(448 days)
Not Found
No
The description details a standard immunoassay technology and does not mention any AI or ML components.
No
This device is an in vitro diagnostic immunoassay used for the qualitative detection of IgM antibodies to Toxoplasma gondii, which aids in diagnosing infection rather than treating it.
Yes
The intended use explicitly states it is an "in vitro diagnostic immunoassay" and its purpose is for the "qualitative detection of IgM antibodies to Toxoplasma gondii in serum or plasma" to indicate an infection.
No
The device description clearly outlines physical reagents (paramagnetic particles, acridinium ester) and its use with specific hardware systems (ADVIA Centaur and ADVIA Centaur XP systems), indicating it is a hardware-based in vitro diagnostic assay, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The ADVIA Centaur Toxoplasma M (Toxo M) assay is an IgM antibody capture microparticle direct chemiluminometric in vitro diagnostic immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii in serum or plasma..." This directly identifies it as an in vitro diagnostic.
- Device Description: The description details how the assay works by analyzing a biological sample (serum or plasma) outside of the body to detect specific antibodies. This is the core function of an in vitro diagnostic.
- Analysis of Biological Samples: The device analyzes serum or plasma, which are biological samples taken from a patient.
- Detection of a Specific Analyte: It detects IgM antibodies to Toxoplasma gondii, which is a specific analyte indicative of a medical condition.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur Toxoplasma M (Toxo M) assay is an IgM antibody capture microparticle direct chemiluminometric in vitro diagnostic immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii in serum or plasma (EDTA, heparin) using the ADVIA Centaur and ADVIA Centaur XP systems.
The ADVIA Centaur Toxo M assay is used to measure IgM antibody against T. gondii which is presumptive of an acute, recent, or reactivated toxoplasma infection. Any measurement of IgM antibody to T. gondii must be performed in conjunction with the determination of IgG antibody to T. gondii.
Product codes
LGD
Device Description
The ADVIA Centaur Toxo M assay consists of the following components:
- ADVIA Centaur Toxo M Lite Reagent: 10.0 mL/pack, containing partially purified T. gondii antigen (~3 µg/mL) complexed with a mouse anti- T.gondii p30 monoclonal antibody (F(ab)2 fragment) labeled with acridinium ester in protein buffer with surfactant and preservatives.
- ADVIA Centaur Toxo M Solid Phase: 17.0 mL/pack, containing mouse anti-human IgMµ monoclonal antibody (~24 µg/mL) covalently coupled to paramagnetic particles in protein buffer with surfactant and preservatives.
- ADVIA Centaur Toxo M Calibrators: 600 µL/vial, containing defibrinated recalcified processed human plasma positive for toxoplasma IgM antibodies with preservatives.
- ADVIA Centaur Toxo M Controls: 1.5 mL/vial, containing defibrinated recalcified processed human plasma negative and positive for toxoplasma IgM antibodies with preservatives.
The assay utilizes an immunoglobulin class-capture sandwich immunoassay with direct, chemiluminometric technology. The anti-human IgM monoclonal antibody is coupled to paramagnetic particles in the Solid Phase. In the Lite Reagent, the T. gondii antigen is complexed with an anti-p30 monoclonal antibody (F(ab)2 fragment) labeled with acridinium ester. If toxoplasma IgM is present in the sample, antibody-antigen complexes will form.
