(93 days)
The Platelia™ Toxo IgM kit is an in-vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasma gondii in human serum or plasma (EDTA, Heparin, Citrate)
Note:
- Patient testing with the Platelia™ Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
- The Platelia™ Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection.
- The performance of the Platelia™ Toxo IgM assay has not been established for neonate testing.
- The Platelia™ Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information required to answer all parts of your request comprehensively. The document confirms the device's substantial equivalence to a predicate device and states its intended use, but it does not detail the specific performance study, acceptance criteria, or the methodology of ground truth establishment.
However, based on the information that is present, here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given document. The document is a clearance letter, not a summary of the performance study itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This device is an in-vitro diagnostic test kit for qualitative detection of antibodies, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study with human readers assisting AI or vice-versa would not be applicable in this context. The document does not mention any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an "in-vitro diagnostic test kit" designed for qualitative detection of antibodies. This implies that the 'device' itself performs the detection without further human interpretation beyond reading the results. Therefore, yes, its performance would inherently be 'standalone' in the context of it being a laboratory assay. However, the study details proving this standalone performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. For an antibody detection kit like this, ground truth would typically be established by a combination of a highly sensitive and specific reference method (e.g., Western blot, PCR, or a highly validated serological test with known clinical correlation) and/or clinical diagnosis confirmed by patient outcomes or other established diagnostic criteria for Toxoplasma gondii infection.
8. The sample size for the training set
This information is not provided. For an IVD kit, the term "training set" is less common than for AI models; instead, manufacturers might refer to data used during assay development and optimization.
9. How the ground truth for the training set was established
This information is not provided.
Summary of available information:
- Device Name: Bio-Rad Platelia™ Toxo IgM
- Indication For Use: Qualitative detection of anti-Toxoplasma gondii IgM in human serum or plasma. Presumptive for acute, recent or reactivated Toxoplasma gondii infection. Must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
- Limitations: Not established for neonate testing. Not cleared/approved for blood/plasma donor screening.
- Regulatory Class: II
- Product Code: LGD
- Nature of Device: In-vitro diagnostic test kit (laboratory assay).
To get the detailed information you requested, you would need to consult the full 510(k) submission summary or the actual study reports submitted to the FDA, which are not part of this clearance letter.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUL - 1 2009
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. David Bhend Regulatory Affairs Representative Bio-Rad Laboratories 6565 185th Ave. NW Redmond, WA 98052
Re: K090847
Trade/Device Name: Bio-Rad Platelia™ Toxo IgM Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii serological reagents Regulatory Class: II Product Code: LGD Dated: June 26, 2009 Received: June 30, 2009
Dear Mr. Bhend:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR))), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. Hoivat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): '
Device Name: Platelia™ Toxo IgM kit
Indication For Use: The Platelia™ Toxo IgM kit is an in-vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasma gondii in human serum or plasma (EDTA, Heparin, Citrate)
Note:
- Patient testing with the Platelia™ Toxo IgM assay must be performed in 0 conjunction with an anti-Toxoplasma gondii IgG antibody assay.
- The Platelia™ Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection.
- The performance of the Platelia™ Toxo IgM assay has not been established for neonate testing.
- The Platelia™ Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.
Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
folgart
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KM0047
§ 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).