← Product Code [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL) · K102607

# FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS (K102607)

_Biomedical Diagnostics (Bmd) SA · LLL · Dec 3, 2010 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K102607

## Device Facts

- **Applicant:** Biomedical Diagnostics (Bmd) SA
- **Product Code:** [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL.md)
- **Decision Date:** Dec 3, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5100
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogenous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SS-A (60kDA and TRIM 21 (52kDA)), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere in human serum. (*Antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70, Jo-1, ribosomes and centromere can be reported using this assay). The results of the FIDIS™ Connective 10 are to be used in conjunction with the clinical findings and the laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD) scleroderma, Dermatomyositis and CREST syndrome). FIDISTM Connective 10 kit uses serum only and is to be run on the FIDIS instrument and MLX-BOOSTER Software. FIDISTM Connective 10 kit may be used with the CARIS system (diluting and dispensing device). This kit is for In vitro diagnostic use.

## Device Story

Multiplexed immunoassay for detection of 10 autoantibodies in human serum; utilizes color-coded microspheres conjugated to specific antigens; flow cytometry-based detection. Sample incubated with microspheres; unbound antibodies washed; phycoerythrin-labeled anti-human IgG conjugate added; final wash; flow cytometer measures fluorescence intensity to identify analyte and quantify reaction. Operated on FIDIS 200 Analyzer (Luminex 200) with MLX-Booster software; optional CARIS system for automated dilution/dispensing. Output provides semi-quantitative results (AU/mL or IU/mL) used by clinicians alongside clinical findings to aid diagnosis of connective tissue diseases. Benefits include simultaneous screening for multiple autoantibodies, improving diagnostic efficiency.

## Clinical Evidence

Bench testing only. Precision/reproducibility studies performed (intra-assay CV 1-15%, inter-assay CV 3-15%). Method comparison study (n=80) against predicate device showed high agreement across all 10 analytes (overall agreement 97.5-100%). Automated CARIS system comparison also showed high agreement (97.5-100%). No clinical sensitivity/specificity studies provided.

## Technological Characteristics

Multiplex flow immunoassay using color-coded microspheres. Analyte detection via flow cytometry (red/infrared laser for identification, green laser for quantification). Includes internal anti-IgG standard bead. Software: MLX-BOOSTER™ (Version 2.2). Sample preparation: manual or automated (CARIS™). Assay configuration: 96-well microplate with filtering membrane. Reagents: lyophilized microspheres, buffers, calibrators, controls, and phycoerythrin-conjugated anti-human IgG.

## Regulatory 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

- FIDIS™ CONNECTIVE 10 ([K071210](/device/K071210.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k102607

B. Purpose for Submission:
Modified device: Analyte name change from SS-A 52kDa to TRIM21 and the number of microspheres read per assay is reduced from 200 to 100 with an increase in read time.

C. Measurand:
Anti-dsDNA, anti-SSA (60kDA and TRIM 21 (SS-A 52kDA)), anti-SS-B, anti-Sm, anti-Sm/RNP, anti-Scl-70, anti-Jo-1, anti-ribosomes and anti-centromere)

D. Type of Test:
Semi-quantitative

E. Applicant:
Biomedical Diagnostics, S.A. (bmd)

F. Proprietary and Established Names:
FIDIS™ CONNECTIVE 10

G. Regulatory Information:
1. Regulation section:
21 CFR § 866.5100, Antinuclear Antibody, immunological test systems
2. Classification:
Class II
3. Product codes:
LLL, Extractable Antinuclear Antibody, Antigen, and Control
LKJ, Antinuclear Antibody, Antigen, and Control
LKO, Anti-RNP Antibody, Antigen, and Control
LKP, Anti-Sm Antibody, Antigen, and Control
LSW, Anti-DNA Antibody, Antigen, and Control
LJM, Antinuclear Antibody (Enzyme Labeled), Antigen, and Control
MQA, Anti-Ribosomal P Antibodies
4. Panel:
Immunology (82)

H. Intended Use:
1. Intended use(s):
The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogenous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SS-A (60kDA and TRIM 21 (52kDA)), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere in human serum. (*Antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70, Jo-1, ribosomes and centromere can be reported using this assay).
The results of the FIDIS™ Connective 10 are to be used in conjunction with the clinical findings and the laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD) scleroderma, Dermatomyositis and CREST

{1}

syndrome).

