(532 days)
No
The summary describes a standard in vitro diagnostic immunoassay for hCG detection, focusing on reagent composition, performance characteristics (precision, linearity, interference), and method comparison. There is no mention of AI, ML, image processing, or any data analysis techniques that would suggest the use of such technologies.
No
This device is for in vitro diagnostic use, intended for quantitative determination of human chorionic gonadotropin (hCG) in serum or plasma to aid in early detection of pregnancy. It does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in serum or plasma... Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy." This indicates that the device is used for diagnosis.
No
The device description clearly outlines physical reagents (Lite Reagent, Solid Phase Reagent, Diluent) which are hardware components, not software. The intended use is for an in vitro diagnostic assay using a specific system (ADVIA Centaur® XP system), further indicating a hardware-dependent process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "For in vitro diagnostic use".
- Device Description: Describes reagents and components used to perform a test on biological samples (serum or plasma).
- Intended User/Care Setting: States "For in vitro diagnostic use".
- Performance Studies: Details studies conducted to validate the performance of the assay for diagnostic purposes (detection capability, precision, method comparison, etc.).
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in serum or plasma (EDTA or lithium heparin) using the ADVIA Centaur® XP system.
Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.
Product codes
DHA
Device Description
The ADVIA Centaur® Total hCG assay reagents come in the following configurations:
- 5 ReadyPack primary reagent packs containing ADVIA Centaur Total hCG Lite Reagent and Solid Phase ADVIA Centaur and ADVIA Centaur CP Total hCG Master Curve card (250 tests)
- 1 ReadyPack primary reagent pack containing ADVIA Centaur Total hCG Lite Reagent and Solid Phase ADVIA Centaur and ADVIA Centaur CP Total hCG Master Curve card (50 tests)
The ReadyPack consists of the following:
- ADVIA Centaur ThCG ReadyPack® primary reagent pack; Lite Reagent: 5.0 mL/reagent pack polyclonal goat anti-hCG antibody (~0.1 µg/mL) labeled with acridinium ester in buffered saline with sodium azide (0.1%) and preservatives
- ADVIA Centaur ThCG ReadyPack primary reagent pack; Solid Phase Reagent: 22.5 mL/reagent pack monoclonal mouse anti-hCG antibody (~0.02 mg/mL) covalently coupled to paramagnetic particles in buffered saline with sodium azide (0.1%) and preservatives
- ADVIA Centaur ThCG ReadyPack ancillary reagent pack; ThCG Diluent: 25.0 mL/reagent pack buffered heat-treated equine serum with EDTA, sodium azide (
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
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July 13, 2021
Siemens Healthcare Diagnostics, Inc. Mey Vasquez Regulatory Clinical Affairs Specialist 511 Benedict Ave. Tarrytown, New York 10591
Re: K200210
Trade/Device Name: ADVIA Centaur® Total hCG assay Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: DHA Dated: October 16, 2020 Received: October 20, 2020
Dear Mey Vasquez:
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.
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
1
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 medical devices and radiation-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,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200210
Device Name ADVIA Centaur® Total hCG assay
Indications for Use (Describe)
For in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in serum or plasma (EDTA or lithium heparin) using the ADVIA Centaur® XP system.
Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness
Introduction: According to the requirements of SMDA 1990 and 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: _
APPLICANT 1.
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA
| Contact: | Mey Vasquez |
|---|---|
| Regulatory Clinical Affairs Specialist | |
| Phone: | (201) 982-2455 |
| Fax: | (914) 524-3579 |
| E-mail: | mey.vasquez@siemens-healthineers.com |
Date Prepared: October 16, 2020
Regulatory Information 2.
Assay
| Trade Name | ADVIA Centaur® Total hCG assay |
|---|---|
| Device | system, test, human chorionic gonadotropin |
| Regulation Description | Human chorionic gonadotropin (HCG) test system |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry |
| Product Code | DHA |
| Regulation Number | 21 CFR 862.1155 |
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3. PREDICATE DEVICE
Assay
Name of Device: Atellica IM Total hCG (ThCG)
510 (k): K172322
4. DEVICE DESCRIPTION
The ADVIA Centaur® Total hCG assay reagents come in the following configurations:
| Contents | Number
of Tests |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| 5 ReadyPack primary reagent packs containing ADVIA Centaur
Total hCG Lite Reagent and Solid Phase ADVIA Centaur and
ADVIA Centaur CP Total hCG Master Curve card | 250 |
| 1 ReadyPack primary reagent pack containing ADVIA Centaur Total
hCG Lite Reagent and Solid Phase ADVIA Centaur and ADVIA
Centaur CP Total hCG Master Curve card | 50 |
The ReadyPack consists of the following:
ADVIA Centaur ThCG ReadyPack® primary reagent pack; Lite Reagent
5.0 mL/reagent pack polyclonal goat anti-hCG antibody (~0.1 µg/mL) labeled with acridinium ester in buffered saline with sodium azide (0.1%) and preservatives
ADVIA Centaur ThCG ReadyPack primary reagent pack; Solid Phase Reagent
22.5 mL/reagent pack monoclonal mouse anti-hCG antibody (~0.02 mg/mL) covalently coupled to paramagnetic particles in buffered saline with sodium azide (0.1%) and preservatives
ADVIA Centaur ThCG ReadyPack ancillary reagent pack; ThCG Diluent
25.0 mL/reagent pack buffered heat-treated equine serum with EDTA, sodium azide (