(80 days)
971502, 001552
Not Found
No
The description focuses on the multiplex flow immunoassay technology and standard data processing (calculating RFI and antibody index) without mentioning any AI/ML algorithms for analysis or interpretation.
No.
The Bio-Rad Syphilis IgG kit is a diagnostic device for detecting antibodies, not for treating a condition. Its purpose is to provide "serological evidence of infection" and "confirm reactive test results," which are diagnostic rather than therapeutic functions.
Yes
The device is intended for the qualitative detection of Treponema pallidum IgG antibodies, which provides serological evidence of infection and can be used to confirm reactive test results, indicating its role in diagnosis.
No
The device is a kit containing reagents (dyed beads, calibrators, controls) and is intended for use with a specific hardware system (BioPlex 2200 System). It is not solely software.
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 kit is intended for the "qualitative detection of Treponema pallidum IgG antibodies in human serum." This is a diagnostic test performed on a biological sample (serum) outside of the body (in vitro) to provide information about a person's health status (presence of antibodies indicating syphilis infection).
- Device Description: The description details a laboratory-based assay using reagents and a system (BioPlex 2200) to analyze a patient sample. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document describes various performance studies (reproducibility, precision, comparative testing, correlation with disease stages, cross-reactivity) conducted to validate the device's performance in a laboratory setting using human samples. This is a requirement for IVD devices.
- Predicate Devices: The mention of predicate devices (Macro-Vue RPR Card, Serodia TPPA, Trep-Chek Anti-Treponemal EIA) which are known IVD devices further supports that this device falls into the same category.
N/A
Intended Use / Indications for Use
The Bio-Rad Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system is also indicated for use in confirming reactive test results from non-treponemal based screening assays.
The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors.
Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
Product codes
LIP
Device Description
The Syphilis IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of dyed beads are coated with recombinant proteins associated with T. pallidum (15kD, 17kD and 47kD). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma.
The system is calibrated using a set of four (4) distinct calibrators vials, supplied separately by Bio-Rad Laboratories. Four (4) vials representing two (2) or three (3) different antibody concentrations are used for calibration. Results are calculated for each of the three (3) antibodies and are compared against their own respective cut-off and are expressed as an antibody index (AI). A single result is reported after completing a composite analysis of all the antibodies (the highest Al value is reported).
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
Prescription Use
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
Comparative Testing:
Study Type: Diagnostic accuracy study comparing BioPlex 2200 Syphilis IgG against reference assays (RPR and TPPA).
Sample Size: A total of 1,750 serum samples.
Data Source: Samples from patients who had a syphilis test ordered (N=500), unselected pregnant women (N=497), serum samples requested to be RPR/TPPA reactive (N=250), pregnant women requested to be treponemal assay positive (N=183), pregnant women requested to be RPR/TPPA nonreactive (N=250), and patients medically diagnosed with syphilis (N=70).
Annotation Protocol: Reference assay equivocal results were assigned to the opposite result than that of the corresponding BioPlex 2200 Syphilis IgG result for purposes of percent agreement calculations. Discordant samples were further tested by a treponemal EIA kit to determine the final result.
Key Results:
- Serum Samples From Patients Who Had a Syphilis Test Ordered (N=500):
- Positive Agreement: 100% (46/46)
- Negative Agreement: 93.8% (426/454)
- Unselected Serum Samples From Pregnant Women (N=497):
- Positive Agreement: 100% (5/5)
- Negative Agreement: 99.8% (491/492)
- Serum Samples Requested to be RPR and TPPA Reactive (N=250):
- Positive Agreement: 100% (249/249)
- Serum Samples From Pregnant Women Requested to be Treponemal Assay Positive (N=183):
- Positive Agreement: 100% (166/166)
- Serum Samples From Pregnant Women Requested to be RPR/TPPA Nonreactive (N=250):
- Negative Agreement: 98.8% (247/250)
- Combined Pregnant Women Samples (N=433):
- Positive Agreement: 100% (166/166)
- Negative Agreement: 94.4% (252/267)
- Serum Samples From Patients Medically Diagnosed With Syphilis (N=70):
- Positive Agreement: 100.0% (63/63)
- 95.7% (67/70) of medically diagnosed patients were reactive with BioPlex 2200 Syphilis IgG.
