(226 days)
Not Found
No
The description mentions "method-specific algorithms" for processing fluorescent signals, which is standard digital signal processing and not indicative of AI/ML. There is no mention of learning, training data, or adaptive capabilities.
No.
This device is a diagnostic tool designed to detect influenza antigens, aiding in the rapid diagnosis of infections, not to provide treatment or therapy.
Yes
The device is intended for use as an "aid in the rapid differential diagnosis of acute influenza B viral infections," which directly indicates its purpose in diagnosing medical conditions.
No
The device description explicitly states that the Sofia and Sofia 2 are microprocessor-controlled devices that scan the test strip and measure the fluorescent signal. This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to detect influenza B viral nucleoprotein antigens in patient specimens (nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash). This is a diagnostic purpose, aiming to aid in the rapid differential diagnosis of acute influenza B viral infections.
- Specimen Type: The device analyzes biological specimens taken from the human body (nasal and nasopharyngeal specimens).
- Purpose: The purpose is to provide information about a patient's health status (presence or absence of influenza B antigens) to aid in diagnosis and patient management decisions.
- Professional and Laboratory Use: The intended user is specified as "professional and laboratory use," which is typical for IVD devices.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. This test is intended for professional and laboratory use.
The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, samples should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture samples.
Product codes (comma separated list FDA assigned to the subject device)
PSZ, KHO
Device Description
The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with Sofia and Sofia 2 to detect influenza virus nucleoproteins. This test allows for the differential detection of influenza A and influenza B antigens.
The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test Cassette sample well. From the sample migrates through a test strip containing various unique chemical environments. If influenza viral antigen is present, they will be trapped in a specific location.
Note: Depending upon the user's choice, the Test Cassette is either placed inside of Sofia or Sofia 2 for automatically timed development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode).
Sofia and Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Sofia and Sofia 2 will display the test results (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.
Mentions image processing
Sofia and Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and laboratory 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)
Numerous studies were undertaken to document the performance characteristics of Sofia 2 and the Sofia Influenza A+B assay, as well as to compare the performance between Sofia and Sofia 2. The studies included the following:
-
Limit of Detection (LoD)
This study confirmed that the LoD generated for the Sofia Influenza A+B FIA on Sofia 2 is equivalent to the LoD generated on Sofia. -
Precision
This study confirmed that Sofia and Sofia 2 generated equivalent qualitative results when used by multiple operators to test negative and positive concentrations that are close to the positivity threshold, on multiple device lots, and operated over multiple days. -
Assay development time
This study confirmed that when running Sofia 2 in Read Now mode, a development time of fifteen (15) to thirty (30) minutes is acceptable. -
Early Read
This study confirmed that when running Sofia 2 in Walk Away mode, positive samples (depending on the viral load) can be interpreted as positive as early as 3 minutes. -
Method Comparison
This study demonstrated that Sofia and Sofia 2 have comparable performance when using a panel of clinical samples. -
Reproducibility
This study demonstrated intra- and inter-operator reproducibility and intra- and interlaboratory reproducibility with a panel of test samples at various influenza concentrations. This study also demonstrated comparable performance between Sofia and Sofia 2.
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
§ 866.3328 Influenza virus antigen detection test system.
(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Quidel Corporation Jennifer S. Rial Director, Regulatory Affairs 12544 High Bluff Drive, Suite 200 San Diego CA 92130
Re: K162438
Trade/Device Name: Sofia® Influenza A+B FIA on Sofia 2 Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza virus antigen detection test systems Regulatory Class: II Product Code: PSZ Dated: March 13, 2017 Received: March 14, 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,
Steven R. Gitterman -S
Uwe Scherf 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) K162438
Device Name Sofia® Influenza A+B FIA on Sofia 2
Indications for Use (Describe)
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. This test is intended for professional and laboratory use.
The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California 7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Mortality Weekly Report from the CDC entitled "Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, samples should be collected with appropriate infection sor novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture samples.
| 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/3/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape 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 filled with a blue and purple gradient. Below the square is the word "QUIDEL" in a modern, 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 shape with a smaller square cut out of the lower right corner. The larger square is filled 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.
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
August 26, 2016
5.4. Proprietary and Established Names
Sofia® Influenza A+B FIA on Sofia 2
5.5. Common Name
Same as above
5.6. Regulatory Information
| Product Code / Name | Class | Regulatory Section | Panel |
|---|---|---|---|
| PSZ - Devices detecting influenza a, b, and c virus antigens | II | 21 CFR 866.3328 | Microbiology |
| KHO - Fluorometer for clinical use |
5.7. Predicate Device
Sofia® Influenza A+B FIA on Sofia (K153012, K131606, and K112177)
5.8. Device Description
The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with Sofia and Sofia 2 to detect influenza virus nucleoproteins. This test allows for the differential detection of influenza A and influenza B antigens.
