← Product Code [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) · K173691

# Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (K173691)

_Quidel Corporation · LSR · Feb 28, 2018 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K173691

## Device Facts

- **Applicant:** Quidel Corporation
- **Product Code:** [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR.md)
- **Decision Date:** Feb 28, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3830
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Sofia Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. This qualitative test is intended for use as an aid in the diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. All positive results for IgM and/or IgG should be further tested by a corresponding second-tier western blot assay. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. The Sofia Lyme FIA may be used with Sofia or Sofia 2.

## Device Story

Sofia Lyme FIA is a lateral-flow immunofluorescence assay for qualitative detection of IgM and IgG antibodies to Borrelia burgdorferi. Patient serum/plasma is diluted in buffer and applied to a bi-directional test cassette. The cassette is inserted into the Sofia 2 analyzer, which uses optical scanning to detect fluorescent signals from Europium-chelate-dyed microparticles. The analyzer operates in 'READ NOW' (10-minute development) or 'WALK AWAY' (automated read at 3, 5, 8, and 10 minutes) modes. The device provides automated interpretation of test results on the instrument screen. Results are intended to be used as a first-tier screening tool; positive results require confirmation via second-tier Western blot. The device aids clinicians in diagnosing Lyme disease by providing rapid, objective, automated analysis of antibody presence.

## Clinical Evidence

Prospective study of 325 serum samples from patients undergoing routine Lyme testing. First-tier PPA for IgM was 84.3% and IgG was 90.4% compared to predicate. Second-tier Western blot confirmation showed high agreement (98.0% for IgM, 100% for IgG). Analytical specificity evaluated in 200 healthy individuals (100 endemic, 100 non-endemic) showed 89.5% negative results for IgM and 96.5% for IgG. Reproducibility study across 3 sites showed high overall agreement (94.4%-100%).

## Technological Characteristics

Lateral-flow bidirectional test cassette; immunofluorescence principle. Detection via polystyrene microparticles dyed with Europium chelate. Reagents include recombinant proteins and synthetic peptides of B. burgdorferi. Analyzed by Sofia or Sofia 2 instrument. Storage at room temperature (15-30°C). Built-in procedural and reference control zones scanned by analyzer.

## Regulatory 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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

## Predicate Devices

- Vidas Lyme IgM ([K122979](/device/K122979.md))
- Vidas Lyme IgG ([K122986](/device/K122986.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/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number: K173691

B. Purpose for Submission:
To obtain a substantial equivalence determination for the Sofia Lyme FIA for use with Sofia 2 analyzers

C. Measurand:
IgM antibodies to *Borrelia burgdorferi* proteins
IgG antibodies to *Borrelia burgdorferi* proteins

D. Type of Test:
Fluorescent immunoassay (FIA), bi-directional lateral flow format

E. Applicant:
Quidel Corporation

F. Proprietary and Established Names:
Sofia Lyme FIA

G. Regulatory Information:
1. Regulation section:
21 CFR 866.3830
2. Classification:
Class II
3. Product code:
LSR; Reagent, Borrelia Serological Reagent
4. Panel:

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Immunology and Microbiology Devices

## H. Intended Use:

1. Intended use(s):

The Sofia Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to *Borrelia burgdorferi* from serum and plasma specimens from patients suspected of *B. burgdorferi* infection. This qualitative test is intended for use as an aid in the diagnosis of Lyme disease. A negative result does not preclude infection with *B. burgdorferi*. All positive results for IgM and/or IgG should be further tested by a corresponding second-tier western blot assay. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures.

The Sofia Lyme FIA may be used with Sofia or Sofia 2.

2. Indication(s) for use:

Same as Intended Use(s)

3. Special conditions for use statement(s):

Not Applicable (N/A)

4. Special instrument requirements:

Sofia 2 Instrument

## I. Device Description:

The Sofia Lyme FIA is an immunofluorescence-based, lateral flow assay for detection of IgM and/or IgG antibodies to *Borrelia burgdorferi* in patient specimens. Reagents for the assay are ready-to-use and provided in the kit.

The assay uses a bidirectional test strip format to detect both IgM and IgG antibodies to *B. burgdorferi*. One side of the test strip detects IgM antibodies to *B. burgdorferi* and the other side of the test strip detects IgG antibodies to *B. burgdorferi*.

