MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
Device Facts
| Record ID | K071210 |
|---|---|
| Device Name | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 |
| Applicant | Biomedical Diagnostics (Bmd) SA |
| Product Code | LKO · Immunology |
| Decision Date | Dec 19, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5100 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K071210 · Dec 19, 2007 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | Routine laboratory clinical samples; Blood donor samples | Retrospective clinical samples were used to establish threshold values for the assay and to evaluate the impact of potential biological interferences (e.g., rheumatoid factor, cryoglobulinemia, hemolyzed sera). | Threshold establishment; Interference testing; Retrospective clinical samples |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective analysis of clinical samples | 50 blood donors and 48 samples with potential biological interferences; Sample Size: 98 | Not applicable for this study | Establishment of negative threshold values |
| Retrospective clinical sample testing | 30 negative samples characterized as positive for various potential interferences; Sample Size: 30 | Not applicable for this study | Assessment of assay interference from clinical factors (e.g., Rheumatoid factor, Complement, Hemolysis) |
Indications for Use
The FIDIS™ Connective 10* kit is a fluorescent immunoassay for the semi-quantitative simultaneous detection of 10 autoantibody specificities directed against double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm, Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (*Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).
Device Story
Multiplex bead-based flow cytometric immunoassay; detects 10 autoantibody specificities in human serum. Input: serum samples; antigen-coupled color-coded microspheres; goat anti-human IgG phycoerythrin conjugate. Operation: microspheres mixed with serum; flow cytometer uses red laser to identify microsphere set (analyte) and green laser to quantify bound IgG fluorescence. Output: semi-quantitative results for 10 autoantibodies. Used in clinical laboratories; processed via FIDIS instrument (Luminex 200 platform) with MLX-Booster 2.2 software; optional CARIS system for automated dilution/dispensing. Results assist clinicians in diagnosing systemic autoimmune diseases.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated with four samples across reportable range (within-run CVs 2.1-12.7%; between-run CVs 4.5-14.6%). Method comparison (N=264) between modified and initial FIDIS device showed high positive/negative agreement (overall agreement 95.69-100% across parameters). Comparison between manual and automated CARIS system also performed, showing high agreement. No clinical sensitivity/specificity data provided.
Technological Characteristics
Multiplexed flow cytometry immunoassay. Components: color-coded microsphere beads, anti-human IgG-phycoerythrin conjugate, buffers. Energy source: laser-based flow cytometry (Luminex 200). Connectivity: standalone instrument with MLX-BOOSTER™ software. Software: MLX-BOOSTER™ version 2.2. Form factor: 96-well microplate assay.
Indications for Use
Indicated for the semi-quantitative detection of 10 autoantibody specificities (dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, ribosome, centromere) in human serum to aid in the diagnosis of connective tissue diseases including SLE, Sjogren's syndrome, MCTD, scleroderma, dermatomyositis, and CREST syndrome. For prescription use only.
Regulatory Classification
Identification
An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).
Predicate Devices
- FIDISTM Connective 10* (k053653)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k071210
B. Purpose for Submission:
Design changes (detection system with new platform software)
C. Measurand:
Anti-SS-A, anti-SS-B, anti-Sm, anti-Sm/RNP, anti-dsDNA, anti-Scl-70, anti-Jo1, ribosome and centromere
D. Type of Test:
Multiplex bead-based flow cytometric immunoassay
E. Applicant:
Biomedical Diagnostics (bmd) S.A.
F. Proprietary and Established Names:
FIDIS™ Connective 10*
G. Regulatory Information:
1. Regulation section:
21CFR§ 866.5100, Antinuclear Antibody Immunological Test System
2. Classification:
Class II
1. Product code:
LLL, Extractable Antinuclear Antibody, Antigen, and Control
LKJ, Antinuclear Antibody, Antigen, Control
LKO, Anti-RNP Antibody, Antigen, Control
LKP, Anti-Sm Antibody, Antigen, and Control
LSW, Anti-DNA Antibody, Antigen and Control
LJM, Antinuclear Antibody (Enzyme Labeled), Antigen, Controls
MQA, Anti-Ribosomal P Antibodies
4. Panel:
Immunology (82)
H. Intended Use:
1. Intended use(s):
The FIDIS™ Connective 10* kit is a fluorescent immunoassay for the semi-quantitative simultaneous detection of 10 autoantibody specificities directed against double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm, Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (*Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).
