Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes an immunofluorescence assay read by an instrument that images the test strip and provides results based on the presence and intensity of fluorescence. While it uses imaging and potentially some form of algorithm to interpret the results, there is no mention of AI or ML in the description, device description, or performance studies. The analysis appears to be based on predefined cutoffs for fluorescence intensity.

Therapeutic

No
The device is described as an aid in diagnosis of Lyme disease, not for treatment or therapy. It functions by detecting antibodies to Borrelia burgdorferi.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The Sofia 2 Lyme FIA is intended for use as an aid in diagnosis of Lyme disease."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical test kit including a test strip, capillary tube, reagent solution, reagent tube, and test cassette. While the Sofia 2 instrument utilizes software for imaging and analysis, the core diagnostic component is a physical immunofluorescence assay.

IVD (In Vitro Diagnostic)

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 device is for the "rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection." It is intended "for use as an aid in diagnosis of Lyme disease." This clearly indicates that the device is used to examine specimens derived from the human body to provide information for the diagnosis of a disease.
Device Description: The description details how the device works by detecting antibodies in a patient specimen (finger-stick whole blood).
Specimen Type: The device uses "finger-stick whole blood specimens from patients," which are specimens derived from the human body.
Purpose: The purpose is to aid in the diagnosis of Lyme disease by detecting specific antibodies.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sofia 2 Lyme FIA:

The Sofia 2 Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection of at least 2 weeks' duration. The Sofia 2 Lyme FIA is intended for use as an aid in diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. Positive results must be confirmed by testing with a corresponding second-tier B. burgdorferi 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 assay is to be performed on the Sofia 2 instrument. Professional guidelines should be consulted regarding testing and treatment for Lyme disease when acute B. burgdorferi infection is suspected.

Sofia Lyme Control Set:

The Sofia Lyme Control Set is intended for use as assayed quality control materials to verify the performance of the Sofia Lyme FIA and Sofia 2 Lyme FIA test system.

Product codes (comma separated list FDA assigned to the subject device)

LSR

Device Description

The Sofia 2 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, the patient finger-stick whole blood specimen is obtained with the provided Capillary Tube (a.k.a. whole blood separator device). The Capillary Tube stands or is held vertically to allow the blood to drain. This device separates the red blood cells from the whole blood specimen using a gravimetric flow through a sample pad coated with rabbit anti-human red blood cell (RBC) antibodies. The user dispenses all of the Reagent Solution into the Reagent Tube and inserts the Capillary Tube into the Reagent Tube and shakes the tube vigorously. Two drops of diluted sample are dispensed into the round sample well located near 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 15 minutes. In WALK AWAY Mode, the user immediately after adding the specimen to the cassette, the cassette is inserted into Sofia 2. Sofia 2 will analyze the test strip at 3, 5, 8, 10, and 15 minutes until both IgM and IgG positive results are received. This feature allows for earlier read times.

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

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

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ANALYTICAL STUDIES

Precision a.
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.
b. Reproducibility
This study demonstrated intra- and inter-laboratory reproducibility with a panel of test samples at various concentrations of IgM and IgG antibodies to B. burgdorferi. The operators and laboratories obtained accurate results with the Sofia Lyme FIA on Sofia 2.
Assay Cutoff C.
An Assay Cutoff Study was performed to determine and confirm the two separate assay cutoff limits for the Sofia 2 Lyme FIA. One cutoff limit was established for Lyme IgG and one cutoff limit was established for Lyme IgM. The general procedure was to test matched finger-stick whole blood, serum and plasma samples with the aim of setting the whole blood assay cutoff so that the clinical performance, percent positive agreement (PPA) and the percent negative agreement (NPA), of the whole blood assay is statistically similar to the FDA cleared Sofia Lyme FIA serum and plasma assay. After the cutoffs were established, the values were validated as part of the clinical trial as well as other analytical studies
d. Interference Substances
A study was performed to assess potential interfering substances with the Sofia Lyme FIA with Sofia. There was no interference or cross-reactivity results when tested with the Sofia Lyme FIA.
Cross Reactivity e.
The cross-reactivity of the Sofia Lyme FIA with Sofia was evaluated with 17 disease state sample types that have the potential to interfere.
Note: The results obtained with Leptospirosis (6) and Rickettsia (3) samples may not be conclusive due to low number of samples tested. See also the Limitations section.