The ADVIA Centaur systems automate the assay steps: dispensing sample, Solid Phase incubation, separation and aspiration of unbound reagent, washing, Lite Reagent incubation, separation and aspiration of unbound reagent, washing, and initiation of chemiluminescent reaction with Acid Reagent and Base Reagent. The amount of relative light units (RLUs) detected is directly related to the toxoplasma IgM activity in the sample, determining a reactive (positive) or nonreactive (negative) Index Value.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Applicable
Anatomical Site
Not Applicable
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Analytical performance (precision, interference with endogenous substances and potentially interfering agents) and testing with panel samples and patient samples was evaluated using the modified ADVIA Centaur Toxo M assay. The results were comparable to those established for the previous version of the device (currently-marketed predicate).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance (precision, interference with endogenous substances and potentially interfering agents) and testing with panel samples and patient samples was evaluated using the modified ADVIA Centaur Toxo M assay. The results were comparable to those established for the previous version of the device (currently-marketed predicate).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement: 99.2%
Negative Percent Agreement: 99.2%
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
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized design of three human profiles facing right, arranged in a cascading manner. The profiles are black and have a simple, elegant design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2015
SIEMENS HEALTHCARE DIAGNOSTICS, INC. MATTHEW GEE SENIOR MANAGER, REGULATORY AFFAIRS 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K142826
Trade/Device Name: ADVIA Centaur Toxoplasma M (Toxo M) Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii Serological Reagents Regulatory Class: II Product Code: LGD Dated: December 3, 2015 Received: December 4, 2015
Dear Mr. 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. 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 Parts 801 and 809); medical device reporting (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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -S
For Uwe Scherf, M.Sc., 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) K142826
Device Name ADVIA Centaur Toxoplasma M (Toxo M)
Indications for Use (Describe)
The ADVIA Centaur Toxoplasma M (Toxo M) assay is an IgM antibody capture microparticle direct chemiluminometric in vitro diagnostic immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii in serum or plasma (EDTA, heparin) using the ADVIA Centaur and ADVIA Centaur XP systems.
The ADVIA Centaur Toxo M assay is used to measure IgM antibody against T. gondii which is presumptive of an acute, recent, or reactivated toxoplasma infection. Any measurement of IgM antibody to T. gondii must be performed in conjunction with the determination of IgG antibody to T. gondii.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary of Safety and Effectiveness
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: K142826
1. Date Prepared
April 9, 2015
2. Purpose for Submission
The purpose of this submission is to describe changes to the ADVIA Centaur Toxoplasma M (Toxo M) assay (K010755).
3. Measurand
Toxoplasma IgM antibodies
4. Type of Test
Immunoglobulin class-capture chemiluminescence immunoassay
Applicant Information 5.
- Contact: Matthew Gee, M.Sc. Senior Manager, Regulatory Affairs
- Address: Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5097
Phone: 914-524-2099
Fax: 914-524-3579
- Email: matthew.gee@siemens.com
Proprietary and Established Names 6.
ADVIA Centaur® Toxoplasma M (Toxo M)
Regulatory Information 7.
| Regulation Section: | 21CFR 866.3780; Toxoplasma gondii Serological Reagents |
|---|---|
| Classification: | Class II |
| Product Code: | LGD |
| Device Classification Name: | Enzyme linked immunoabsorbent assay, Toxoplasma gondii |
| Review Panel: | Microbiology (83) |
8. Predicate Device Information
| Name: | ADVIA Centaur Toxoplasma M (Toxo M) |
|---|---|
| Manufacturer: | Siemens Healthcare Diagnostics Inc. |
| 510(K) Number: | K010755 |
4
9. Intended Use
9.1 Intended Use
The ADVIA Centaur Toxoplasma M (Toxo M) assay is an IgM antibody capture microparticle direct chemiluminometric in vitro diagnostic immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii in serum or plasma (EDTA, heparin) using the ADVIA Centaur and ADVIA Centaur XP systems.
The ADVIA Centaur Toxo M assay is used to measure IgM antibody against T. gondii which is presumptive of an acute, recent, or reactivated toxoplasma infection. Any measurement of IgM antibody to T. gondii must be performed in conjunction with the determination of IgG antibody to T. gondii.
9.2 Indications for Use
Same as Intended Use
9.3 Special Conditions for Use Statement(s)
The detection of toxoplasma IgM in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the toxoplasma IgM assay used. Values obtained with different assay methods cannot be used interchangeably. The reported IgM level cannot be correlated to an endpoint titer.
This assay is not intended for use in screening blood, plasma, or tissue donors. The effectiveness of this assay for use in screening blood, plasma, or tissue donors has not been established.
9.4 Special Instrument Requirements
ADVIA Centaur and ADVIA Centaur XP
Device Description 10.
