(90 days)
Not Found
No
The summary describes a multiplex flow immunoassay kit and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis focuses on traditional analytical and clinical performance metrics.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of syphilis antibodies and reagin antibodies, which aids in the diagnosis of syphilis infection. It is not intended for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The test system should be used in conjunction with other laboratory tests and clinical findings to aid in the diagnosis of syphilis infection," indicating its role in the diagnostic process.
No
The device description clearly outlines physical components including vials containing beads, antibodies, buffers, calibrators, and controls. These are tangible reagents and materials, not solely software. The device is intended for use with the Bio-Rad BioPlex 2200 System, which is a hardware instrument.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma." It also states that it is used "in conjunction with other laboratory tests and clinical findings to aid in the diagnosis of syphilis infection." This clearly indicates that the device is intended for use on biological specimens (serum or plasma) outside of the body to provide information for diagnostic purposes.
- Device Description: The device components are reagents (beads, conjugates, buffers, calibrators, controls) designed to react with components in human serum or plasma to detect the presence of specific antibodies. This is characteristic of an in vitro diagnostic test.
- Intended User / Care Setting: The intended user is a "Clinical laboratory," which is where in vitro diagnostic tests are typically performed.
- Performance Studies: The document describes extensive analytical and clinical performance studies, including precision, reproducibility, stability, analytical specificity, comparison studies with predicate devices, and clinical studies evaluating agreement with comparators in various patient populations. These types of studies are required for the regulatory approval of IVD devices.
- Predicate Device(s): The mention of predicate devices (LIAISON Treponema Assay and BD Macro-Vue RPR Card Tests) indicates that this device is being compared to existing, legally marketed IVD devices for the same intended use.
All of these factors strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. The Syphilis Total or RPR assays may be used to supplement a previously determined reactive treponemal or non-treponemal test. The test system should be used in conjunction with other laboratory tests and clinical findings to aid in the diagnosis of syphilis infection.
The BioPlex 2200 Syphilis Total & RPR kit is not intended for use in screening blood or plasma donors
The BioPlex 2200 Syphilis Total & RPR kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis Total & RPR Control Set is intended for use as an assayed quality control to monitor the performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis Total & RPR assay in the clinical laboratory. The performance of the BioPlex 2200 Syphilis Total & RPR Control Set has not been established with any other Syphilis Total & RPR assays.
The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
Product codes (comma separated list FDA assigned to the subject device)
LIP, GMQ, JIT, JJX
Device Description
BioPlex 2200 Syphilis Total & RPR kit includes the following components:
- One (1) 10 mL vial, containing dyed beads coated with recombinant Syphilis ● rTP47/rTP17 fusion protein, a cardiolipin antigen, an Internal Standard Bead (ISB) and a Serum Verification Bead (SVB) in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer containing bovine proteins with protein stabilizers. ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (0.95. Data supported use of serum, lithium heparin, sodium heparin, K2 EDTA, and K3EDTA specimens.
3. Clinical studies:
a. Clinical Performance in Prospectively Collected Specimens in the Intended Use Population:
- Study Type: Prospective clinical evaluation.
- Sample Size: 1001 specimens.
- Key Results:
- BioPlex Syphilis Total Assay: Overall Positive Percent Agreement (PPA) 92.5% (147/159, 95% CI 87.3%-95.6%), Negative Percent Agreement (NPA) 97.9% (824/842, 95% CI 96.6%-98.6%).
- BioPlex RPR Assay: Overall PPA 81.5% (75/92, 95% CI 72.4%-88.1%), NPA 96.5% (877/909, 95% CI 95.1%-97.5%).
b. Clinical Performance in Retrospective known Syphilis Positive Samples:
- Study Type: Retrospective clinical evaluation.
- Sample Size: 544 samples.
- Key Results:
- BioPlex Syphilis Total Assay: Overall PPA 99.6% (486/488, 95% CI 98.5%-99.9%), NPA 100% (56/56, 95% CI 93.6%-100%).
- BioPlex RPR Assay: Overall PPA 98.1% (422/430, 95% CI 96.4%-99.1%), NPA 80.7% (92/114, 95% CI 72.5%-86.9%).
c. Clinical Performance in Clinically Diagnosed Individuals:
- Study Type: Clinical evaluation for sensitivity.
