(84 days)
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No
The device description and performance studies focus on a standard immunoassay technology and do not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for the qualitative detection of IgG antibodies to cytomegalovirus (CMV) to determine serological status and aid in diagnosis. It does not treat or alleviate a disease, therefore it is not a therapeutic device.
Yes
The device detects IgG antibodies to CMV, which is used to determine CMV IgG serological status and aid in the diagnosis of CMV infection. This direct detection of disease markers for diagnostic purposes makes it a diagnostic device.
No
The device is an in vitro diagnostic assay kit that includes reagents, calibrators, and quality control materials, which are physical components, not solely software. It is used on the ADVIA Centaur XP system, which is a hardware platform.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "for in vitro diagnostic use" for both the ADVIA Centaur CMV IgG assay and the ADVIA Centaur CMV IgG Quality Control. It also describes the intended use as detecting antibodies in human serum and plasma to aid in the diagnosis of CMV infection.
- Device Description: The description details the components of the assay kit, including reagents and calibrators, which are typical for IVD devices used in laboratory settings.
- Intended User/Care Setting: The mention of "in vitro diagnostic use" implies use in a laboratory or clinical setting by trained personnel.
- Performance Studies: The document provides detailed information about performance studies, including method comparison with a predicate device, precision, reproducibility, interference, cross-reactivity, and matrix comparison. These types of studies are required for regulatory approval of IVD devices to demonstrate their accuracy and reliability.
- Predicate Device(s): The identification of a predicate device (bioMerieux VIDAS CMV IgG (CMVG) Assay) is a strong indicator that this device is being submitted for regulatory review as an IVD, as comparison to a legally marketed predicate is a common pathway for IVD clearance.
N/A
Intended Use / Indications for Use
ADVIA Centaur CMV lgG:
The ADVIA Centaur® CMV IgG (CMV IgG) assay is for in vitro diagnostic use in the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human pediatric and adult serum and plasma (dipotassium EDTA, lithium heparin) using the ADVIA Centaur XP system. The assay is used to determine CMV IgG serological status and as an aid in the diagnosis of CMV infection in individuals for whom a CMV IgG test was ordered, including pregnant women. The ADVIA Centaur CMV IgG assay is not intended for blood and tissue donor screening.
ADVIA Centaur® CMV IgG Quality Control:
The ADVIA Centaur® CMV IgG) Quality Control material is for in vitro diagnostic use for monitoring the performance of the ADVIA Centaur CMV IgG (CMV IgG) assay on ADVIA Centaur systems.
Product codes (comma separated list FDA assigned to the subject device)
LFZ, OCH
Device Description
CMV IgG Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CMV IgG Lite Reagent and Solid Phase reagent, and 1 ReadyPack ancillary reagent pack that contains ADVIA Centaur CMV IgG Diluent, and a set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each). The reagents and calibrators are packaged together in the ADVIA Centaur CMV IgG Assay kit, while the associated ADVIA Centaur CMV IgG Quality Control is packaged separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
pediatric and adult
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
A comparison study between ADVIA Centaur CMV IgG assay and a comparator CMV IgG assay was performed to determine the placement of the cutoff value at a 1.00 Index by testing 389 remnant clinical samples. Of these, 196 samples were negative, 186 samples were positive, and the rest were equivocal by the comparator device. The cutoff value was set at ≥ 95% positive agreement and ≥ 95% negative agreement to the comparator device. Assigned values for calibrators and controls are based on the cutoff Index determination.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Principle: The ADVIA Centaur CMV IgG assay is a fully automated, 2-step sandwich immunoassay using indirect chemiluminometric technology. The patient specimen is diluted with ADVIA Centaur CMV IgG Diluent and incubated with the Solid Phase reagent. The Solid Phase reagent contains a heterogeneous mixture of biotinylated CMV viral lysate antigens, preformed to streptavidin-coated magnetic particles. The antigen-coated particles subsequently capture CMV-specific antibodies in the specimen. The antibody-antigen complex is washed and Lite reagent is added. The Lite reagent consists of an acridinium-ester (AE)-labeled anti-human IgG mouse monoclonal antibody. The entire complex is washed and the signal is generated in the presence of Lite Reagent bound to the Solid Phase via the CMV IgG-CMV antigen complex.
Precision: Precision was evaluated according to CLSI document EP05-A3. Repeatability and Within-Lab imprecision were evaluated by testing 5 serum-based samples (serum sample pools), and 2 plasma-based samples (controls. negative and positive). The samples were assayed in duplicate over the course of 20 days, 2 runs per day, for a total of 40 runs and 80 replicates.
