(249 days)
Not Found
No
The document describes a standard immunoassay system and does not mention any AI or ML components. The performance evaluation is based on traditional statistical metrics for diagnostic tests.
No
This device is an in vitro diagnostic assay used for the qualitative determination of antibodies to Treponema pallidum, which aids in the diagnosis of syphilis infection. It does not provide any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "Lumipulse G TP-N can be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection." This clearly indicates its role in diagnosing a condition.
No
The device is described as an "assay system, including a set of immunoassay reagents" and utilizes "CLEIA technology" on a "LUMIPULSE G System," indicating it is a hardware-based in vitro diagnostic device that uses reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "For in vitro diagnostic use."
Furthermore, the description of the device and its intended use (qualitative determination of antibodies to Treponema pallidum in human serum and plasma) clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of disease.
N/A
Intended Use / Indications for Use
Lumipulse G TP-N Immunoreaction Cartridges Set
For in vitro diagnostic use.
WARNING: Lumipulse G TP-N is not intended for blood and tissue donor screening. United States federal law restricts this device to sale by or on the order of a physician.
Lumipulse G TP-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the qualitative determination of antibodies (1gG and 1gM) to Treponema pallidum in human serum and plasma (sodium citrate, or dipotassium EDTA) on the LUMIPULSE & System. Lumipulse G TP-N can be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.
Product codes
LIP
Device Description
The Lumipulse G TP-N is an assay system, including a set of immunoassay reagents, for the qualitative detection of anti-TP antibodies (IgG and IgM) in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System.
Lumipulse G TP-N Immunoreaction Cartridges Set REF 235041 The Lumipulse G TP-N Immunoreaction Cartridges Set contains the following:
- Lumipulse G TP-N Immunoreaction Cartridges 3 x 14 tests
Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 75 ug/mL recombinant TP antigen (Tp15-17)-coated particles, 75 ug/mL recombinant TP antigen (TpN47)-coated particles, protein stabilizers (bovine) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: sodium azide.
Enzyme-Labeled Antigen Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.075 µg/mL alkaline phosphatase (ALP: calf) labeled recombinant TP antigen (Tp15-17), 0.075 µg/mL ALP (calf)-labeled recombinant TP antigen
(TpN47) and protein stabilizers (bovine and calf) and chemical stabilizers in 0.1 M sodium chloride/Tris buffer. Preservative: sodium azide.
- Lumipulse G TP-N Calibrators CAL Liquid, 1 x 2 Concentrations
CAL N TP calibrator-N (1 x 2.0 mL)
CAL P TP calibrator-P (1 x 2.0 mL)
Contains 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). The material of TP calibrator-P is processed from anti-TP positive but inactivated human serum. Preservative: sodium azide.
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
14 to 92
Intended User / Care Setting
Clinical and Hospital laboratories
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
Cross-reactivity study (Analytical Specificity):
- Sample Size: 282 specimens
- Data Source: Specimens obtained from patients known to have a variety of microbial and viral infections, biological abnormalities, and from drug users.
- Annotation Protocol: The presence of the potential cross-reactant was confirmed with an FDA cleared assay (where applicable).
Cut-off establishment:
- Sample Size: 312 negative specimens, 99 positive specimens, and 6 intermediate specimens.
- Data Source: Previously assigned using TP-PA.
- Annotation Protocol: These samples were measured with Lumipulse G TP-N to establish its cut-off index.
Method Comparison (multi-center clinical study):
- Sample Size: A total of 2791 subjects were submitted for testing. After exclusions due to hemolyzed/lipemic samples, lack of test results, and/or protocol deviations, there were 1290 evaluable prospective samples and 1472 evaluable retrospective samples (total 2762 evaluable samples).
- Data Source:
- Prospective Collection: 1316 specimens collected sequentially from patients prescribed a laboratory test for syphilis between a defined period of time from 7 sites across different geographical regions of the US (low and high prevalence sites).
- Retrospective Collection: 1475 pre-selected specimens including:
- 379 pregnant women (250 without syphilis, 129 with syphilis)
- 520 HIV positive subjects (298 remnant samples from reference laboratories and 222 collected at a research facility)
- 130 known to be T. pallidum (TP)-reactive by previous laboratory testing.