- Sample Size: 160 individuals.
- Key Results:
- BioPlex Syphilis Total: Total 96.8% (151/156, 95% CI 92.7%-98.6%) sensitivity.
- BioPlex RPR: Total 84.0% (131/156, 95% CI 77.4%-88.9%) sensitivity.
d. Clinical Performance in HIV Positive Individuals:
- Study Type: Clinical evaluation in HIV positive individuals.
- Sample Size: 362 samples.
- Key Results:
- BioPlex Syphilis Total Assay: Overall PPA 93.3% (140/150, 95% CI 88.2%-96.3%), NPA 93.9% (199/212, 95% CI 89.8%-96.4%).
- BioPlex RPR Assay: Overall PPA 85.7% (36/42, 95% CI 72.2%-93.3%), NPA 90.6% (290/320, 95% CI 86.9%-93.4%).
e. Clinical Performance in Pregnant Women:
- Study Type: Clinical evaluation in pregnant women.
- Sample Size: 372 specimens.
- Key Results:
- BioPlex 2200 Syphilis Total Assay: Overall PPA 100% (32/32, 95% CI 89.3%-100.0%), NPA 99.4% (338/340, 95% CI 97.9%-99.8%).
- BioPlex RPR Assay: Overall PPA 100% (25/25, 95% CI 86.7%-100%), NPA 98.3% (341/347, 95% CI 96.3%-99.2%).
f. Clinical Performance in Apparently Healthy Subjects:
- Study Type: Clinical evaluation in apparently healthy subjects.
- Sample Size: 301 samples.
- Key Results:
- BioPlex 2200 Syphilis Total Assay: NPA 99.0% (294/297, 95% CI 97.1%-99.7%); PPA 75.0% (3/4, 95% CI 30.1%-95.5%).
- BioPlex 2200 RPR Assay: NPA 98.0% (291/297, 95% CI 95.7%-99.1%); PPA 0% (0/4, 95% CI 0.0%-49.0%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics presented as Positive Percent Agreement (% Pos Agreement) and Negative Percent Agreement (% Neg Agreement), and Sensitivity. Specificity, PPV, NPV are not explicitly named as "specificity", "PPV" or "NPV" in this document.
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.
LIAISON Treponema Assay, K061247, BD Macro-Vue RPR Card Tests
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features 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. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
May 11, 2017
BIO-RAD Laboratories Juang Wang Regulatory Affairs Representative, Clinical Immunology Division 5500 E. 2nd Street Benicia, CA 94510
Re: K170413
Trade/Device Name: Bioplex 2200 Syphilis Total & RPR Kit Bioplex 2200 Syphilis Total & RPR Calibrator Set Bioplex 2200 Syphilis Total & RPR Control Set Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LIP, GMQ, JIT, JJX Dated: February 9, 2017 Received: February 10, 2017
Dear Mr. Wang:
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 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
1
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 regulations (21 CFR 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
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) K170413
Device Name BioPlex 2200 Syphilis Total & RPR BioPlex 2200 Syphilis Total & RPR Control Set BioPlex 2200 Syphilis Total & RPR Calibrator Set
Indications for Use (Describe)
The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. The Syphilis Total or RPR assays may be used to supplement a previously determined reactive treponemal or non-treponemal test. The test system should be used in conjunction with other laboratory tests and clinical findings to aid in the diagnosis of syphilis infection.
The BioPlex 2200 Syphilis Total & RPR kit is not intended for use in screening blood or plasma donors
The BioPlex 2200 Syphilis Total & RPR kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis Total & RPR Control Set is intended for use as an assayed quality control to monitor the performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis Total & RPR assay in the clinical laboratory. The performance of the BioPlex 2200 Syphilis Total & RPR Control Set has not been established with any other Syphilis Total & RPR assays.
The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
BioPlex 2200 Syphilis Total & RPR 510(k) Summary
Bio-Rad Laboratories hereby submits this 510(k) in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. This summary of 510(k) safety and effectiveness information provides detail as a basis for a determination of substantial equivalence for the BioPlex 2200 Syphilis Total & RPR kit.
Applicant/Sponsor I.
Bio-Rad Laboratories, INC Clinical Immunology Division 5500 E. Second Street Benicia, CA 94510
Contact Person: Juang Wang, PhD, RAC Tel: 510-741-4609 FAX: 510-741-3941 Juang_wang@bio-rad.com
Date Prepared: May 09, 2017
Device Name II.