2. Indication(s) for use:
The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjogren’s syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.
3. Special conditions for use statement(s):
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This device is for prescription use only.
4. Special instrument requirements:
FIDISTM Instrument (Luminex $200^{\mathrm{TM}}$ plus FIDISTM MLX-Booster 2.2Software)
CARISTM (Optional diluting and dispensing device)
# I. Device Description:
The device consists of the following: color-coded sets of microspheres (lyophilized). Each microsphere set is conjugated to one of the following antigens: dsDNA, SSa (60 kDA and 52 kDA), SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere; calibrator (ready to use); positive control (to be diluted); negative control (to be diluted); goat anti-human IgG conjugate coupled phycoerythrin (ready to use) and washing buffer (ready to use).
# J. Substantial Equivalence Information:
1. Predicate device name(s):
FIDISTM Connective 10*
2. Predicate 510(k) number(s):
k053653
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Modified FIDISTM Connective 10* | Initial FIDISTM Connective 10* |
| Intended Use | Individual determination of IgG antibodies to dsDNA, SSA 60 kDA and 52 kDA, SSB, Sm, Sm/RNP, ScL-70, Jo-1, ribosome and centromere | Same |
| Assay type | Flow cytometer based | Same |
| Assay format | Multiplexed | Same |
| Solid phase capture | Color-coded microsphere | Same |
| Conjugate | Phycoerythrin | Same |
| Sample type | Serum | Same |
| Type of test | Semi-quantitative | Same |
| Differences | | |
| --- | --- | --- |
| Item | Modified FIDISTM Connective 10* | Initial FIDISTM Connective 10* |
| Material supplied | Microplate without caps | Microplate with caps |
| Beads | Vial of color-coded microsphere set Lyophilized (sp 6mL) | 6mL of vial of color-coded microsphere set ready to use |
| Sample Dilution | Sample dilution buffer ready to use | PBS-Tween concentrated |
| Wash buffer | Sample dilution buffer ready to use | PBS-Tween concentrated |
| Assay configuration | 1 “reagent-blank” well 1 “negative control” well | 1 “reagent-blank” well 1 “calibrator” well |
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| Differences | | |
| --- | --- | --- |
| Item | Modified FIDISTM Connective 10* | Initial FIDISTM Connective 10* |
| | 1 “positive control” well
2 “calibrator” wells
Diluted sample wells | 1 “negative control” well
1 “positive control” well
Diluted sample wells
A second calibrator well every 32 well series |
| Assay protocol | Final wash step (not optional) | Optional final wash step |
| Software | Booster Version 2.2 | Booster Version 1.35 |
| Detection | Based on Luminex 200 | Based on Luminex 100 |
K. Standard/Guidance Document Referenced (if applicable):
CLSI C24A - Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
CLSI M29A – Protection of Laboratory Workers from Occupationally Acquired Infection
CLSI H18A – Procedures for the Handling and Processing of Blood Specimens
L. Test Principle:
FIDISTM CONNECTIVE 10* is based on the use of distinct uniform size color-coded microspheres and a benchtop flow cytometer interfaced to a digital signal processing hardware and software. A red diode laser beam of the flow cytometer classifies each set of microspheres on the basis of its unique fluorescence intensity (red to orange) which allows to identify which analyte is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the specific reaction related to each analyte.
Each antigen required for the assay is covalently coupled to an individual set of microspheres through its surface functional groups. The different antigen-coupled microspheres are mixed together to constitute the final microsphere reagent.
FIDISTM CONNECTIVE 10* allows the detection of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes and Centromeres. The microspheres are classified on the basis of their unique fluorescence intensity ratio that allows the identity of analyte being tested. Each dot in a white plot corresponds to an individual microsphere.