The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test Cassette sample well. From the sample migrates through a test strip containing various unique chemical environments. If influenza viral antigen is present, they will be trapped in a specific location.
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Image /page/5/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a stylized square divided into two sections. The larger section is a gradient of colors, including yellow, orange, red, purple, blue, and green. The smaller section is a darker shade of blue. Below the square is the word "QUIDEL" in a sans-serif font.
Note: Depending upon the user's choice, the Test Cassette is either placed inside of Sofia or Sofia 2 for automatically timed development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode).
Sofia and Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Sofia and Sofia 2 will display the test results (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.
5.9. Intended Use
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. This test is intended for professional and laboratory use.
The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, samples should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture samples.
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Image /page/6/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 resembling a rainbow. A smaller square is cut out from the lower right corner of the larger square. Below the square is the word "QUIDEL" in a stylized, sans-serif font.
Substantial Equivalence Information: 5.10
-
- Predicate Device Name: Sofia Influenza A+B FIA on Sofia
-
- Comparison with Predicate:
| Similarities and Differences | ||
|---|---|---|
| Item | Sofia Influenza A+B FIA on Sofia | Sofia 2 Influenza A+B FIA on Sofia and Sofia 2 |
| Intended Use | The Sofia Influenza A+B FIA employs | |
| immunofluorescence to detect influenza A and | ||
| influenza B viral nucleoprotein antigens in nasal | ||
| swab, nasopharyngeal swab, and nasopharyngeal | ||
| aspirate/wash in fresh or transport media | ||
| specimens from symptomatic patients. This | ||
| qualitative test is intended for use as an aid in the | ||
| rapid differential diagnosis of acute influenza A | ||
| and influenza B viral infections. The test is not | ||
| intended to detect influenza C antigens. A negative | ||
| test is presumptive and it is recommended these | ||
| results be confirmed by viral culture or an FDA- | ||
| cleared influenza A and B molecular assay. | ||
| Negative results do not preclude influenza virus | ||
| infections and should not be used as the sole basis | ||
| for treatment or other patient management | ||
| decisions. This test is intended for professional and | ||
| laboratory use. | ||
| Performance characteristics for influenza A and B | ||
| were established during February through March | ||
| 2011 when influenza viruses A/California/7/2009 | ||
| (2009 H1N1), A/Perth/16/2009 (H3N2), | ||
| and | ||
| B/Brisbane/60/2008 (Victoria-Like) were | ||
| the | ||
| predominant influenza viruses in circulation | ||
| according to the Morbidity and Mortality Weekly | ||
| Report from the CDC entitled "Update: Influenza | ||
| Activity--United States, 2010-2011 Season, and | ||
| Composition of the 2011-2012 Influenza Vaccine." | ||
| Performance characteristics may vary against other | ||
| emerging influenza viruses. | ||
| If infection with a novel influenza virus is | ||
| suspected | ||
| based | ||
| on | ||
| current | ||
| clinical | ||
| and | ||
| epidemiological screening criteria recommended | ||
| by public health authorities, samples should be | ||
| collected | ||
| with appropriate infection control | ||
| precautions for novel virulent influenza viruses | ||
| and sent to state or local health department for | ||
| testing. Viral culture should not be attempted in | ||
| these cases unless a BSL 3+ facility is available to | ||
| receive and culture samples. | The Sofia Influenza A+B FIA employs | |
| immunofluorescence to detect influenza A and | ||
| influenza B viral nucleoprotein antigens in direct | ||
| nasal swab, nasopharyngeal swab, and | ||
| nasopharyngeal aspirate/wash specimens and | ||
| nasopharyngeal swab and nasopharyngeal | ||
| aspirate/wash specimens in transport media from | ||
| symptomatic patients. This qualitative test is | ||
| intended for use as an aid in the rapid differential | ||
| diagnosis of acute influenza A and influenza B | ||
| viral infections. The test is not intended to detect | ||
| influenza C antigens. A negative test is | ||
| presumptive and it is recommended these results be | ||
| confirmed by viral culture or an FDA-cleared | ||
| influenza A and B molecular assay. Negative | ||
| results do not preclude influenza virus infections | ||
| and should not be used as the sole basis for | ||
| treatment or other patient management decisions. | ||
| This test is intended for professional and laboratory | ||
| use. | ||
| The Sofia Influenza A+B FIA may be used with | ||
| Sofia or Sofia 2. | ||
| Performance characteristics for influenza A and B | ||
| were established during February through March | ||
| 2011 when influenza viruses A/California/7/2009 | ||
| (2009 H1N1), A/Perth/16/2009 (H3N2), | ||
| and | ||
