(174 days)
No
The device description mentions "method-specific algorithms" for processing results, but there is no mention of AI, ML, or any related concepts like training or test sets for such technologies. The focus is on fluorescent signal detection and standard algorithmic processing.
No
The device is a diagnostic tool designed to detect Group A Streptococcal antigens, aiding in the diagnosis of infection rather than providing direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is "intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection."
No
The device description clearly outlines hardware components like the Test Cassette, Reagent Tube, and the Sofia or Sofia 2 instrument, which is a microprocessor-controlled device with a UV light source. The software is part of a larger system that includes physical components for sample processing and detection.
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 intended for "professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection." This clearly indicates its use in examining specimens from the human body to provide information for the diagnosis of a disease.
- Device Description: The description details how the device analyzes a patient's swab sample to detect the presence of Group A Streptococcal antigens. This process of analyzing a biological sample outside of the body is a core characteristic of an in vitro diagnostic device.
- Sample Type: The device uses "Throat swabs," which are biological specimens taken from the human body.
- Purpose: The purpose is to detect the presence of a specific pathogen (Group A Streptococcus) to aid in the diagnosis of an infection.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GTY, KHO
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
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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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 company name, "QUIDEL," is written in a sans-serif font below the square logo.
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 | Clinical | |
| Chemistry | |||
| per | |||
| regulation; Microbiology | |||
| because it is used with the | |||
| Sofia 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
5
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 A | |
| Streptococcal antigens from throat swabs | ||
| from patients with signs and symptoms of | ||
| pharyngitis, such as sore throat. All | ||
| negative test results should be confirmed | ||
| by bacterial culture 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 detects Group A | |
| Streptococcal antigens from throat swabs | ||
| 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 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. | ||
| 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 | Walk Away Only | Read Now and Walk Away |
| 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. | ||
| Development Time | 5 minutes for Sofia Strep A+ FIA | Same |
| 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 |
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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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Image /page/8/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a stylized square with rounded corners, filled with a mosaic of colors ranging from red and orange to yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.
5.12. Conclusion
These studies demonstrated equivalent performance of the Sofia Strep A+ FIA on the Sofia and Sofia 2 analyzer.