(34 days)
No
The document describes a calibration material for an in vitro diagnostic assay and does not mention any AI or ML components.
No
Explanation: The device is for in vitro diagnostic use in the verification of calibration and reportable range of an assay, not for treating or diagnosing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use." The "Device Description" also describes it as an "in vitro diagnostic product."
No
The device description clearly states it is an in vitro diagnostic product containing lyophilized human plasma with additives, which is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The ADVIA Centaur® IgE Master Curve Material is for in vitro diagnostic use...". This is the most direct indicator.
- Device Description: The description further reinforces this by stating it is "an in vitro diagnostic product".
- Purpose: The intended use is to verify the calibration and reportable range of an assay (the ADVIA Centaur Total IgE assay), which is a common function of IVD devices used in laboratory settings to ensure the accuracy of diagnostic tests.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® IgE Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Total IgE assay.
Product codes
JJX
Device Description
ADVIA Centaur® IgE Master Curve Material is an in vitro diagnostic product containing various levels of IgE spiked in lyophilized human plasma with sodium azide (0.1%) and preservatives. Each set contains seven levels (MCM1–7); with a reconstituted volume of 1.0 mL/vial per level. MCM1contains no analyte. The MCMs assigned values are lot-specific of target values: 0.0, 12.5, 40.0, 270, 1000, 1700, and 3150 IU/mL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only. Intended users would be laboratory professionals in a clinical diagnostic setting (e.g., hospitals, reference labs).
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
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)
Non-Clinical Performance Testing:
Stability Studies:
Stability studies were conducted on the ADVIA Centaur system to support the shelf life (unopened) and reconstituted material for the ADVIA Centaur IgE MCMs.
- Real Time/Shelf Life (unopened) Stability: Test IgE MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months, 8 months, 9 months, 11 months, 12 months, 18 months, 35 months and 36 months. Shelf life claims are based upon real time stability carried out one month after the duration claimed. Current testing supports a shelf-life claim of 8 months.
- In Use Open Vial (reconstituted) stored at 2-8°C Stability: Test IgE 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 on the ADVIA Centaur XP system. Acceptance criteria were met up to the 29 days' time point, supporting an open vial claim of 28 days when properly stored at 2-8°C.
- On-Board Stability: Pooled aliquots of test IgE MCMs in sample cups were stored on the ADVIA Centaur XP system and measured at time point T=0, 2, 4 and 5 hours. Acceptance criteria were met up to 5 hours, supporting an on-board stability claim for 4 hours.
Stability Acceptance Criteria:
- Real Time/Shelf life (Unopened): 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.
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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 features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2015
Siemens Healthcare Diagnostics, Inc. c/o Ms. Fatima Pacheco Regulatory Clinical Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K143680
Trade/Device Name: ADVIA Centaur® IgE Master Curve Material Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJX Dated: December 19, 2014 Received: January 5, 2015
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Leonthena R. Carrington -A
Leonthena Carrington, MS, MBA, MT (ASCP) Director (Acting) Division of Immunology and Hematology 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) K143680
Device Name
ADVIA Centaur® IgE Master Curve Material
Indications for Use (Describe)
The ADVIA Centaur® IgE Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Total IgE 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)
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SIEMENS
510(k) Summary
510(k) Summary – ADVIA Centaur IgE 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: K143680
| 1. Applicant Information | Siemens Healthcare Diagnostics Inc. |
|---|---|
| Mailing Address: | 511 Benedict Avenue |
| Tarrytown, NY 10591 USA | |
| Contact Person: | Fatima Pacheco |
| Regulatory Clinical Affairs Specialist | |
| Phone Number: | (914) 524-2450 |