FIDISTM Connective 10 kit uses serum only and is to be run on the FIDIS instrument and MLX-BOOSTER Software.

FIDISTM Connective 10 kit may be used with the CARIS system (diluting and dispensing device).

This kit is for In vitro diagnostic use.

2. Indication(s) for use:

Same as Intended use.

3. Special conditions for use statement(s):

For prescription only.

4. Special instrument requirements:

FIDISTM 200 Analyzer (Luminex 200™)

FIDISTM MLX-Booster Software version 2.2

FIDISTM XY Platform

FIDISTM Sheath Delivery System (SD)

Computer Central Processing Unit (PC)

Computer Monitor Screen

FIDISTM Washer

CARISTM (Optional diluting and dispensing device)

I. Device Description:

Each device contains the following: distinct uniform size color-coded microspheres (each microsphere set is conjugated to one of the following antigens: dsDNA, SS-A 60kDA, TRIM21 (SS-A 52kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere CENP-B (ready to use); calibrator (ready to use); positive control (to be diluted); negative control (to be diluted); goat anti-human IgG coupled to phycoerythrin (ready to use); sample dilution buffer (ready to use); wash buffer (ready to use); one 96 wells microplate including a filtering membrane and a lid.

J. Substantial Equivalence Information:

1. Predicate device name(s):

FIDISTM Connective 10

2. Predicate K number(s):

k071210

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | New Device | Predicate Device  |
|   | FIDISTM Connective 10 | FIDISTM Connective 10  |
|  Sample type | Serum | Same  |
|  Type of test | Semi-quantitative | Same  |
|  Platform | 96 well plates | Same  |
|  Technology | Flow Cytometer based | Same  |
|  Assay Format | Multiplexed | Same  |
|  Solid-phase capture | Color-coded microspheres | Same  |
|  Conjugate | Phycoerythrin | Same  |
|  Detection method | Fluorescence | Same  |

{2}

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | New Device | Predicate Device  |
|  Calibrator | 2 wells/test | Same  |
|  Instrument | Luminometer (Luminex 200™) | Same  |
|  Software version | MLX Booster version 2.2 | Same  |
|  Result Interpretation for each antibody specificity | Negative: < 30 AU/mL Borderline: 31-40 AU/mL Positive: >40 AU/mL | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended use | Individual determination of IgG antibodies to dsDNA, SS-A 60kDa, TRIM21 (SS-A 52kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B) | Individual determination of IgG antibodies to dsDNA, SS-A 60kDA, SS-A 52, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere  |
|  New terminology of analyte name | TRIM21 (SSA 52kDa) | SSA 52kDA  |
|  Time for microspheres count | 90 seconds | 60 seconds  |
|  Number of counted microspheres per parameter | 100 microspheres | 200 microspheres  |

# K. Standard/Guidance Document Referenced (if applicable):

None provided.

# L. Test Principle:

$\mathrm{FIDIS}^{\mathrm{TM}}$  Connective 10 is based on the use of distinct uniform size color-coded microspheres and a bench top flow cytometer interfaced to digital signal processing hardware and software. A red diode laser beam in the flow cytometer classifies each set of microspheres on the basis of its unique fluorescence intensity (red to orange) thus identifying which analyte is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the reaction related to each specific 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, constituting the final microspheres reagent.

The test is performed in a 96 wells blank microplate including a filtering membrane at the bottom of the wells.

{3}

- In the first step, the sample is distributed in each well containing the microspheres mixture. If this sample contains one or more of the specific antibodies, they bind to the corresponding antigen(s) on one or more sets of microspheres.
After incubation, the unbound antibodies are removed by a wash step using a filtration process.
- A phycoerythrin labeled anti-human IgG conjugate is then added that binds to the previously bound antibodies.
A final wash step stops the reaction.
- The reaction is then directly measured by the flow cytometer, which differentiates each set of microspheres according to its fluorescence color while simultaneously measures the average fluorescence emitted by the conjugate.