To perform the test, a patient serum or plasma specimen is obtained and added to a pre-filled vial containing the Lyme running buffer. The diluted sample is then pipetted into the round sample port in the center of the Test Cassette.

The Test Cassette is loaded into Sofia 2 in either the READ NOW Mode or WALK AWAY Mode. In READ NOW Mode, the user allows the cassette to develop on the countertop for 10 minutes. In WALK AWAY Mode, the user immediately after adding the specimen to the

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cassette, the cassette is inserted into Sofia 2. Sofia 2 will analyze the test strip at 3, 5, 8, and 10 minutes until both IgM and IgG positive results are received. This feature allows for earlier read times.

Each Sofia Lyme FIA kit will contain one Positive and one Negative Control—each provided in separate dropper bottles. The Positive QC control is formulated with patient Lyme IgM and IgG positive plasma diluted into 1X PBS, and 0.3% Microcide is added to the solution as an antimicrobial. The Negative QC control is formulated with patient negative serum diluted into 1X PBS and 0.3% Microcide is added to the solution as an antimicrobial. External Controls will be tested by adding 2 drops to the test cassette.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Vidas Lyme IgM

Vidas Lyme IgG2.

Predicate 510(k) number(s):

K122979

K122986

3. Comparison with predicate:

|  Item | Proposed Device | Predicate IgM Device | Predicate IgG Device  |
| --- | --- | --- | --- |
|  Features | Sofia Lyme FIA with Sofia 2 | bioMérieux Vidas Lyme IgM | bioMérieux Vidas Lyme IgG  |
|  Intended Use | The Sofia Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. This qualitative test is intended for use as an aid in the diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. All positive results for IgM and/or IgG should be further tested by a corresponding second-tier western blot assay. Test results are to be used in | The VIDAS Lyme IgM assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burdorferi in human serum or plasma. It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorferi. | The VIDAS Lyme IgG assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burdorferi in human serum or plasma. It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorferi.  |

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|  Item | Proposed Device | Predicate IgM Device | Predicate IgG Device  |
| --- | --- | --- | --- |
|  Features | Sofia Lyme FIA with Sofia 2 | bioMerieux Vidas Lyme IgM | bioMerieux Vidas Lyme IgG  |
|   | conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.The Sofia Lyme FIA may be used with Sofia or Sofia 2. |  |   |
|  Instrument | Sofia 2 (and Sofia) | VIDAS and miniVIDAS | VIDAS and miniVIDAS  |
|  Analyte | Human IgM and IgG antibodies against B. burgdorferi proteins | Human IgM antibodies against B. burgdorferi proteins | Human IgG antibodies against B. burgdorferi proteins  |
|  Automated Analysis | Yes | Yes | Yes  |
|  Read Results | Read results on instrument screen or print with optional printer | Result report is printed | Result report is printed  |
|  Read Result Time | Sofia 2 - Potential for early read in Walk-Away Mode with Sofia 2. Sofia 2 will image cassette at 3, 5, 8, and 10 minutes until both IgM and IgG positive results are received.Sofia - 10 minutes | 27 minutes | 27 minutes  |
|  Specimen Types | Serum and plasma | Serum and plasma | Serum and plasma  |
|  Qualitative | Yes | Yes | Yes  |
|  Test Principle | Immunofluorescence Device | Immunofluorescence Device | Immunofluorescence Device  |
|  Format | Lateral-flow Bi-directional Test Cassette | Enzyme-linked fluorescent assay (ELFA) | Enzyme-linked fluorescent assay (ELFA)  |
|  Antibodies Used | Monoclonal anti-human IgG and polyclonal anti-human IgM | Anti-human IgM antibodies | Anti-human IgG antibodies  |
|  Antigens Used | Recombinant Proteins and synthetic peptides of B. burgdorferi | Recombinant proteins of B. burgdorferi | Recombinant proteins of B. burgdorferi  |
|  Detection Method | Polystyrene microparticles dyed with Europium chelate | Alkaline phosphatase/4-MUP | Alkaline phosphatase/4-MUP  |
|  Storage | Room Temperature (15-30°C) | 2-8°C | 2-8°C  |
|  Running | One pre-filled vial containing | Sample diluent and wash | Sample diluent and wash  |
|   | sample with 100 ml of water |  |   |

