(33 days)
Not Found
No
The summary describes a standard immunoassay using chemiluminescence detection for qualitative detection of antibodies. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance metrics.
No
Explanation: This device is an in vitro diagnostic (IVD) test intended to detect IgM antibodies to the Zika virus for diagnostic purposes, not to directly treat or prevent a disease.
Yes
The device is explicitly stated for "in vitro diagnostic use" and "intended for the presumptive clinical laboratory diagnosis of Zika virus infection," directly supporting its function as a diagnostic tool.
No
The device description explicitly lists multiple physical components (reagents, calibrators, controls) that are part of the device. It also mentions the use of ADVIA Centaur XP and ADVIA Centaur XPT systems, which are hardware platforms. This indicates it is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states "The ADVIA Centaur® Zika test is for in vitro diagnostic use". This is the most direct indicator.
- Specimen Type: The test is designed to analyze human serum and plasma specimens, which are biological samples taken from the body but tested outside of it.
- Purpose: The intended use is for the "qualitative detection of IgM antibodies to the Zika virus" and the "presumptive clinical laboratory diagnosis of Zika virus infection." This clearly indicates a diagnostic purpose performed on biological samples.
- Device Description: The components listed are reagents, calibrators, and controls, which are typical components of an in vitro diagnostic assay.
- Performance Studies: The document details performance studies evaluating the test's ability to detect Zika antibodies in human samples, including sensitivity, specificity, and agreement with other tests. This is standard for demonstrating the performance of an IVD.
- Intended User/Care Setting: The intended user is a "clinical laboratory," which is where in vitro diagnostic testing is performed.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Zika test is for in vitro diagnostic use in the qualitative detection of IgM antibodies to the Zika virus in human serum and plasma (potassium EDTA or lithium heparin) specimens using the ADVIA Centaur XP and ADVIA Centaur XPT systems.
The ADVIA Centaur Zika test is intended for the presumptive clinical laboratory diagnosis of Zika virus infection. The test is intended for use only in individuals (children, adolescents and adults, including pregnant women) with clinical signs and symptoms consistent with Zika virus infection, and/or meeting the CDC Zika virus epidemiological criteria (history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day 4 post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
The ADVIA Centaur Zika test is not indicated for testing blood or plasma donors.
Product codes (comma separated list FDA assigned to the subject device)
QFO, QCH
Device Description
The ADVIA Centaur Zika test consists of several components for the detection of IgM antibodies to the Zika virus. These include:
ADVIA Centaur Zika Ab Primary Reagent ReadyPack:
- ADVIA Centaur Zika Ab Lite Reagent: 5.0 mL/pack (x1), containing NS1 Antigen labeled with acridinium ester (0.4 microg/mL) in buffered saline with surfactant, blockers, sodium azide (
§ 866.3935 Zika virus serological reagents.
(a)
Identification. Zika virus serological reagents arein vitro diagnostic devices that consist of antigens or antibodies for the detection of Zika virus or Zika antibodies in human specimens from individuals who have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The detection aids in the diagnosis of current or recent Zika virus infection or serological status. Negative results obtained with this test do not preclude the possibility of Zika virus infection, past or present. Positive results should be interpreted with consideration of other clinical information and laboratory findings and should not be used as the sole basis for treatment or other patient management decisions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The labeling required under § 809.10(b) of this chapter must include:
(i) An intended use with a detailed description of what the device detects (Zika IgM antibodies, other Zika antibodies, or Zika antigens), the type of results provided to the user, the specimen type for which testing is indicated (
e.g., serum, whole blood), the clinical indications appropriate for test use, and the specific population(s) for which the test is intended.(ii) Performance characteristics from analytical and clinical studies required under paragraphs (b)(2)(ii) and (iii) of this section.
(iii) A detailed explanation of the interpretation of results and criteria for validity of results (
e.g., criteria that internal or external quality controls must meet in order for a test/test run to be valid, minimum signal strength that the sample has to yield to be interpretable as a valid result).(iv) Limiting statements indicating that:
(A) Results are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. The test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence.
(B) Device results are intended to be followed up according to the latest professional guidelines (
e.g., recommendations from the Centers for Disease Control and Prevention) for the diagnosis of Zika virus infection.(C) Negative test results do not preclude the possibility of Zika virus infection, past or present.
