(53 days)
Not Found
No
The document describes a calibration material for an in vitro diagnostic assay, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is described as an in vitro diagnostic (IVD) product used for verifying calibration and reportable range in an assay, not for treating a disease or condition.
No
This device is described as "Master Curve Material" for "verification of calibration and reportable range" in an assay. It is a control material used to ensure the accuracy of another diagnostic assay, rather than being a diagnostic device itself.
No
The device description clearly states it is a material (buffer, serum, estradiol) in vials, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "for in vitro diagnostic use".
- Device Description: The description details the composition of the material, which is used in a laboratory setting to verify the performance of an assay (the ADVIA Centaur® Enhanced Estradiol (eE2) assay). This is a typical characteristic of an IVD.
- Performance Studies: The "Summary of Performance Studies" mentions validation and traceability, which are standard requirements for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K062501) indicates that this device is being compared to a previously cleared IVD by a regulatory body like the FDA.
All these points strongly indicate that the ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay.
Product codes
JJX
Device Description
The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material, Level 1 is buffer with bovine serum albumin and preservatives. Levels 2-6 are various levels of USP-Grade estradiol in Ivophilized normal male serum with sodium azide (0.1% after reconstitution) and preservatives.
The eE2 Master Curve Materials have expected values (lot specific) of 0, 60, 175, 450, 1500 and 2700 pg/mL.
The eE2 Master Curve Material (1.0 mL/vial) are Ivophilized material and stored at 2 -8°C.
CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAq), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The traceability, value assignment, and stability of the ADVIA Centaur® Enhanced Estradiol Master Curve Materials have been validated following procedures of Siemens Healthcare Diagnostics. These Enhanced Estradiol Master Curve Material are substantially equivalent to currently marketed devices with similar intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
| Submitter information
Contact person: | Clare Santulli
Sr. Regulatory Technical Specialist | NOV 2 3 2010 |
|-----------------------------------------------------|-----------------------------------------------------------------------------------|--------------|
| Address: | Siemens Healthcare Diagnostics, Inc
511 Benedict Avenue
Tarrytown, NY 10591 | |
| Phone: | 914-524-2701
914-524-3579 (fax) | |
| Date summary prepared: | September 29, 2010 | |
| Device Trade or Proprietary Name: | ADVIA Centaur® Enhanced Estradiol (eE2)
Master Curve Material | |
| Device Common/Usual Name or
Classification Name: | Single (Specified) Analyte Controls (Assayed And
Unassayed) | |
| Classification Number/Class: | JJX / Class I | |
| Classification Panel: | Clinical Chemistry (75) | |
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: ________________________________________
Predicate Devices:
| Device Name | VALIDATE Thyroid Calibration Verification Test Set |
|---|---|
| Common name | VALIDATE THY Calibration Verification Test Set |
| 510(k) Number | K062501 |
| Manufacturer | Maine Standards Company |
1
Device Description:
The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material, Level 1 is buffer with bovine serum albumin and preservatives. Levels 2-6 are various levels of USP-Grade estradiol in Ivophilized normal male serum with sodium azide (0.1% after reconstitution) and preservatives.
The eE2 Master Curve Materials have expected values (lot specific) of 0, 60, 175, 450, 1500 and 2700 pg/mL.
The eE2 Master Curve Material (1.0 mL/vial) are Ivophilized material and stored at 2 -8°C.
CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAq), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.
Statement of Intended Use:
The ADVIA Centaur® Enhanced Estradiol Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay,
Performance:
The traceability, value assignment, and stability of the ADVIA Centaur® Enhanced Estradiol Master Curve Materials have been validated following procedures of Siemens Healthcare Diagnostics. These Enhanced Estradiol Master Curve Material are substantially equivalent to currently marketed devices with similar intended uses.
2
Comparison to the Predicate Device:
Similarities and Differences between the devices and the predicate are shown below:
Comparison Table*
| Device | Predicate | |
|---|---|---|
| Item | ADVIA Centaur® Master Curve | |
| Material | Maine Standards Company | |
| VALIDATE Thyroid Calibration | ||
| Verification Test Set | ||
| (K062501) | ||
| Intended Use | The ADVIA Centaur® Enhanced | |
| Estradiol Master Curve Material | ||
| is for in vitro diagnostic use in | ||
| the verification of calibration and | ||
| reportable range in the ADVIA | ||
| Centaur® Enhanced Estradiol | ||
| (eE2) assay. | The VALIDATE Thyroid | |
| Calibration Verification Test Set | ||
| solutions are for in vitro | ||
| diagnostic use in the quantitative | ||
| determination of linearity, | ||
| calibration verification and | ||
| verification of reportable range in | ||
| automated, semi-automated and | ||
| manual chemistry systems. | ||
| Form | Lyophilized | Liquid |
| Analytes | Enhanced Estradiol only | Multiple analytes including |
| Triiodothyronine (Ta), Thyroxine | ||
| ff4), human Thyroid Stimulating | ||
| Hormone (TSH), and Cortisol | ||
| Matrix | Human Serum | Human Serum |
| Storage | 2°C to 8°C | -10°C to -20°C |
| Stability | Unopened - until expiration date | |
| on the vial label |
Reconstituted - 14 days
or
On-board - 6 hours | Unopened - until expiration date
on storage container when stored
as directed |
| Differences | Verification of calibration and
reportable range for the ADVIA
Centaur® Enhanced Estradiol
assay. | Verification of calibration,
linearity, and reportable range for
multiple assays (Triiodothyronine
(Ta), Thyroxine ff4), human
Thyroid Stimulating Hormone
(TSH), and Cortisol) |
- From Instructions for Use
3
Conclusions:
The ADVIA Centaur® Enhanced Estradiol Master Curve Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Maine Standards Company, VALIDATE Thyroid Calibration Verification Test Set (K062501) in intended use and matrix.
Siemens Healthcare Diagnostics, Inc ADVIA Centaur eE2 Master Curve Materials Premarket Notification - Abbreviated 510(k) September 2010
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and monochromatic.
Public Health Service
Siemens Healthcare Diagnostics c/o Clare Santulli 511 Benedict Avenue Tarrytown. NY 10591 USA
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K102904
Trade Name: ADVIA Centaur Enhanced Estradiol (eE2) Master Curve Material Regulation Number: 21 CFR 862.1660. Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX NOV 2 3 2010 Dated: November 5, 2010 Received: November 8, 2010
Dear Ms. Santulli:
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).
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Page 2 -
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/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
G.C.
Courmey 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
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Indication for Use
NOV 2 3 2010
510(k) Number (if known) K 1029DY
Device Name: ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material
Indication For Use:
The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay.
Prescription Use _ V (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)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102904