CLINICAL STUDIES

f. Matrix Equivalency
The finger-stick whole blood matrix on the Sofia 2 Lyme FIA was demonstrated to be equivalent to the serum/plasma matrix on the Sofia Lyme FIA. A field study was conducted using matched finger-stick whole blood, serum and plasma.
n=321
IgM results: Finger-stick Whole Blood - Positive 136, Negative 185, %Positivity 42.4%; Serum - Positive 135, Negative 186, %Positivity 42.1%; Plasma - Positive 133, Negative 188, %Positivity 41.4%.
IgG results: Finger-stick Whole Blood - Positive 105, Negative 216, %Positivity 32.7%; Serum - Positive 96, Negative 225, %Positivity 29.9%; Plasma - Positive 98, Negative 223, %Positivity 30.5%.
CDC Reference Panel g.
When testing the CDC reference panel, the overall agreement for Clinical Status of IgG and IgM samples between Sofia Lyme FIA and Clinical Status and Western Blot was good.
For IgM:
Negative Controls (n=190): Sofia Lyme IgM - Pos 33, Neg 157, % Agreement with clinical Status 82.6%; Western Blot Lyme IgM - Pos 0, Neg 190, % Agreement with clinical Status 100.0%.
Early Lyme EM Positive (n=60): Sofia Lyme IgM - Pos 49, Neg 11, % Agreement with clinical Status 81.7%; Western Blot Lyme IgM - Pos 31, Neg 29, % Agreement with clinical Status 51.7%.
Late Lyme (n=30): Sofia Lyme IgM - Pos 22, Neg 8, % Agreement with clinical Status 73.3%; Western Blot Lyme IgM - Pos 17, Neg 13, % Agreement with clinical Status 56.7%.
For IgG:
Negative Controls (n=190): Sofia Lyme IgG - Pos 25, Neg 165, % Agreement with clinical Status 86.8%; Western Blot Lyme IgG - Pos 0, Neg 190, % Agreement with clinical Status 100.0%.
Early Lyme EM Positive (n=60): Sofia Lyme IgG - Pos 49, Neg 11, % Agreement with clinical Status 81.7%; Western Blot Lyme IgG - Pos 19, Neg 41, % Agreement with clinical Status 31.7%.
Late Lyme (n=30): Sofia Lyme IgG - Pos 30, Neg 0, % Agreement with clinical Status 100%; Western Blot Lyme IgG - Pos 26, Neg 4, % Agreement with clinical Status 86.7%.
h. Specificity Study
This study evaluated the analytical specificity of the Sofia Lyme FIA on Sofia 2 using samples obtained from asymptomatic (healthy, normal) populations in both endemic and non-endemic regions. The overall specificity of the Sofia Lyme FIA was very good.
Overall Specificity: Endemic (n=100) - Sofia IgM 86.0%, Predicate IgM 80.0%, Sofia IgG 95.0%, Predicate IgG 98.0%; Non-Endemic (n=100) - Sofia IgM 93.0%, Predicate IgM 93.0%, Sofia IgG 98.0%, Predicate IgG 99.0%; Total (n=200) - Sofia IgM 89.5%, Predicate IgM 86.5%, Sofia IgG 96.5%, Predicate IgG 98.5%.
i. Sensitivity Study
This study evaluated the clinical sensitivity of the Sofia Lyme FIA device using well characterized clinically or culture confirmed Lyme disease samples. The clinical sensitivity was compared to a 510(k) cleared test and the performance was comparable.
Lyme IgM Results:
Acute, 1 yr), Neuro or Arthritic (n=12): Sofia IgM Sens 66.7% (95% CI 38.8-86.5%); Predicate IgM Sens 83.3% (95% CI 54.0-96.5%).
All Categories (n=95): Sofia IgM Sens 64.2% (95% CI 54.2-73.1%); Predicate IgM Sens 58.9% (95% CI 48.9-68.3%).
Lyme IgG Results:
Acute, 1 yr), Neuro or Arthritic (n=12): Sofia IgG Sens 100% (95% CI 78.4-100.0%); Predicate IgG Sens 83.3% (95% CI 54.0-96.5%).
All Categories (n=95): Sofia IgG Sens 80.0% (95% CI 70.8-86.9%); Predicate IgG Sens 49.5% (95% CI 39.6-59.4%).
j. Method Comparison
This study demonstrated that Sofia 2 Lyme FIA with Sofia 2 has comparable performance to the Vidas Lyme IgG and Vidas Lyme IgM tests when testing prospectively collected specimens from subjects suspected of having Lyme disease.
Lyme IgM Results for Sofia 2 Lyme FIA with Sofia 2 Compared to Predicate Assay IgM Method Comparison: 1st Tier PPA and NPA Analysis
Predicate Lyme IgM Positive n=62, Equivocal n=29, Negative n=233.
Sofia 2 IgM Positive (n=90): Predicate Positive 57, Equivocal 18, Negative 47. PPA = 82.4% (75/91) CI 73.2%-89.0%.
Sofia 2 IgM Negative (n=202): Predicate Positive 5, Equivocal 11, Negative 186. NPA = 79.8% (186/233) CI 74.2%-84.5%.
IgM Second Tier Testing IgM Method Comparison: 2nd Tier PPA Analysis
Predicate IgM Tier 1+ or ± n=91, IgM WB+ 51, IgM WB- 40. 1st Tier PPA 82.4% (73.2-89.0%) (75/91).
Sofia 2 IgM Tier 1+ or ± n=122, IgM WB+ 52, IgM WB- 70. 2nd Tier PPA 94.1% (83.5-98.6%) (48/51).
Predicate + Sofia IgM Tier 1+ or ± n=75, IgM WB+ 48, IgM WB- 27.

