(294 days)
Not Found
No
The description focuses on immunofluorescence and lateral flow assay technology, with the Sofia device performing automated scanning and analysis of the fluorescent signal. There is no mention of AI, ML, or complex algorithms beyond basic signal processing for qualitative results (positive, negative, invalid).
No
Explanation: This device is an in vitro diagnostic (IVD) device intended to aid in the diagnosis of Lyme disease by detecting antibodies, not to treat or therapeutically manage a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as an aid in the diagnosis of Lyme disease."
No
The device description clearly outlines a physical test strip, reagent vials, and a Test Cassette, which are hardware components. The Sofia system itself, which scans the test strip and analyzes the signal, is also a hardware component. While there is likely software involved in the analysis and display of results, the device is not solely software.
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 serum and plasma specimens from patients suspected of B. burgdorferi infection." It also states it is "intended for use as an aid in the diagnosis of Lyme disease." This clearly indicates the device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Specimen Type: The device uses "serum and plasma specimens from patients," which are biological specimens derived from the human body.
- Diagnostic Purpose: The test is intended to "aid in the diagnosis of Lyme disease," which is a diagnostic purpose.
- Device Description: The description details a "lateral flow assay for detection of IgM and/or IgG antibodies to Borrelia burgdorferi in patient specimens," further confirming its use in analyzing human specimens for diagnostic markers.
These points align directly with the definition of an In Vitro Diagnostic device.
N/A
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 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 Control Set is intended for use as assayed quality control materials to verify the performance of the Sofia Lyme FIA test system.
Product codes (comma separated list FDA assigned to the subject device)
LSR
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, the patient specimen (30 uL serum/plasma) is added to a pre-filled Reagent Vial. 100 uL of the diluted sample is then dispensed into the round sample well located near the center of the Test Cassette. The Test Cassette is loaded into Sofia for an automatically defined development time (WALK AWAY Mode) or pre-incubated on the bench top prior to loading into Sofia (READ NOW Mode). Sofia scans the test strip, analyzes the fluorescent signal, and then displays two (2) test results: IgM (positive, negative or invalid) and IgG (positive, negative or invalid). As an option, the results are automatically printed on the integrated printer.
Each Sofia 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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
a. Various Analytical Studies
Analytical studies included Limit of Detection, cross-reactivity, interfering substances, specimen collection and handling, operating temperature, and various flex studies. All studies demonstrated good performance.
b. Precision
This study evaluated the within laboratory precision / repeatability of the Sofia Lyme FIA using serum samples. 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.
c. CDC Reference Panel
When testing the CDC reference panel, the overall agreement for Clinical Status of IgG and IgM samples between Sofia Lyme FIA and Western Blot was good.
d. 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.
e. Specificity Study
This study evaluated the analytical specificity of the Sofia Lyme FIA using serum obtained from asymptomatic (healthy, normal) populations in both endemic and nonendemic regions. The overall specificity of the Sofia Lyme FIA was very good.
f. Method Comparison
This study demonstrated that Sofia Lyme FIA has comparable performance to the Vidas Lyme IgG and Vidas Lyme IgM tests when testing prospectively collected serum specimens from subjects suspected of having Lyme disease.
g. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2017
QUIDEL CORPORATION JENNIFER RIAL DIRECTOR, REGULATORY AFFAIRS 12544 HIGH BLUFF DRIVE, SUITE 200 SAN DIEGO CA 92130
Re: K163713
Trade/Device Name: Sofia Lyme Fia. Sofia Lyme Control Set Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: May 17, 2017 Received: May 19, 2017
Dear Ms. 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 Parts 801 and 809); medical device reporting (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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kristian M. Roth -S
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
2
Indications for Use
510(k) Number (if known) K163713
Device Name Sofia Lyme FIA Sofia Lyme Control Set
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 Control Set is intended for use as assayed quality control materials to verify the performance of the Sofia Lyme FIA test system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 two sections. The top section is a gradient of colors, including red, orange, yellow, green, blue, and purple. The bottom section is a smaller square that is blue and purple. Below the square is the word "QUIDEL" in a sans-serif font.
5. 510(K) SUMMARY
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Image /page/4/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with a smaller square cut out of the bottom right corner. The larger square is filled with a gradient of colors, including red, orange, yellow, green, blue, and purple. The smaller square is filled with a gradient of blue and purple. Below the square is the word "QUIDEL" in a sans-serif font.
5.1. Submitter
Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, California 92130 Telephone: 858-552-7910 Fax: 858-646-8045
5.2. Submission Contact
Jennifer S. Rial
5.3. Date Prepared/Updated
October 18, 2017
5.4. Proprietary and Established Names
Sofia 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 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.