| Fax Number: | (914) 524-3579 |
| E-mail Address: | fatima.pacheco@siemens.com |
| Date Prepared: | January 26, 2015 |
| 2. Device Name | |
| Proprietary Name: | ADVIA Centaur® IgE Master Curve Material |
| Measurand: | Quality Control materials for ADVIA Centaur IgE assay |
| Type of Test: | Master Curve Material (MCM) for ADVIA Centaur IgE assay |
| 21 CFR 862.1660, Quality Control Material | |
| Regulation Section: | Class I Reserved |
| Classification: | JJX - Single (Specified) Analyte Controls (Assayed and |
| Unassayed) | |
| Products Code: | Unassayed) |
| Panel: | Immunology (82) |
| 3. Predicate Device Name | IMMULITE 2000 Total IgE Calibration Verification Material |
| (CVM) | |
| Predicate 510(k) No: | K133122 |
| 4. Device Description: | ADVIA Centaur® IgE Master Curve Material is an in vitro |
| diagnostic product containing various levels of IgE spiked in | |
| lyophilized human plasma with sodium azide (0.1%) and | |
| preservatives. Each set contains seven levels (MCM1–7); with a | |
| reconstituted volume of 1.0 mL/vial per level. MCM1contains | |
| no analyte. The MCMs assigned values are lot-specific of target |
4
SIEMENS
| values: 0.0, 12.5, 40.0, 270, 1000, 1700, and 3150 IU/mL. | |
|---|---|
| 5. Intended Use: | |
| Indication for Use: | See Indications for Use Statement below: |
| The ADVIA Centaur® IgE Master Curve Material is for in vitro | |
| diagnostic use in the verification of calibration and reportable | |
| range of the ADVIA Centaur Total IgE 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 IgE 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 IgE MCM | IMMULITE 2000 Total IgE |
| Calibration Verification Material | ||
| (CVM) | ||
| Intended | ||
| Use | The ADVIA Centaur IgE Master Curve | |
| Material is for in vitro diagnostic use in | ||
| the verification of calibration and | ||
| reportable range of the ADVIA | ||
| Centaur tIgE assay. | The IMMULITE 2000 Total IgE | |
| Calibration Verification Material | ||
| (CVM) is intended for in vitro | ||
| diagnostic use, as a control for | ||
| calibration verification of the | ||
| IMMULITE 2000 Total IgE assay on | ||
| IMMULITE 2000 systems as | ||
| indicated in the CVM Package Insert. | ||
| Analyte | IgE | Same |
| DIFFERENCES | ||
| Form | Lyophilized | Liquid |
| Storage | 2-8°C | ≤ -20°C |
| Use | Multiple Use | Single Use |
| Matrix | Human plasma | Equine serum |
| Levels | 7 | 4 |
| Stability | Unopened - Stable when stored | |
| unopened at 2-8°C for 8 months. | ||
| Opened (Reconstituted) – Stable | ||
| when stored at 2-8°C for 28 days; or | ||
| on-board for 4 hours. | Unopened - Stable until the | |
| expiration date on the vial. |
Table 1: Substantial Equivalence Comparison
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic ● Calibrators
- Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control ● Material
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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 on the ADVIA Centaur system to support the shelf life (unopened) and reconstituted material for the ADVIA Centaur IgE 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 IgE MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur IgE MCM:
- Real Time/Shelf Life (unopened) Stability
- In Use Open Vial (reconstituted) stored at 2-8°C Stability ●
- On-Board Stability
Real time shelf-life studies (unopened): Test IgE MCMs were stored unopened at 2-8°C and tested at T=0 and at the following time points: 7 months, 8 months, 9 months, 11 months,12 months, 18 months, 35 months and 36 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 at T=0. Current testing meets the sponsor's acceptance criteria for the real-time stability study up to the 9 months' time point, which supports a shelf-life claim of 8 months. Storage shelf-life (unopened) at 2-8°C is indicated by the expiration date on the vial label.
In-Use Open Vial (Reconstituted): Test IgE 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 on the ADVIA Centaur XP system. 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.
7
On-board Stability: Pooled aliquots of test IgE MCMs in sample cups were stored on the ADVIA Centaur XP system and measured at time point T=0, 2, 4 and 5 hours. On-board stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. 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 IgE MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be . ≤ 2.0 IU/mL dose; MCM2-7, the % dose recovery met the sponsor's required acceptance criteria.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 must be