The ADVIA Centaur Toxo M assay consists of the following:
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur Toxo M | ||
| Lite Reagent | 10.0 mL/pack | partially purified T. gondii antigen (~3 µg/mL) |
| complexed with a mouse anti- T.gondii p30 | ||
| monoclonal antibody (F(ab)2 fragment) labeled with | ||
| acridinium ester in protein buffer with surfactant and | ||
| preservatives | ||
| ADVIA Centaur Toxo M | ||
| Solid Phase | 17.0 mL/pack | mouse anti-human IgMµ monoclonal antibody (~24 µg/mL) covalently coupled to paramagnetic particles |
| in protein buffer with surfactant and preservatives | ||
| ADVIA Centaur Toxo M | ||
| Calibrators | 600 µL/vial | defibrinated recalcified processed human plasma |
| positive for toxoplasma IgM antibodies with | ||
| preservatives | ||
| ADVIA Centaur Toxo M | ||
| Controls | 1.5 mL/vial | defibrinated recalcified processed human plasma |
| negative and positive for toxoplasma IgM antibodies | ||
| with preservatives |
Table 1. Summary of Ingredients of the ADVIA Centaur Toxo M Assay Components
5
Purpose of the Submission 11.
The purpose of this submission is to submit a modification to the ADVIA Centaur Toxo M assay.
In addition to manufacturing process changes to improve operational effectiveness, and buffer changes to decrease the likelihood of non-specific binding, the main change to the ADVIA Centaur Toxo M assay is a truncation of the anti-p30 antibody in the Lite Reagent to remove the Fc portion of the molecule. This antibody is used to link the acridinium ester (chemiluminescent tag) to the toxoplasma p30 antigen. It is not involved in the binding of analyte from patient samples (i.e. not a component of reaction mechanism).
Comparison of Predicate Device and Modified Device 12.
Table 3 provides a list the similarities of the currently marketed predicate ADVIA Centaur Toxo M assay (with a whole IgG antibody in the Lite Reagent) and the modified ADVIA Centaur Toxo M assay with a F(ab), fragment in the Lite Reagent. Table 4 provides a list of differences between the predicate and modified devices.
| Item | Predicate Device (K010755) | Modified Device |
|---|---|---|
| Intended Use | The ADVIA Centaur Toxoplasma M | |
| (Toxo M) assay is an IgM antibody | ||
| capture microparticle direct | ||
| chemiluminometric in vitro diagnostic | ||
| immunoassay intended for the | ||
| qualitative detection of IgM | ||
| antibodies to Toxoplasma gondii in | ||
| serum or plasma (EDTA, heparin) | ||
| using the ADVIA Centaur and ADVIA | ||
| Centaur XP systems. | ||
| The ADVIA Centaur Toxo M assay is | Same | |
| used to measure IgM antibody | ||
| against T. gondii which is | ||
| presumptive of an acute, recent, or | ||
| reactivated toxoplasma infection. | ||
| Any measurement of IgM antibody to | ||
| T. gondii must be performed in | ||
| conjunction with the determination of | ||
| IgG antibody to T. gondii. | ||
| Instrument Platforms | ADVIA Centaur | |
| ADVIA Centaur XP | Same | |
| Methodology | Immunoglobulin class-capture | |
| sandwich immunoassay using direct, | ||
| chemiluminometric technology | Same | |
| Capture Antibody | ||
| (Solid Phase) | Mouse anti-human IgMµ | |
| monoclonal antibody | Same | |
| Tracer | ||
| (Lite Reagent) | Toxoplasma p30 antigen | |
| bound to acridinium ester | ||
| (via mouse anti-T. gondii p30 | ||
| monoclonal antibody) | Same |
Table 2. Similarities of Modified ADVIA Centaur Toxo M Assay and Predicate
6
510(k) Summary of Safety and Effectiveness
| ltem | Predicate Device (K010755) | Modified Device |
|---|---|---|
| Specimen Type | Serum or plasma (EDTA, heparin) | Same |
| Sample Volume | 10 µL | Same |
| Calibration | 2-point calibration using Toxo M Cal | Same |
| Performance | ||
| Characteristics | Positive Percent Agreement: 99.2% | |
| Negative Percent Agreement: 99.2% | Same |
Table 2. Similarities of Modified ADVIA Centaur Toxo M Assay and Predicate
Table 3. Differences Between Modified ADVIA Centaur Toxo M Assay and Predicate
| Item | Predicate Device (K010755) | Modified Device |
|---|---|---|
| Toxoplasma IgM Source | ||
| (Calibrators, Controls) | Toxoplasma IgM positive | |