A calibration system permits the determination of the antibody in  $\mathrm{AU / mL}$  of each sample by interpolation for each antigenic specificity: SS-A 60kDa, TRIM21 (SS-A 52kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B; and the titer in I.U/mL for the dsDNA antigenic specificity.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

For the intra-assay study, six samples for dsDNA, SS-A 60kDa, TRIM21 (SS-A 52kDa), SS-B, Sm, Sm/RNP, Jo-1, and centromere; and five samples for Scl-70 and ribosomes were analyzed 10 times (for each specificity) in one run. For the inter-assay study, the same samples were analyzed in 5 different runs. The intra-assay CV ranges for Anti-dsDNA, Anti-SS-A 60kDa &amp; Anti-TRIM21 (SS-A 52kDa), Anti-SS-B, Anti-Sm, Anti-Sm/RNP, Anti-Scl-70, Anti-Jo-1, Anti-centromere and Anti-ribosomes were:  $4 - 7\%$  ;  $3 - 6\%$  ;  $1 - 6\%$  ;  $5 - 15\%$  ;  $2 - 10\%$  ;  $3 - 5\%$  ;  $2 - 5\%$  ;  $3 - 7\%$  ; and  $3 - 9\%$  respectively. The inter-assay CV ranges on Anti-dsDNA, Anti-SS-A 60kDa &amp; Anti-TRIM21 (SS-A 52kDa), Anti-SS-B, Anti-Sm, Anti-Sm/RNP, Anti-Scl-70, Anti-Jo-1, Anti-centromere and Anti-ribosomes were:  $5 - 10\%$  ;  $4 - 13\%$  ;  $7 - 14\%$  ;  $6 - 15\%$  ;  $3 - 15\%$  ;  $6 - 10\%$  ;  $4 - 11\%$  ; and  $7 - 14\%$  % respectively (see table below).

|   |   | Within-run (10 tests in the same run) |   | Between-run (1 test in 5 different runs)  |   |
| --- | --- | --- | --- | --- | --- |
|  Antigen | Sample number | Mean value | CV (%) | Mean value | CV (%)  |
|  dsDNA | Sample 1 | 149 | 7 | 169 | 10  |
|   |  Sample 2 | 65 | 5 | 66 | 5  |
|   |  Sample 3 | 47 | 4 | 41 | 6  |
|   |  Sample 4 | 42 | 5 | 45 | 7  |
|   |  Sample 5 | 30 | 5 | 27 | 7  |
|   |  Sample 6 | 20 | 4 | 24 | 10  |

{4}

|   |   | Within-run (10 tests in the same run) |   | Between-run (1 test in 5 different runs)  |   |
| --- | --- | --- | --- | --- | --- |
|  Antigen | Sample number | Mean value | CV (%) | Mean value | CV (%)  |
|  SS-A 60kDa & TRIM21 (SS-A 52kDa) | Sample 7 | 195 | 3 | 192 | 5  |
|   |  Sample 8 | 168 | 6 | 178 | 9  |
|   |  Sample 9 | 75 | 4 | 67 | 4  |
|   |  Sample 10 | 48 | 6 | 45 | 13  |
|   |  Sample 11 | 39 | 4 | 32 | 10  |
|   |  Sample 12 | 11 | 5 | 10 | 6  |
|  SS-B | Sample 13 | 96 | 1 | 98 | 7  |
|   |  Sample 14 | 75 | 3 | 84 | 12  |
|   |  Sample 15 | 39 | 4 | 37 | 13  |
|   |  Sample 16 | 34 | 6 | 39 | 14  |
|   |  Sample 17 | 23 | 5 | 27 | 14  |
|   |  Sample 18 | 15 | 6 | 21 | 9  |
|  Sm | Sample 19 | 250 | 8 | 237 | 9  |
|   |  Sample 20 | 103 | 10 | 92 | 15  |
|   |  Sample 21 | 75 | 8 | 72 | 10  |
|   |  Sample 22 | 56 | 5 | 51 | 9  |
|   |  Sample 23 | 45 | 6 | 38 | 6  |
|   |  Sample 24 | 29 | 15 | 29 | 14  |
|  Sm/RNP | Sample 25 | 227 | 10 | 212 | 8  |
|   |  Sample 26 | 78 | 2 | 72 | 3  |
|   |  Sample 27 | 62 | 5 | 57 | 9  |
|   |  Sample 28 | 46 | 5 | 40 | 4  |
|   |  Sample 29 | 42 | 4 | 36 | 12  |
|   |  Sample 30 | 28 | 5 | 23 | 15  |
|  Scl-70 | Sample 31 | 276 | 3 | 290 | 10  |
|   |  Sample 32 | 119 | 3 | 127 | 7  |
|   |  Sample 33 | 63 | 4 | 57 | 10  |
|   |  Sample 34 | 49 | 5 | 44 | 8  |
|   |  Sample 35 | 29 | 4 | 26 | 6  |
|  Jo-1 | Sample 36 | 289 | 2 | 307 | 7  |
|   |  Sample 37 | 64 | 2 | 74 | 7  |
|   |  Sample 38 | 54 | 5 | 62 | 11  |
|   |  Sample 39 | 49 | 5 | 49 | 4  |
|   |  Sample 40 | 33 | 3 | 32 | 8  |
|   |  Sample 41 | 22 | 5 | 22 | 9  |
|  Centromere | Sample 42 | 191 | 4 | 172 | 11  |
|   |  Sample 43 | 189 | 3 | 185 | 9  |
|   |  Sample 44 | 60 | 7 | 46 | 8  |
|   |  Sample 45 | 51 | 5 | 56 | 11  |
|   |  Sample 46 | 44 | 3 | 39 | 4  |
|   |  Sample 47 | 21 | 7 | 18 | 15  |