Reproducibility: The reproducibility study was conducted at three external sites using 2 reagent lots. The protocol was run over 5 days, 2 runs per day, and 3 replicates per run for the sample pools, and 6 replicates per run for the negative and positive control materials. Reproducibility data was pooled for each reagent lot across three sites.
Interference: Interference by endogenous substances in the ADVIA Centaur CMV IgG assay was evaluated at four CMV IgG levels (low negative, high negative, low positive, and high positive). Interfering substances at the levels indicated were tested as described in CLSI Document EP07-A2. There was no change in clinical interpretation throughout the assay range at the levels indicated.
Cross-reactivity: The ADVIA Centaur CMV IgG assay was evaluated for potential cross-reactivity in specimens with other viral and microbial antibodies and other disease states. The CMV IgG status of each sample was compared using the comparator assay. Sample size: 297.
Matrix Comparison: The ADVIA Centaur CMV IgG assay was evaluated using different specimen matrices. ADVIA Centaur CMV IgG results that ranged from 0.74-28.55 Index were analyzed using orthogonal regression. Sample size: 38 (Dipotassium EDTA plasma), 38 (Lithium heparin plasma).
Method Comparison with predicate device: Percent agreement was determined by comparing the performance of the ADVIA Centaur CMV IgG assay to a comparator CMV IgG assay. A total of 1842 samples that were sent for CMV IgG testing were analyzed, including: 1699 prospectively collected specimens (684 general population subjects, 348 pregnant subjects, 229 pediatric subjects (2-21 years old), 44 HIV-positive subjects, 394 transplant-patient subjects) and 143 retrospective HIV-positive specimens.
CDC Panel: A panel of 80 previously characterized serum samples was obtained from the CDC and evaluated with the ADVIA Centaur CMV IgG assay to determine the performance of the assay. There was 100% agreement with the serological status provided by the CDC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Study - Combined Population:
Positive agreement: 99.6% (1037/1041), 95% Confidence Interval: 99.0%-99.9%
Negative agreement: 96.8% (637/658), 95% Confidence Interval: 95.2%-98.0%
Subjects Sent for CMV IgG Testing:
Positive agreement: 99.5% (375/377), 95% Confidence Interval: 98.1%-99.9%
Negative agreement: 95.8% (294/307), 95% Confidence Interval: 92.9%-97.7%
Pregnant Women Subgroup:
Positive agreement: 100.0% (287/287), 95% Confidence Interval: 98.7%-100.0%
Negative agreement: 98.4% (60/61), 95% Confidence Interval: 91.2%-99.9%
Pediatric Subgroup:
Positive agreement: 98.8% (80/81), 95% Confidence Interval: 93.3%-99.9%
Negative agreement: 98.6% (146/148), 95% Confidence Interval: 95.2%-99.8%
HIV-Positive Patient Subgroup:
Positive agreement: 100.0% (43/43), 95% Confidence Interval: 91.8%–100.0%
Negative agreement: 100.0% (1/1), 95% Confidence Interval: 2.5%–100.0%
Transplant Patient Subgroup - Preoperative:
Positive agreement: 100.0% (151/151), 95% Confidence Interval: 97.6%–100.0%
Negative agreement: 100.0% (87/87), 95% Confidence Interval: 95.8%–100.0%
Transplant Patient Subgroup - Postoperative:
Positive agreement: 99.0% (101/102), 95% Confidence Interval: 94.7%-99.9%
Negative agreement: 90.7% (49/54), 95% Confidence Interval: 79.7%-96.9%
Retrospective HIV-Positive Patient Subgroup:
Positive agreement: 100.0% (135/135), 95% Confidence Interval: 97.3%-100.0%
Negative agreement: 100.0% (8/8), 95% Confidence Interval: 63.1%-100.0%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 30, 2018
Siemens Healthcare Diagnostics, Inc. Kira Gordon Sr. Regulatory Affairs Specialist 511 Benedict Ave Tarrytown, New York 10591
Re: K181213
Trade/Device Name: ADVIA Centaur CMV IgG ADVIA Centaur CMV IgG Quality Control Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: Class II Product Code: LFZ, OCH Dated: May 1, 2018 Received: May 7, 2018
Dear Kira Gordon:
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. 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Steven R. Gitterman -S for
Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181213
Device Name ADVIA Centaur® CMV IgG ADVIA Centaur® CMV IgG Quality Control
Indications for Use (Describe)
ADVIA Centaur CMV lgG:
The ADVIA Centaur® CMV IgG (CMV IgG) assay is for in vitro diagnostic use in the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human pediatric and adult serum and plasma (dipotassium EDTA, lithium heparin) using the ADVIA Centaur XP system. The assay is used to determine CMV IgG serological status and as an aid in the diagnosis of CMV infection in individuals for whom a CMV IgG test was ordered, including pregnant women. The ADVIA Centaur CMV IgG assay is not intended for blood and tissue donor screening.