Correlation with Known HIV-1 Positive Samples:
Study Type: Evaluation of BioPlex 2200 Syphilis IgG performance in known HIV-1 positive samples.
Sample Size: 220 banked, known HIV-1 positive serum samples.
Key Results:
- Negative agreement with reference assay testing: 68.0% (123/181)
- Positive agreement with reference assay testing: 100% (39/39)
Correlation with Disease Stages and Clinical Sensitivity:
Study Type: Evaluation of BioPlex 2200 Syphilis IgG performance against CDC panel and prospectively collected samples with known disease state and treatment status.
Sample Size:
- CDC panel (N=140): Treated and untreated patients with primary, secondary, or latent infections.
- Prospectively collected samples (N=10): Treated and untreated patients with primary and secondary syphilis infections.
Key Results: - BioPlex 2200 Syphilis IgG vs. CDC Panel (N=140):
- Overall Clinical Sensitivity: 91.4% (128/140)
- Combined CDC Panel and Prospectively Collected Samples (N=150):
- Overall Clinical Sensitivity for BioPlex 2200 Syphilis IgG: 92.0% (138/150)
- Overall Clinical Sensitivity for Reference Assays: 89.5% (137/150)
- Overall Positive Agreement: 100% (137/137)
Cross-Reactivity Study:
Study Type: Evaluation of potential cross-reactivity with samples from various disease states.
Sample Size: Ten (10) specimens positive for each cross reactant.
Key Results: The study demonstrated that the evaluated disease state samples generally do not cross-react with the BioPlex 2200 Syphilis IgG kit. Most positive results were confirmed by another treponemal antibody test (TPPA), indicating reactivity to Syphilis (T. pallidum) IgG antibodies rather than cross-reactivity.
Key Metrics
Sensitivity, Specificity, Positive Percent Agreement, Negative Percent Agreement, Standard Deviation (SD), Percent Coefficient of Variation (%CV).
Predicate Device(s)
Macro-Vue RPR Card (Becton Dickenson) Pre-Amendment, Serodia TPPA (Fujirebio Inc.) 971502, Trep-Chek Anti-Treponemal EIA (Phoenix Bio-Tech Corp.) 001552
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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MAR 1 9 2007
BIOPLEX 2200 SYPHILIS IgG 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number | 510(k) Summary Report Date |
|---|---|
| K063866 | March 8, 2007 |
MANUFACTURER INFORMATION
| Manufacturer | |
|---|---|
| Manufacturer Address | Bio-Rad Laboratories, Inc. |
| Clinical Systems Division | |
| 4000 Alfred Nobel Drive | |
| Hercules, CA 94547 | |
| Telephone | (510) 724-7000 |
| Establishment Registration No. | 2915274 |
| Owner / Operator | Bio-Rad Laboratories, Inc. |
| 4000 Alfred Nobel Drive | |
| Hercules, CA 94547 | |
| Owner / Operator No. | 9929003 |
| Official Correspondent for the BioPlex 2200 EBV IgG | |
| Official Correspondent Address | Bio-Rad Laboratories |
| 6565 185th Ave NE | |
| Redmond, WA 98052 | |
| Telephone | 425-881-8300 |
| Establishment Registration No. | 3022521 |
| Owner / Operator | Bio-Rad Laboratories |
| 6565 185th Ave NE | |
| Redmond, WA 98052 | |
| Official Correspondent | Mr. Christopher Bentsen |
| Telephone | (425) 498-1709 |
| Fax | (425) 498-1651 |
CLASSIFICATION INFORMATION
| Classification Name | Treponema Pallidum Treponemal Test Reagents |
|---|---|
| Common Name: | Multi-Analyte Detection System Syphilis IgG |
| Product Trade Name | BioPlex 2200 Syphilis IgG on the BioPlex 2200 Multi-Analyte |
| Detection System | |
| Device Class | Class II |
| Classification Panel | Microbiology |
| Regulation Number | 866.3830 |