(D) Specimens can result in false negative results on the device if collected outside of the appropriate response window for specific Zika virus antigens or antibodies, as determined by scientific evidence (
e.g., for IgM
0
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Siemens Healthcare Diagnostics Inc. Matthew Gee Senior Manager, Regulatory Affairs 511 Benedict Avenue Tarrytown, New York 10591
July 17, 2019
Re: K191578
Trade/Device Name: ADVIA Centaur Zika test. ADVIA Centaur Zika Ab (100 tests). ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control Regulation Number: 21 CFR 866.3935 Regulation Name: Zika Virus Serological Reagents Regulatory Class: Class II Product Code: QFO, QCH Dated: June 12, 2019 Received: June 14, 2019
Dear Matthew Gee:
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
1
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 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,
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ADVIA Centaur Zika test
Indications for Use (Describe)
The ADVIA Centaur Zika test is for in vitro diagnostic use in the qualitative detection of IgM antibodies to the Zika virus in human serum and plasma (potassium EDTA or lithium heparin) specimens using the ADVIA Centaur XPT systems.
The ADVIA Centaur Zika test is intended for the presumptive clinical laboratory diagnosis of Zika virus infection. The test is intended for use only in individuals (children, adolescents and adults, including pregnant women) with clinical signs and symptoms consistent with Zika virus infection, and/or meeting the CDC Zika virus epidemiological criteria (history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day 4 post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
The ADVIA Centaur Zika test is not indicated for testing blood or plasma donors.
| 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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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: K191578
Date Prepared 1.
July 15, 2019
Applicant Information 2.
| Contact: | Matthew Gee, M.Sc.
Senior Manager, Regulatory Affairs |
|----------|-----------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-372-9169 |
| Fax: | 914-524-3579 |
Email: matthew.gee@siemens.com
3. Regulatory Information
Table 1. Regulatory Information for ADVIA Centaur Zika Test
| Trade Name | ADVIA Centaur® Zika test |
|---|---|
| Model Numbers | ADVIA Centaur Zika Ab (100 tests): 11202473 |
| ADVIA Centaur Zika IgM (50 tests): 11202471 | |
| ADVIA Centaur Zika Ab Quality Control: 11202474 | |
| ADVIA Centaur Zika IgM Quality Control: 11202472 | |
| Regulation Number | 866.3935 |
| Regulation Name | Zika Virus Serological Reagents |
| Regulation Definition | Zika virus serological reagents are devices that consist of |
| antigens and antisera for the diagnosis of Zika virus infection | |
| in human clinical specimens from individuals that have signs | |
| and symptoms consistent with Zika virus infection and/or | |
| epidemiological risk factors. The device aids in the | |
| presumptive clinical diagnosis of Zika virus infection in | |
| conjunction with other clinical and laboratory findings. | |
| Product Code | QFO |
| Regulatory Class | Class II |
| Review Panel | Microbiology (83) |
4. Predicate Device Information
Predicate Device Name: ZIKV Detect 2.0 IgM Capture ELISA
De Novo Request Number: DEN180069
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Intended Use / Indications for Use 5.
The ADVIA Centaur® Zika test is for in vitro diagnostic use in the qualitative detection of IgM antibodies to the Zika virus in human serum and plasma (potassium EDTA or lithium heparin) specimens using the ADVIA Centaur XP and ADVIA Centaur XPT systems.
The ADVIA Centaur Zika test is intended for the presumptive clinical laboratory diagnosis of Zika virus infection. The test is intended for use only in individuals (children, adolescents and adults, including pregnant women) with clinical signs and symptoms consistent with Zika virus infection, and/or meeting the CDC Zika virus epidemiological criteria (history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Neqative results may be seen in specimens collected before day 4 post onset of symptoms or after the window of detectable IqM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
The ADVIA Centaur Zika test is not indicated for testing blood or plasma donors.
6. Device Description
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur Zika Ab Primary Reagent ReadyPack (included in Zika Ab assay kit) | ||
| ADVIA Centaur Zika Ab Lite Reagent | 5.0 mL/pack (x1) | NS1 Antigen labeled with acridinium ester (0.4 µg/mL) in buffered saline with surfactant, blockers, sodium azide ( 1.90: |
| Presumptive Zika Positive |
Initial: Zika Ag OD450 ≥ Threshold Zika Ag
OD450 AND 1.50 ≤ Zika ISR ≤ 1.90:
Retest in duplicate
Retest: Zika Ag OD450 ≥ Threshold Zika Ag
OD450 AND Zika ISR value ≥ 1.70
Presumptive Zika Positive
Not Presumptive Zika Positive & CCA /
NCA ratio ≥ 5.00:
Presumptive Other Flavivirus Positive
Not Presumptive Zika Positive & CCA /
NCA ratio