(139 days)
Not Found
Not Found
No
The description focuses on immunoassay technology and light scattering for measurement, with no mention of AI or ML. The analysis of results is based on comparing measured values to a cutoff, a standard method in immunoassays.
No.
The device is an in vitro diagnostic assay used for the qualitative detection of antibodies and aids in the confirmation of syphilis disease; it does not treat or alleviate a disease.
Yes
The input states the device is "an aid in the confirmation of syphilis disease" and detects "antibodies (IgG and IgM) to recombinant Treponema pallidum antigens in human serum," which is a diagnostic function.
No
The device description clearly outlines a physical immunoassay using microparticles, reaction wells, and a flow cell, which are hardware components. The instrument uses light scattering technology to measure monomer concentration, indicating a hardware-based detection system. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative detection of total antibodies (IgG and IgM) to recombinant Treponema pallidum antigens in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a disease state (syphilis).
- Device Description: The description details a laboratory-based assay using microparticles and light scattering technology to analyze a patient sample. This is characteristic of an in vitro diagnostic test.
- Clinical Trials and Performance Studies: The document describes clinical trials where human serum samples were tested and performance metrics like sensitivity and agreement with predicate devices were evaluated. This is a standard process for demonstrating the performance of an IVD.
- Predicate Devices: The mention of predicate devices (FTA-ABS and TP-PA) which are known IVDs for syphilis testing further supports that this device falls into the same category.
- Intended User / Care Setting: The intended users are clinical and reference laboratories, which are typical settings for performing in vitro diagnostic tests.
The core function of the device is to analyze a biological sample (human serum) outside the body to diagnose or aid in the diagnosis of a disease (syphilis). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Copalis Treponemal Antibody Assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to recombinant Treponema pallidum antigens in human serum using the Copalis I Immunoassay System. The presence of antibodies is indicative of current or prior infection with T. pallidum. The assay is indicated as an aid in the serological confirmation of syphilis disease following a positive result with a nontreponemal screening test. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
NOTE: The Copalis Treponemal Antibody Assav has not been evaluated as an initial or single test for the serodiagnosis of syphilis. The predictive value of a positive Copalis Treponemal Antibody Assay result has not been determined with RPR negative specimens.
Product codes (comma separated list FDA assigned to the subject device)
LIP
Device Description
INTENDED USE: The Copalis Treponemal Antibody Assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to recombinant Treponema pallidum antigens in human serum using the Copalis I Immunoassay System. The presence of antibodies is indicative of current or prior infection with T. pallidum. The assay is indicated as an aid in the confirmation of syphilis disease following a positive result with a nontreponemal screening test. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
KIT DESCRIPTION: The Copalis® Treponemal Antigen Total Antibody Assay is based on Coupled Particle Light Scattering (Copalis) technology which provides a rapid method for the measurement of antibodies to specific pathogens.
The assay is a microparticle agglutination test using the Copalis light scattering technology. Polystyrene microparticles are coated with recombinant antigen derived from T. pallidum and are contained within a special covered reaction well in the test cup. The dried reagent is reconstituted with a reaction buffer on the instrument at the start of the assay. Patient sample is added to the reaction mixture and incubated for 10 minutes. The presence of antibodies specific to T. pallidum in the patient sample results in agglutination of the monomer microparticles to form aggregrates. The reaction mixture is passed through a flow cell and the instrument uses light scattering technology to measure the monomer concentration. The decrease in the monomer population resulting from agglutination is related to the amount of antibody in the sample. The residual monomer concentration in each reaction mixture is compared to a cutoff value to determine sample reactivity and nonreactivity.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Correlation: Clinical trials were conducted at four sites (2 clinical laboratories, 1 reference laboratory and the laboratory located at DiaSorin Inc.) to evaluate the performance of the Copalis Treponemal Antibody Assay in detecting antibodies to Treponema pallidum on the Copalis I Immunoassay System. The assay performance was compared to the Zeus Scientific Inc. FTA-ABS assay and the FUJIREBIO Inc. TP-PA, both of which are confirmatory tests.
Samples from 188 patients with diagnosis of syphilis were analyzed using the Copalis® Treponemal Antigen Total Antibody Assay. These samples were characterized by disease state and treatment status. The clinical sensitivity of the assay is shown below.
| Stage | Treatment Status | Copalis Sensitivity RPR + FTA + | Copalis Sensitivity RPR - FTA + | Copalis Specificity RPR +/- FTA - |
|---|---|---|---|---|
| Primary | Untreated | 100% (15.8-100%) | -- | 100% (2.5-100%) |
| Treated | 100% (75.3-100%) | 66.7% (22.2-95.7%) | 100% (2.5-100%) | |
| Secondary | Untreated | 100% (86.3-100%) | -- | -- |
| Treated | 100% (88.1-100%) | 100% (2.5-10%) | -- | |
| Latent | Treated | 97.8% (92.2-99.7%) | 100% (66.4-100%) | 100% (15.8-100%) |
| Late, Cardiovascular | 100% (29.2-100%) | 100% (2.5-100%) | -- | |
| Congenital | 100%* (15.8-100%) | 100% (15.8-100%) | -- |
Clinical Sensitivity and 95% Confidence Limits From Syphilitic Sera: *excludes 1 equivocal result
In addition, 2086 sera from a variety of diseases and 45 CDC or commercial panel samples were tested. The results are summarized below.