Lyme IgG Results for Sofia 2 Lyme FIA with Sofia 2 Compared to Predicate Assay IgG Method Comparison: 1st Tier PPA and NPA Analysis
Predicate Lyme IgG Positive n=54, Negative n=270.
Sofia 2 IgG Positive (n=86): Predicate Positive 48, Negative 38. PPA = 88.9% (48/54) CI 77.5%-95.2%.
Sofia 2 IgG Negative (n=238): Predicate Positive 6, Negative 232. NPA = 85.9% (232/270) CI 81.2%-89.6%.
IgG Second Tier Testing IgG Method Comparison: 2nd Tier PPA Analysis
Predicate IgG Tier 1+ n=54, IgG WB+ 23, IgG WB- 31.
Sofia 2 IgG Tier 1+ n=86, IgG WB+ 23, IgG WB- 63.
Predicate + Sofia 2 IgG Tier 1+ n=48, IgG WB+ 22, IgG WB- 26.
2nd Tier PPA 95.7% (77.3->99.9) (22/23).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies"

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122979 and K122986

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image features the logo for QuidelOrtho Corporation. The logo consists of a square shape with rounded corners, filled with a gradient of colors resembling a rainbow. The bottom right corner of the square is a darker shade of blue. Below the square is the word "QUIDEL" in a modern, sans-serif font.

ട്. 510(K) SUMMARY

5.1. Submitter

Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, California 92130 Telephone: 858-552-7910 Fax: 858-646-8045

Submission Contact 5.2.

Jennifer S. Rial

5.3. Date Prepared

November 10, 2017

5.4. Proprietary and Established Names

Sofia 2 Lyme FIA Sofia Lyme Control Set

5.5. Common Name

Lyme IgG and Lyme IgM test and assayed external controls

5.6. Regulatory Information

Product Code	Classification	Regulatory Section	Panel
LSR	II	21 CFR 866.3830	Immunology and
Microbiology Devices

5.7. Predicate Device

Vidas Lyme IgG and Vidas Lyme IgM

5.8. Device Description

The Sofia 2 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.

1

Image /page/1/Picture/0 description: The image features the logo of Quidel. The logo consists of a square shape divided into two sections. The larger section is a gradient of colors, transitioning from yellow to green to blue to red. The smaller section is a solid dark blue. Below the square is the word "QUIDEL" in a modern, sans-serif font, with a small trademark symbol next to the "L".