- 68 samples collected at a research facility from patients clinically diagnosed with syphilis.
- 375 samples consisting of remnants of specimens sent to a laboratory for routine syphilis testing.
- Additionally, 289 samples from subjects with well-characterized medically diagnosed syphilis and 474 samples from apparently healthy subjects (including 75 pediatric and 399 adult/not pregnant subjects).
- Annotation Protocol:
- The study samples were tested at four clinical sites.
- The clinical performance of the Lumipulse G TP-N was evaluated by comparing its results with a comparator result based on an algorithm of results from three FDA cleared tests: a treponemal test (EIA), a non-treponemal Rapid Plasma Reagin (RPR) test, and a second treponemal test, Treponema pallidum particle agglutination (TP-PA).
- A determination of positive, negative, or indeterminate result was made for each test according to the directions in the labeling.
- The final comparator result was determined using a "2 out of 3" rule (EIA, RPR, and TP·PA). Cases where the EIA result was "equivocal" and the TP-PA result was "inconclusive" led to an indeterminate final comparator result and were excluded from the final analysis.
Matrix Comparison:
- Sample Size: Sixty (60) matched sets of serum (red top and serum separator tubes (SST)) and plasma (K2EDTA and sodium citrate) samples.
- Data Source: Not explicitly stated, implied to be clinical samples.
- Annotation Protocol: Lumipulse G TP-N on the LUMIPULSE G1200 was evaluated by performing the study using these matched sets.
Summary of Performance Studies
1. Analytical performance:
-
a. Precision/Reproducibility:
- Study type: Precision was evaluated at one internal site, and reproducibility at 3 laboratory sites, consistent with CLSI Protocol EP05-A3.
- Sample size: One human sodium citrate-based sample (specimen pool) and five human serum-based samples (specimen pools), two reactive controls and one nonreactive control were assayed.
- Key results (Reproducibility): Samples were assayed in replicates of two at two separate times of the day at each of the sites for 10 days (n=120 for each sample).
- Relative standard deviation (CV%) for Sodium Citrate Plasma (moderate positive) was 4.1%.
- Relative standard deviation (CV%) for Serum 1 (low negative) and Nonreactive Control was 0.0%.
- Relative standard deviation (CV%) for Serum 2 (high negative) was 5.6%.
- Relative standard deviation (CV%) for Serum 3 (low positive) was 4.9%.
- Relative standard deviation (CV%) for Serum 4 (high positive) was 4.5%.
- Relative standard deviation (CV%) for Serum 5 (moderate positive) was 3.9%.
- Relative standard deviation (CV%) for Reactive Control 1 was 3.2%.
- Relative standard deviation (CV%) for Reactive Control 2 was 3.5%.
- Key results (Lot-to-lot precision): Evaluated using 3 lots, samples assayed in replicates of two at two separate times of the day for each of the lots for 10 days (n=120 for each sample). The %CV for between-lot imprecision was = 1.0 are reactive.
-
e. Analytical specificity:
- Study type: Evaluation for potential interference from endogenous substances and therapeutic drugs consistent with CLSI Protocol EP7-A2. Also evaluated for potential cross-reactivity in other diseases and biological conditions.
- Sample size: Not specified for interference. 282 specimens for cross-reactivity from various microbial/viral infections, biological abnormalities, drug users.
- Key results: Not susceptible to interference from listed endogenous substances (e.g., Bilirubin, Triglycerides, Hemoglobin, HAMA, RF) and therapeutic drugs (e.g., Abacavir Sulfate, Metformin, Penicillin G Benzathine) at specified concentrations. For cross-reactivity, 33 samples were reactive with Lumipulse G TP-N. All Lumipulse G TP-N reactive samples were also reactive with TP-PA, except 1 Rubella IgG sample and 2 drug user samples, indicating reactivity to Syphilis (T. Pallidum antibodies) rather than cross-reactivity.
2. Comparison studies:
-
a. Method Comparison:
- Study type: Multi-center clinical study comparing Lumipulse G TP-N results to a final comparator result based on an algorithm of three FDA cleared tests (EIA, RPR, TP-PA).
- Sample size: Total of 2762 evaluable samples (1290 prospective, 1472 retrospective).