Proprietary Name: BioPlex 2200 Syphilis Total & RPR BioPlex 2200 Syphilis Total & RPR Calibrator BioPlex 2200 Syphilis Total & RPR Control
Classification Name:
- Enzyme Linked Immunoabsorption Assay, Treponema pallidum
- Antigens, Nontreponemal, All
- Calibrator, Secondary
- Single (specified) Analyte Controls (Assayed and Unassayed)
Regulatory Information: III.
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| Enzyme linked | |||
| immunoabsorption assay, | |||
| Treponema pallidum | |||
| (LIP) | Class II | 21 CFR §866.3830 – Treponema pallidum treponemal test | |
| reagents | Microbiology | ||
| (83) | |||
| Antigens, Nontreponemal, | |||
| All (GMQ) | Class II | 21 CFR §866.3820 – Treponema pallidum nontreponemal test | |
| reagents | Microbiology | ||
| (83) |
4
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| Calibrator, Secondary(JIT) | Class II | 21 CFR § 862.1150 – Calibrator | Clinical |
| Chemistry | |||
| Single (specified) analyte | |||
| controls (assayed and | |||
| unassayed) (JJX) | Class I | 21 CFR § 862.1660-Quality | |
| control Material (Assayed and | |||
| Unassayed) | Clinical | ||
| Chemistry |
IV. Predicate Devices
LIAISON Treponema Assay, K061247 BD Macro-Vue RPR Card Tests, Pre-amendment prior to May 28, 1976
V. Device Description:
BioPlex 2200 Syphilis Total & RPR kit includes the following components:
- One (1) 10 mL vial, containing dyed beads coated with recombinant Syphilis ● rTP47/rTP17 fusion protein, a cardiolipin antigen, an Internal Standard Bead (ISB) and a Serum Verification Bead (SVB) in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer containing bovine proteins with protein stabilizers. ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (1:64 | within $\pm$ 1 titer
(95% CI) |
| Negative Control | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100%
(83.9 - 100%) |
| Positive Control | 0 | 20 | 20 | 0 | 0 | 0 | 0 | 0 | 100%
(83.9 - 100%) |
| Low Reactive (1:8) | 0 | 0 | 0 | 1 | 19 | 0 | 0 | 0 | 100%
(83.9 - 100%) |
| Moderately Reactive
(1:16) | 0 | 0 | 0 | 0 | 0 | 20 | 0 | 0 | 100%
(83.9 - 100%) |
| High Reactive (>1:64) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 100%
(83.9 - 100%) |
| High Reactive (>1:64) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 100%
(83.9 - 100%) |
b. Traceability:
Value Assignment:
Calibrator assignment is established for the matched lot of BioPlex 2200 Syphilis Total & RPR kit using the internal reference standards. For each calibrator level, three vials are tested in replicates of five on three BioPlex 2200 analyzers for a total of 45 data points. The mean values obtained for each kit calibrator level are verified and must fall within specified acceptable range as shown below.
| Calibrator Set | Assay | Range (AI) |
|---|---|---|
| Vial 1 | Syphilis Total | |
| and RPR | 0.0 - 0.2 | |
| Vial 2 | Syphilis Total | 1.4 - 2.2 |
| Vial 3 | Syphilis Total | 2.8 - 4.2 |
| Vial 4 | Syphilis Total | 4.8 - 7.2 |
11
| Calibrator Set | Assay | Range (AI) |
|---|---|---|
| Vial 5 | RPR | 1.4 – 2.6 |
Calibrator
There is no international or certified reference material available. The BioPlex Syphilis Total & RPR Calibrators are traceable to internal standard. The internal reference standard is manufactured by spiking high positive plasma into non-reactive immunodepleted human plasma. The internal reference calibrators are frozen at ≤ -80℃.
The BioPlex Syphilis Total assay is calibrated using a set of four levels of distinct serum based calibrators whereas the BioPlex RPR assay is calibrated with a set of two levels of calibrators.