| Category | Number | Agreement |
|---|---|---|
| RPR positive samples sent to hospital laboratories for confirmation of disease | 1005 | 96.3% (944/980) (25 equivocal) |
| Apparently healthy adults | 1002 | Prevalence: Copalis = 3.2% (32/1002) FTA = 2.2% (22/1002) |
| Other (Obstetric; Pediatric >18 months old) | 35 | 100% (34/34) (1 Copalis eq/FTA -) |
| Category | Number | Agreement |
|---|---|---|
| CDC Panel | 20 | 90% (18/20) |
| Characterized commercial syphilis mixed titer panel | 25 | 100% (25/25) |
Reproducibility: Reproducibility studies were performed at the 3 sites using one lot of reagents. Assay reproducibility was determined by testing 6 samples that spanned the range of the assay's CTRs. Samples were tested in duplicate once a day for 5 days. The results are summarized below.
COPALIS TREPONEMAL ASSAY REPRODUCIBILITY RESULTS COMBINED SITES CTR
| SAMPLE | MEAN CTR | WITHIN RUN %CV | TOTAL %CV |
|---|---|---|---|
| Negative Control | 101 | - | 1.4 |
| Positive Control | 171 | - | 8.7 |
| RP1 | 103 | 1.4 | 1.9 |
| RP2 | 1470 | 16.2 | 18.0 |
| RP3 | 101 | 1.5 | 1.8 |
| RP4 | 280 | 13.1 | 16.7 |
| RP5 | 1068 | 12.9 | 16.7 |
| RP6 | 172 | 7.6 | 13.3 |
The Copalis TTA Quality Control procedures include the running of a negative and a positive control at least every 24 hours of use. This procedure was followed by all sites during the clinical trials. A summary of the control data is presented here.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity
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.
Not Found
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
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
DEC I 6 1999
December 10, 1999
510(K) SUMMARY
| SUBMITTED BY: | Judith J. Smith
Vice President,
Worldwide Regulatory Affairs and Quality Systems |
|----------------------------|----------------------------------------------------------------------------------------|
| NAME OF DEVICES: | |
| Trade Name: | Copalis Treponemal Antigen Total Antibody Assay |
| Common Names/Descriptions: | Immunoassay for the Detection of Total Antibodies
to Treponema pallidum |
| Classification Names: | Treponema pallidum treponemal test |
| PREDICATE DEVICES: | Zeus Scientific Inc. FTA-ABS and FUJIREBIO INC.
SERODIA® TP-PA |
DEVICE DESCRIPTION:
INTENDED USE: The Copalis Treponemal Antibody Assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to recombinant Treponema pallidum antigens in human serum using the Copalis I Immunoassay System. The presence of antibodies is indicative of current or prior infection with T. pallidum. The assay is indicated as an aid in the confirmation of syphilis disease following a positive result with a nontreponemal screening test. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
KIT DESCRIPTION: The Copalis® Treponemal Antigen Total Antibody Assay is based on Coupled Particle Light Scattering (Copalis) technology which provides a rapid method for the measurement of antibodies to specific pathogens.
The assay is a microparticle agglutination test using the Copalis light scattering technology. Polystyrene microparticles are coated with recombinant antigen derived from T. pallidum and are contained within a special covered reaction well in the test cup. The dried reagent is reconstituted with a reaction buffer on the instrument at the start of the assay. Patient sample is added to the reaction mixture and incubated for 10 minutes. The presence of antibodies specific to T. pallidum in the patient sample results in agglutination of the monomer microparticles to form aggregrates. The reaction mixture is passed through a flow cell and the instrument uses light scattering technology to measure the monomer concentration. The decrease in the monomer population resulting from agglutination is related to the amount of antibody in the sample. The residual monomer concentration in each reaction mixture is compared to a cutoff value to determine sample reactivity and nonreactivity.
1
PERFORMANCE DATA:
Clinical Correlation: Clinical trials were conducted at four sites (2 clinical laboratories, 1 reference laboratory and the laboratory located at DiaSorin Inc.) to evaluate the performance of the Copalis Treponemal Antibody Assay in detecting antibodies to Treponema pallidum on the Copalis I Immunoassay System. The assay performance was compared to the Zeus Scientific Inc. FTA-ABS assay and the FUJIREBIO Inc. TP-PA, both of which are confirmatory tests.