- Key results (Prospective Samples):
- Population: 1290 evaluable subjects, age 18-92 (median 42), 66% male, 34% female.
- Positive Percent Agreement (PPA): 92.7% (CI 88.6%, 95.4%)
- Negative Percent Agreement (NPA): 99.6% (CI 99.0%, 99.9%)
- Key results (Retrospective Samples):
- Population: 1472 evaluable subjects, age 14-89 (median 33), 43% male, 57% female.
- Positive Percent Agreement (PPA): 94.3% (CI 92.0%, 96.0%)
- Negative Percent Agreement (NPA): 98.1% (CI 97.0%, 98.8%)
- Key results (Medically Diagnosed Subjects - 289 samples):
- Primary Syphilis (Treated/Untreated): 100% reactive with Lumipulse G TP-N (2/2 treated, 27/27 untreated).
- Secondary Syphilis (Treated/Untreated): 100% reactive with Lumipulse G TP-N (25/25 treated, 30/30 untreated).
- Latent Syphilis (Treated/Untreated): 100% reactive for treated (5/5), 91.5% reactive for untreated (183/200). 17 untreated latent samples were nonreactive (13/17 nonreactive by TP-PA, 15/17 nonreactive by RPR).
- Key results (Apparently Healthy Individuals - 474 samples):
- Adults: 0.3% reactive (1/399 samples, this one also reactive by TP-PA and RPR).
- Pediatrics: 0% reactive (0/75 samples).
- Total: 0.2% reactive (1/474 samples).
-
b. Matrix Comparison:
- Study type: Evaluation of matrix differences using matched sets of serum (red top/SST) and plasma (K2EDTA/sodium citrate) samples.
- Sample size: 60 matched sets.
- Key results: Demonstrated equivalency between the matrices (SST, K2EDTA, Sodium Citrate vs. Red Top). Correlation coefficients ranged from 0.987 to 0.997.
3. Clinical studies: Not Applicable (refer to 2a, Method Comparison).
4. Clinical cut-off: Not applicable.
5. Expected values/Reference range: Distribution of Lumipulse G TP-N results in prospective population by age and gender provided in a table.
6. Conclusion: Performance is substantially equivalent to the ADVIA Centaur Syphilis (SYPH) assay.
Key Metrics
Precision (CV%):
- Within-run: 0.0% to 5.3%
- Between Run: 0.0% to 1.9%
- Between-Day: 0.0% to 3.2%
- Within-Laboratory (Total): 0.0% to 6.8%
- Reproducibility (Total, includes between-site): 0.0% to 5.6%
Method Comparison (Prospective Samples):
- Positive Percent Agreement (PPA): 92.7% (CI 88.6%, 95.4%)
- Negative Percent Agreement (NPA): 99.6% (CI 99.0%, 99.9%)
Method Comparison (Retrospective Samples):
- Positive Percent Agreement (PPA): 94.3% (CI 92.0%, 96.0%)
- Negative Percent Agreement (NPA): 98.1% (CI 97.0%, 98.8%)
Predicate Device(s)
ADVIA Centaur Syphilis (SYPH) Assay K112343
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are white against a dark background. 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
July 5, 2016
Diana Dickson Director, Clinical and Regulatory Science Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
Re: K153145
Trade/Device Name: LUMIPULSE G TP-N Immunoreaction Cartridges Set Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LIP Dated: May 31, 2016 Received: June 1, 2016
Dear Ms. Dickson:
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
1
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 801), 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/Resourcesfor You/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 vours.
Steven R. Gitterman -S
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
2
Indications for Use
510(k) Number (if known) K153145
Device Name
Lumipulse G TP-N Immunoreaction Cartridges set
Indications for Use (Describe) Lumipulse G TP-N Immunoreaction Cartridges Set
For in vitro diagnostic use.
WARNING: Lumipulse G TP-N is not intended for blood and tissue donor screening. United States federal law restricts this device to sale by or on the order of a physician.