Controls
The BioPlex Syphilis & RPR Control Set contains one negative control, one positive control for Syphilis Total and one positive control for RPR. Positive controls are made from the human disease state serum containing anti-T. pallidum and reagin antibodies. The control set is provided in a human serum matrix stabilized with ≤ 0.3% ProClin 300, ≤0.1% sodium benzoate and 0.95.
| Matrix | BioPlex
Assay | Slope
(95% CI) | Intercept
(95% CI) | Correlation
(r) | N |
|--------------------|-------------------|------------------------------|---------------------------------|--------------------|-----|
| Lithium
heparin | Syphilis
Total | 0.8421
(0.8148 to 0.8694) | 0.0316
(-0.0312 to 0.0944) | 0.9899 | 89 |
| | RPR | 0.8684
(0.8333 to 0.9035) | 0.0908
(0.0625 to 0.1191) | 0.9893 | 113 |
| Sodium
heparin | Syphilis
Total | 0.8333
(0.8148 to 0.8519) | 0.0500
(0.0050 to 0.0950) | 0.9924 | 89 |
| | RPR | 0.8353
(0.8095 to 0.8611) | 0.1147
(0.0833 to 0.1461) | 0.9849 | 113 |
| K2EDTA | Syphilis
Total | 1.1923
(1.1538 to 1.230) | -0.0923
(-0.1538 to -0.0308) | 0.9943 | 83 |
| | RPR | 1.0930
(1.0709 to 1.1151) | -0.0314
(-0.0663 to 0.0035) | 0.9864 | 112 |
| K3EDTA | Syphilis
Total | 1.1667
(1.1290 to 1.2043) | -0.0625
(-0.1073 to -0.0177) | 0.9915 | 82 |
| | RPR | 1.0776
(1.0500 to 1.1052) | -0.0233
(-0.0484 to 0.0018) | 0.9810 | 113 |
The resulting data support the package insert claim that serum, lithium heparin, sodium heparin, K2 EDTA, and K3EDTA specimens are acceptable for use with the BioPlex Syphilis Total and RPR assays.
Clinical studies: 3.
The clinical Performance of the BioPlex 2200 Syphilis Total & RPR kit was evaluated in three testing sites from November 2016 using a total of 2008 samples prospectively and retrospectively collected from multiple commercial suppliers (approximately 91% in the US and 9% from outside of the US). There were 6 samples that generated no values due to repeat instrument error flags. The tested specimens consisted of 1347 prospective samples (301 apparently healthy subjects, 201 syphilis and 200 RPR test ordered for a total of 401 test ordered samples, 295 pregnant women and 45 pregnant women with STD, 305 HIV positive individuals) and 661 retrospective samples (412 RPR/VDRL positive, 160 clinically diagnosed syphilis, 32 pregnant syphilis positive, 57 HIV/Syphilis dual positive).
The 2008 specimens enrolled in the multiple site study were collected in the following areas:
- . US : 90.7%
- 23.6% Northeast (Maryland, Massachusetts, New York, Pennsylvania)
16
- -18.7% Southwest (California, Hawaii, New Mexico)
- 28.4% Southeast (Florida, Georgia) -
- 9.2% Midwest -
- -10.8% Unknown
- Outside US: 9.3% ●
- -3.5% Argentina
- -3.2% France/Europe
- -1.4% China
- 1.2% Others -
Performance of the BioPlex Syphilis Total assay was evaluated by calculating positive percent agreement and negative percent agreement of the assay with the final comparator results based on an algorithm of results from three commercially available assays: treponemal chemiluminescence immunoassay (Predicate), RPR Card Test, and a second treponemal assay (TP-PA). The final comparator results were determined using a "2 out of 3" rule (TP-CLIA, RPR Card and TP-PA) as shown below. Results with indeterminate final comparator results would be excluded from the data analysis.
Performance of the BioPlex RPR assay was also evaluated by calculating positive percent agreement and negative percent agreement against a commercially available RPR Card Test (Predicate).
