(371 days)
Platelia® Toxo IgM
Not Found
No
The summary describes a standard immunoassay for detecting antibodies and does not mention any AI or ML components in its operation or analysis.
No.
This device is an in vitro diagnostic assay used for qualitative detection of anti-Toxoplasma IgM antibodies to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections".
No
The device description explicitly states it is a "paramagnetic-particle chemiluminescent immunoassay" and is used with the "Access® Immunoassay System," indicating it is a physical assay kit and requires specific hardware for operation, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of anti-Toxoplasma IgM in adult human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a medical condition (Toxoplasma gondii infection).
- Device Description: The description reiterates the same purpose and method, confirming it's an assay performed on a biological sample.
- Performance Studies: The performance studies involve testing patient serum samples and comparing the results to another diagnostic assay (Platelia® Toxo IgM). This is characteristic of IVD device validation.
- Predicate Device: The mention of a predicate device (Platelia® Toxo IgM) which is also a diagnostic assay further supports its classification as an IVD.
The core function of the device is to analyze a biological sample in vitro to aid in the diagnosis of a disease, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
Product codes
LGD
Device Description
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or nonpregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In clinical studies, the ACCESS® Toxo IgM assay was compared to Platelia® Toxo IgM on 822 patient serum samples. The overall sensitivity and specificity compared to Platelia® were 96% and 99.7%, respectively. After discrepancy analysis, the resolved sensitivity and resolved specificity remained 96% and 99.7%, respectively. In a prospective population with a prevalence of 1.25% (5/400), specificity was 99.2% relative to a consensus result.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
overall sensitivity and specificity compared to Platelia® were 96% and 99.7%
resolved sensitivity and resolved specificity remained 96% and 99.7%
specificity was 99.2% relative to a consensus result
Predicate Device(s)
Platelia® Toxo IgM
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 word "BECKMAN" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word appears to be a logo or brand name.
SEP 17 1998
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990.
1. General Information
Device Classification Name:
Device Trade Name:
Applicant's Name and Address:
ELISA, Toxoplasma gondii
ACCESS® Toxo IgM Reagents
Beckman Instruments, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
2. Predicate Device
Platelia® Toxo IgM Sanofi Diagnostics Pasteur, Inc. France
Device Description 3.
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or nonpregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
4. Summary of Studies
In clinical studies, the ACCESS® Toxo IgM assay was compared to Platelia® Toxo IgM on 822 patient serum samples. The overall sensitivity and specificity compared to Platelia® were 96% and 99.7%, respectively. After discrepancy analysis, the resolved sensitivity and resolved specificity remained 96% and 99.7%, respectively. In a prospective population with a prevalence of 1.25% (5/400), specificity was 99.2% relative to a consensus result.
The ACCESS® Toxo IgM assay demonstrates intra-assay precision CV's of Trade Name: Access Toxoplasma IgM Reagents on the Access Immunoassay Analyzer Regulatory Class: II
Product Code: LGD Dated: July 23, 1998 Received: July 24, 1998
Dear Ms. Burtness:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not .... affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket" notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number ( if known):
Device Name:
ACCESS® Toxo IgM Reagents on the ACCESS® Immunoassay Analyzer
Indications For Use:
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Woody Dechoin | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K973448 |
PRESCRIPTION USE X
02/20/98