{5}

|   |   | Within-run (10 tests in the same run) |   | Between-run (1 test in 5 different runs)  |   |
| --- | --- | --- | --- | --- | --- |
|  Antigen | Sample number | Mean value | CV (%) | Mean value | CV (%)  |
|  Ribosome | Sample 48 | 312 | 3 | 312 | 12  |
|   |  Sample 49 | 140 | 4 | 129 | 14  |
|   |  Sample 50 | 44 | 6 | 46 | 10  |
|   |  Sample 51 | 44 | 5 | 37 | 7  |
|   |  Sample 52 | 31 | 9 | 30 | 10  |

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 WHO International Standard for anti-dsDNA, human code: WO/80. Other calibrators and controls (positive and negative) were prepared in-house and assigned arbitrary units per mL (AU/mL) during the development process.

d. Detection limit:

Not applicable.

e. Analytical specificity:

Interference study: Thirty samples were selected for evaluation of potential interference and crossreactivity: 2 Cryoglobulinemia, 7 Complement, 1 IgG monoclonal immunoglobulins, 5 IgM monoclonal immunoglobulins, 8 Rheumatoid Factor, 3 citrated plasmas, 2 hemolyzed samples and 1 Antismooth muscle antibody. Twenty six samples were negative; one of the two positive Complement sample was positive for dsDNA and other was positive for SS-A 60kDa, SS-B, Sm, and Sm/RNP; one of the two positive Rheumatoid factor sample was positive for dsDNA, SS-A 60kDa, TRIM21 (SSA 52kDa), SSB, and Sm/RNP and other was positive for SS-A 60kDa, and TRIM (SSA 52kDa). To ensure appropriate samples are used in the test, the package insert states to avoid hemolyzed, lipemic, icteric, or samples with abnormal concentration of IgG and/ or complement levels, or samples with rheumatoid factor.

f. Assay cut-off:

See Expected values/ Reference range section.

2. Comparison studies:

a. Method comparison with predicate device:

Since the modifications between the predicate and this new device were minor, a smaller sample size method comparison study was done to show the substantial equivalence of this device to the predicate device. The method comparison between the predicate and new device was performed on the same group of eighty samples for each of the ten given analytes. The positive, negative and total percent agreement for each analyte were as follows for: Anti-dsDNA:  $100\%$ ,  $98.4\%$  and  $98.8\%$ ; Anti-SS-A60kDa:  $100\%$ ,  $98.2\%$ , and  $98.8\%$ ; Anti-TRIM21 (SS-A 52kDa):  $95.8\%$ ,  $100\%$ , and  $98.8\%$ ; Anti-SS-B:

{6}

100%, 98.5% and 98.8%; Anti-Sm: 100%, 100% and 100%; Anti-Sm/RNP: 100%, 98.4% and 98.8%; Anti-Scl-70: 100%, 96.9% and 97.5%; Anti-Jo-1: 100%, 100% and 100%; Anti-centromere CENP-B): 100%, 98.6% and 98.8%; and Anti-ribosomes: 100%, 100% and 100%. Tabulated results are shown below. (Note: All equivocal results were considered negative)

|  Anti-dsDNA | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 16 | 1* | 17  |
|   |  Negative | 0 | 63 | 63  |
|   |  Total | 16 | 64 | 80  |

