(259 days)
BD RPR, Difco USR
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No
The summary describes performance studies for a syphilis antigen test (RPR antigen) and does not mention any computational or algorithmic components, let alone AI/ML.
No.
The device is described as an RPR antigen testing kit used for diagnostic purposes (detecting Treponema pallidum infection), not for treating any condition.
Yes
The document describes performance studies of an RPR antigen, which is used for syphilis testing (reactive samples tested against MHA-TP, Treponema pallidum). Antigens used for in vitro testing to detect specific antibodies or antigens in patient samples are diagnostic tools.
No
The summary describes performance studies related to RPR antigen testing, which is a laboratory assay involving physical reagents and samples, not a software-only device.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: While the specific intended use is not explicitly stated in the "Intended Use / Indications for Use" section, the "Description of the test set" and "Summary of Performance Studies" clearly indicate that the device is an "RPR antigen" used for testing patient samples (specifically for Treponema pallidum, the causative agent of syphilis). This type of testing on biological samples outside of the body is the definition of an in vitro diagnostic.
- Description of the test set: The description details testing of "patient genders were documented for all specimens," "reactive samples were titered," and "stage infection with Treponemal pallidum and historical treatment on many of the reactive samples were recorded." This confirms the device is used to analyze patient samples.
- Summary of Performance Studies: This section explicitly mentions "in vitro studies" and describes testing the RPR antigen against patient samples and comparing its performance to other RPR antigens and the MHA-TP test. This further reinforces its use as an in vitro diagnostic.
- Key Metrics: The mention of "relative sensitivity and specificity data" are common performance metrics for IVD devices.
Therefore, the context strongly indicates that this device is an IVD.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies
Two batches of RPR antigen were tested at the University of Texas in comparison to the BD RPR antigen. Antigen #1 was made by REMEL and evaluated by the CDC before use in determining its performance. This material was considered "Satisfactory" by the CDC. Antigen #2 was made for REMEL at LEE Laboratories in Grayson, GA and was also tested and deemed "Satisfactory" by the CDC. Both materials were evaluated since REMEL would like the option to make or purchase this antigen as needed.
The REMEL manufactured RPR antigen (Ag#1) was tested at U. of Texas without any significant discrepancies. It was tested vs the BD RPR and MHA-TP (for all reactives). Patient genders were documented for all specimens. Patient gender did not affect the Many of the reactive samples were titered outcome of the tests. for both RPR antigens and there was no statistically significant difference in performance between the two. Additionally, data is provided on several of the reactive samples which includes stage of infection with Treponema pallidum and history of treatment. Reactive results are consistent with the history of treatment and staging of illness.
The LEE Labs RPR antigen (Ag#2) was tested at both the Univ. of Texas vs the BD RPR antigen and Michigan Dept. of Health. vs the Difco USR antigen. Again, patient genders were recorded. Gender had no affect on the outcome of the tests. Also, stage infection with Treponemal pallidum and historical treatment on many of the reactive samples were recorded. All reactive samples were also tested vs the MHA-TP test with results consistent with the There were a number history of treatment and staging of illness. of the reactive samples tested at the U. of Texas that were read as nonreactive with the Agg2 and reactive (undiluted endpoint titer) with the BD Ag. Repeat testing of the same samples with the same material at the U. of Texas yielded the same results. Because the same antigen (#2) was used at the Michigan site without any significant # of discrepancies, the remainder of the U. of Texas discrepant samples along with 12 known reactive samples and 12 known nonreactive samples were sent blinded to Michigan. Michigan reported results which were consistent between the known results at Texas and between RPR and USR. Additionally, except with only a couple of samples, the RPR results were consistent with the USR test in the discrepant samples. The raw data is enclosed and a summary of the testing follows.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
The 2 9 199
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850
RE: 510(k) Submission for RPR Card Test Kit Summary of Safety and Effectiveness
November 8, 1995
Dear Sir:
In accordance with 21 CFR Chapter 1, Subpart E, Sec. 807.93, and as part of the 510(k) submission for the RPR Liquid Controls, the following information is provided.
Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies. The results of these studies are summarized in the attached Technical Insert.
This device is effective when tested under the conditions for its intended use. Each test kit contains a technical insert which provides adequate directions and precautions for use. Lastly, each insert contains information on the limitations and the performance characteristics of the test (including relative sensitivity and specificity data) when used according to the directions.
SUMMARY OF SAFETY AND EFFECTIVENESS DATA:
Raw performance data Intended use of the product Limitations of the product Relative sensitivity and specificity data Directions for procedure 510(k) Submission
Should there be any questions concerning this matter, please contact me at (706)736-6011.
sincerely,
David A. Wall
David A. Wall Manager, Immunodiagnostics
5
1
RPR CARD TEST
PERFORMANCE CHARACTERISTICS
University of Texas Dr. Beth Hartwell Michigan Department of Public Health Mr. Harlan Stiefel
Two batches of RPR antigen were tested at the Univ. of Texas in comparison to the BD RPR antigen. Antigen $1 was made by REMEL and evaluated by the CDC before use in determining its performance This material was considered "Satisfactory" by characteristics. the CDC (copy of report enclosed). Antigen $2 was made for REMEL at LEE Laboratories in Grayson, GA and was also tested and deemed "Satisfactory" by the CDC. Both materials were evaluated since REMEL would like the option to make or purchase this antigen as needed.
The REMEL manufactured RPR antigen (Ag#1) was tested at U. of Texas without any significant discrepancies. It was tested vs the BD RPR and MHA-TP (for all reactives). Patient genders were antigen, documented for all specimens. Patient gender did not affect the Many of the reactive samples were titered outcome of the tests. for both RPR antigens and there was no statistically significant difference in performance between the two. Additionally, data is provided on several of the reactive samples which includes stage of infection with Treponema pallidum and history of treatment. Reactive results are consistent with the history of treatment and staging of illness.
The LEE Labs RPR antigen (Ag#2) was tested at both the Univ. of Texas vs the BD RPR antigen and Michigan Dept. of Health. vs the Difco USR antigen. Again, patient genders were recorded. Gender had no affect on the outcome of the tests. Also, stage infection with Treponemal pallidum and historical treatment on many of the reactive samples were recorded. All reactive samples were also tested vs the MHA-TP test with results consistent with the There were a number history of treatment and staging of illness. of the reactive samples tested at the U. of Texas that were read as nonreactive with the Agg2 and reactive (undiluted endpoint titer) with the BD Ag. Repeat testing of the same samples with the same material at the U. of Texas yielded the same results. Because the same antigen (#2) was used at the Michigan site without any significant # of discrepancies, the remainder of the U. of Texas discrepant samples along with 12 known reactive samples and 12 known nonreactive samples were sent blinded to Michigan. Michigan reported results which were consistent between the known results at Texas and between RPR and USR. Additionally, except with only a couple of samples, the RPR results were consistent with the USR test in the discrepant samples. The raw data is enclosed and a summary of the testing follows.