5
Image /page/5/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with a gradient of colors, including red, orange, yellow, green, blue, and purple. Inside the square is a stylized letter "Q" in white. Below the square is the word "QUIDEL" in a simple, sans-serif font.
To perform the test, the patient specimen (30 uL serum/plasma) is added to a pre-filled Reagent Vial. 100 uL of the diluted sample is then dispensed into the round sample well located near the center of the Test Cassette. The Test Cassette is loaded into Sofia for an automatically defined development time (WALK AWAY Mode) or pre-incubated on the bench top prior to loading into Sofia (READ NOW Mode). Sofia scans the test strip, analyzes the fluorescent signal, and then displays two (2) test results: IgM (positive, negative or invalid) and IgG (positive, negative or invalid). As an option, the results are automatically printed on the integrated printer.
Each Sofia 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
Sofia Lyme FIA:
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.
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 test system.
5.10. Substantial Equivalence Information:
- Predicate Device Name: Vidas Lyme IgM and Vidas Lyme IgG 1.
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Image /page/6/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with a smaller square cut out of the lower right corner. The larger square is filled with a mosaic of colors, including yellow, orange, red, purple, blue, and green. Below the square is the word "QUIDEL" in a simple, sans-serif font.
| 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 | Sofia Lyme FIA: | ||
| 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. | |||
| 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 test system. | 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 IgM 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 | 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 |
| Item | Proposed Device | Predicate IgM Device | Predicate IgG Device |
| Features | Sofia Lyme FIA with Sofia | Biomerieux Vidas Lyme IgM | Biomerieux Vidas Lyme IgG |
| Read Results | Read results on instrument screen or print with optional printer | Result report is printed | Result report is printed |
| Read Result Time | 10 Minutes | 27 minutes | 27 minutes |
| Specimen Types | Human serum and plasma | Human serum and plasma | Human 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 |
| 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 | • 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. | |
| Item | Proposed Device | Predicate IgM Device | Predicate IgG Device |
| Features | Sofia Lyme FIA with | ||
| Sofia | Biomerieux Vidas Lyme | ||
| IgM | Biomerieux Vidas Lyme | ||
| IgG | |||
| side of the assay. | |||
| • Analyzer prevents | |||
| used or expired | |||
| cartridge from being | |||
| read by the reader | |||
| • Cassette must be | |||
| properly inserted |
Comparison with Predicate
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Image /page/7/Picture/0 description: The image shows the logo for Quidel. The logo features a square with rounded corners, filled with a gradient of colors from red to yellow to green to blue. Inside the square is a smaller white square, with a portion of the colored square visible in the lower right corner. Below the square is the word "QUIDEL" in a simple, sans-serif font.
8
Image /page/8/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 ranging from yellow and orange to red, purple, and blue. A smaller, solid white square is positioned in the upper left corner of the larger square, creating a visual break. Below the square is the word "QUIDEL" in a simple, sans-serif font.
5.11. Performance Data
Numerous studies were undertaken to document the performance characteristics of Sofia Lyme FIA and the Sofia Lyme Control Set, as well as to compare the performance between Sofia Lyme and the Vidas IgG and IgM tests. The studies included the following:
-
a. Various Analytical Studies
Analytical studies included Limit of Detection, cross-reactivity, interfering substances, specimen collection and handling, operating temperature, and various flex studies. All studies demonstrated good performance. -
b. Precision
This study evaluated the within laboratory precision / repeatability of the Sofia Lyme FIA using serum samples. 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. -
CDC Reference Panel C.
When testing the CDC reference panel, the overall agreement for Clinical Status of IgG and IgM samples between Sofia Lyme FIA and Western Blot was good. -
Sensitivity Study d.
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. -
Specificity Study e.
This study evaluated the analytical specificity of the Sofia Lyme FIA using serum obtained from asymptomatic (healthy, normal) populations in both endemic and nonendemic regions. The overall specificity of the Sofia Lyme FIA was very good.
9
Image /page/9/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with rounded corners, divided into four quadrants. The top and left quadrants are filled with a gradient of colors, including green, yellow, orange, and red. The bottom right quadrant is filled with shades of blue and purple. Below the square is the word "QUIDEL" in a modern, sans-serif font.
-
f. Method Comparison
This study demonstrated that Sofia Lyme FIA has comparable performance to the Vidas Lyme IgG and Vidas Lyme IgM tests when testing prospectively collected serum specimens from subjects suspected of having Lyme disease. -
g. 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.
5.12. Conclusion
These studies demonstrated the substantial equivalence of the Sofia 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.