(118 days)
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No
The summary describes a standard immunoassay and its performance characteristics. There is no mention of AI, ML, or any computational methods that would suggest their use in the device's operation or interpretation.
No.
The device is an immunoassay intended as an aid in diagnosis, not for direct therapy.
Yes
The document states that the test is "intended as an aid in the diagnosis of syphilis infection with clinical signs and symptoms."
No
The device is an immunoassay kit and associated controls intended for use on a specific analyzer (cobas e 411). This involves physical reagents and a hardware analyzer, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The "Device Description" further clarifies that the assay is "fully automated qualitative assay detecting IgG and IgM antibodies to Treponema pallidum." This describes a test performed outside of the body on biological samples.
- Sample Type: The test uses "human serum and plasma," which are biological specimens commonly used in in vitro diagnostics.
- Purpose: The test is intended as an "aid in the diagnosis of syphilis infection," which is a diagnostic purpose.
- Control: The mention of "PreciControl Syphilis" for quality control of the immunoassay is also consistent with IVD practices.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection with clinical signs and symptoms.
The Elecsys Syphilis immunoassay is not intended for use in screening blood or tissue donors. The effectiveness of this assay in testing blood or tissue donors has not been established.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 analyzer.
PreciControl Syphilis is intended for the quality control of the Elecsys Syphilis immunoassay on the cobas e 411 analyzer.
Product codes (comma separated list FDA assigned to the subject device)
LIP, JJX
Device Description
The Elecsys Syphilis assay is a fully automated qualitative assay detecting IgG and IgM antibodies to Treponema pallidum, the causative agent of syphilis. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of active or previous infection with Treponema pallidum in persons with signs and symptoms of syphilis, as well as in patients at risk for syphilis infection. This assay does not determine the stage of infection or associated disease.
PreciControl Syphilis is a lyophilized control based on human serum. It is used for monitoring the accuracy of the Elecsys Syphilis immunoassay.
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
A total of 2282 prospectively collected samples of the intended use population were tested at 3 sites using the Elecsys Syphilis assay, including 1524 subjects for routine syphilis testing, 457 HIV positive subjects and 301 pregnant women. In addition, all samples were tested according to a composite algorithm using FDA-cleared tests that included the predicate Syphilis immunoassay, the Rapid Plasma Reagin (RPR) non-treponemal specific assay and the Treponema pallidum Particle Agglutination, treponemal-specific assay.
Clinical performance in the pre-selected retrospective cohort included a total of 169 specimens, including 15 pregnant positive women and 154 subjects medically diagnosed with syphilis at different stages.
Specimens were collected from 209 apparently healthy individuals. Of these, 80 were female and 129 male.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study:
Precision was evaluated with serum samples on a single cobas e 411 Immunoassay Analyzer according to CLSI guideline EP5-A2. One reagent lot was evaluated. The protocol was performed by testing 2 controls (PreciControl 1 and PreciControl 2) and 6 human sera (HS) (negative, near cut-off, positive) in duplicate per run, 2 runs per day for 21 days. The samples were run in randomized order on the analyzer. Sample size (n) was 84 for all samples tested.
Reproducibility Study:
A reproducibility study was conducted following CLSI EP5-A2 at three sites incorporating a 7 member panel consisting of 5 serum pools (high negative, low positive and moderately positive) and 2 controls that were assayed for 5 days, 2 runs per day, 3 replicates per run. Data from all three sites were combined. Sample size (N) for each sample type was 90.
Clinical Performance in Prospective Cohorts:
A total of 2282 prospectively collected samples were tested at 3 sites. The Elecsys Syphilis assay was compared with a composite algorithm using FDA-cleared tests (predicate Syphilis immunoassay, RPR, TP-PA).
Key results: For the total prospective cohorts (n=2282), Positive Percent Agreement (PPA) was 100% (228/228; 95% CI: 98.40 to 100.00) and Negative Percent Agreement (NPA) was 99.2% (2038/2054; 95% CI: 98.74 to 99.55).