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, the patient finger-stick whole blood specimen is obtained with the provided Capillary Tube (a.k.a. whole blood separator device). The Capillary Tube stands or is held vertically to allow the blood to drain. This device separates the red blood cells from the whole blood specimen using a gravimetric flow through a sample pad coated with rabbit anti-human red blood cell (RBC) antibodies. The user dispenses all of the Reagent Solution into the Reagent Tube and inserts the Capillary Tube into the Reagent Tube and shakes the tube vigorously. Two drops of diluted sample are dispensed into the round sample well located near 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 15 minutes. In WALK AWAY Mode, the user immediately after adding the specimen to the cassette, the cassette is inserted into Sofia 2. Sofia 2 will analyze the test strip at 3, 5, 8, 10, and 15 minutes until both IgM and IgG positive results are received. This feature allows for earlier read times.

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

5.9. Intended Use

Intended Use Statements for Sofia 2 Lyme FIA and Sofia Lyme Control Set:

Sofia 2 Lyme FIA:

The Sofia 2 Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection of at least 2 weeks' duration. The Sofia 2 Lyme FIA is intended for use as an aid in diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. Positive results must be confirmed by testing with a corresponding second-tier B. burgdorferi 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 assay is to be performed on the Sofia 2 instrument. Professional guidelines should be consulted regarding testing and treatment for Lyme disease when acute B. burgdorferi infection is suspected.

Sofia Lyme Control Set:

The Sofia Lyme Control Set is intended for use as assayed quality control materials to verify the performance of the Sofia Lyme FIA and Sofia 2 Lyme FIA test system.

2

Image /page/2/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with rounded corners, filled with a gradient of colors from yellow to red to blue. Below the square is the word "QUIDEL" in a simple, sans-serif font. The logo is clean and modern, with the colorful square representing the company's diverse range of products and services.

Substantial Equivalence Information: 5.10.

1. Predicate Device Name: Vidas Lyme IgM and Vidas Lyme IgG

2. Predicate 510(k) Numbers: K122979 and K122986 Comparison with Predicate

Item	Proposed Device	Predicate IgM Device	Predicate IgG Device
Features	Sofia 2 Lyme FIA with
Sofia	Biomerieux Vidas Lyme
IgM	Biomerieux Vidas Lyme
IgG
Intended Use	Sofia 2 Lyme FIA:
The Sofia 2 Lyme FIA
employs
immunofluorescence for
the rapid differential
detection of human IgM
and IgG antibodies to
Borrelia burgdorferi
from finger-stick whole
blood specimens from
patients suspected of B.
burgdorferi infection of
at least 2 weeks'
duration. The Sofia 2
Lyme FIA is intended
for use as an aid in
diagnosis of Lyme
disease. A negative
result does not preclude
infection with B.
burgdorferi. Positive
results must be
confirmed by testing
with a corresponding
second-tier B.
burgdorferi 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 assay is
to be performed on the
Sofia 2 instrument.
Professional guidelines
should be consulted
regarding testing and	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 IgM 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.
Item	Proposed Device	Predicate IgM Device	Predicate IgG Device
Features	Sofia 2 Lyme FIA with
Sofia	Biomerieux Vidas Lyme
IgM	Biomerieux Vidas Lyme
IgG
Features	treatment for Lyme
disease when acute B.
burgdorferi infection is
suspected.

3

Image /page/3/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with rounded corners, divided into four sections. The top and left sections are filled with a gradient of colors, including yellow, orange, red, and green. The bottom right section is filled with shades of blue and purple. Below the square is the word "QUIDEL" in a sans-serif font.

4

Image /page/4/Picture/0 description: The image features the logo for Quidel. The logo consists of a square with rounded corners, filled with a gradient of colors resembling a mosaic. The colors transition from yellow and green in the upper-left corner to red in the upper-right, and blue in the lower-right. Below the square is the word "QUIDEL" in a simple, sans-serif font.