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LEGALLY MARKETED EQUIVALENT (SE) DEVICES
| Comparative FDA Cleared
PREDICATE DEVICE | 510(k) Number | Decision
Date |
|--------------------------------------------------------|---------------|------------------|
| Macro-Vue RPR Card (Becton Dickenson) | Pre-Amendment | N/A |
| Serodia TPPA (Fujirebio Inc.) | 971502 | 11/13/1997 |
| Trep-Chek Anti-Treponemal EIA (Phoenix Bio-Tech Corp.) | 001552 | 10/19/2000 |
DEVICE DESCRIPTION
The Syphilis IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube.19 Three (3) different populations of dyed beads are coated with recombinant proteins associated with T. pallidum (15kD, 17kD and 47kD). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information.
The system is calibrated using a set of four (4) distinct calibrators vials, supplied separately by Bio-Rad Laboratories. Four (4) vials representing two (2) or three (3) different antibody concentrations are used for calibration. Results are calculated for each of the three (3) antibodies and are compared against their own respective cut-off and are expressed as an antibody index (AI). A single result is reported after completing a composite analysis of all the antibodies (the highest Al value is reported).
KIT COMPONENTS
Syphilis IgG (665-1450). The reagent pack contains supplies sufficient for 100 tests.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing dyed beads coated with affinity-purified E. |
| coli derived recombinant proteins to T. pallidum (15kD, 17kD, and 47kD), | |
| an Internal Standard (ISB), a Serum Verification (SVB), and a Reagent | |
| Blank (RBB), with Glycerol and protein stabilizers (bovine) in a MOPS (3- | |
| [NMorpholino] propanesulfonic acid) buffer. ProClin® 300 (0.3%) and sodium | |
| azide (T. pallidum (15kD, 17kD, and 47kD) antibodies in a human serum matrix | |
| made from defibrinated plasma. ProClin® 300 (0.3%) as a preservative for | |
| all calibrators. | |
| 663-1430 | BioPlex 2200 Syphilis IgG Control Set: Two (2) 1.5 mL vials of Positive |
| Control containing antibodies to T. pallidum 17kD and two (2) 1.5 mL vials | |
| of Positive Control containing antibodies to T. pallidum 15kD and 47kD in a | |
| human serum matrix made from defibrinated plasma, and two (2) 1.5 mL | |
| vials of Negative Control in a human serum matrix made from defibrinated | |
| plasma. ProClin® 300 (0.3%) as a preservative for all controls. | |
| 660-0817 | BioPlex 2200 System Sheath Fluid: Two (2) 4 L bottles containing |
| Phosphate Buffered Saline (PBS). ProClin® 300 (0.3%) and Sodium azide | |
| (0.1%) as preservatives. | |
| 660-0818 | BioPlex 2200 System Wash Solution: One (1) 10 L bottle containing |
| Phosphate Buffered Saline (PBS) and Tween 20. ProClin® 300 (0.3%) and | |
| Sodium azide (0.1%) as preservatives. | |
| 660-0000 | BioPlex 2200 Instrument and Software. |
INTENDED USE / INDICATIONS FOR USE
The Bio-Rad Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system is also indicated for use in confirming reactive test results from nontreponemal based screening assays.
The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors.
Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
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TECHNOLOGICAL CHARACTERISTICS
The following tables summarize similarities and differences between the BioPlex 2200 Syphilis IgG Kit and the predicate devices used in comparative studies with the BioPlex 2200 Syphilis IgG Kit.