Clinical Performance in Retrospective Medically Diagnosed Individuals:
Clinical performance in the pre-selected retrospective cohort included a total of 169 specimens from medically diagnosed individuals at different stages of syphilis, including 15 pregnant positive women.
Key results: For the overall retrospective cohorts (n=169), PPA was 98.7% (155/157; 95% CI: 95.47 to 99.85) and NPA was 100% (12/12; 95% CI: 73.54 to 99.55).
Clinical Performance in Pregnant Women:
A total of 316 pregnant female samples were tested (301 prospective, 15 retrospective).
Key results for prospective pregnant women (n=301): NPA was 100% (301/301; 95% CI: 98.78 to 100.00). PPA was N/A as there were no positive prospective samples.
Key results for retrospective pregnant women (n=15): PPA was 100% (15/15; 95% CI: 78.20 to 100.00). NPA was N/A as there were no negative retrospective samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Cohorts:
Positive Percent Agreement:
Routine Syphilis: 100% (66/66) (95% CI: 94.56 to 100.00)
HIV: 100% (162/162) (95% CI: 97.75 to 100.00)
Pregnant: N/A (0/0)
Total: 100% (228/228) (95% CI: 98.40 to 100.00)
Negative Percent Agreement:
Routine Syphilis: 99.8% (1455/1458) (95% CI: 99.40 to 99.96)
HIV: 95.6% (282/295) (95% CI: 92.58 to 97.63)
Pregnant: 100% (301/301) (95% CI: 98.78 to 100.00)
Total: 99.2% (2038/2054) (95% CI: 98.74 to 99.55)
Retrospective Cohorts:
Positive Percent Agreement:
Pregnant (Retrospective): 100% (15/15) (95% CI: 78.20 to 100.00)
Staged: 98.6% (140/142) (95% CI: 95.00 to 99.83)
Overall (Retrospective): 98.7% (155/157) (95% CI: 95.47 to 99.85)
Negative Percent Agreement:
Pregnant (Retrospective): N/A (0/0)
Staged: 100% (12/12) (95% CI: 73.54 to 100.00)
Overall (Retrospective): 100% (12/12) (95% CI: 73.54 to 99.55)
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.
Immulite 2000 Syphilis Screen test system, K091361
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.
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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).
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§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a row, with the first profile being the most prominent and the other two slightly behind it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Roche Diagnostics Angelo Pereira Regulatory Affairs Senior Program Manager 9115 Hague Road Indianapolis, IN, 46250
Re:K160910
Trade/Device Name: Elecsys Syphilis and PreciControl Syphilis Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LIP, JJX Dated: July 22, 2016 Received: July 25, 2016
Dear Mr. Pereira:
This letter corrects our substantially equivalent letter of July 28, 2016.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160910
Device Name Elecsys Syphilis PreciControl Syphilis
Indications for Use (Describe)
Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection with clinical signs and symptoms.
The Elecsys Syphilis immunoassay is not intended for use in screening blood or tissue donors. The effectiveness of this assay in testing blood or tissue donors has not been established.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 analyzer.
PreciControl Syphilis is intended for the quality control of the Elecsys Syphilis immunoassay on the cobas e 411 analyzer.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Elecsys Syphilis
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0416 | |
| Contact | Angelo Pereira |
| Phone: (317) 521-3544 | |
| FAX: (317) 521-2324 | |
| Email: angelo.pereira@roche.com | |
| Date Prepared | July 21, 2016 |
| Proprietary Name | Elecsys Syphilis |
| Common Name | Syphilis assay |
| Classification Name | Treponema pallidum treponemal test reagent |
| Product Codes | Product Code: LIP; 21CFR866.3830 |
| Control Product Code: JJX | |
| Predicate Devices | Immulite 2000 Syphilis Screen test system, K091361 |
| Establishment Registration | For Elecsys Syphilis, the establishment registration number for Roche |
| Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg, | |
| Germany, 9610529. The establishment registration number for Roche | |
| Diagnostics in the United States is 1823260. |
DEVICE DESCRIPTION 1.