5.11. Performance Data

Studies were undertaken to document the performance characteristics of Sofia 2 Lyme FIA and the Sofia Lyme Control Set, as well as to compare the performance between Sofia 2 Lyme and the Vidas IgG and IgM tests. The studies included the following:

5

ANALYTICAL STUDIES

Precision a.
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.

| IgM or IgG
Sample | IgM Positive | | IgM % Positivity | | IgG Positive | IgG %
Positivity |
|---------------------------------|--------------|-------|------------------|-------|--------------|---------------------|
| | Run 1 | Run 2 | Total (n=96) | Run 1 | Run 2 | Total (n=96) |
| 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% |

Sofia Lyme FIA with Sofia 2 Precision – Within Run

	Sofia Lyme FIA with Sofia 2 Precision - Between Operator
--	----------------------------------------------------------	--

| IgM or IgG
Sample | IgM Positive | | IgM %
Positivity
Total (n=96) | IgG Positive | | IgG %
Positivity
Total
(n=96) |
|---------------------------------|--------------|------------|-------------------------------------|--------------|------------|----------------------------------------|
| | Operator 1 | 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% |

b. Reproducibility

This study demonstrated intra- and inter-laboratory reproducibility with a panel of test samples at various concentrations of IgM and IgG antibodies to B. burgdorferi. The operators and laboratories obtained accurate results with the Sofia Lyme FIA on Sofia 2.

6

Image /page/6/Picture/0 description: The image shows the Quidel logo. The logo features a square shape with a gradient of colors, including red, orange, yellow, green, blue, and purple. The word "QUIDEL" is written in a sans-serif font below the square.

| 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%) |

Sofia Lyme FIA with Sofia 2 Reproducibility Study Inter-Laboratory Agreement

Assay Cutoff C.

An Assay Cutoff Study was performed to determine and confirm the two separate assay cutoff limits for the Sofia 2 Lyme FIA. One cutoff limit was established for Lyme IgG and one cutoff limit was established for Lyme IgM. The general procedure was to test matched finger-stick whole blood, serum and plasma samples with the aim of setting the whole blood assay cutoff so that the clinical performance, percent positive agreement (PPA) and the percent negative agreement (NPA), of the whole blood assay is statistically similar to the FDA cleared Sofia Lyme FIA serum and plasma assay. After the cutoffs were established, the values were validated as part of the clinical trial as well as other analytical studies

d. Interference Substances

A study was performed to assess potential interfering substances with the Sofia Lyme FIA with Sofia. There was no interference or cross-reactivity results when tested with the Sofia Lyme FIA.

7

Image /page/7/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with a smaller square cut out of the lower right corner. The larger square is filled with a mosaic of colors, including red, orange, yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.

ia Lyme FIA with Sofia Interfering Substances
Interfering Substance	Concentrations Tested
Bilirubin	15 mg/dL
Hemoglobin	20 g/dL
Lipids	750 mg/dL
Albumin	5.0 g/dL
Acetylsalicylic Acid	3.62 mmol/L
Amoxicillin	206 umol/L
Azithromycin	15.3 umol/L
Ceftriaxone	1460 umol/L
Cefuroxime Axetil	1416 umol/L
Doxycycline Hyclate	67.5 umol/L
Erythromycin	81.6 umol/L
Ibuprofen	2425 umol/L
Minocycline	10.33 umol/L
Penicillin G	33.67 umol/L
Penicillin Phenoxymethyl	14.27 umol/L
Prednisolone	8.31 umol/L
Tetracyclines	34 umol/L

Sofia L .............................................................................................................................................................................. Class

Cross Reactivity e.

The cross-reactivity of the Sofia Lyme FIA with Sofia was evaluated with 17 disease state sample types that have the potential to interfere.

Disease State Diagnosis	# of Samples	IgM Positive Results	IgG Positive Results
Anti-Nuclear Antibodies	10	4/10	1/10
Babesiosis	12	3/12	4/12
Chronic Fatigue Syndrome	12	2/12	2/12
Cytomegalovirus	11	2/11	1/11
Epstein Barr Virus	10	4/10	0/10
Fibromyalgia	10	1/10	0/10
H. pylori	10	4/10	0/10
HIV	11	2/11	0/11
Influenza	11	0/11	0/11
Leptospirosis	6	1/6	2/6
Lupus	20	8/20	4/20
Multiple Sclerosis	10	1/10	1/10
Parvovirus B19	15	4/15	1/15
Rheumatoid Factor	10	0/10	0/10
Rickettsia	3	0/3	0/3
Rocky Mountain Spotted Fever	10	0/10	0/10
Syphilis	28	8/28	4/28

Sofia Lyme FIA with Sofia Cross-Reactivity

Note: The results obtained with Leptospirosis (6) and Rickettsia (3) samples may not be conclusive due to low number of samples tested. See also the Limitations section.

