(174 days)
The Sofia Strep A+ FIA detects Group A Streptococcal antigens from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not prection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.
The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.
The Sofia Strep A+ FIA involves the extraction of the antigenic components of the Group A Streptococcus (GAS) bacteria. The patient's Swab sample is placed in the Reagent Tube containing the Reagent Solution, during which time the bacterial antigens are extracted, making them more accessible to the specific antibodies. An aliquot of the extracted sample is dispensed into the Test Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Group A Streptococcal antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles containing bound antigen will be captured by antibodies at a defined location on the test strip where they are detected by Sofia or Sofia 2. If antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia or Sofia 2.
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 or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (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.
The Sofiea Strep A+ FIA is a device intended to detect Group A Streptococcal antigens from throat swabs of patients with signs and symptoms of pharyngitis. All negative test results must be confirmed by either bacterial culture or an FDA-cleared molecular assay.
As this is a 510(k) submission, the device does not have explicit acceptance criteria mentioned, but rather demonstrates substantial equivalence to a predicate device. The performance data section of the document describes several studies undertaken to document the performance characteristics of the Sofia 2 and the Sofia Strep A+ assay, as well as to compare performance between Sofia and Sofia 2.
Here's the information about the studies presented:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) | LoD on Sofia 2 is equivalent to LoD on Sofia. | Confirmed that the LoD generated for the Sofia Strep A+ FIA on Sofia 2 is equivalent to the LoD generated on Sofia. |
| Precision | Equivalent qualitative results between Sofia and Sofia 2 for negative and positive concentrations near threshold | Confirmed that Sofia and Sofia 2 generated equivalent qualitative results for negative and positive concentrations near the positivity threshold, across multiple operators, device lots, days, and two calibration cycles. |
| Assay Development Time | Development time of 5-10 minutes is acceptable for Sofia 2 in Read Now mode. | Confirmed that when running Sofia 2 in Read Now mode, a development time of five (5) to ten (10) minutes is acceptable. |
| Method Comparison | Comparable performance between Sofia and Sofia 2 using a panel of clinical samples. | Demonstrated that Sofia and Sofia 2 have comparable performance when using a panel of clinical samples. |
| Reproducibility | Intra- and inter-operator, and intra- and inter-laboratory reproducibility with various antigen concentrations. Comparable performance between Sofia and Sofia 2. | Demonstrated intra- and inter-operator reproducibility and intra- and inter-laboratory reproducibility with a panel of test samples at various Group A Streptococcal antigen concentrations. Also demonstrated comparable performance between Sofia and Sofia 2. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each test set in these studies, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. It refers to "a panel of clinical samples" for the Method Comparison study and "a panel of test samples" for the Reproducibility study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The nature of the device (antigen detection) likely implies a microbiological gold standard (e.g., bacterial culture), rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study involving human readers and AI assistance is not mentioned. The studies focus on the performance of the device itself and its equivalence to a predicate device.
6. Standalone Performance Study:
Yes, standalone performance studies were done. All the studies listed in the "Performance Data" section (LoD, Precision, Assay development time, Method Comparison, Reproducibility) assess the performance of the Sofia Strep A+ FIA on Sofia 2 (and its comparison to Sofia) as a standalone algorithm/device without explicit human-in-the-loop performance measurement.
7. Type of Ground Truth Used:
The document mentions that negative test results "should be confirmed by either bacterial culture or an FDA-cleared molecular assay." This implies that bacterial culture or an FDA-cleared molecular assay would serve as the ground truth for determining the presence or absence of Group A Streptococcal infection in the clinical sample studies.
8. Sample Size for the Training Set:
The document does not provide information about a specific training set or its sample size. This is common for this type of in vitro diagnostic device, where performance is evaluated against known concentrations or clinical samples with confirmed status, rather than training a machine learning model in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a traditional training set for a machine learning model, the method for establishing ground truth for a training set is not applicable or described in this document. The "ground truth" for the performance evaluation studies would be established using validated methods like bacterial culture or FDA-cleared molecular assays, as mentioned in the indications for use.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of it.
December 21, 2017
Ouidel Corporation Edward Brehm Regulatory Affairs Manager 12544 High Bluff Drive, Suite 200 San Diego, California 92130
Re: K171976
Trade/Device Name: Sofia Strep A+ FIA, Sofia 2 Analyzer Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. serological reagents Regulatory Class: Class I Product Code: GTY, KHO Dated: June 29, 2017 Received: June 30, 2017
Dear Edward Brehm:
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
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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 medical devices and radiation-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,
Steven R. Gitterman -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
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Indications for Use
510(k) Number (if known) K171976
Device Name Sofia Strep A+ FIA for use on Sofia 2
Indications for Use (Describe)
The Sofia Strep A+ FIA detects Group A Streptococcal antigens from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not prection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.
The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.
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 Quidel. 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, including red, orange, yellow, green, blue, and purple. The word "QUIDEL" is written in a sans-serif font below the square.
5. 510(K) SUMMARY
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5.1. Submitter
Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, California 92130 Telephone: 858-552-1100, X-21015 Fax: 858-646-8045
Submission Contact 5.2.
Edward C. Brehm, Ph.D.