Positive percent agreement: 100% (16/16)

Negative percent agreement: 98.4% (63/64)

Overall percent Agreement: 98.8% (79/80)

|  Anti-SS-A 60kDa | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 25 | 1 | 26  |
|   |  Negative | 0 | 54 | 54  |
|   |  Total | 25 | 55 | 80  |

Positive percent agreement: 100% (25/25)

Negative percent agreement: 98.2% (54/55)

Overall percent Agreement: 98.8% (79/80)

|  Anti-TRIM21 (SS-A 52kDa) | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 23 | 0 | 23  |
|   |  Negative | 1 | 56 | 57  |
|   |  Total | 24 | 56 | 80  |

Positive percent agreement: 95.8% (23/24)

Negative percent agreement: 100% (56/56)

Overall percent Agreement: 98.8% (79/80)

|  Anti-SS-B | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 14 | 1 | 15  |
|   |  Negative | 0 | 65 | 65  |
|   |  Total | 14 | 66 | 80  |

Positive percent agreement: 100% (14/14)

Negative percent agreement: 98.5% (65/66)

Overall percent Agreement: 98.8% (79/80)

{7}

8

|  Anti-Sm | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 17 | 0 | 17  |
|   |  Negative | 0 | 63 | 63  |
|   |  Total | 17 | 63 | 80  |

Positive percent agreement: 100% (17/17)

Negative percent agreement: 100% (63/63)

Overall percent Agreement: 100% (80/80)

|  Anti-Sm/RNP | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 19 | 1 | 20  |
|   |  Negative | 0 | 60 | 60  |
|   |  Total | 19 | 61 | 80  |

Positive percent agreement: 100% (19/19)

Negative percent agreement: 98.4% (60/61)

Overall percent Agreement: 98.8% (79/80)

|  Anti-Scl-70 | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 15 | 2 | 17  |
|   |  Negative | 0 | 63 | 63  |
|   |  Total | 15 | 65 | 80  |

Positive percent agreement: 100% (15/15)

Negative percent agreement: 96.9% (63/65)

Overall percent Agreement: 97.5% (78/80)

|  Anti-Jo-1 | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 10 | 0 | 10  |
|   |  Negative | 0 | 70 | 70  |
|   |  Total | 10 | 70 | 80  |

Positive percent agreement: 100% (10/10)

Negative percent agreement: 100% (70/70)

Overall percent Agreement: 100% (80/80)

|  Anti-CENP-B | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 7 | 1 | 8  |
|   |  Negative | 0 | 72 | 72  |
|   |  Total | 7 | 73 | 80  |

Positive percent agreement: 100% (7/7)

Negative percent agreement: 98.6% (72/73)

Overall percent Agreement: 98.8% (79/80)

{8}

9

|  Anti-Ribosome | FIDISTM Connective 10  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 | Positive | 6 | 0 | 6  |
|   |  Negative | 0 | 74 | 74  |
|   |  Total | 6 | 74 | 80  |

Positive percent agreement: 100% (6/6)
Negative percent agreement: 100% (74/74)
Overall percent Agreement: 99.1% (80/80)

Comparison of manual preparation and the automated CARISTM System: The method comparison between the manual preparation and the automated CARISTM System was performed on the same group of eighty samples for each of the ten given analytes. The positive, negative and total percent agreement for each of the analyte were as follows for Anti-dsDNA: 100%, 98.4% and 98.8%; Anti-SS-A 60kDa: 100%, 98.1%, and 98.8%; Anti-TRIM21 (SS-A 52kDa): 100%, 98.3%, and 98.8%; Anti-SS-B: 100%, 100%, and 100%; Anti-Sm: 100%, 98.4%, and 98.8%; Anti-Sm/RNP: 100%, 100%, and 100%; Anti-Scl-70: 100%, 96.9%, and 97.5%; Anti-Jo-1: 100%, 100%, 100%; Anti-centromere: 100%, 100%, and 100%; and Anti-ribosomes: 100%, 100%, and 100%. Tabulated results are shown below. (Note: All equivocal results were considered negative)

|  Anti-dsDNA | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 CARISTM | Positive | 16 | 1 | 17  |
|   |  Negative | 0 | 63 | 63  |
|   |  Total | 16 | 64 | 80  |