ADVIA Centaur® CMV IgG Quality Control:
The ADVIA Centaur® CMV IgG) Quality Control material is for in vitro diagnostic use for monitoring the performance of the ADVIA Centaur CMV IgG (CMV IgG) assay on ADVIA Centaur systems.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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.
1. Applicant:
| Contact: | Kira Gordon, PhD
Sr. Regulatory Affairs Specialist |
|----------|--------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown, NY 10591 |
| Phone: | (914) 524-2996 |
| FAX: | (914) 524-3579 |
| Email: | kira.gordon@siemens-healthineers.com |
-
- Date: May 01, 2018
3. Proprietary and Established Names:
ADVIA® Centaur CMV IgG ADVIA® Centaur CMV IgG Quality Control
4. Regulatory Information:
Classification Names: | Cytomegalovirus serological reagents |
---|---|
Regulation Number: | 21 CFR § 866.3175 |
Classification: | Class II |
Product Code: | LFZ |
Panel: | Microbiology (83) |
4. Predicate Device:
Device Name: bioMerieux VIDAS CMV IgG (CMVG) Assay 510(k) Number: K920661 Manufacturer: bioMerieux
5. Indications for Use:
ADVIA Centaur CMV lgG:
The ADVIA Centaur® CMV IgG Assay is for in vitro diagnostic use in the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human pediatric and adult serum and plasma (dipotassium EDTA, lithium heparin) using the ADVIA Centaur XP system. The assay is used to determine CMV IgG serological status and as an aid in the diagnosis of CMV infection in individuals for whom a CMV IgG test was ordered, including pregnant women.
The ADVIA Centaur CMV IgG assay is not intended for blood and tissue donor screening.
ADVIA Centaur® CMV IgG Quality Control: The ADVIA Centaur® CMV IgG (CMV IgG) Quality Control material is for in vitro
4
diagnostic use for monitoring the performance of the ADVIA Centaur CMV IgG (CMV IgG) assay on ADVIA Centaur systems.
9. Device Description:
CMV IgG Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CMV IgG Lite Reagent and Solid Phase reagent, and 1 ReadyPack ancillary reagent pack that contains ADVIA Centaur CMV IgG Diluent, and a set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each). The reagents and calibrators are packaged together in the ADVIA Centaur CMV IgG Assay kit, while the associated ADVIA Centaur CMV IgG Quality Control is packaged separately.
10. Test Principle
The ADVIA Centaur CMV IgG assay is a fully automated, 2-step sandwich immunoassay using indirect chemiluminometric technology. The patient specimen is diluted with ADVIA Centaur CMV IgG Diluent and incubated with the Solid Phase reagent. The Solid Phase reagent contains a heterogeneous mixture of biotinylated CMV viral lysate antigens, preformed to streptavidin-coated magnetic particles. The antigen-coated particles subsequently capture CMV-specific antibodies in the specimen. The antibody-antigen complex is washed and Lite reagent is added. The Lite reagent consists of an acridinium-ester (AE)-labeled anti-human IgG mouse monoclonal antibody. The entire complex is washed and the signal is generated in the presence of Lite Reagent bound to the Solid Phase via the CMV IgG-CMV antigen complex.
The system automatically performs the following steps:
- Dispenses 20 uL of sample into a cuvette. -
- Dispenses 195 µL of ADVIA Centaur CMV IgG Diluent into the cuvette with the sample. -
- Removes 100 uL of the diluted sample from the cuvette and dispenses it into a second cuvette.
- -Dispenses 200 uL of Solid Phase and incubates the mixture for 18.0 minutes at 37°C.
- -Separates the Solid Phase from the mixture and aspirates the unbound reagent.
- -Washes the cuvette with ADVIA Centaur Wash 1.
- -Re-suspends the washed particles in 250 uL of ADVIA Centaur Wash 1.
- Dispenses 100 uL Lite Reagent and incubates the mixture for 18.0 minutes at 37°C. -
- -Separates the Solid Phase from the mixture and aspirates the unbound reagent.
- Washes the cuvette with ADVIA Centaur Wash 1. -
- Dispenses 300 uL of ADVIA Centaur Acid Reagent and 300 uL of ADVIA Centaur Base -Reagent to initiate the chemiluminescent reaction.
- Reports results according to the selected option, as described in the system operating -Instructions.
A direct relationship exists between the amount of bound anti-CMV IgG present in the patient specimen and the amount of relative light units (RLUs) detected by the system. A result of reactive or nonreactive is determined according to the Index established with the calibrators:
- . Samples with an Index Value of 4 to