A. BioPlex 2200 EBV IgG Assay vs. Predicate RPR Test
Table 1: Similarities between reagents and materials
| Similarities between
| Components / Materials | BioPlex 2200 Syphilis IgG Kit | Predicate RPR Test |
|---|---|---|
| Reagents | The Bead Set reagent containing | |
| dyed antigen coated beads reacts with | ||
| the patient sample. | The Antigen Suspension reagent | |
| reacts with the patient sample. |
Table 2: Similarities between reagents with regard to function and use
| Similarities between
| Function and Use | BioPlex 2200 Syphilis IgG Kit | Predicate RPR Test |
|---|---|---|
| Intended Use | Aid in the diagnosis of Syphilis | Aid in the diagnosis of Syphilis |
Table 3: Differences between reagents and materials
| Differences between
| Components / Materials | BioPlex 2200 Syphilis IgG Kit | Predicate RPR Test |
|---|---|---|
| Solid Phase | Bead Set reagent - dyed antigen | |
| coated beads. | None. | |
| Reagents | Conjugate, Sample Diluent, Wash | |
| Buffer. | Antigen Suspension. | |
| Sheath Fluid | Sheath Fluid is used to suspend the | |
| bead reagent and introduce it into the | ||
| detector. | Not similar; not utilized in RPR | |
| tests. | ||
| Calibrators | Calibrators. | None. |
| Control | Negative Control and multi-analyte | |
| Positive Control. | User provided controls with | |
| established patterns of graded | ||
| activity (optional Control Card Sets | ||
| available) |
Table 4: Differences between reagents with regard to function and use
| Differences between
| Function and Use | BioPlex 2200 Syphilis IgG Kit | Predicate RPR Test |
|---|---|---|
| Analyte Detection | Multi-analyte qualitative detection of | |
| human IgG antibodies to Treponema | ||
| pallidum. | Non-treponemal qualitative and | |
| quantitative detection of human | ||
| reagin. | ||
| Matrices | Serum. | Serum and Plasma. |
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B. BioPlex 2200 EBV IgG Assay vs. Predicate TPPA Test
Table 5: Similarities between reagents and materials
| Similarities between
| Components / Materials | BioPlex 2200 Syphilis IgG Kit | Predicate TPPA |
|---|---|---|
| Reagents | Sample Diluent | Sample Diluent |
| Controls | Negative Control and multi-analyte | |
| Positive Control | Non-reactive Control Serum and | |
| Positive Control Serum (containing | ||
| rabbit antibodies to Treponema | ||
| pallidum) |
Table 6: Similarities between reagents with regard to function and use
| Similarities between
| Function and Use | BioPlex 2200 Syphilis IgG Kit | Predicate TPPA |
|---|---|---|
| Intended Use | Aid in the diagnosis of Syphilis | Aid in the diagnosis of Syphilis |
Table 7: Differences between reagents and materials
| Differences between
| Components / Materials | BioPlex 2200 Syphilis IgG Kit | Predicate TPPA |
|---|---|---|
| Solid Phase | Bead reagent - dyed antigen coated | |
| beads. | None. | |
| Reagents | Conjugate, Wash Buffer. | Sensitized Particles, Unsensitized |
| Particles. | ||
| Sheath Fluid | Sheath Fluid is used to suspend the | |
| bead reagent and introduce it into the | ||
| detector. | Not similar; not utilized in TPPA | |
| tests. | ||
| Calibrators | Calibrators. | None. |
Table 8: Differences between reagents with regard to function and use
| Differences between
| Function and Use | BioPlex 2200 Syphilis IgG Kit | Predicate TPPA |
|---|---|---|