| B/Brisbane/60/2008 (Victoria-Like) | ||
| were | ||
| the | ||
| predominant influenza viruses in circulation | ||
| according to the Morbidity and Mortality Weekly | ||
| Report from the CDC entitled "Update: Influenza | ||
| Activity--United States, 2010-2011 Season, and | ||
| Composition of the 2011-2012 Influenza Vaccine.'" | ||
| Performance characteristics may vary against other | ||
| emerging influenza viruses. | ||
| If infection with a novel influenza virus is | ||
| suspected based on current clinical and | ||
| epidemiological screening criteria recommended | ||
| by public health authorities, samples should be | ||
| collected with appropriate infection control | ||
| precautions for novel virulent influenza viruses and | ||
| sent to state or local health department for testing. | ||
| Viral culture should not be attempted in these cases | ||
| unless a BSL 3+ facility is available to receive and | ||
| culture samples. | ||
| Similarities and Differences | ||
| Item | Sofia Influenza A+B FIA on Sofia | Sofia 2 Influenza A+B FIA on Sofia and Sofia 2 |
| Calibration Check | Calibration Check required every 30 days or less, | |
| as set by the supervisor. A special Calibration | ||
| Cassette is provided with the Installation Pack. | Same and uses the same Calibration Cassette | |
| Development Modes | Two basic assay development modes: | |
| Walk-Away: User can walk away during the | ||
| assay cassette development period | ||
| Read Now: User manually times the assay | ||
| • | ||
| cassette development period outside of Sofia, | ||
| then places cassette in Sofia to image and | ||
| provide test result. | Same | |
| Development Time | 15 minutes for Sofia Influenza A+B FIA | Potential for early read in Walk-Away Mode. |
| Sofia 2 will image cassette at 3, 5, 8, 10, and 15 | ||
| minutes until a positive result is received. | ||
| System Components | ||
| User interface | 3.5 inch diagonal color LCD display and numeric | |
| keypad with function specific buttons | 4 inch color LCD touchscreen display | |
| User Types | Has 2 distinct security levels; user and supervisor | |
| plus a Quidel only service level | Same | |
| Barcode | ||
| scanner(sample) | External hand held barcode scanner | Integrated barcode scanner but same functionality |
| Barcode | ||
| scanner(cassette) | Integrated barcode scanner | Same using custom integrated 0.3 MP camera |
| Assay / instrument | ||
| interface | Drawer (electro-mechanical) | Same (manual) |
| Determine test type | Instrument scans barcode on cassette | Same |
| Power Supply | 100 - 240 VAC, self-switching, or with 4 AA | |
| batteries | 100 - 240 VAC, self-switching, or with | |
| rechargeable lithium polymer battery | ||
| Printer | Integrated printer | External printer connected via USB port (DYMO |
| LabelWriter 450 Printer supported), optional | ||
| network printer. | ||
| Dimensions | 24 cm deep x 16 cm wide x 10 cm high | 19.7 cm deep x 11.4 cm wide x 12.7 cm high |
| Weight | 3 lbs | ∼2.5 lbs |
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Image /page/7/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with a gradient of colors, including yellow, orange, red, purple, blue, and green. Below the square is the word "QUIDEL" in a simple, sans-serif font.
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Image /page/8/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with rounded corners, divided into four quadrants. The top and left quadrants are filled with a gradient of colors, including yellow, orange, red, and purple. The bottom right quadrant is filled with a blue color. Below the square shape, the word "QUIDEL" is written in a sans-serif font.
5.11. Performance Data
Numerous studies were undertaken to document the performance characteristics of Sofia 2 and the Sofia Influenza A+B assay, as well as to compare the performance between Sofia and Sofia 2. The studies included the following:
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Limit of Detection (LoD) a.
This study confirmed that the LoD generated for the Sofia Influenza A+B FIA on Sofia 2 is equivalent to the LoD generated on Sofia. -
b. Precision
This study confirmed that Sofia and Sofia 2 generated equivalent qualitative results when used by multiple operators to test negative and positive concentrations that are close to the positivity threshold, on multiple device lots, and operated over multiple days. -
Assay development time C.
This study confirmed that when running Sofia 2 in Read Now mode, a development time of fifteen (15) to thirty (30) minutes is acceptable. -
d. Early Read
This study confirmed that when running Sofia 2 in Walk Away mode, positive samples (depending on the viral load) can be interpreted as positive as early as 3 minutes. -
Method Comparison e.
This study demonstrated that Sofia and Sofia 2 have comparable performance when using a panel of clinical samples. -
f. Reproducibility
This study demonstrated intra- and inter-operator reproducibility and intra- and interlaboratory reproducibility with a panel of test samples at various influenza concentrations. This study also demonstrated comparable performance between Sofia and Sofia 2.
5.12. Conclusion
These studies demonstrated equivalent performance of the Sofia Influenza A+B FIA on the Sofia and Sofia 2 analyzers.