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|  Item | Proposed Device | Predicate IgM Device | Predicate IgG Device  |
| --- | --- | --- | --- |
|  Features | Sofia Lyme FIA with Sofia 2 | bioMerieux Vidas Lyme IgM | bioMerieux Vidas Lyme IgG  |
|  Buffer Solution | PBS | buffer | buffer  |
|  Quality Control Features | Built-in features include:
Built-in procedural control zone scanned by the analyzer to determine whether adequate flow occurred on the IgG side of the assay.
Built-in reference control line scanned by the analyzer to determine whether adequate flow occurred on the IgM side of the assay.
Analyzer prevents used or expired cartridge from being read by the reader
Cassette must be properly inserted | One positive and one negative control are included and must be tested after opening a new kit to monitor reagent failure. | One positive and one negative control are included and must be tested after opening a new kit to monitor reagent failure.  |

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

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi

L. Test Principle:

Immunofluorescence

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The precision of the Sofia Lyme FIA with Sofia 2 was evaluated at one Quidel site utilizing 2 operators and 2 Sofia 2 instruments. Contrived samples were prepared at levels that ranged from negative to moderate positive for both IgM and IgG. Each sample was tested by 2 operators in duplicate with a total of 24 different runs (2 runs per day over a total of 12 days) for a total of 96 times over the course of the study. See Tables 1 and 2 for results.

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Table 1. Sofia Lyme FIA with Sofia 2 Precision – Within Run

|  IgM or IgG Sample | IgM Positive |   | IgM % Positivity
Total (n=96) | IgG Positive |   | IgG % Positivity
Total (n=96)  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  Run 1 | Run 2 |   | Run 1 | Run 2  |   |
|  Negative | 0/48 | 0/48 | 0% | 0/48 | 0/48 | 0%  |
|  High Negative (C5) | 0/48 | 0/48 | 0% | 0/48 | 0/48 | 0%  |
|  Low Positive (C95) | 48/48 | 48/48 | 100% | 48/48 | 46/48 | 100%  |
|  Moderate Positive (2-3X) | 48/48 | 48/48 | 100% | 48/48 | 48/48 | 100%  |

Table 2. Sofia Lyme FIA with Sofia 2 Precision – Between Operator

|  IgM or IgG Sample | % IgM Positivity |   | IgM % Positivity
Total (n=96) | % IgG Positivity |   | IgG % Positivity
Total (n=96)  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  Operator1 | Operator 2 |   | Operator 1 | Operator 2  |   |
|  Negative | 0/48 | 0/48 | 0% | 0/48 | 0/48 | 0%  |
|  High Negative (C5) | 0/48 | 0/48 | 0% | 0/48 | 0/48 | 0%  |
|  Low Positive (C95) | 48/48 | 48/48 | 100% | 48/48 | 48/48 | 100%  |
|  Moderate Positive (2-3X) | 48/48 | 48/48 | 100% | 48/48 | 48/48 | 100%  |

The reproducibility of the Sofia Lyme FIA with Sofia 2 was evaluated at 3 different laboratories, 1 of which was Quidel. Two operators at each site tested a series of coded, contrived samples ranging from negative to moderate positive IgM and IgG concentrations. Testing occurred for a minimum of 5 separate days, spanning a period of approximately 2 weeks. See Table 3 for results.

Table 3. Sofia Lyme FIA with Sofia 2 Reproducibility Study Inter-laboratory Agreement

|  Site | IgM Negative (C0) | IgM High Negative (C5) | IgM Low Positive (C95) | IgM Moderate Positive (2-3X LOD) | IgG Negative (C0) | IgG High Negative (C5) | IgG Low Positive (C95) | IgG Moderate Positive (2-3X LOD)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  1 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30  |
|  2 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30 | 30/30  |
|  3 | 30/30 | 30/30 | 27/30 | 28/30 | 30/30 | 30/30 | 25/30 | 30/30  |
|  Total | 90/90 | 90/90 | 87/90 | 88/90 | 90/90 | 90/90 | 85/90 | 90/90  |
|  % Overall Agreement (95% CI) | 100% (95.1-100%) | 100% (95.1-100%) | 96.7% (90.3-99.3%) | 97.8% (91.8-99.9%) | 100% (95.1-100%) | 100% (95.1-100%) | 94.4% (87.3-97.9%) | 100% (95.1-100%)  |

b. Linearity/assay reportable range: Not applicable (N/A)
c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A
d. Detection limit: N/A
e. Analytical specificity:

To determine the analytical specificity of the Sofia Lyme FIA with Sofia 2, 200 seemingly healthy individuals with no known history of physician-diagnosed Lyme disease were evaluated. Half of the samples (100) were collected from a non-endemic Lyme region while the other half of the samples (100) were collected from an

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endemic Lyme region of the United States. Samples were tested on Sofia Lyme FIA and the predicate Lyme IgM and IgG assays. The Analytical Specificity results for Sofia Lyme FIA and the predicate devices are summarized in Table 4.

Table 4. Sofia Lyme FIA with Sofia 2 and Predicate Analytical Specificity

|   | n | Sofia IgM (% negative results) | Predicate IgM* (% negative results) | Sofia IgG (% negative results) | Predicate IgG (% negative results)  |
| --- | --- | --- | --- | --- | --- |
|  Endemic | 100 | 86.0% | 80.0% | 95.0% | 98.0%  |
|  Non-Endemic | 100 | 93.0% | 93.0% | 98.0% | 99.0%  |
|  Total | 200 | 89.5% | 86.5% | 96.5% | 98.5%  |

*Equivocal results were considered Positive.

f. Assay cut-off: N/A
i. Matrix Effects:

The purpose of this study is to compare plasma and serum using Sofia Lyme FIA with Sofia 2. Paired samples were used to compare matrix performance. The specimens tested were from non-selected prospectively collected donors, targeting 60 IgG positive and 60 IgM positive samples and selected (known positive) prospectively collected donors, targeting 60 IgG positive and 60 IgM positive samples.

Table 5. Sofia Lyme FIA with Sofia 2 – IgM Performance - Plasma vs. Serum

|   | Serum IgM |   | Total  |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive |   | Negative  |
|  Plasma IgM | Positive | 129 | 3 | 132  |
|   |  Negative | 6 | 183 | 189  |
|  Total |   | 135 | 186 | 321  |

Table 6. Sofia Lyme FIA with Sofia 2 – IgG Performance - Plasma vs. Serum

|   | Serum IgG |   | Total  |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive |   | Negative  |
|  Plasma IgG | Positive | 86 | 12 | 98  |
|   |  Negative | 10 | 213 | 223  |
|  Total |   | 96 | 225 | 321  |

2. Comparison studies:

a. Method comparison with predicate device:

A prospective study was performed using 325 serum samples collected from patients that were submitted for routine Lyme disease testing in the United States. These samples were prospectively collected from nine different clinical sites located in endemic areas of 6 states. Sofia Lyme FIA testing was performed at 3 laboratories,

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including 1 Quidel site. The predicate Lyme IgM and IgG assays and western blot Lyme IgM and IgG assays were performed at a single laboratory site. First tier results for Sofia Lyme FIA using the Sofia 2 and the predicate assays are shown in Tables 7 and 8.

Table 7. First Tier Lyme IgM Results for Sofia Lyme FIA Tested on Sofia 2 Compared to Predicate Assay

|   | Predicate Lyme IgM |   |   |  |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |  Positive | Equivocal | Negative | % Agreement | 95% CI  |
|  Sofia IgM | Positive | 57 | 18 | 46 | PPA² = 84.3% (75/89) | 75.2% - 90.5%  |
|   |  Negative | 5 | 9¹ | 190 | NPA = 80.5% (190/236) | 75.0% - 85.1%  |
|  Total |   | 62 | 27 | 236 |   |   |

¹Of the 9 specimens that were Sofia Lyme FIA negative and predicate equivocal, all 9 were negative by western blot
²Four specimens that were negative by the predicate were positive by Sofia Lyme FIA and confirmed positive by western blot

Table 8. First Tier Lyme IgG Results for Sofia Lyme FIA Tested on Sofia 2 Compared to Predicate Assay

|   | Predicate Lyme IgG |   |  |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | % Agreement | 95% CI  |
|  Sofia IgG | Positive | 47 | 27 | PPA = 90.4% (47 / 52) | 79.0% - 96.3%  |
|   |  Negative | 5 | 246 | NPA = 90.1% (246/273) | 86.0% - 93.2%  |
|  Total |   | 52 | 273 |   |   |

## Second-Tier Testing

As recommended by CDC guidelines, second tier Western blot testing was performed on all positive (and equivocal with the predicate assay) samples when tested by either Sofia Lyme FIA or the predicate. The percent agreement between Sofia Lyme FIA and the predicate Lyme test are shown in Tables 9 and 10.