| human plasma pools | Cell culture supernatant of | |
| human anti-toxoplasma IgM | ||
| monoclonal antibody-producing | ||
| cells | ||
| Particle Resuspension | Particle resuspension with | |
| water | Particle resuspension with Wash | |
| 1 (phosphate buffered saline) | ||
| Lite Reagent Conjugate* | Ab format = Whole IgG | |
| Ab Concentration = 30 ng/mL | ||
| Conjugate Loading Ratio = 30:1 | Ab format = F(ab)2 fragment | |
| Ab Concentration = 12.5 ng/mL | ||
| Conjugate Loading Ratio = 18:1 | ||
| Solid Phase Buffer | Buffer: Tris (pH =8.0) | |
| NaCl: 150 mM | ||
| Surfactant: CHAPS = 0.1 g/L | ||
| Blocker: Gelatin = 22.2 g/L | ||
| Mouse IgG: 25 mg/L | ||
| EDTA: none | Buffer: Tricine (pH = 8.0) | |
| NaCl: 300 mM | ||
| Surfactant: Tween-20 = 2.2 g/L | ||
| Blocker: sm-BSA = 10.0 g/L | ||
| Mouse IgG: 100 mg/L | ||
| EDTA: 0.7 g/L | ||
| Claimed Measuring | ||
| Range^ | 0.10–40.00 Index | 0.10–10.00 Index |
- The modified antibody in the Lite Reagent recognizes same epitope as the antibody in the cleared device. It is simply used to attach the acridinium ester (chemiluminescent tag) to the toxoplasma p30 antigen. It is not part of the analyte-binding reaction mechanism.
13. Standard/Guidance Document References
The following recognized standards from Clinical Laboratory Standards Institute (CLSI) were used as a basis of the study procedures described in this submission:
- Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition (CLSI EP05-A2, 2004; Recognition No. 7-110)
- l Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (CLSI EP07-A2, 2005; Recognition No. 7-127)
- l Stability testing of in vitro diagnostic reagents (European Committee for Standardization EN 13640:2002; Recognition No. 7-84)
- Medical devices - Application of risk management to medical devices (ANSI/AAMI/ISO 14971:2007/(R)2010; Recognition No. 5-70)
7
14. Test Principle
The ADVIA Centaur Toxo M assay is an immunoqlobulin class-capture sandwich immunoassay using direct, chemiluminometric technology. The anti-human IgM monoclonal antibody is covalently coupled to paramagnetic particles in the Solid Phase. In the Lite Reagent, the T. gondii antigen is complexed with an anti-p30 monoclonal antibody (F(ab)> fragment) labeled with acridinium ester. Antibody-antigen complexes will form if toxoplasma IgM is present in the sample.
ADVIA Centaur systems automatically perform the following steps for the Toxo M assay:
- 트 Dispenses 10 µL of sample into a cuvette.
- I Dispenses 340 µL of Solid Phase and incubates the mixture for 18 minutes at 37°C.
- . Separates the Solid Phase from the mixture and aspirates the unbound reagent.
- I Washes the cuvette with Wash 1.
- I Dispenses 200 µL Lite Reagent and incubates the mixture for 18 minutes at 37°C.
- I Separates the Solid Phase from the mixture and aspirates the unbound reagent.
- I Washes the cuvette with Wash 1.
- . Dispenses 300 µL each of Acid Reagent and Base Reagent to initiate the chemiluminescent reaction.
A direct relationship exists between the amount of toxoplasma IgM activity present in the patient sample and the amount of relative light units (RLUs) detected by the system. A result of reactive (positive) or nonreactive (negative) is determined using an Index Value.
Performance Characteristics 15.
Analytical performance (precision, interference with endogenous substances and potentially interfering agents) and testing with panel samples and patient samples was evaluated using the modified ADVIA Centaur Toxo M assay. The results were comparable to those established for the previous version of the device (currently-marketed predicate).
16. Conclusions
The results of performance testing and verification activities demonstrate that the design modifications to the ADVIA Centaur Toxo M assay do not impact its safety or effectiveness and do not alter its performance claims or alter its intended use, as described in the labeling.
Based on the results of comparative testing, the modified ADVIA Centaur Toxo M assay is substantially equivalent in principle and performance to the currently-marketed predicate device, ADVIA Centaur Toxo M, cleared under 510(k) K010755.