K Number

Device Name

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

Manufacturer

Quidel Corporation

Date Cleared

2018-02-28

(89 days)

Product Code

LSR

Regulation Number

866.3830

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 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 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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K122979, K122986

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on immunofluorescence and lateral flow assay technology, with no mention of AI or ML. The "Early Read" feature on Sofia 2 appears to be a timed analysis, not an AI/ML-driven interpretation.

Therapeutic

No.
This device is an in vitro diagnostic device used to detect antibodies for diagnostic purposes, not to treat or prevent a disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that this test is "intended for use as an aid in the diagnosis of Lyme disease."

SaMD (Software as a Medical Device)

The device description clearly outlines a physical test kit with reagents, a test strip, and a cassette, which is then analyzed by a hardware analyzer (Sofia or Sofia 2). This is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's 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 involves testing biological samples (serum and plasma) in vitro (outside the body) to aid in diagnosis.
Device Description: The description details an "immunofluorescence-based, lateral flow assay" that uses "patient serum or plasma specimen" and "reagents" to detect antibodies. This is a classic description of an in vitro diagnostic test.
Regulatory Context: The mention of "Predicate Device(s)" with K numbers (K122979 and K122986) strongly indicates that this device has gone through or is intended to go through the FDA's regulatory process for medical devices, specifically IVDs. Predicate devices are used for comparison in the 510(k) submission process for IVDs.
Performance Studies: The description of performance studies like "Analytical Studies," "Precision," "Specificity Study," "Method Comparison," and "Reproducibility" are typical studies conducted to demonstrate the performance and reliability of an IVD.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 disease. A negative result does not preclude infection with B. burgdorferi. All positive results for 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.

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

LSR

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

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

Various Analytical Studies
Analytical studies included Limit of Detection, Sofia and Sofia 2 Comparison, Matrix Comparison, Early Read, System Temperature (Read Now vs. Walk Away). All studies demonstrated good performance.

Precision
This study evaluated the within laboratory precision / repeatability of the Sofia Lyme FIA and the Sofia 2 analyzer. The total precision results for IgM and IgG were not significantly different within-run, within-day, between day and total when tested with the negative (C0), high negative (C5), low positive (C95) and moderate positive (2-3X LOD) samples.

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.

Method Comparison
This study demonstrated that Sofia 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.

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.

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

Specificity: The overall specificity of the Sofia Lyme FIA was very good.

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, 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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 28, 2018

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

Re: K173691

Trade/Device Name: Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: November 29, 2017 Received: December 1, 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Kristian M. Roth-S For:

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

Enclosure

Indications for Use

510(k) Number (if known) K173691

Device Name Sofia Lyme FIA

Indications for Use (Describe)

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 disease. A negative result does not preclude infection with B. burgdorferi. All positive results for 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Image /page/3/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square shape with rounded corners, divided into two sections. The larger section is filled with a mosaic of colors, creating a rainbow-like effect. The smaller section is a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font, with the trademark symbol next to it.

510(K) SUMMARY ട.

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 29, 2017

5.4. Proprietary and Established Names

Sofia Lyme FIA

5.5. Common Name

Lyme IgG and Lyme IgM test

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

Image /page/4/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a stylized square divided into two sections. The top section is a gradient of colors, including red, orange, yellow, green, and blue. The bottom section is a geometric pattern of blue and purple triangles. Below the square is the word "QUIDEL" in a simple, sans-serif font.

5.8. Device Description

5.9. Intended Use

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

5.10. Substantial Equivalence Information:

1. Predicate Device Name: Vidas Lyme IgM and Vidas Lyme IgG
1. Predicate 510(k) Numbers: K122979 and K122986

Image /page/5/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with a smaller square in the bottom right corner. The larger square is filled with a gradient of colors, including yellow, green, blue, and red. The word "QUIDEL" is written in black font below the square.

Item	Proposed Device	Predicate IgM Device	Predicate IgG Device
Features	Sofia Lyme FIA with
Sofia	Biomerieux Vidas Lyme
IgM	Biomerieux 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
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.	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 .
Instrument	Sofia 2 (and Sofia)	VIDAS and miniVIDAS	VIDAS and miniVIDAS
Item	Proposed Device	Predicate IgM Device	Predicate IgG Device
Features	Sofia Lyme FIA with
Sofia	Biomerieux Vidas Lyme
IgM	Biomerieux Vidas Lyme
IgG
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
Buffer
Solution	One pre-filled vial
containing PBS	Sample diluent and wash
buffer	Sample diluent and wash
buffer
Item	Proposed Device	Predicate IgM Device	Predicate IgG Device
Features	Sofia Lyme FIA with Sofia	Biomerieux Vidas Lyme IgM	Biomerieux Vidas Lyme IgG
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.

Comparison with Predicate

Image /page/6/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, transitioning from red and orange at the top to blue and purple at the bottom. Below the square is the word "QUIDEL" in a sans-serif font.

Image /page/7/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, transitioning from red and orange at the top to blue and purple at the bottom. Below the square is the word "QUIDEL" in a sans-serif font.

5.11. Performance Data

Additional studies were performed to document the performance characteristics of Sofia Lyme FIA with the Sofia 2 analyzer. The studies included the following:

Various Analytical Studies a.
Analytical studies included Limit of Detection, Sofia and Sofia 2 Comparison, Matrix Comparison, Early Read, System Temperature (Read Now vs. Walk Away). All studies demonstrated good performance.
b. Precision
This study evaluated the within laboratory precision / repeatability of the Sofia Lyme FIA and the Sofia 2 analyzer. The total precision results for IgM and IgG were not significantly different within-run, within-day, between day and total when tested with the negative (C0), high negative (C5), low positive (C95) and moderate positive (2-3X LOD) samples.

Image /page/8/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. Below the square is the word "QUIDEL" in a sans-serif font.

Specificity Study C.
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.
d. Method Comparison
This study demonstrated that Sofia 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.
Reproducibility e.
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.

5.12. Conclusion

These studies demonstrated the substantial equivalence of the Sofia Lyme FIA with Sofia 2 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.