Seventy (70) µL of each sample are needed for each analysis. FIDISTM Connective 10* assay was optimized by flow cytometry for the average binding capacity at the given dilution (1:200) from the median fluorescence value using 200 microspheres per parameter.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
To evaluate intra-assay and inter assay reproducibility, four samples covering the reportable range of the assay were analyzed on the modified FIDISTM Connective 10*. For within-run, the four samples were assayed 6 times in one run and for between-run; the four samples were assayed 2 times per run for 6 runs. Additional study was performed for dsDNA on the low end of the measuring range. Results
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were as follows:
| | Within-run
(10 tests in the same run) | | Between-run
(3 tests in 6 different runs) | |
| --- | --- | --- | --- | --- |
| Antigen | Mean value | CV (%) | Mean value | CV (%) |
| dsDNA | 496 | 5.9 | 508 | 10.5 |
| | 87 | 6.1 | 104 | 13.8 |
| | 63 | 8.9 | 63 | 6.7 |
| | 52 | 8.0 | 64 | 12.6 |
| | 14 | 8.2 | 14 | 10.8 |
| | 12 | 8.6 | 14 | 8.3 |
| SSA 60 kDa and 52 kDa | 209 | 2.1 | 202 | 5.4 |
| | 81 | 7.8 | 81 | 4.5 |
| | 64 | 5.3 | 64 | 5.5 |
| | 19 | 11.2 | 23 | 8.8 |
| SSB | 192 | 2.6 | 176 | 8.8 |
| | 74 | 8.0 | 76 | 7.0 |
| | 26 | 5.2 | 25 | 14.6 |
| | 19 | 2.5 | 18 | 10.9 |
| Sm | 306 | 3.2 | 303 | 6.8 |
| | 81 | 9.1 | 87 | 9.4 |
| | 66 | 8.6 | 63 | 10.8 |
| | 49 | 12.7 | 48 | 12.7 |
| Sm/RNP | 236 | 8.4 | 236 | 9.3 |
| | 133 | 7.9 | 139 | 7.6 |
| | 92 | 11.5 | 100 | 14.3 |
| | 75 | 6.2 | 70 | 9.5 |
| Scl70 | 278 | 4.5 | 281 | 7.1 |
| | 162 | 5.4 | 153 | 9.2 |
| | 67 | 4.7 | 67 | 6.5 |
| | 5 | 5.9 | 6 | 13.6 |
| Jo1 | 282 | 9.7 | 268 | 9.7 |
| | 100 | 3.0 | 92 | 9.4 |
| | 57 | 7.7 | 65 | 11.5 |
| | 9 | 12.8 | 9 | 12.2 |
| Centromere | 225 | 9.0 | 223 | 10.1 |
| | 94 | 3.6 | 92 | 6.7 |
| | 25 | 9.0 | 25 | 8.2 |
| | 22 | 6.7 | 21 | 8.5 |
| Ribosome | 154 | 6.9 | 152 | 10.1 |
| | 73 | 6.9 | 79 | 11.8 |
| | 50 | 6.4 | 53 | 8.4 |
| | 15 | 4.2 | 17 | 14.4 |
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b. Linearity/assay reportable range:
Linearity is not claimed for this assay.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The dsDNA values in the calibrator are established using the WHO International Standard for anti-double stranded DNA (dsDNA), human code: WO/80. Other calibrator titers are expressed in arbitrary units per mL (AU/mL).
d. Detection limit:
Not applicable
e. Analytical specificity:
Interfering substances
To evaluate the system for potential cross reactivity to other antibodies and interference from blood components, 30 samples were tested. High level of complement proteins were used but the specific kind of complement was not provided. A statement to avoid the use of abnormal concentration of these samples was added to the Limitations of the Procedure. The following results were obtained:
| | Number of Positive Samples | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | dsDNA | SSA 60/52kD | SSB | Sm | Sm/RNP | Scl70 | Jo1 | Centromere | Ribosome |
| Cryoglobulinemia (2) | | | | | | | | | |
| Complement (7) | 2 | 1 | 1 | 1 | 1 | | | | |
| IgG monoclonal Ig (1) | | | | | | | | | |
| IgM monoclonal Ig (5) | | | | | | | | | |
| Rheumatoid Factor (8) | 1 | 2/2 | 1 | | | | | | |
| Blood Plasma (3) | | | | | | | | | |
| Hemolyzed sera (3) | | | | | | | | | |
| Anti-smooth muscle antibodies (1) | | | | | | | | | |
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
The tables below show the comparison of serum samples (N=264) that were tested with the Modified FIDISTM Connective 10* and the predicate device (Initial FIDISTM Connective 10*). No information about age, gender, and clinical status was provided.
