(79 days)
No
The summary describes standard in vitro diagnostic immunoassays and their performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies. The studies focus on analytical performance metrics like linearity, precision, and method comparison, which are typical for quantitative assays and do not indicate the use of AI/ML for data analysis or interpretation.
No.
The device is an in vitro diagnostic immunoassay that quantifies total testosterone and sex hormone-binding globulin in human serum and plasma for diagnostic purposes, rather than directly providing a therapeutic effect.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assays are "used in the diagnosis and treatment of disorders" (for Testosterone II) and "intended for use as an aid in the diagnosis of androgen disorders" (for SHBG). The "Device Description" also refers to them as "in vitro diagnostic immunoassays."
No
The device is an in vitro diagnostic immunoassay kit (reagents) used on a specific hardware system (ADVIA Centaur XP system) to measure analytes in biological samples. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Both the ADVIA Centaur® Testosterone II (TSTII) and the ADVIA Centaur® SHBG assays are explicitly stated as being "for the quantitative determination of total testosterone... in human serum and plasma" and "for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma," respectively. They are also intended for use "as an aid in the diagnosis and treatment of disorders involving the male sex hormones" and "as an aid in the diagnosis of androgen disorders." These descriptions clearly indicate that the devices are intended for use in vitro (outside the body) to examine specimens derived from the human body (serum and plasma) for the purpose of providing information for diagnosis and treatment.
- Device Description: The device description explicitly states that both assays "are in vitro diagnostic immunoassays."
These statements directly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ADVIA Centaur® Testosterone II (TSTII)
The ADVIA Centaur® Testosterone II (TSTII) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur® XP system.
Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries. and adrenogenital syndromes.
ADVIA Centaur® SHBG
The ADVIA Centaur® SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur® XP system.
The ADVIA Centaur® SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
Product codes (comma separated list FDA assigned to the subject device)
CDZ
Device Description
Table 3. Summary of Ingredients of the Re-standardized ADVIA Centaur® Testosterone II (TSTII) Components
Component: ADVIA Centaur® Testosterone II (TSTII) Primary Reagent ReadyPack (included in assay kit)
ADVIA Centaur® Testosterone II (TSTII) Lite Reagent: 10.0 mL/pack, Acridinium ester-labeled hapten (36 micrograms/mL) in buffered saline with preservatives
ADVIA Centaur® Testosterone II (TSTII) Solid Phase Reagent: 17.0 mL/pack, Streptavidin-coated latex particles (0.33 g/L) in buffered saline with preservatives
ADVIA Centaur® Testosterone II (TSTII) Ancillary Reagent ReadyPack (included in assay kit)
ADVIA Centaur® Testosterone II (TSTII) Releasing Agent: 10.0 mL/pack, Steroid releasing agent (0.4 micrograms/mL) and biotinylated sheep monoclonal anti-testosterone antibody (27 micrograms/L) in buffered saline and preservatives
Table 4. Summary of Ingredients of the ADVIA Centaur® SHBG Components
Component: ADVIA Centaur® SHBG Primary Reagent ReadyPack (included in assay kit)
ADVIA Centaur® SHBG Lite Reagent: 3.0 mL/pack, Mouse monoclonal anti-SHBG antibody (~130 ng/mL) labeled with acridinium ester in HEPES-buffered saline with bovine serum albumin, mouse serum, sodium azide (
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.
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September 20, 2019
Siemens Healthcare Diagnostics Inc. Paul DaSilva Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K191533
Trade/Device Name: ADVIA Centaur® Testosterone II (TSTII), ADVIA Centaur® SHBG Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I, reserved Product Code: CDZ Dated: June 7, 2019 Received: June 10, 2019
Dear Paul DaSilva:
This letter corrects our substantially equivalent letter of August 28, 2019.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191533
Device Name ADVIA Centaur® Testosterone II (TSTII) ADVIA Centaur® SHBG
Indications for Use (Describe)
ADVIA Centaur® Testosterone II (TSTII)
The ADVIA Centaur® Testosterone II (TSTI) assav is for in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system.
Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
ADVIA Centaur® SHBG
The ADVIA Centaur® SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system.
The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K191533
Date Prepared 1.
June 7, 2019
Applicant Information 2.
| Contact: | Paul DaSilva
Regulatory Affairs Specialist |
|----------|-----------------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591-5097 |
| Phone: | 914-524-3141 |
| Fax: | 914-524-2101 |
| Email: | paul.dasilva@siemens-healthineers.com |
Regulatory Information 3.
Table 1. Regulatory Information for ADVIA Centaur® Testosterone II (TSTII)
| Trade Name | ADVIA Centaur® Testosterone II (TSTII) |
|---|---|
| Common Name | Radioimmunoassay, testosterones and dihydrotestosterone |
| Classification Name | Testosterone test system |
| FDA Classification | Class I (Reserved) |
| Review Panel | Clinical Chemistry |
| Product Code | CDZ |
| Regulation Number | 862.1680 |
Table 2. Regulatory Information for ADVIA Centaur® SHBG
| Trade Name | ADVIA Centaur® SHBG |
|---|---|
| Common Name | Radioimmunoassay, testosterones and dihydrotestosterone |
| Classification Name | Testosterone test system |
| FDA Classification | Class I (Reserved) |
| Review Panel | Clinical Chemistry (75) |
| Product Code | CDZ |
| Regulation Number | 862.1680 |
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Predicate Device Information 4.
