(121 days)
K913467/D
K913467/D
No
The description details a traditional in vitro diagnostic test based on latex particle agglutination, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic test used to detect antibodies in human serum, which aids in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Toxogen is an in vitro diagnostic, rapid latex particle agglutination test."
No
The device is an in vitro diagnostic test that uses latex particle agglutination, which is a physical/chemical process, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states this multiple times:
- "Toxogen is an in vitro diagnostic..." in the "Intended Use / Indications for Use" section.
- "Toxogen is an in vitro diagnostic..." in the "Device Description" section.
N/A
Intended Use / Indications for Use
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis.
This assay is not FDA cleared for use in blood or plasma donor screening.
Product codes
GMM
Device Description
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The new Toxogen is a modified version of the predicate Toxogen with a larger latex particle size to increase sensitivity from 10 IU/mL to 5 IU/mL.
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
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
Not Found
Summary of Performance Studies
In a method comparison study evaluating 100 serum samples using the qualitative method, the relative sensitivity of the modified Toxogen as compared to the predicate Toxogen was 100% and the relative specificity was 91%.
In a reproducibility study, a panel of 9 serum samples (3 negative, 3 weak positive and 3 high positive) was tested by three different operators on 3 consecutive days following the semiquantitative procedure for Toxogen. The results, as defined by the ability to give agreement to within one 2-fold dilution on the replicates indicated 100% reproducibility.
Key Metrics
Relative sensitivity of 100%, relative specificity of 91% for method comparison. 100% reproducibility for reproducibility study.
Predicate Device(s)
K913467/D
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
SECTION 3 Toxogen - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax:
Contact Person:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
April 6, 1997
Name of the device:
Toxogen
Classification name(s):
866.3780 Toxoplasma gondii serological reagents Class II
Identification of predicate device(s):
K913467/D Toxogen
Description of the device/intended use(s):
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis. This assay is not FDA cleared for use in blood or plasma donor screening.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
The new Toxogen is a modified version of the predicate Toxogen with a larger latex particle size to increase sensitivity from 10 IU/mL to 5 IU/mL. It is substantially equivalent in performance, intended use, safety and effectiveness to the predicate device as supported by the performance data and labeling.
Summary of Performance Data:
In a method comparison study evaluating 100 serum samples using the qualitative method, the relative sensitivity of the modified Toxogen as compared to the predicate Toxogen was 100% and the relative specificity was 91%.
In a reproducibility study, a panel of 9 serum samples (3 negative, 3 weak positive and 3 high positive) was tested by three different operators on 3 consecutive days following the semiquantitative procedure for Toxogen. The results, as defined by the ability to give agreement to within one 2-fold dilution on the replicates indicated 100% reproducibility.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 6 1998
Carol Marble Senior Regulatory Affairs Specialist Instrument Laboratory 101 Hartwell Avenue Lexington, MA 02173-3190
K981263 Re: Trade Name: Toxogen Regulatory Class: II Product Code: GMM Dated: June 10, 1998 Received: June 11, 1998
Dear Ms. Marble:
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 OS 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.
2
Page 2
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 vours.
Steven Butman
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
3
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Toxogen
Indications for Use:
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis.
This assay is not FDA cleared for use in blood or plasma donor screening.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
510(k) Number
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.019) |
Over-The-Counter Use
Toxogen 510(k)
OR