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall percent Agreement: 98.8% (79/80)

|  Anti-SS-A 60kDa | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 CARISTM | Positive | 26 | 1 | 27  |
|   |  Negative | 0 | 53 | 53  |
|   |  Total | 26 | 54 | 80  |

Positive percent agreement: 100% (26/26)
Negative percent agreement: 98.1% (53/54)
Overall percent Agreement: 98.8% (79/80)

{9}

10

|  Anti-TRIM21
(SS-A 52kDa) | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM
Connective 10 CARISTM | Positive | 22 | 1 | 23  |
|   |  Negative | 0 | 57 | 57  |
|   |  Total | 22 | 58 | 80  |

Positive percent agreement: 100% (22/22)
Negative percent agreement: 98.3% (57/58)
Overall percent Agreement: 98.8% (79/80)

|  Anti-SS-B | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM
Connective 10 CARISTM | Positive | 15 | 0 | 15  |
|   |  Negative | 0 | 65 | 65  |
|   |  Total | 15 | 65 | 80  |

Positive percent agreement: 100% (15/15)
Negative percent agreement: 100% (65/65)
Overall percent Agreement: 100% (80/80)

|  Anti-Sm | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM
Connective 10 CARISTM | Positive | 16 | 1 | 17  |
|   |  Negative | 0 | 63 | 63  |
|   |  Total | 16 | 64 | 80  |

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall percent Agreement: 98.8% (78/80)

|  Anti-Sm/RNP | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM
Connective 10 CARISTM | Positive | 20 | 0 | 20  |
|   |  Negative | 0 | 60 | 60  |
|   |  Total | 20 | 60 | 80  |

Positive percent agreement: 100% (20/20)
Negative percent agreement: 100% (60/60)
Overall percent Agreement: 100% (80/80)

{10}

11

|  Anti-Scl-70 | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 CARISTM | Positive | 15 | 2 | 17  |
|   |  Negative | 0 | 63 | 63  |
|   |  Total | 15 | 65 | 80  |

Positive percent agreement: 100% (15/15)

Negative percent agreement: 96.9% (63/65)

Overall percent Agreement: 97.5% (78/80)

|  Anti-Jo-1 | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 CARISTM | Positive | 8 | 0 | 8  |
|   |  Negative | 0 | 72 | 72  |
|   |  Total | 8 | 72 | 80  |

Positive percent agreement: 100% (8/8)

Negative percent agreement: 100% (72/72)

Overall percent Agreement: 100% (80/80)

|  Anti-CENP-B | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 CARISTM | Positive | 6 | 0 | 6  |
|   |  Negative | 0 | 74 | 74  |
|   |  Total | 6 | 74 | 80  |

Positive percent agreement: 100% (6/6)

Negative percent agreement: 100% (74/74)

Overall percent Agreement: 100% (80/80)

|  Anti-Ribosome | FIDISTM Connective 10 Manual  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Modified FIDISTM Connective 10 CARISTM | Positive | 6 | 0 | 6  |
|   |  Negative | 0 | 74 | 74  |
|   |  Total | 6 | 74 | 80  |

Positive percent agreement: 100% (6/6)

Negative percent agreement: 100% (74/74)

Overall percent Agreement: 99.1% (80/80)

b. Matrix comparison:
Serum is the only recommended matrix.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.

{11}

b. Clinical specificity: Not applicable.
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) for Anti-dsDNA | <30 IU/mL | 30-40 IU/mL | >40 IU/mL  |
|  Interpretation | Negative | Equivocal | Positive  |

The negative thresholds (30 AU/mL or 30 IU/mL correspond to the 97.9th percentile due the Anti-dsDNA, Anti-SSA (60 kDa and TRIM21/ 52 kDa), Anti-Sm/RNP, 99.0% for Anti-centromere and Anti-ribosome, and 100% for Anti-SSB, Anti-Sm, Anti-Scl-70 and Anti-Jo-I for the populations studies.

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.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K102607](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K102607)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com