- 194 positive samples for one or more parameters related to systemic autoimmune diseases
- 70 negative samples
All borderline results with the two devices were considered negative.
| | Initial FIDISTM Connective 10* dsDNA | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM Connective 10* dsDNA | Pos | 45 | 1 | 46 |
| | Neg | 4 | 66 | 70 |
| | Total | 49 | 67 | 116 |
Positive % agreement: 91.84% (95% CI: 84.2% - 99.5%)
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Negative % agreement: 98.51% (95% CI: 95.6% - 100%)
Overall % agreement: 95.69% (95% CI: 92.0% - 99.4%)
| | Initial FIDISTM Connective 10*
SSA 60/kDa | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM
Connective 10*
SSA 60/kDa | Pos | 48 | 1 | 49 |
| | Neg | 0 | 69 | 70 |
| | Total | 48 | 70 | 119 |
| Positive % agreement: 100%
Negative % agreement: 98.57% (95% CI: 95.8%-100%)
Overall % agreement: 99.15% (95% CI: 97.52% - 100%) | | | | |
| | Initial FIDISTM Connective 10*
SSA 52kDa | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM
Connective 10*
SSA 52kDa | Pos | 58 | 2 | 60 |
| | Neg | 3 | 64 | 67 |
| | Total | 61 | 66 | 127 |
| Positive % agreement: 95.08% (95% CI: 89.7%, -100.0%)
Negative % agreement: 96.97% (95% CI: 92.8 - 100%)
Overall % agreement: 96.06% (95% CI: 92.7% -99.4%) | | | | |
| | Initial FIDISTM Connective 10* SSB | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM
Connective 10*
SSB | Pos | 23 | 2 | 25 |
| | Neg | 0 | 68 | 68 |
| | Total | 23 | 70 | 93 |
| Positive % agreement: 100%
Negative % agreement: 97.14% (95%CI: 93.2% - 100%)
Overall % agreement: 97.85% (95% CI: 94.9% - 100%) | | | | |
| | Initial FIDISTM Connective 10* Sm | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM
Connective 10* Sm | Pos | 23 | 2 | 25 |
| | Neg | 1 | 73 | 74 |
| | Total | 24 | 75 | 99 |
| Positive % agreement: 95.83% (95% CI: 87.8% - 100%)
Negative % agreement: 97.33% (95%CI: 93.7% - 100%)
Overall % agreement: 96.97% (95% CI: 93.6%- 100%) | | | | |
| | Initial FIDISTM Connective 10* Sm/RNP | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM
Connective 10*
Sm/RNP | Pos | 31 | 2 | 33 |
| | Neg | 1 | 76 | 77 |
| | Total | 32 | 78 | 110 |
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Positive % agreement: 96.88% (95% CI: 90.8% - 100%)
Negative % agreement: 97.44% (95%CI: 93.9% - 100%)
Overall % agreement: 97.27% (95% CI: 94.2% - 100%)
| | Initial FIDISTM Connective 10* Scl70 | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM Connective 10* Scl70 | Pos | 27 | 2 | 29 |
| | Neg | 1 | 68 | 69 |
| | Total | 28 | 70 | 98 |
Positive % agreement: 96.43% (95%CI: 89.2%-100%)
Negative % agreement: 97.14% (95%CI: 93.2% - 100%)
Overall % agreement: 96.94% (95% CI: 93.5% - 100%)
| | Initial FIDISTM Connective 10* Jo1 | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM Connective 10* Jo1 | Pos | 26 | 0 | 26 |
| | Neg | 1 | 69 | 70 |
| | Total | 27 | 69 | 96 |
Positive % agreement: 96.3% (95%CI: 89.2% - 100.0%)
Negative % agreement: 100%
Overall % agreement: 98.96% (95% CI: 96.9% - 100%)
| | Initial FIDISTM Connective 10* Centromere | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM Connective 10* Centromere | Pos | 20 | 0 | 20 |
| | Neg | 0 | 69 | 69 |
| | Total | 20 | 69 | 89 |
Positive % agreement: 83.33% (95%CI: 68.4% - 98.2%)
Negative % agreement: 100%
Overall % agreement: 95.83% (95% CI: 91.8% - 99.8%)
| | Initial FIDISTM Connective 10* Ribosome | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Modified FIDISTM Connective 10* Ribosome | Pos | 18 | 0 | 18 |
| | Neg | 0 | 69 | 69 |
| | Total | 18 | 69 | 87 |
Positive % agreement: 100%
Negative % agreement: 100%
Overall % agreement: 100%
Comparison of the automated CARIS system and manual method
A comparison study between the manual method and the automated CARISTM system was also performed. All borderline results with the two methods were considered negative.
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| dsDNA | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 43 | 0 | 43 |
| | Neg | 0 | 69 | 69 |
| | Total | 43 | 69 | 112 |
Positive % agreement: 100.0%
Negative % agreement: 100.0%
Overall % agreement: 100.0%
| SSA (60kDa) | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 42 | 0 | 42 |
| | Neg | 0 | 68 | 68 |
| | Total | 42 | 68 | 110 |
Positive % agreement: 100.0%
Negative % agreement: 100.0%
Overall % agreement: 100.0%
| SSA (52kDa) | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 52 | 1 | 53 |
| | Neg | 0 | 65 | 65 |
| | Total | 52 | 66 | 118 |
Positive % agreement: 100.0%
Negative % agreement: 98.5%
Overall % agreement: 99.2%
| SSB | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 25 | 0 | 25 |
| | Neg | 0 | 67 | 67 |
| | Total | 25 | 67 | 92 |
Positive % agreement: 100.0%
Negative % agreement: 100.0%
Overall % agreement: 100.0%
| Sm | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 24 | 3 | 27 |
| | Neg | 0 | 69 | 69 |
| | Total | 24 | 72 | 96 |
Positive % agreement: 100.0%
Negative % agreement: 95.8%
Overall % agreement: 96.9%
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| Sm/RNP | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 32 | 3 | 35 |
| | Neg | 0 | 68 | 68 |
| | Total | 32 | 71 | 103 |
Positive % agreement: 100.0%
Negative % agreement: 95.8%
Overall % agreement: 97.1%
| Scl70 | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 29 | 0 | 29 |
| | Neg | 0 | 68 | 68 |
| | Total | 29 | 68 | 97 |
Positive % agreement: 100.0%
Negative % agreement: 100.0%
Overall % agreement: 100.0%
| Jo1 | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 26 | 0 | 26 |
| | Neg | 0 | 69 | 69 |
| | Total | 26 | 69 | 112 |
Positive % agreement: 100.0%
Negative % agreement: 100.0%
Overall % agreement: 100.0%
| Centromere | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 20 | 4 | 24 |
| | Neg | 0 | 69 | 69 |
| | Total | 20 | 73 | 93 |
Positive % agreement: 100.0%
Negative % agreement: 94.5%
Overall % agreement: 95.7%
| Ribosome | Manual FIDIS | | | |
| --- | --- | --- | --- | --- |
| | | Pos | Neg | Total |
| Caris FIDIS | Pos | 8 | 0 | 8 |
| | Neg | 0 | 68 | 68 |
| | Total | 8 | 68 | 78 |
Positive % agreement: 100.0%
Negative % agreement: 100.0%
Overall % agreement: 100.0%
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b. Matrix comparison: Serum is the only recommended matrix.
3. Clinical studies:
a. Clinical Sensitivity: Not provided
b. Clinical specificity: Not provided
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable
4. Clinical cut-off: Not applicable
5. Expected values/Reference range: The reported expected ranges were estimated from 2 populations:
50 samples from blood donors
48 samples selected from their potential biological interferences and according to WHO standard for dsDNA specificity
| Arbitrary units (AU/mL) | <30 AU/mL | 30-40 AU/mL | >40 AU/mL |
| --- | --- | --- | --- |
| International units (IU/mL) | <30 | 30-40 | >40 |
| For dsDNA | IU/mL | IU/mL | IU/mL |
| Interpretation | Negative | Equivocal1 | Positive |
The negative thresholds (30 AU/mL or 30 IU/mL) correspond to the $97.9^{\text{th}}$ percentile for dsDNA, SSA, Sm/RNP; $99.0\%$ for centromere and ribosome, and $100\%$ for SSB, Sm, Scl70 and Jo1 for the populations studied.
# N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
# O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