| Analyte Detection | Multi-analyte detection of human | |
| IgG antibodies to Treponema | ||
| pallidum. | Detection of human antibodies to | |
| Treponema pallidum. | ||
| Matrices | Serum. | Serum and Plasma. |
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C. BioPlex 2200 EBV IgG Assay vs. Predicate EIA Test
| Similarities between
| Components / Materials | BioPlex 2200 Syphilis IgG Kit | Predicate EIA |
|---|---|---|
| Reagents | Wash Buffer, Sample Diluent | Sample Diluent, Wash Buffer |
| Calibrator(s) | Calibrators | Calibrator |
| Controls | Negative Control and multi-analyte Positive Control | Negative Control and Positive Control |
Table 9: Similarities between reagents and materials
Table 10: Similarities between reagents with regard to function and use
| Similarities between
| Function and Use | BioPlex 2200 Syphilis IgG Kit | Predicate EIA |
|---|---|---|
| Intended Use | Qualitative detection of IgG | |
| antibodies to Treponema pallidum. | Qualitative detection of IgG | |
| antibodies to Treponema pallidum. |
Table 11: Differences between reagents and materials
| Differences between
| Components / Materials | BioPlex 2200 Syphilis IgG Kit | Predicate EIA |
|---|---|---|
| Solid Phase | Bead reagent - dyed antigen coated | |
| beads. | 96 well microplate - antigen coated | |
| microwells. | ||
| Reagents | Conjugate: Anti-human IgG / | |
| Phycoerythrin. | Conjugate: goat anti-human IgG | |
| horseradish peroxidase, Substrate | ||
| (TMB), Stop Solution. | ||
| Sheath Fluid | Sheath Fluid is used to suspend the | |
| bead reagent and introduce it into the | ||
| detector. | Not similar; not utilized in EIA's. |
Table 12: Differences between reagents with regard to function and use
| Differences between
| Function and Use | BioPlex 2200 Syphilis IgG Kit | Predicate EIA |
|---|---|---|
| Analyte Detection | Multi-analyte detection of human | |
| IgG antibodies to Treponema | ||
| pallidum. | Detection of human IgG antibodies | |
| to Treponema pallidum. | ||
| Matrices | Serum. | Serum and Plasma. |
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PERFORMANCE SUMMARY
A. Expected Values
Prevalence
Expected values for the Syphilis IgG kit are presented by age and gender in the following tables for serum samples from unselected hospitalized patients (N=300), serum samples from patients who had a syphilis test ordered (N=500), and serum samples from unselected pregnant women (N=497). For all analytes, results of ≤0.8 Ai are nonreactive, 0.9 and 1.0 Al are equivocal, and ≥1.1 Al are reported as reactive.
| Age | Gender | Reactive | Equivocal | Nonreactive | Total | |||
|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | N | ||
| 0-9 years of age | F | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 0 |
| M | 0 | 0.0% | 0 | 0.0% | 1 | 100% | 1 | |
| 10-19 years of age | F | 0 | 0.0% | 0 | 0.0% | 3 | 100% | 3 |
| M | 0 | 0.0% | 0 | 0.0% | 9 | 100% | 9 | |
| 20-29 years of age | F | 1 | 5.3% | 0 | 0.0% | 18 | 94.7% | 19 |
| M | 0 | 0.0% | 0 | 0.0% | 16 | 100% | 16 | |
| 30-39 years of age | F | 1 | 8.3% | 0 | 0.0% | 11 | 91.7% | 12 |
| M | 3 | 10.0% | 0 | 0.0% | 27 | 90.0% | 30 | |
| 40-49 years of age | F | 3 | 10.7% | 0 | 0.0% | 25 | 89.3% | 28 |
| M | 4 | 9.3% | 0 | 0.0% | 39 | 90.7% | 43 | |
| 50-59 years of age | F | 2 | 7.4% | 0 | 0.0% | 25 | 92.6% | 27 |