17
| Treponemal
IgG/IgM
(Predicate) | Non-treponemal
(Predicate) | 2nd Treponemal
(TP-PA)
(Predicate) | Final Comparator
Algorithm Result |
|--------------------------------------|-------------------------------|------------------------------------------|--------------------------------------|
| Negative | Non-reactive | Reactive | Negative |
| | | Non-reactive | Negative |
| | | Inconclusive | Negative |
| Negative | Reactive | Reactive | Positive |
| | | Non-reactive | Negative |
| | | Inconclusive | Negative |
| Positive | Reactive | Reactive | Positive |
| | | Non-reactive | Positive |
| | | Inconclusive | Positive |
| Positive | Non-reactive | Reactive | Positive |
| | | Non-reactive | Negative |
| | | Inconclusive | Positive |
| Equivocal | Non-reactive | Reactive | Positive |
| | | Non-reactive | Negative |
| | | Inconclusive | Indeterminate |
| Equivocal | Reactive | Reactive | Positive |
| | | Non-reactive | Negative |
| | | Inconclusive | Indeterminate |
a. Clinical Performance in Prospectively Collected Specimens in the Intended Use Population
The 1001 prospectively collected specimens in the intended use population evaluated with the BioPlex 2200 Syphilis Total & RPR kit consisted of 401 specimens sent for routine syphilis or RPR testing (194 females, 207 males,7 - 96 years old), 295 pregnant women (15 -42 years old), and 305 HIV positive individuals (97 females, 208 males, 17 -75 years old).
The comparison between the BioPlex Syphilis Total assay result and the final comparator result for the prospectively-collected specimens in the intended use population is shown below.
18
| Prospective Samples | Final Comparator Algorithm Result | |||||
|---|---|---|---|---|---|---|
| R (+) | NR(-) | Total | % Pos | |||
| Agreement | ||||||
| (95% CI) | % Neg | |||||
| Agreement | ||||||
| (95% CI) | ||||||
| Syphilis | ||||||
| Test Ordered | Pos (+) | 26 | 3 | 29 | 89.7% (26/29) | |
| 73.6%-96.4% | 98.3% (169/172) | |||||
| 95.0%-99.4% | ||||||
| EQ | 1 | 0 | 1 | |||
| Neg (-) | 2 | 169 | 171 | |||
| Total | 29 | 172 | 201 | |||
| RPR Test Ordered | Pos (+) | 31 | 0 | 31 | 96.9% (31/32) | |
| 84.3%-99.4% | 100% (168/168) | |||||
| 97.8%-100% | ||||||
| EQ | 0 | 0 | 0 | |||
| Neg (-) | 1 | 168 | 169 | |||
| Total | 32 | 168 | 200 | |||
| HIV Positive | Pos (+) | 90 | 11 | 101 | 91.8% (90/98) | |
| 84.7% - 95.8% | 93.7%(194/207) | |||||
| 89.6% - 96.3% | ||||||
| EQ | 2 | 2 | 4 | |||
| Neg (-) | 6 | 194 | 200 | |||
| Total | 98 | 207 | 305 | |||
| Pregnant Women | Pos (+) | 0 | 2 | 2 | N/A | 99.3% (293/295) |
| 97.6% - 99.8% | ||||||
| EQ | 0 | 0 | 0 | |||
| Neg (-) | 0 | 293 | 293 | |||
| Total | 0 | 295 | 295 | |||
| Overall | Pos (+) | 147 | 16 | 163 | 92.5% (147/159) | |
| 87.3% - 95.6% | 97.9% (824/842) | |||||
| 96.6% - 98.6% | ||||||
| EQ | 3 | 2 | 5 | |||
| Neg (-) | 9 | 824 | 833 | |||
| Total | 159 | 842 | 1001 | |||
| BioPlex 2200 Syphilis Total Assay (Treponemal Test) |
R- Reactive; EQ-Equivocal; NR-Non-reactive; Pos – Positive; Neg- Negative
The comparison between the BioPlex RPR assay result and the predicate RPR result is shown below.
