(181 days)
For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.
The ADVIA Centaur® Calibrator 80 is a 2 level human IgE in equine serum containing detergents and preservatives. All human source materials 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. The Total IgE Calibrators have expected values of 35 and 1825 IU/mL. The Calibrator 80 (2.0 mL/vial) is lyophilized. Storage for the lyophilized calibrators is at 2 - 8℃ until expiration date specified on label, the reconstituted calibrator storage is at 2 - 8ºC up to 60 days, and on board is up to 8 hours.
The provided text describes the ADVIA Centaur® Calibrator 80, a device for in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay. As a calibrator, its performance is assessed through its traceability, value assignment, and stability, rather than metrics like sensitivity or specificity typically associated with diagnostic tests for disease detection.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device's performance was "validated following procedures of Siemens Healthcare Diagnostics." Specific numerical acceptance criteria are not explicitly detailed in this summary. However, the performance characteristics are implicitly linked to its ability to function as a calibrator with specified concentrations and stability.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Traceability | Validated following Siemens Healthcare Diagnostics procedures. |
| Value Assignment | Validated following Siemens Healthcare Diagnostics procedures. Expected values: 35 IU/mL (low) and 1825 IU/mL (high). |
| Stability | Validated following Siemens Healthcare Diagnostics procedures. Unopened until expiration; Reconstituted up to 60 days (2-8°C); On-board up to 8 hours. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of device performance studies in the way a diagnostic algorithm might have. Instead, it refers to the validation of traceability, value assignment, and stability. There is no information provided regarding sample size or data provenance (country of origin, retrospective/prospective) for these validation studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable or provided for a calibrator device. Calibrators are assigned values based on metrological traceability to reference standards, not through expert-established ground truth in the context of clinical interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable or provided for a calibrator device. Adjudication methods are relevant for studies involving human interpretation or uncertain outcomes, which is not the case for a calibrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for a calibrator device. These studies are typically employed to assess the impact of a diagnostic tool (like an AI algorithm) on human reader performance in interpreting images or data. The ADVIA Centaur® Calibrator 80 is a physical substance used to standardize an assay, not an interpretative tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
This device is not an algorithm, so a "standalone algorithm performance study" is not applicable.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" for a calibrator is established through metrological traceability to reference standards. The document mentions "The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 80 have been validated following procedures of Siemens Healthcare Diagnostics." This implies that the assigned values (35 IU/mL and 1825 IU/mL) are linked back to a defined hierarchy of standards, ensuring accuracy and consistency. Human IgE is used as the active ingredient.
8. The Sample Size for the Training Set:
This information is not applicable or provided. The device is a calibrator, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided as there is no "training set" for this type of device.
{0}------------------------------------------------
ADVIA Centaur® Calibrator 80
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
K103548 A. 510(k) Number:
- B. Date of Preparation: May 11, 2011
- C. Proprietary and Established Names: ADVIA Centaur® Calibrator 80
D. Applicant
| Contact: | Sandra D. White, MS, RACSr. Regulatory Technical Specialist |
|---|---|
| Address: | Siemens Healthcare Diagnostics, Inc333 Coney StreetEast Walpole, MA 02032 |
| Phone: | (508) 660-4553(508) 660-4591 (fax) |
E. Regulatory Information:
-
- Regulation section: 21 CFR §862.1150 Calibrator, Secondary
-
- Classification: Class II
-
- Product Code: JIT
-
- Panel: 75 - Clinical Chemistry
F. Predicate Device:
-
- Device Name: Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.) ACS Calibrator B
-
- Common Name: Calibrator B
-
- 510(k) Number: K920372
-
- Manufacturer: Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.)
G. Intended Use:
For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.
{1}------------------------------------------------
H. Device Description:
"
The ADVIA Centaur® Calibrator 80 is a 2 level human IgE in equine serum containing detergents and preservatives. All human source materials 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. The Total IgE Calibrators have expected values of 35 and 1825 IU/mL.
The Calibrator 80 (2.0 mL/vial) is lyophilized. Storage for the lyophilized calibrators is at 2 - 8℃ until expiration date specified on label, the reconstituted calibrator storage is at 2 - 8ºC up to 60 days, and on board is up to 8 hours.
I. Substantial Equivalence Information:
- Predicate device name: Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.) Calibrator B
-
- Predicate K number: K920372
-
- Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | ADVIA Centaur® Calibrator 80(New Device) | ADVIA Centaur® Calibrator B(Predicate Device) |
| Number of Levéls | 2 | Same |
| Form | Lypholized | Same |
| Matrix | Equine serum | Same |
| Total IgE TargetConcentrations | Low Calibrator = 35 IU/mLHigh Calibrator = 1825 IU/mL | Same |
| Storage Temperature | 2 - 8°C | Same |
| Differences | ||
| Item | ADVIA Centaur® Calibrator 80(New Device) | ADVIA Centaur® Calibrator B(Predicate Device) |
| Analytes | Single Analyte:Total IgE (tIgE) | Multi Analyte:Digoxin, FSH, Total IgE, LH LH2,Prolactin, Total hCG, TSH |
| Ingredients | After reconstitution, low or highlevels of human IgE in equineserum, detergents andpreservatives | After reconstitution, low or highlevels of the analytes listed inIntended Use in equine serumwith preservatives and proteinstabilizers |
| Stability | Unopened - until expiration date on thevial labelReconstituted - 60 daysOn-board - 8 hours | Unopened - until expiration date onthe vial labelReconstituted - 28 daysOn-board - 4 hours |
| Fill Volume | 2 mL/vial | 5 mL/vial |
J. Performance Characteristics:
The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 80 have been validated following procedures of Siemens Healthcare Diagnostics.
{2}------------------------------------------------
K. Conclusion:
The ADVIA Centaur® Calibrator 80 is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.) ACS Calibrator B (K920372).
:
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three human profiles forming its body and wings. The profiles are facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Ms. Sandra D. White Manager Regulatory Affairs 333 Coney Street East Walpole, MA 02032
JUN 0 2 2011
Re: K103548
Trade/Device Name: ADVIA Centaur® Calibrator 80 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 25, 2011 Reccived: April 28, 2011
Dear Ms. White:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
{4}------------------------------------------------
Page 2 - Ms. Sandra D. white
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation.(21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/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/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
Kost Maria M. Chan, Ph.D. Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indication for Use
K103548 510(k) Number (if known):
Device Name: ADVIA Centaur® Calibrator 80
Indication for Use: .
For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.
Prescription Use X_ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103548
Page 1 of
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.