Samples from 188 patients with diagnosis of syphilis were analyzed using the Copalis® Treponemal Antigen Total Antibody Assay. These samples were characterized by disease state and treatment status. The clinical sensitivity of the assay is shown below.
| Stage | Treatment
Status | Copalis
Sensitivity
RPR + FTA + | Copalis
Sensitivity
RPR - FTA + | Copalis
Specificity
RPR +/- FTA - |
|----------------|---------------------|---------------------------------------|---------------------------------------|-----------------------------------------|
| Primary | Untreated | 100%
(15.8-100%) | -- | 100%
(2.5-100%) |
| | Treated | 100%
(75.3-100%) | 66.7%
(22.2-95.7%) | 100%
(2.5-100%) |
| Secondary | Untreated | 100%
(86.3-100%) | -- | -- |
| | Treated | 100%
(88.1-100%) | 100%
(2.5-10%) | -- |
| Latent | Treated | 97.8%
(92.2-99.7%) | 100%
(66.4-100%) | 100%
(15.8-100%) |
| Late, | | 100%
(29.2-100%) | 100%
(2.5-100%) | -- |
| Cardiovascular | | 100%*
(15.8-100%) | 100%
(15.8-100%) | -- |
| Congenital | | | | |
Clinical Sensitivity and 95% Confidence Limits From Syphilitic Sera:
*excludes 1 equivocal result
In addition, 2086 sera from a variety of diseases and 45 CDC or commercial panel samples were tested. The results are summarized below.
| Category | Number | Agreement |
|---|---|---|
| RPR positive samples sent to hospital | ||
| laboratories for confirmation of disease | 1005 | 96.3% |
| (944/980) | ||
| (25 equivocal) | ||
| Apparently healthy adults | 1002 | Prevalence: |
| Copalis = 3.2% | ||
| (32/1002) | ||
| FTA = 2.2% | ||
| (22/1002) | ||
| Other (Obstetric; Pediatric >18 months | ||
| old) | 35 | 100% |
| (34/34) | ||
| (1 Copalis eq/FTA -) |
2
| Category | Number | Agreement |
|---|---|---|
| CDC Panel | 20 | 90% |
| (18/20) | ||
| Characterized commercial syphilis | ||
| mixed titer panel | 25 | 100% |
| (25/25) |
Reproducibility: Reproducibility studies were performed at the 3 sites using one lot of reagents. Assay reproducibility was determined by testing 6 samples that spanned the range of the assay's CTRs. Samples were tested in duplicate once a day for 5 days. The results are summarized below.
COPALIS TREPONEMAL ASSAY REPRODUCIBILITY RESULTS COMBINED SITES CTR
| SAMPLE | MEAN CTR | WITHIN
RUN %CV | TOTAL
%CV |
|------------------|----------|-------------------|--------------|
| Negative Control | 101 | - | 1.4 |
| Positive Control | 171 | - | 8.7 |
| RP1 | 103 | 1.4 | 1.9 |
| RP2 | 1470 | 16.2 | 18.0 |
| RP3 | 101 | 1.5 | 1.8 |
| RP4 | 280 | 13.1 | 16.7 |
| RP5 | 1068 | 12.9 | 16.7 |
| RP6 | 172 | 7.6 | 13.3 |
The Copalis TTA Quality Control procedures include the running of a negative and a positive control at least every 24 hours of use. This procedure was followed by all sites during the clinical trials. A summary of the control data is presented here.
CONTROL RESULTS, SITES COMBINED
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------
AND A L Children and and states | A CON CALL A C
ANNUAL ALL
|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A MIN LINE OF LEAR LEASE LE BEA |
| The Property of Children
- A Chicago Comer
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CARACH CLASS CLASS CLASS CLASS OF
- | 1
PAGES
NA A MANAGER OF MALE A |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEC I 6 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Judith J. Smith Vice President Worldwide Regulatory Affairs and Quality Systems DiaSorin, Inc. 9175 Guilford Road Quarry Park Place, Suite 100 Columbia, Maryland 21046
- Re: K992552
Trade Name: DiaSorin Copalis™ Treponemal Antigen Total Antibody Assay Regulatory Class: II Product Code: LIP Dated: October 20, 1999 Received: October 25, 1999
Dear Ms. Smith:
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.
4
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 yours,
Steven Autman
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
5
510(k) Number (if known): K992552
Device Name: DiaSorin Copalis®Treponemal Antigen Total Antibody Assay
Indications For Use:
The Copalis Treponemal Antibody Assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to recombinant Treponema pallidum antigens in human serum using the Copalis I Immunoassay System. The presence of antibodies is indicative of current or prior infection with T. pallidum. The assay is indicated as an aid in the serological confirmation of syphilis disease following a positive result with a nontreponemal screening test. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
NOTE: The Copalis Treponemal Antibody Assav has not been evaluated as an initial or single test for the serodiagnosis of syphilis. The predictive value of a positive Copalis Treponemal Antibody Assay result has not been determined with RPR negative specimens.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
vision of Clinical Laboratory Devices K 992552 510(k) Number ...
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)