(45 days)
No
The document describes a calibrator solution for an in vitro diagnostic assay and does not mention any AI or ML components.
No
The device is an in vitro diagnostic calibrator used to establish points of reference for measuring Estradiol levels, not to treat or diagnose a medical condition.
No
The device is a calibrator, used to establish reference points for assays that measure Estradiol. While it supports diagnostic assays, it does not directly diagnose a condition itself.
No
The device description clearly states it is a "human plasma based solution" and is "lyophilized," indicating it is a physical substance, 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 "For in vitro diagnostic use". It also describes its use in calibrating assays for measuring Estradiol in human serum and plasma, which are biological samples tested outside the body.
- Device Description: It is a "human plasma based solution" used in a laboratory setting to establish reference points for a diagnostic test.
- Summary of Performance Studies: The mention of "traceability, value assignment, and stability" being validated for use in a diagnostic context further supports its IVD nature.
- Predicate Device(s): The listed predicate devices are also calibrators used in diagnostic assays, indicating that this device falls within the same regulatory category.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems.
Enhanced Estradiol (eE2)
ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.
Product codes
JIT
Device Description
The ADVIA Centaur Calibrator 30 is a 2 level human plasma based solutions containing varying concentrations of Estradiol in charcoal stripped defibrinated human plasma, 0.1% Sodium azide and preservatives. The Estradiol calibrators have expected values of 35 and 2500 pg/mL.
The Cal 30 (2.0 mL/vial) is lyophilized. Storage for lyophilized cal is at 2 - 8°C until expiration date specified on label, reconstituted calibrator storage is at 2-80 up to 14 days, and on board is up to 4 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
The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 30 have been validated following procedures of Siemens Healthcare Diagnostics.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
510(K) Summary of Safety and Effectiveness for the
ADVIA® Centaur Calibrator 30
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.
A. 510(K) Number: K100293
B. Date of Preparation: January 20, 2010
C. Proprietary and Established Names:
MAR 1 9 2D10
ADVIA Centaur systems, ADVIA Centaur Calibrator 30
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Ernest Joseph, Senior Regulatory Specialist
Office: (914) 524-2431 Fax: (914) 524-2500
E. Regulatory Information:
ADVIA Centaur systems, ADVIA Centaur Calibrator 30
- Regulation section: 21 CFR § 862.1150 Calibrator, Secondary
-
- Classification: Class II
-
- Product Code: JIT
-
- Panel: Clinical Chemistry
F. Predicate Device:
The ADVIA Centaur Calibrator 30 is substantially equivalent to the ADVIA Centaur Calibrator E which was cleared under K932715/K954697
G. Device Description:
The ADVIA Centaur Calibrator 30 is a 2 level human plasma based solutions containing varying concentrations of Estradiol in charcoal stripped defibrinated human plasma, 0.1% Sodium azide and preservatives. The Estradiol calibrators have expected values of 35 and 2500 pg/mL.
The Cal 30 (2.0 mL/vial) is lyophilized. Storage for lyophilized cal is at 2 - 8°C until expiration date specified on label, reconstituted calibrator storage is at 2-80 up to 14 days, and on board is up to 4 hours.
1
Statement of Intended Use:
For in vitro diagnostic use in calibrating the following assays using the ADVIA Centaur® systems.
Enhanced Estradiol (eE2) Comparison to the Predicate Device:
Similarities and Differences between the devices and the predicate are shown below:
| Device | Predicate | |
|---|---|---|
| Item | ADVIA Centaur® Calibrator 30 | ADVIA Centaur® Calibrator E |
| K 932715/K954697 | ||
| Number of Levels | 2 | 2 |
| Form | Lyophilized | Lyophilized |
| Matrix | charcoal stripped defibrinated | |
| plasma | charcoal stripped defibrinated | |
| plasma | ||
| Intended Use | For in vitro diagnostic use | For in vitro diagnostic use |
| Storage (Lyophilized and | ||
| open vial) | 2°C to 8°C | 2°C to 8°C |
| Stability | Unopened - until expiration date | |
| on the vial label |
Opened - 14 days
or | Unopened - until expiration date
on the vial label
Opened - 14 days
or |
Similarities
2
| Device | Predicate | |
|---|---|---|
| Item | ADVIA Centaur® Calibrator 30 | ADVIA Centaur® Calibrator E |
| K 932715/ K954697 | ||
| Constituents | Estradiol, Testosterone, | |
| Progesterone and Cortisol. | Estradiol, Testosterone, | |
| Progesterone and Cortisol. |
Differences
| Device | Predicate | |
|---|---|---|
| Item | ADVIA Centaur® Calibrator 30 | ADVIA Centaur® Calibrator E |
| K 932715/ K954697 | ||
| Intended use | For use in calibrating the following | |
| assays using the ADVIA Centaur® | ||
| systems: |
Enhanced Estradiol (eE2) | For use in calibrating the following
assays using the ADVIA Centaur®
systems:
Estradiol, Testosterone,
Progesterone and Cortisol |
| Analyte Values | Enhanced Estradiol (eE2) | Estradiol, Testosterone,
Progesterone and Cortisol |
| Targeted Concentration of
levels | Low = 35 pg/mL
High = 2500 pg/mL | Low = 120 pg/mL
High = 1450 pg/mL |
Performance:
The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 30 have been
validated following procedures of Siemens Healthcare Diagnostics.
3
Conclusions:
The ADVIA Centaur Calibrator 30 is substantially equivalent to previously cleared ADVIA
Centaur Calibrator E.
:
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Siemens Healthcare Diagnostics Inc. c/o Ernest Joseph Senior Regulatory Specialist 511 Benedict Avenue Tarrytown, NY 10591
Har 1 9 2010
Re: K100293
Trade Name: ADVIA Centaur Calibrator 30 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator, Secondary Regulatory Class: Class II Product Codes: JIT Dated: January 31, 2010 Received: February 2, 2010
Dear Mr. Joseph:
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 either class II (Special Controls) or class III (PMA), 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known): Device Name: ADVIA Centaur Ca Indication for Use:
For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems.
Enhanced Estradiol (eE2)
ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.
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 (OVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) jk/00293
Page 1 of 1 -