(222 days)
No
The device description details a standard immunoassay process and the performance studies focus on method comparison and agreement, with no mention of AI/ML algorithms or training/test data sets for such technologies.
No
The IMMULITE 2000 Syphilis Screen is an in vitro diagnostic device used to detect antibodies for syphilis. It aids in diagnosis but does not directly treat or cure the condition, which is the function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is used "as an aid in the diagnosis of syphilis."
No
The device description clearly outlines a solid-phase, one-step chemiluminescent immunoassay involving physical components like beads, reagents, and an analyzer (IMMULITE 2000). This indicates a hardware-based in vitro diagnostic device, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "treponemal testing procedure for the qualitative detection of antibodies to Treponema pallidum in human serum or heparinized plasma... as an aid in the diagnosis of syphilis." This clearly indicates that the device is used to test samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description details a "solid-phase, one-step chemiluminescent immunoassay" that analyzes patient samples (serum or plasma) to detect antibodies. This is a typical description of an in vitro diagnostic test.
- Input Imaging Modality: The "Not Applicable (Immunoassay)" for Input Imaging Modality further supports that this is a laboratory-based test performed on biological samples, not an imaging device used directly on the patient.
- Anatomical Site: The "Not Applicable (In vitro diagnostic)" for Anatomical Site reinforces that the test is performed on samples outside the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 in the diagnosis of syphilis.
The IMMULITE 2000 Syphilis Screen is not intended for use in screening blood or plasma donors.
Product codes
LIP
Device Description
The IMMULITE 2000 Syphilis Screen is a solid-phase, one-
step chemiluminescent immunoassay. The solid phase (bead) is
coated with biotinylated recombinant Treponema pallidum p17
(Tp17) antigen. The liquid phase consists of alkaline
phosphatase (bovine calf intestine) conjugated to purified
recombinant Treponema pallidum p17 (Tp17) antigen.
The patient sample and reagent are incubated together with the
coated bead for 30 minutes. During this time, total antibody to
Treponema pallidum in the sample forms an antigen sandwich
complex with biotinylated recombinant Treponema pallidum
pl 7 (Tp17) antigen on the bead and enzyme conjugated purified
recombinant Treponema pallidum p17 (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.
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
As part of the clinical study, samples from various patient populations were tested with both the IMMULITE Syphilis Screen and the LIAISON Treponema Assay.
Table 2: Method Comparison, Medically Diagnosed Syphilis Patients
Sample Size: 281
Study type: Method Comparison
Key Results:
Positive Agreement: 270/272 = 99.3% (95% Confidence Interval: 97.4% - 99.9%)
Negative Agreement: 6/8 = 75% (95% Confidence Interval: 34.9% - 96.8%)
Overall Agreement: 276/281 = 98.2% (95% Confidence Interval: 95.9% - 99.4%)
Table 3: Method Comparison, Samples Sent for Syphilis Testing
Sample Size: 924
Study type: Method Comparison
Key Results:
Positive Agreement: 359/361 = 99.4% (95% Confidence Interval: 98.0% - 99.9%)
Negative Agreement: 558/563 = 99.1% (95% Confidence Interval: 97.9% - 99.7%)
Overall Agreement: 917/924 = 99.2% (95% Confidence Interval: 98.4% - 99.7%)
Precision/ reproducibility information from product insert:
The reproducibility of the IMMULITE Syphilis Screen as measured by between-site CV ranged from 7.1% to 22.6% for Lot 1 and from 6.1% to 29.7% for Lot 2. Seven samples were tested with both IMMULITE lots.
Key Metrics
Positive Agreement, Negative Agreement, Overall Agreement, Coefficients of Variation (CV)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are large and evenly spaced, filling most of the frame. The background is plain white, providing a stark contrast to the bold text.
!
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
....
DEC 1 6 2009
| 510(k) Summary as Required by 21 CFR 807.92 | |||
|---|---|---|---|
| Submitter: | Siemens Healthcare Diagnostics Inc. | ||
| 5210 Pacific Concourse Drive | |||
| Los Angeles, CA 90045-6900 | |||
| Contact Person: | Robert C. Eusebio | ||
| Director Regulatory Affairs | |||
| 1584 Enterprise Blvd | |||
| West Sacramento, CA 95691 | |||
| (916) 374-3183 | |||
| Date Prepared: | September 10, 2009 | ||
| Device Trade Name: | IMMULITE® 2000 Syphilis Screen | ||
| Common Name: | Immunoassay for Treponema pallidum | ||
| 21 CFR 866.3830 | |||
| Substantial Equivalence: | K061247 | ||
| DiaSorin LIASION® Treponema Assay | |||
| Device Description: | The IMMULITE 2000 Syphilis Screen is a solid-phase, one- | ||
| step chemiluminescent immunoassay. The solid phase (bead) is | |||
| coated with biotinylated recombinant Treponema pallidum p17 | |||
| (Tp17) antigen. The liquid phase consists of alkaline | |||
| phosphatase (bovine calf intestine) conjugated to purified | |||
| recombinant Treponema pallidum p17 (Tp17) antigen. | |||
| The patient sample and reagent are incubated together with the | |||
| coated bead for 30 minutes. During this time, total antibody to | |||
| Treponema pallidum in the sample forms an antigen sandwich | |||
| complex with biotinylated recombinant Treponema pallidum | |||
| pl 7 (Tp17) antigen on the bead and enzyme conjugated purified | |||
| recombinant Treponema pallidum p17 (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. |
.
Ji
・
ﺮ
1
| Intended Use: | 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 in the diagnosis of syphilis.
The IMMULITE 2000 Syphilis Screen is not intended
for use in screening blood or plasma donors. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Aspects: | A comparison of the device features, intended use, laboratory
data and other information demonstrate that the IMMULITE®
2000 Syphilis Screen is substantially equivalent to the
currently marketed DiaSorin LIASION® Treponema Assay,
as summarized in the following tables. |
| Table 1: Comparison of IMMULITE® with LIAISON® Assay | |
|---|---|
| IMMULITE 2000 | LIAISON | |
|---|---|---|
| Indications for Use | 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 | ||
| in the diagnosis of syphilis. |
The IMMULITE 2000 Syphilis
Screen is not intended for use in
screening blood or plasma donors. | The LIAISON Treponema assay uses
chemiluminescence immunoassay
(CLIA) technology for the qualitative
detection of total antibodies directed
against Treponema pallidum in
human serum. The presence of
antibodies to Treponema pallidum
specific antigen, in conjunction with
non-treponemal laboratory tests and
clinical findings, may aid in the
diagnosis of syphilis infection.
The LIAISON Treponema Assay is
not intended for use in screening
blood or plasma donors. |
| Assay Type | Enzyme labeled, one-step
chemiluminescent immunoassay | One-step sandwich chemiluminescent
immunoassay |
| Capture/Detection
Antigen/Antibody | Beads coated with purified
recombinant Treponema pallidum p17
(TpN17) antigens are linked to
enzyme conjugated purified
recombinant Treponema pallidum p17
antigen in the reagent. | Magnetic particles coated with Tp17
DNA recombinant protein specific for
Treponema pallidum are linked to an
isoluminol derivative (isoluminol-
antigen conjugate). |
| Cut-Offs | Test value = ratio of signal from
sample to that of signal of adjustor
curve parameter P1. | Index value = ratio of signal from
sample to that of the standard |
| | $\geq$ 1.1 Reactive
0.9 to $