Table 9. IgM Second Tier Testing on Sofia 2

|   | Tier 1 + or ± | IgM WB + | IgM WB -  |
| --- | --- | --- | --- |
|  Predicate IgM | 89 | 51 | 38  |
|  Sofia IgM | 121 | 54 | 67  |
|  Predicate + Sofia IgM | 75 | 50 | 25  |
|  1st Tier PPA (95% CI) | 84.3% (75.2-90.5%) | 75/89  |
| --- | --- | --- |
|  2nd Tier PPA (95% CI) | 98.0% (88.7-99.9%) | 50/51  |

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Table 10. IgG Second Tier Testing on Sofia 2

|   | Tier 1 + | IgG WB + | IgG WB -  |
| --- | --- | --- | --- |
|  Predicate IgG | 52 | 21 | 31  |
|  Sofia IgG | 74 | 22 | 52  |
|  Predicate + Sofia IgG | 47 | 21 | 26  |
|  1st Tier PPA (95% CI) | 90.4% (79.0-96.3%) | 47/52  |
| --- | --- | --- |
|  2nd Tier PPA (95% CI) | 100% (81.8-100%) | 21/21  |

# b. Method comparison with original Sofia

The performance of Sofia Lyme FIA when used with Sofia vs. Sofia 2 was compared using a panel of plasma samples at one Quidel site. Panel members were prepared so that a broad range of negative and positive samples were evenly distributed across the dynamic range of the assay, including negative and high negative samples and low, moderate, and high positive samples. The Sofia vs. Sofia 2 comparison results for IgM and IgG are shown below in Tables 11 and 12 respectively.

Table 11. Sofia Lyme FIA - Sofia vs. Sofia 2 Comparison for IgM

|  TYPE IgM  |   |   |   |   |
| --- | --- | --- | --- | --- |
|   | Sofia |   |   |   |
|   |  Pos | Neg  |   |   |
|  Sofia 2 Pos | 105 | 11 | PPA (95% CI) | 105/111 = 94.6% (88.5% -97.7%)  |
|  Sofia 2 Neg | 62 | 123 | NPA (95% CI) | 123/124 = 99.2% (94.4% -97.9%)  |
|  Total | 111 | 124 |  |   |

1 There was one discordant Sofia 2 positive/ Sofia negative result for IgM which was a high negative specimen.
2 There were six discordant Sofia 2 negative/ Sofia positive results for IgM which were all low positive specimens.

Table 12. Sofia Lyme FIA - Sofia vs. Sofia 2 Comparison for IgG

|  TYPE IgG  |   |   |   |   |
| --- | --- | --- | --- | --- |
|   | Sofia |   |   |   |
|   |  Pos | Neg  |   |   |
|  Sofia 2 Pos | 107 | 62 | PPA (95% CI) | 107/110 = 97.3% (91.9% -99.4%)  |
|  Sofia 2 Neg | 32 | 119 | NPA (95% CI) | 119/125 = 95.2% (89.7% -98.0%)  |
|  Total | 110 | 125 |  |   |

1 There were six discordant Sofia 2 positive/ Sofia negative results for IgG which were all high negative specimens.
2 There were three discordant Sofia 2 negative/ Sofia positive results for IgG which were all low positive specimens.

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3. Clinical Studies:
a. Clinical Sensitivity: See K163713
b. Clinical specificity: N/A
c. Other clinical supportive data (when a. and b. are not applicable): N/A

N. Instrument Name:
Sofia 2

O. System Descriptions:

1. Modes of Operation:
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
☐ Yes ☑ X or No

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?
☐ Yes ☑ X or No

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
☐ Yes ☑ X or No

P. Other Supportive Instrument Performance Characteristics Data Not Covered in The "Performance Characteristics" Section above:

10

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Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

R. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K173691](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K173691)

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