ADVIA Centaur® Testosterone II (TSTII)
Predicate Device Name: ADVIA Centaur® Testosterone II (TSTII)
510(k) Number: K151986
The re-standardized ADVIA Centaur® Testosterone II (TSTII) is substantially equivalent to the ADVIA Centaur® Testosterone II (TSTII) that was cleared under 510(k) (K151986), as shown below in the Substantial Equivalence Information section.
ADVIA Centaur® SHBG
Predicate Device Name: ADVIA Centaur® SHBG
510(k) Number: K151986
The ADVIA Centaur® SHBG with new reference intervals in the Instructions for Use (Package Insert) does not require any other device modifications (i.e. no change to design or manufacturing process). Therefore, as shown below in the Substantial Equivalence Information section, the predicate and subject devices are the same.
5. Intended Use / Indications for Use
ADVIA Centaur® Testosterone II (TSTII)
The ADVIA Centaur® Testosterone II (TSTII) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur® XP system.
Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries. and adrenogenital syndromes.
ADVIA Centaur® SHBG
The ADVIA Centaur® SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur® XP system.
The ADVIA Centaur® SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
Device Description 6.
Table 3. Summary of Ingredients of the Re-standardized ADVIA Centaur® Testosterone II (TSTII) Components
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur ® Testosterone II (TSTII) Primary Reagent ReadyPack (included in assay kit) | ||
| ADVIA Centaur ® | ||
| Testosterone II (TSTII) | ||
| Lite Reagent | 10.0 mL/pack | Acridinium ester-labeled hapten (36 µg/mL) in |
| buffered saline with preservatives |
5
| Table 3. Summary of Ingredients of the Re-standardized ADVIA Centaur® Testosterone | |
|---|---|
| II (TSTII) Components |
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur® | ||
| Testosterone II (TSTII) | ||
| Solid Phase Reagent | 17.0 mL/pack | Streptavidin-coated latex particles (0.33 g/L) in |
| buffered saline with preservatives | ||
| ADVIA Centaur® Testosterone II (TSTII) Ancillary Reagent ReadyPack (included in assay | ||
| kit) | ||
| ADVIA Centaur® | ||
| Testosterone II (TSTII) | ||
| Releasing Agent | 10.0 mL/pack | Steroid releasing agent (0.4 $ \mu $ g/mL) and biotinylated |
| sheep monoclonal anti-testosterone antibody (27 $ \mu $ g/L) in buffered saline and preservatives |
| Table 4. Summary of Ingredients of the ADVIA Centaur® SHBG Components | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | ----------------------------------------------------------------------- |
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur® SHBG Primary Reagent ReadyPack (included in assay kit) | ||
| ADVIA Centaur® SHBG | ||
| Lite Reagent | 3.0 mL/pack | Mouse monoclonal anti-SHBG antibody (~130 ng/mL) labeled with acridinium ester in HEPES-buffered saline with bovine serum albumin, mouse serum, sodium azide (AR* |
- AR = Assay Range
Performance Characteristics: ADVIA Centaur® SHBG 11.
The change in reference intervals in the Instructions for Use (Package Inserts) for the ADVIA Centaur® SHBG that was cleared in 2016 under 510(k) K151986 does not require the collection of additional analytical performance data. Therefore, all analytical performance data previously reviewed for the ADVIA Centaur® SHBG continues to apply to this assay. because the assay was not modified. These performance data are cross-referenced to the 510(k) submission for the ADVIA Centaur® SHBG (K151986 and K091867).
Specifically, the following studies are not needed for the purpose of this submission:
- Detection Capability (LoB, LoD, LoQ)
- Linearity ●
- Precision
- . Dilution Recovery
- Method Comparison
- Calibrator/Assay Traceability ●
- Reagent On-Board Stability and Calibration Interval
- Cross reactivity ●
- Interfering substances
- Matrix Comparison
- Shelf Life Stabilitv ●
- Onboard Stability ●
- Open Vial Stability ●
Clinical Studies 11.1
Not applicable.
11.2 Clinical Cut-off
Not applicable.
11.3 Biotin Interference
Specimens that contain biotin at a concentration of 300 ng/mL demonstrate a less than or equal to 10% change in results. A summary of the results is presented below.
13
| Analyte
Concentration
| (nmol/L) | Biotin Test Level (ng/mL) | |||||
|---|---|---|---|---|---|---|
| 38 | 75 | 150 | 300 | 600 | 1200 | |
| % Bias | ||||||
| 19.6 | -3 | -3 | -9 | -7 | -7 | -25 |
| 44.1 | -2 | 1 | -3 | -7 | -9 | -26 |
Conclusions 12.
Based on the results of comparative testing, the re-standardized ADVIA Centaur® Testosterone II (TSTII) is substantially equivalent in principle and performance to the currently-marketed predicate device, the ADVIA Centaur® Testosterone II (TSTII) cleared under 510(k) K151986.
The ADVIA Centaur® SHBG with the new reference intervals in the Instructions for Use (package insert) is substantially equivalent to the currently marketed ADVIA Centaur® SHBG (K151986). The new reference intervals that will replace the current reference intervals in the Instructions for Use (Package Inserts) for the currently marketed assay do not require collection of additional analytical performance data.