Lumipulse G TP-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the qualitative determination of antibodies (1gG and 1gM) to Treponema pallidum in human serum and plasma (sodium citrate, or dipotassium EDTA) on the LUMIPULSE & System. Lumipulse G TP-N can be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/1 description: The image is the logo for Fujirebio Diagnostics, Inc. The logo features a stylized blue and white graphic on the left, resembling a water droplet or a stylized flower. To the right of the graphic is the company name, "FUJIREBIO" in large, bold, blue letters, with the words "Diagnostics, Inc." in smaller, gray letters underneath.
Section 5 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurand:
IgG and IgM antibodies to Treponema pallidum (T. pallidum)
D. Type of Test:
Qualitative assay, automated chemiluminescent enzyme immunoassay (CLEIA)
E. Applicant:
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|-----------------|------------------------------------------------------------------------------|
| Contact person: | Stacey Dolan
(610) 240-3843 |
Summary preparation date: June 28, 2016
F. Proprietary and Established Names:
Lumipulse G TP-N Immunoreaction Cartridges Set
G. Regulatory Information:
-
- Regulation section: 21 CFR § 866.3830, Treponema pallidum treponemal test reagents
dolans@fdi.com
- Regulation section: 21 CFR § 866.3830, Treponema pallidum treponemal test reagents
-
- Classification: Class II
-
- Product code: LIP, Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
-
- Panel: 83, Microbiology
4
Image /page/4/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left, featuring blue and green shapes. To the right of the graphic, the word "FUJIREBIO" is written in large, bold, blue letters. Below "FUJIREBIO", the words "Diagnostics, Inc." are written in smaller, black letters.
H. Intended Use:
-
- Intended use(s): See indications for use below.
-
- Indication(s) for use:
Lumipulse G TP-N Immunoreaction Cartridges Set
For in vitro diagnostic use.
WARNING: LUMIPULSE G TP-N is not intended for blood and tissue donor screening. United States federal law restricts this device to sale by or on the order of a physician.
Lumipulse G TP-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the qualitative determination of antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma (sodium citrate or dipotassium EDTA) on the LUMIPULSE G System. Lumipulse G TP-N can be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.
-
- Special conditions for use statement(s): Prescription use only
-
- Special instrument requirements: LUMIPULSE G1200 System
. Device Description:
The Lumipulse G TP-N is an assay system, including a set of immunoassay reagents, for the qualitative detection of anti-TP antibodies (IgG and IgM) in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System.
Lumipulse G TP-N Immunoreaction Cartridges Set REF 235041 The Lumipulse G TP-N Immunoreaction Cartridges Set contains the following:
-
- Lumipulse G TP-N Immunoreaction Cartridges 3 x 14 tests
Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 75 ug/mL recombinant TP antigen (Tp15-17)-coated particles, 75 ug/mL recombinant TP antigen (TpN47)-coated particles, protein stabilizers (bovine) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: sodium azide.
- Lumipulse G TP-N Immunoreaction Cartridges 3 x 14 tests
Enzyme-Labeled Antigen Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.075 µg/mL alkaline phosphatase (ALP: calf) labeled recombinant TP antigen (Tp15-17), 0.075 µg/mL ALP (calf)-labeled recombinant TP antigen
5
Image /page/5/Picture/1 description: The image contains the logo for Fujirebio Diagnostics, Inc. On the left side of the logo is a graphic of three overlapping shapes in blue, white, and green. To the right of the graphic is the company name in blue, with "Diagnostics, Inc." in a smaller font size and in black.
(TpN47) and protein stabilizers (bovine and calf) and chemical stabilizers in 0.1 M sodium chloride/Tris buffer. Preservative: sodium azide.
- Lumipulse G TP-N Calibrators CAL Liquid, 1 x 2 Concentrations 2.
Image /page/5/Picture/4 description: The image shows two lines of text describing TP calibrators. The first line says "CAL N TP calibrator-N (1 x 2.0 mL)". The second line says "CAL P TP calibrator-P (1 x 2.0 mL)".
TP calibrator-P (1 x 2.0 mL)
Contains 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). The material of TP calibrator-P is processed from anti-TP positive but inactivated human serum. Preservative: sodium azide.
J. Substantial Equivalence Information:
-
- Predicate device name(s): ADVIA Centaur Syphilis (SYPH) Assay
-
- Predicate 510(k) number(s): K112343
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Image /page/6/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and green abstract symbol on the left, followed by the company name in blue, bold letters. Below the company name, the words "Diagnostics, Inc." are written in a smaller, black font.
3. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Lumipulse G TP-N | ||
| (K153145) | ADVIA Centaur Syphilis | |
| (SYPH) Assay | ||
| (Predicate Device) | ||
| K112343 | ||
| Device Type | ||
| Classification | In vitro diagnostic | |
| Class II | In vitro diagnostic | |
| Class II | ||
| Regulation Number | 21CFR § 866.3830 | |
| Treponema pallidum | ||
| treponemal test reagents | 21CFR § 866.3830 | |
| Treponema pallidum | ||
| treponemal test reagents | ||
| Product Usage | Clinical and Hospital | |
| laboratories | Clinical and Hospital | |
| laboratories | ||
| Intended Use | Lumipulse G TP-N is a | |
| Chemiluminescent Enzyme | ||
| Immunoassay (CLEIA) for the | ||
| qualitative determination of | ||
| antibodies (IgG and IgM) to | ||
| Treponema pallidum in | ||
| human serum and plasma | ||
| (sodium citrate, or | ||
| dipotassium EDTA) on the | ||
| LUMIPULSE G | ||
| System. Lumipulse G TP-N | ||
| can be used as an initial | ||
| diagnostic test or in | ||
| conjunction with a | ||
| nontreponemal laboratory test | ||
| and clinical findings to aid in | ||
| the diagnosis of syphilis | ||
| infection. | The ADVIA Centaur Syphilis | |
| (SYPH) assay is an in-vitro | ||
| diagnostics immunoassay for | ||
| the qualitative determination | ||
| of antibodies to Treponema | ||
| pallidum in human serum or | ||
| plasma (EDTA, lithium or | ||
| sodium heparinized, citrate) | ||
| using the ADVIA Centaur® | ||
| and ADVIA Centaur® XP | ||
| systems as an aid in the | ||
| diagnosis of syphilis. | ||
| Black box warning | ||
| (PRECAUTION) | WARNING: LUMIPULSE G | |
| TP-N is not intended for blood | ||
| and tissue donor screening. | ||
| United States federal law | ||
| restricts this device to sale by | ||
| or on the order of a physician. | WARNING. The ADVIA | |
| Centaur SYPH assay is not | ||
| intended for blood and tissue | ||
| donor screening. | ||
| United States federal law | ||
| restricts this device to sale by | ||
| or on the order of a physician. | ||
| Assay Type | Direct sandwich | |
| immunoassay based on | ||
| chemiluminescent | ||
| technology | Direct sandwich | |
| immunoassay based on | ||
| chemiluminescent | ||
| technology | ||
| Specimen Collection | ||
| Method | Routine Phlebotomy | |
| Techniques | Routine Phlebotomy | |
| Techniques | ||
| Differences | ||
| Lumipulse G TP-N | ||
| (K153145) | ADVIA Centaur Syphilis | |
| (SYPH) Assay | ||
| (Predicate Device) | ||
| K112343 | ||
| Instrument System | LUMIPULSE G System | ADVIA Centaur |
| Principle of Operation | Automated | |
| Chemiluminescent | ||
| Microparticle Immunoassay | ||
| (CMIA) | Chemiluminescence Enzyme | |
| Immunoassay | ||
| (CLEIA) | ||
| Sample Volume | 60 µL | 100 µL |
| Capture/Detection | ||
| Antigen/Antibody | Recombinant antigens | |
| TpN15-17 and TpN47 on | ||
| microparticles and | ||
| recombinant antigens TpN15- | ||
| 17 and TpN47 alkaline | ||
| phosphatase conjugates | Recombinant antigens | |
| TpN17 and TpN15 as biotin | ||
| conjugates and recombinant | ||
| antigens TpN17 and TpN15 | ||
| as acridinium ester | ||
| conjugates | ||
| Calibrators | 2 calibrators - anti-TP positive | |
| human plasma is used in the | ||
| Lumipulse G TP-N positive | ||
| calibrator and delipidized | ||
| normal human sera are used | ||
| in the Lumipulse G TP-N | ||
| negative calibrator. | 2 calibrators - liquid in | |
| human plasma | ||
| Cut-off |