| M | 7 | 16.3% | 0 | 0.0% | 36 | 83.7% | 43 | |
| 60-69 years of age | F | 1 | 8.3% | 0 | 0.0% | 11 | 91.7% | 12 |
| M | 4 | 19.0% | 0 | 0.0% | 17 | 81.0% | 21 | |
| 70-79 years of age | F | 4 | 36.4% | 0 | 0.0% | 7 | 63.6% | 11 |
| M | 2 | 18.2% | 0 | 0.0% | 9 | 81.8% | 11 | |
| 80-89 years of age | F | 0 | 0.0% | 0 | 0.0% | 6 | 100% | 6 |
| M | 0 | 0.0% | 0 | 0.0% | 3 | 100% | 3 | |
| > 89 years of age | F | 1 | 25.0% | 0 | 0.0% | 3 | 75.0% | 4 |
| M | 0 | 0.0% | 0 | 0.0% | 1 | 100% | 1 | |
| Total | 33 | 11.0% | 0 | 0.0% | 267 | 89.0% | 300 |
Table 13. Samples From Unselected Hospitalized Patients (N=300)
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| Age | Gender | Reactive | Equivocal | Nonreactive | Total | |||
|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | N | ||
| E. Coli | 4*.+++ | BioPlex 2200 | 0 | HTLV | 10 | BioPlex 2200 | 0 | |
| TPPA | N/A | TPPA | 0 | |||||
| Discrepants | 0 | Discrepants | 0 | |||||
| HSV-1 IgG | 10 | BioPlex 2200 | 1 | Pregnant | ||||
| women | 10 | BioPlex 2200 | 0 | |||||
| TPPA | 0 | TPPA | 0 | |||||
| Discrepants | 1 | Discrepants | 0 | |||||
| Lyme IgG | ||||||||
| Borrelia | ||||||||
| burgdorferi | 10 | BioPlex 2200 | 1 | HSV-2 IgG | 10 | BioPlex 2200 | 1 | |
| TPPA | 1 | TPPA | 1 | |||||
| Discrepants | 0 | Discrepants | 0 | |||||
| VZV IgG | 10 | BioPlex 2200 | 0 | Lyme IgG | ||||
| Afzelli / Garnii | 49*.+ | BioPlex 2200 | 1 | |||||
| TPPA | 0 | TPPA | 1++ | |||||
| Discrepants | 0 | Discrepants | 0 | |||||
| Hyper- | ||||||||
| gamma- | ||||||||
| globulinemia | 10 | BioPlex 2200 | 2 | EBV IgG | 10 | BioPlex 2200 | 0 | |
| TPPA | 1 | TPPA | 0 | |||||
| Discrepants | 1 | Discrepants | 0 | |||||
| Leptospirosis | 7 | BioPlex2200 | 2 | Small Pox | 10+++ | BioPlex 2200 | 0 | |
| Predicate | 2 | TPPA | N/A | |||||
| Discrepants | 0 | Discrepants | 0 |
Table 37. Cross-Reactivity
- Due to limited availability of samples, only four E. coli specimens were evaluated.
** Additional samples were tested to evaluate the various lyme strains.
† Only positive samples were tested by the predicate.
ttt Testing was only performed on the BioPlex 2200 Syphilis IgG assay.
tt Sample was negative by TPPA but positive by both RPR and EIA
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Bhend Regulatory Affairs Associate Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE Redmond, WA 98052
MAR 1 9 2007
Re: K063866
Trade/Device Name: BioPlex 2200 Syphilis IgG kit on the BioPlex 2200 Multi-Analyte Detection System Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LIP Dated: March 8, 2007 Received: March 9, 2007
Dear Mr. Bhend:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Sally artman
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K063866
BioPlex 2200 Syphilis IgG kit on the Device Name: BioPlex 2200 Multi-Analyte Detection System
Indications for Use:
The Bio-Rad Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system is also indicated for use in confirming reactive test results from non-treponemal based screening assays.
The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors.
Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
x Prescription Use: (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use: (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evelyn M. Poole
on Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K063866