The Elecsys Syphilis assay is a fully automated qualitative assay detecting IgG and IgM antibodies to Treponema pallidum, the causative agent of syphilis. Assay results, in conjunction
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with other laboratory results and clinical information, may be used to provide presumptive evidence of active or previous infection with Treponema pallidum in persons with signs and symptoms of syphilis, as well as in patients at risk for syphilis infection. This assay does not determine the stage of infection or associated disease.
PreciControl Syphilis is a lyophilized control based on human serum. It is used for monitoring the accuracy of the Elecsys Syphilis immunoassay.
2. INTENDED USE
Elecsys Syphilis:
Immunoassay for the in vitro qualitative determination of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection in conjunction with clinical signs and symptoms.
The Elecsys Syphilis immunoassay is not intended for use in screening blood or tissue donors. The effectiveness of this assay in testing of blood and tissue donors has not been established.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 analyzer.
PreciControl Syphilis:
PreciControl Syphilis is intended for the quality control of the Elecsys Syphilis immunoassay on cobas e 411 analyzer.
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TECHNOLOGICAL CHARACTERISTICS 3.
The Elecsys Syphilis assay is a qualitative assay that uses the established double antigen sandwich format. Biotinylated T. pallidum-specific recombinant antigens (TpN15, TpN17 and TpN47) and T. pallidum-specific recombinant antigens (TpN15, TpN17 and TpN47) labeled with a ruthenium complex react with anti T. pallidum-specific antibodies to form a sandwich complex. The assay uses monomeric and polymeric antigens, ensuring the detection of both IgG and IgM anti-treponemal antibodies. After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically bound onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
The predicate device is a solid phase, one-step chemiluminescent enzyme immunoassay. The solid phase (bead) is coated with purified recombinant T. pallidum 17 (Tp17) antigen. The liguid phase consists of alkaline phosphatase (bovine calf intestine) conjugated to purified recombinant T. pallidum 17 (Tp17) antigen.
Patient sample and the reagent are incubated together with the coated bead. During this time, total antibody to T. pallidum in the sample forms the antigen sandwich complex with purified recombinant T. pallidum 17 (Tp17) antigen on the bead and enzyme conjugated purified recombinant T. pallidum 17 (Tp17) antigen in the reagent. Unbound patient sample and enzyme conjugate are then removed by centrifugal washes. Finally, chemiluminescent substrate is added to the reaction tube containing the bead and the signal is generated in proportion to the bound enzyme.
Both the predicate device and Elecsys Syphilis provide prepackaged reagents, calibrators and controls for use on automated test systems. A comparison of the important similarities and differences of these assays is provided in the following table:
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Table of similarities and differences
| Parameter | New Device | Predicate |
|---|---|---|
| Intended Use | Immunoassay for the in vitro | |
| qualitative determination of total | ||
| antibodies (IgG and IgM) to | ||
| Treponema pallidum in human serum | ||
| and plasma. The test is intended as an | ||
| aid in the diagnosis of syphilis infection | ||
| in conjunction with clinical signs and | ||
| symptoms. | ||
| The Elecsys Syphilis assay is not | ||
| intended for use in screening blood or | ||
| plasma donors. | ||
| The electrochemiluminescence | ||
| immunoassay "ECLIA" is intended for | ||
| use on cobas e 411 analyzer | The IMMULITE 2000 Syphilis Screen | |
| test is a treponemal testing procedure | ||
| for the qualitative detection of | ||
| antibodies to Treponema pallidum in | ||
| human serum or heparinized plasma | ||
| on the IMMULITE 2000 analyzer as | ||
| an aid I the diagnosis of syphilis. | ||
| The IMMULITE 2000 Syphilis Screen | ||
| test is not intended for use in | ||
| screening blood or plasma donors. | ||
| Analytes measured | Antibodies to Treponema pallidum | same |
| Instrument | Cobas e 411 | IMMULITE 2000 Systems |
| Measurement | Qualitative | same |
| Antigens used | Recombinant antigens TpN17, | |
| TpN15 andTpN47 | Recombinant antigen Tp17 | |
| Cut-off |