| Predicate RPR Result | |||||||
|---|---|---|---|---|---|---|---|
| Prospective Samples | R (+) | NR (-) | Total | % Pos | |||
| Agreement | |||||||
| (95% CI) | % Neg | ||||||
| Agreement | |||||||
| (95% CI) | |||||||
| BioPlex 2200 RPR Assay | |||||||
| (Non-Treponemal Test) | Syphilis Test | ||||||
| Ordered | R (+) | 19 | 5 | 24 | 79.2% (19/24) | ||
| 59.5%-90.8% | 97.2% (172/177) | ||||||
| 93.6%-98.8% | |||||||
| NR (-) | 5 | 172 | 177 | ||||
| Total | 24 | 177 | 201 | ||||
| RPR Test | |||||||
| Ordered | R (+) | 27 | 2 | 29 | 77.1% (27/35) | ||
| 61.0%-87.9% | 98.8% (163/165) | ||||||
| 95.7%-99.7% | |||||||
| NR (-) | 8 | 163 | 171 | ||||
| Total | 35 | 165 | 200 | ||||
| HIV Positive | R (+) | 29 | 21 | 50 | 87.9% (29/33) | ||
| 72.7%-95.2% | 92.3% (251/272) | ||||||
| 88.5%-94.9% | |||||||
| NR (-) | 4 | 251 | 255 | ||||
| Total | 33 | 272 | 305 |
19
| R (+) | ||||||
|---|---|---|---|---|---|---|
| Pregnant | ||||||
| Women | NR (-) | 0 | 4 | 4 | N/A | 98.6% (291/295) |
| 96.6%-99.5% | ||||||
| Total | 0 | 291 | 291 | |||
| 0 | 295 | 295 | ||||
| Overall | R(+) | 75 | 32 | 107 | ||
| NR (-) | 17 | 877 | 894 | 81.5% (75/92) | ||
| 72.4% -88.1% | 96.5%(877/909) | |||||
| 95.1% - 97.5% | ||||||
| Total | 92 | 909 | 1001 |
b. Clinical Performance in Retrospective known Syphilis Positive Samples
Clinical performance in the retrospective known syphilis positive samples was evaluated by testing a total of 544 samples including 412 known RRP/VDRL positive (106 females, 305 males, 1 unknown gender, 61 | Male | 27 | 10 (37.0%) | 0 (0.0%) | 17 (63.0%) | 7 (25.9%) | 20 (74.1%) |
| | Female | 20 | 2 (10%) | 0 (0.0%) | 18 (90.0%) | 3 (15.0%) | 17 (85.0%) |
| Overall
7 – 96 | Male | 25 | 7 (28.0%) | 0 (0.0%) | 18 (72.0%) | 5 (20.0%) | 20 (80.0%) |
| | Female | 194 | 15 (7.7%) | 0 (0.0%) | 179 (92.3%) | 20 (10.3%) | 174 (89.7%) |
| Combined | | 207 | 45 (21.7%) | 1 (0.5%) | 161 (77.8%) | 33 (15.9%) | 174 (84.1%) |
| | | 401 | 60 (15.0%) | 1 (0.2%) | 340 (84.8%) | 53 (13.2%) | 348 (86.8%) |
Prevalence of Pregnant Women for whom syphilis testing is ordered
| Age
(years) | N | BioPlex Syphilis Total
N (%) | | | BioPlex RPR
N (%) | |
|--------------------|-----|---------------------------------|----------|-------------|----------------------|-------------|
| | | R(+) | EQ | NR(-) | R(+) | NR(-) |
| 41 | 2 | 0 (0.0%) | 0 (0.0%) | 2 (100%) | 0 (0.0%) | 2 (100%) |
| Overall
15 - 42 | 295 | 2 (0.7%) | 0 (0.0%) | 293 (99.3%) | 4 (1.4%) | 291 (98.6%) |
Prevalence of HIV Positive individuals
| Age
(years) | Gender | N | BioPlex Syphilis Total
N (%) | | | BioPlex RPR
N (%) | |
|----------------|--------|----|---------------------------------|----------|------------|----------------------|------------|
| | | | R(+) | EQ | NR(-) | R(+) | NR(-) |
| 71 | Female | 0 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| | Male | 2 | 0 (0.0%) | 0 (0.0%) | 2 (100%) | 0 (0.0%) | 2 (100%) |
| Unknown | Male | 2 | 0 (0.0%) | 0 (0.0%) | 2 (100%) | 0 (0.0%) | 2 (100%) |
| All
17-75 | Female | 97 | 27 (27.8%) | 0 (0.0%) | 70 (72.2%) | 13 (13.4%) | 84 (86.6%) |
| | Male | 208 | 74 (35.6%) | 4 (1.8%) | 130 (62.5%) | 37 (17.8%) | 171 (82.2%) |
| Combined | | 305 | 101 (33.1%) | 4 (1.3%) | 200 (65.6%) | 50 (16.4%) | 255 (83.6%) |
Instrument Name: X.
The BioPlex 2200 System, software version 4.3
XI. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.