(181 days)
Not Found
No
The device is a calibrator for an in vitro diagnostic assay, consisting of a biological material with assigned values. There is no mention of any computational or algorithmic processing, let alone AI/ML.
No
The device is a calibrator for an in vitro diagnostic assay, used to ensure the accuracy of a quantitative measurement, not to treat a condition.
No
This device is described as a calibrator for an in vitro diagnostic assay, meaning it is used to ensure the accuracy of a diagnostic test, rather than being a diagnostic device itself.
No
The device description clearly states it is a physical product (human IgE in equine serum) that is lyophilized and stored at specific temperatures. It is a calibrator for an in vitro diagnostic assay, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Function: The device is a calibrator used to calibrate a quantitative assay (ADVIA Centaur® Total IgE) performed on a system (ADVIA Centaur system). Calibrators are essential components in many in vitro diagnostic tests to ensure accurate measurement of analytes in patient samples.
- Device Description: The description details the composition of the calibrator, which is a reagent used in a laboratory setting to perform a diagnostic test.
The information provided clearly indicates that this device is intended to be used outside of the body to examine specimens (in this case, for calibrating a test that measures IgE levels) to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.
Product codes (comma separated list FDA assigned to the subject device)
JIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 80 have been validated following procedures of Siemens Healthcare Diagnostics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 862.1150 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.
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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, RAC
Sr. Regulatory Technical Specialist |
|----------|-----------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics, Inc
333 Coney Street
East 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.
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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 Target | ||
| Concentrations | Low Calibrator = 35 IU/mL | |
| High 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 high | |
| levels of human IgE in equine | ||
| serum, detergents and | ||
| preservatives | After reconstitution, low or high | |
| levels of the analytes listed in | ||
| Intended Use in equine serum | ||
| with preservatives and protein | ||
| stabilizers | ||
| Stability | Unopened - until expiration date on the | |
| vial label | ||
| Reconstituted - 60 days | ||
| On-board - 8 hours | Unopened - until expiration date on | |
| the vial label | ||
| Reconstituted - 28 days | ||
| On-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.
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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).
:
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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
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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
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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
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