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Image /page/8/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, filled with a gradient of colors ranging from green to red. A smaller, blue square is positioned in the lower right corner of the larger square. Below the square is the word "QUIDEL" in a sans-serif font.

CLINICAL STUDIES

f. Matrix Equivalency

The finger-stick whole blood matrix on the Sofia 2 Lyme FIA was demonstrated to be equivalent to the serum/plasma matrix on the Sofia Lyme FIA. A field study was conducted using matched finger-stick whole blood, serum and plasma.

		IgM			IgG
n=321		Finger-stick
Whole Blood	Serum	Plasma	Finger-stick
Whole Blood	Serum	Plasma
Positive		136	135	133	105	96	98
Negative		185	186	188	216	225	223
%
Positivity		42.4%	42.1%	41.4%	32.7%	29.9%	30.5%

Matrix Equivalency

CDC Reference Panel g.

When testing the CDC reference panel, the overall agreement for Clinical Status of IgG and IgM samples between Sofia Lyme FIA and Clinical Status and Western Blot was good.

| Clinical

Status		Sofia Lyme IgM			Western Blot Lyme IgM
	n	Pos	Neg	% Agreement
with clinical Status	Pos	Neg	% Agreement
with clinical Status
Negative
Controls	190	33	157	82.6%	0	190	100.0%
Early
Lyme EM
Positive	60	49	11	81.7%	31	29	51.7%
Late Lyme	30	22	8	73.3%	17	13	56.7%

Sofia Lyme FIA with Sofia tested with CDC Panel – IgM Results

Sofia Lyme FIA with Sofia tested with CDC Panel – IgG Results

| Clinical

Status	n	Sofia Lyme IgG			Western Blot Lyme IgG
		Pos	Neg	% Agreement with
clinical Status	Pos	Neg	% Agreement with
clinical Status
Negative
Controls	190	25	165	86.8%	0	190	100.0%
Early Lyme
EM Positive	60	49	11	81.7%	19	41	31.7%
Late Lyme	30	30	0	100%	26	4	86.7%

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Image /page/9/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with a smaller square cut out of the bottom right corner. The larger square is filled with a gradient of colors, ranging from red and orange to yellow, green, blue, and purple. The company name, "QUIDEL," is written in a simple, sans-serif font below the square.

h. Specificity Study

This study evaluated the analytical specificity of the Sofia Lyme FIA on Sofia 2 using samples obtained from asymptomatic (healthy, normal) populations in both endemic and non-endemic regions. The overall specificity of the Sofia Lyme FIA was very good.

| | n | Sofia
IgM | Predicate IgM* | Sofia IgG | Predicate
IgG |
|-------------|-----|--------------|----------------|-----------|------------------|
| 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% |

Sofia Lyme FIA with Sofia 2 and Predicate Analytical Specificity

*Equivocal results were considered Positive.

i. Sensitivity Study

This study evaluated the clinical sensitivity of the Sofia Lyme FIA device using wellcharacterized clinically or culture confirmed Lyme disease samples. The clinical sensitivity was compared to a 510(k) cleared test and the performance was comparable.