5.3. Date Prepared
June 29, 2017
5.4. Proprietary and Established Names
Sofia® Strep A+ FIA performed on Sofia 2
ર્સ. Common Name
Same as above
5.6. Regulatory Information
| Product Code | Classification | Regulatory Section | Panel |
|---|---|---|---|
| GTY | 21 CFR 866.3740 | Microbiology | |
| KHO | 21 CFR 862.2560 | ClinicalChemistryperregulation; Microbiologybecause it is used with theSofia Strep A+ FIA |
5.7. Predicate Device
Sofia Strep A+ FIA performed on Sofia
5.8. Device Description
The Sofia Strep A+ FIA involves the extraction of the antigenic components of the Group A Streptococcus (GAS) bacteria. The patient's Swab sample is placed in the Reagent Tube containing the Reagent Solution, during which time the bacterial antigens are extracted, making them more accessible to the specific antibodies. An aliquot of the extracted sample is dispensed into the Test Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Group A Streptococcal antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the
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Image /page/5/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 including red, orange, yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a sans-serif font.
test strip. The fluorescent microparticles containing bound antigen will be captured by antibodies at a defined location on the test strip where they are detected by Sofia or Sofia 2. If antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia or Sofia 2.
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 or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (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 Strep A+ FIA detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharvngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.
The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.
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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 including yellow, green, blue, and red. A smaller, darker 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, with a trademark symbol to the right.
Substantial Equivalence Information: 5.10.
-
- Predicate Device Name: Sofia Strep A+ FIA performed on Sofia
-
- Predicate 510(k) Number: K141775
-
- Comparison with Predicate:
| Similarities and Differences | ||
|---|---|---|
| Item | Sofia Strep A+ FIA on Sofia | Sofia Strep A+ FIA on Sofia 2 |
| 510(k) Number | K141775 | K171976 |
| Intended Use | The Sofia Strep A+ FIA detects Group AStreptococcal antigens from throat swabsfrom patients with signs and symptoms ofpharyngitis, such as sore throat. Allnegative test results should be confirmedby bacterial culture because negativeresults do not preclude Group A Strepinfection and should not be used as thesole basis for treatment. The test isintended for professional and laboratoryuse as an aid in the diagnosis of Group AStreptococcal infection. | The Sofia Strep A+ FIA detects Group AStreptococcal antigens from throat swabsfrom patients with signs and symptoms ofpharyngitis, such as sore throat. Allnegative test results should be confirmedby either bacterial culture or an FDA-cleared molecular assay because negativeresults do not preclude Group A Strepinfection and should not be used as thesole basis for treatment. The test isintended for professional and laboratoryuse as an aid in the diagnosis of Group AStreptococcal infection.The Sofia Strep A+ FIA may be used withSofia or Sofia 2. |
| Calibration Check | Calibration Check required every 30 daysor less, as set by the supervisor. A specialCalibration Cassette is provided with theInstallation Pack. | Same and uses the same CalibrationCassette |
| DevelopmentModes | Walk Away Only | Read Now and Walk AwayWalk-Away: User can walk awayduring the assay cassette developmentperiod Read Now: User manually times theassay cassette development periodoutside of Sofia, then places cassette inSofia to image and provide test result. |
| Development Time | 5 minutes for Sofia Strep A+ FIA | Same |
| System Components | ||
| User interface | 3.5 inch diagonal color LCD display andnumeric keypad with function specificbuttons | 4 inch color LCD touchscreen display |
| User Types | Has 2 distinct security levels; user andsupervisor plus a Quidel only servicelevel. | Same |
| Barcodescanner(sample) | External hand held barcode scanner | Integrated barcode scanner but samefunctionality |
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Image /page/7/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a stylized square with rounded corners, divided into four quadrants, each filled with a different color gradient. The colors transition from red and orange in the top left, to yellow and green in the bottom left, and blue and purple in the bottom right. Below the square is the word "QUIDEL" in a sans-serif font, with the trademark symbol next to it.
| Similarities and Differences | ||
|---|---|---|
| Item | Sofia Strep A+ FIA on Sofia | Sofia Strep A+ FIA on Sofia 2 |
| 510(k) Number | K141775 | K171976 |
| 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 |
5.11. Performance Data
Numerous studies were undertaken to document the performance characteristics of Sofia 2 and the Sofia Strep A+ assay, as well as to compare the performance between Sofia and Sofia 2. The studies included the following:
-
a. Limit of Detection (LoD)
This study confirmed that the LoD generated for the Sofia Strep A+ 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, operated over multiple days, and two calibration cycles. -
Assay development time C.
This study confirmed that when running Sofia 2 in Read Now mode, a development time of five (5) to ten (10) minutes is acceptable. -
d. Method Comparison
This study demonstrated that Sofia and Sofia 2 have comparable performance when using a panel of clinical samples. -
e. Reproducibility
This study demonstrated intra- and inter-operator reproducibility and intra- and interlaboratory reproducibility with a panel of test samples at various Group A Streptococcal antigen concentrations. This study also demonstrated comparable performance between Sofia and Sofia 2.
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5.12. Conclusion
These studies demonstrated equivalent performance of the Sofia Strep A+ FIA on the Sofia and Sofia 2 analyzer.
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.