptide 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 CpS MCM
is substantially equivalent to the predicate device as
summarized in Table 1. |
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| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur CpS MCM | Elecsys C-Peptide CalCheck 5 |
| Intended | ||
| Use | The ADVIA Centaur C-peptide (CpS) | |
| Master Curve Material is for in vitro | ||
| diagnostic use in the verification of | ||
| calibration and reportable range of the | ||
| ADVIA Centaur C-peptide assay. | The Elecsys C-Peptide CalCheck 5 is | |
| an assayed control for use in | ||
| calibration verification and for use in | ||
| the verification of the serum and | ||
| plasma assay range established by the | ||
| Elecsys C-Peptide reagent on the | ||
| indicated Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Analyte | C-peptide | Same |
| Use | Multiple Use | Same |
| Storage | 2-8°C | Same |
| DIFFERENCES | ||
| Form | Liquid | Lyophilized |
| Matrix | Citric acid buffered casein | HEPES buffered equine serum matrix |
| Levels | 10 | 5 |
| Stability | Unopened – Stable when stored | |
| unopened at 2-8°C for 12 months. | ||
| Opened - Stable on-board for 4 hours. | Unopened - Stable at 2-8°C for | |
| 15 months. | ||
| Reconstituted – Stable for 4 hours at | ||
| 20-25°C. |
Table 1: Substantial Equivalence Comparison
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7. 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.
8. Performance Characteristics
8.1 Performance Studies
Stability Studies 8.1.1
Stability studies were conducted to support the shelf life of unopened and opened ADVIA Centaur CpS 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 CpS MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur CpS MCM:
- Real Time/Shelf Life (unopened) Stability
- On-Board Stability .
Real time shelf-life studies (unopened): Test CpS MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 3 months, 9 months, 12 months, and 13 months. At each time point 3 replicates were run for each MCM level. 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 13 month time point, which supports a shelf-life claim of 12 months. Unopened storage shelf-life is indicated by the expiration date on the MCM vial label.
On-board Stability: Pooled aliquots of test CpS MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. On-board stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours. At each time point 3 replicates were run for each MCM level.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur CpS MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ● in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Insulin assay. | The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Analyte | Insulin | Same |
| Use | Multiple Use | Same |
| Storage | 2-8°C | Same |
| DIFFERENCES | | |
| Matrix | Buffered saline with casein, potassium
thiocyanate and azide | Bovine Serum matrix |
| Form | Liquid | Lyophilized |
| Levels | 10 | 5 |
| Stability | Unopened – Stable when stored
unopened at 2-8°C for 11 months.
Opened - Stable on-board for 8 hours. | Unopened - Stable at 2-8°C for
18 months.
Opened (Reconstituted) - Stable for
4 hours at 20-25°C. |
Table 1: Substantial Equivalence Comparison
7. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration verification checks of the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
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8. Performance Characteristics
8.1 Performance Studies:
Stability Studies 8.1.1
Stability studies were conducted to support the shelf life unopened material for the ADVIA Centaur IRI 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 IRI MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur IRI MCM:
- Real Time/Shelf Life (unopened) Stability ●
- . On-Board Stability
Real time shelf-life studies (unopened): Test IRI MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 3 months, 7 months, 9 months and 12 months. At each time point 3 replicates were run for each MCM level. 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 12 month time point. which supports a shelf-life claim of 11 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
On-board Stability: Pooled aliquots of test IRI MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0. 2. 4. 6. 8. and 9 hours. Acceptance criteria for the on-board stability study were met up to 9 hours, which supports the on-board stability claim for 8 hours. At each time point 3 replicates were run for each MCM level.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur IRI MCM are as follows:
- . Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ≤ 1.5 mU/L dose; MCM2, the % dose recovery must be within 85 to 115%; MCM3-10, the % dose recovery must be within 88 to 112% calculated to Day 0 and/or no adverse trends.
- On-Board: The dose recovery for MCM1 must be ≤ 1.5 mU/L dose; MCM2, the % dose recovery must be within 85 to 115%; MCM3-10, the % dose recovery must be within 88% to 112% calculated to Time=0.
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8.1.2 Value Assignment
The ADVIA Centaur IRI MCMs are value assigned using assigned reference standards. The assigned reference standards are prepared using IRI stock and are standardized against World Health Organization (WHO) 1st IRP 66/304 reference material. The MCMs are manufactured using qualified materials and measurement procedures.
MCM1-10 are run in replicates of three across two ADVIA Centaur instruments using two reagent kit lots, run twice on each instrument for a total of 24 replicates per MCM level. MCM10 is also run diluted 1:2 using the MCM1 level as diluent. The average MCMs dose values are generated using the master curve standard calibration. Two lots of commercially available controls (3 levels) are used to verify acceptable value assignment runs and validate the results. The average dose for each commercial control from the value assignment runs are expected to be within +/- 10% of the assigned targets and the coefficient of variation value from each commercial control is to be within 10%. The average dose values obtained are the new MCM dose values (target). The MCM10 dose value (target) is the average dose value of the neat and diluted samples. The new MCM doses must fall within the target range for each MCM level as outlined in Table 1.
| MCM | Target | Target Range |
|---|---|---|
| Level | (mU/L) | (mU/L) |
| MCM1 | 0.00 |