Lyme IgM Results for Sofia Lyme FIA with Sofia Compared to Predicate Assay

Category	n	Pos	Neg	Sofia IgM		Predicate IgM
				Sens	95% CI	Pos	Equiv	Neg	Sens¹	95% CI
Acute, 1 yr),
Neuro or Arthritic	12	8	4	66.7%	38.8-
86.5%	7	3	2	83.3%	54.0-96.5%
All Categories	95	61	34	64.2%	54.2-
73.1%	43	13	39	58.9%	48.9-68.3%

1 Of the 13 samples that were "equivocal" by the predicate, 12 of 13 were negative by FDA approved western blot.

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Lyme IgG Results for Sofia Lyme FIA with Sofia Compared to Predicate Assay
	Sofia IgG					Predicate IgG
Category	n	Pos	Neg	Sens	95%CI	Pos	Neg	Sens	95%CI
Acute, 1 yr),
Neuro or Arthritic	12	12	0	100%	78.4-100.0%	10	2	83.3%	54.0-96.5%
All Categories	95	76	19	80.0%	70.8-86.9%	47	48	49.5%	39.6-59.4%

Lyme IgG Results for Sofia Lyme FIA with Sofia Compared to Predicate Assay

j. Method Comparison

This study demonstrated that Sofia 2 Lyme FIA with Sofia 2 has comparable performance to the Vidas Lyme IgG and Vidas Lyme IgM tests when testing prospectively collected specimens from subjects suspected of having Lyme disease.

Lyme IgM Results for Sofia 2 Lyme FIA with Sofia 2 Compared to Predicate Assay IgM Method Comparison: 1st Tier PPA and NPA Analysis

			Predicate Lyme IgM
			Positive	Equivocal	Negative	% Agreement	95% CI
Sofia
2 IgM	Positive	57	18	47	PPA = 82.4% (75/91)	73.2%-89.0%
	Negative	5	11	186	NPA =79.8% (186/233)	74.2%-84.5%
Total		62	29	233

IgM Second Tier Testing IgM Method Comparison: 2st Tier PPA Analysis

| | Tier 1 + or ± | IgM WB + | IgM WB - | 1st Tier PPA
(95% CI) | | |
|--------------------------|---------------|----------|----------|--------------------------|-----------------------|-------|
| Predicate IgM | 91 | 51 | 40 | 82.4%
(73.2-89.0%) | 75/91 | |
| Sofia 2 IgM | 122 | 52 | 70 | 2nd Tier PPA
(95% CI) | 94.1%
(83.5-98.6%) | 48/51 |
| Predicate +
Sofia IgM | 75 | 48 | 27 | | | |

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Image /page/11/Picture/0 description: The image features the logo of Quidel. The logo consists of a square shape with rounded corners, divided into two sections. The upper section is a gradient of colors, transitioning from yellow to red to blue, creating a rainbow effect. The lower section is a solid blue color. Below the square is the word "QUIDEL" in a simple, sans-serif font.

Lyme IgG Results for Sofia 2 Lyme FIA with Sofia 2 Compared to Predicate Assay IgG Method Comparison: 1st Tier PPA and NPA Analysis

		Predicate Lyme IgG
		Positive	Negative	% Agreement	95% CI
Sofia
2
IgG	Positive	48	38	PPA = 88.9% (48/54)	77.5%-95.2%
	Negative	6	232	NPA = 85.9% (232/270)	81.2%-89.6%
Total		54	270

IgG Second Tier Testing IgG Method Comparison: 2st Tier PPA Analysis

	Tier 1 +	IgG WB +	IgG WB -
Predicate
IgG	54	23	31
Sofia 2
IgG	86	23	63
Predicate

Sofia 2
IgG | 48 | 22 | 26 |

| 1st Tier PPA
(95% CI) | 88.9%
(77.5-95.2%) | 48/54 |
|--------------------------|-----------------------|-------|
| 2nd Tier PPA
(95% CI) | 95.7%
(77.3->99.9) | 22/23 |

5.12. Conclusion

These studies demonstrated the substantial equivalence of the Sofia 2 Lyme FIA to the Vidas Lyme IgG and Vidas Lyme IgM tests. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/13/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure. The text on the right is in blue and white, with "FDA" in a larger font size than the rest of the text.

August 30, 2018

Quidel Corporation Jennifer Rial Director, Regulatory Affairs 12544 High Bluff Drive, Suite 200 San Diego, California 92130

Re: K173496

Trade/Device Name: Sofia 2 Lyme FIA Sofia Lyme Control Set Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR, QCH Dated: November 10, 2017 Received: November 13, 2017

Dear Jennifer Rial:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

14

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure