SOFIA STREP A FIA
Device Facts
| Record ID | K123793 |
|---|---|
| Device Name | SOFIA STREP A FIA |
| Applicant | Quidel Corporation |
| Product Code | GTY · Microbiology |
| Decision Date | Jun 17, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
| Attributes | Pediatric |
Intended Use
The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. 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.
Device Story
Sofia Strep A FIA is a qualitative immunofluorescence lateral flow assay for detecting Group A Streptococcus pyogenes antigens in throat swabs. The device uses a sandwich assay design with europium chelate-impregnated polystyrene microbeads coated with anti-Strep A polyclonal antibodies. Input consists of an extracted clinical sample applied to a test cassette. The Sofia Analyzer performs automated scanning, data collection, and analysis of fluorescence signals at the analyte and procedural control zones. The analyzer eliminates visual interpretation subjectivity, providing objective results (Positive, Negative, or Invalid) on a screen or via printer/LIS. Used in professional/laboratory settings, the device supports 'Walk Away' (automated timing) or 'Read Now' (manual timing) modes. The system includes fail-safe features, such as procedural control zone monitoring, to ensure adequate specimen flow and prevent reporting of incorrect results. By providing rapid, objective detection, the device aids clinicians in timely diagnosis and management of pharyngitis.
Clinical Evidence
Multi-center clinical study evaluated sensitivity and specificity using throat swab specimens. Reproducibility study assessed intra-/inter-operator and intra-/inter-laboratory performance across various Strep A concentrations. Analytical studies included Limit of Detection, inclusivity, cross-reactivity, interfering substances, operating temperature, transport stability, inter-analyzer precision, and calibration cycle.
Technological Characteristics
Lateral-flow immunoassay using polyclonal rabbit antibodies specific to Group A Strep antigens. Detection utilizes polystyrene microparticles dyed with Europium chelate. Instrument-based fluorescence measurement. Includes calibration cassette and QC card. Operates at room temperature. Software-based automated analysis.
Indications for Use
Indicated for symptomatic patients requiring diagnosis of Group A Streptococcal infection via throat swab specimens. Intended for professional and laboratory use. Negative results require confirmation by bacterial culture.
Regulatory Classification
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 identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus 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.
Predicate Devices
Related Devices
- K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer · Quidel Corporation · Dec 21, 2017
- K141775 — SOFIA (R) STREP A+ FIA · Quidel Corporation · Dec 16, 2014
Submission Summary (Full Text)
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K123793
## 510(k) SUMMARY
# JUN 11, 7, 2013 11:51 PM
| Submitted By: | Quidel Corporation<br>10165 McKellar Court<br>San Diego, California 92121<br>Telephone: 858-552-7908<br>Fax: 858-646-8045 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | John D. Tamerius, Ph.D. |
| Date Prepared: | June 11, 2013 |
| Device Trade Name: | Sofia® Strep A FIA and Sofia Analyzer |
| Common Name: | Strep A immunological test system and Fluorometer |
| Predicate Devices: | Quick Vue® Dipstick Strep A Test, K011097<br>Sofia Analyzer, K112177 |
| Device Classification/Name: | 21 CFR 866.3740 / Streptococcus Group A serological<br>reagents |
| Intended Use: | The Sofia Strep A FIA employs immunofluorescence<br>technology to detect Group A Streptococcal antigens from<br>throat swabs of symptomatic patients. All negative test<br>results should be confirmed by bacterial culture because<br>negative results do not preclude Group A Strep infection<br>and should not be used as the sole basis for treatment. The<br>test is intended for professional and laboratory use as an aid<br>in the diagnosis of Group A Streptococcal infection. |
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#### Device Description:
The Sofia Strep A FIA employs immunofluorescence technology that is used with the Sofia Analyzer to detect Group A Streptococcal antigens.
The Sofia Strep A FIA is a lateral-flow immunoassay that uses polyclonal antibodies that are specific for Group A Streptococcal antigens.
Throat swab specimens are used for this test. The patient specimen is placed in the Reagent Tube, during which time the bacteria in the specimen are disrupted, exposing Group A Streptococcal antigens. After disruption, the specimen is dispensed into the cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If the Group A Streptococcal antigen is present, they will be trapped in a specific location.
Note: Depending upon the user's choice, the cassette is either placed inside of the Sofia Analyzer for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned (Read Now Mode).
The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using methodspecific algorithms. The Sofia Analyzer will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
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#### Device Comparison:
Note: The shaded cells in the table below identify where there are differences between the proposed and predicate devices.
| Item<br>Features | Proposed Device | Predicate Device for Assay | Predicate Device for Analyzer |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sofia Analyzer and Strep A<br>FIA | QuickVue Dipstick Strep A Test | Sofia Analyzer and Influenza<br>A+B FIA |
| Intended Use | The Sofia Strep A FIA<br>employs<br>immunofluorescence<br>technology to detect Group<br>A Streptococcal antigens<br>from throat swabs of<br>symptomatic patients. All<br>negative test results should<br>be confirmed by bacterial<br>culture because negative<br>results do not preclude<br>Group A Strep infection and<br>should not be used as the<br>sole basis for treatment. The<br>test is intended for<br>professional and laboratory<br>use as an aid in the diagnosis<br>of Group A Streptococcal<br>infection. | The QuickVue Dipstick<br>Strep A is a sensitive<br>immunoassay for the<br>qualitative detection of<br>Group A Streptococcal,<br>antigen from throat swab<br>specimens or confirmation of<br>presumptive Group A<br>Streptococcal colonies from<br>culture. This test is to be<br>used to aid in the diagnosis<br>of disease caused by Group<br>A Streptococcus. | The Sofia Influenza A+B FIA employs<br>immunofluorescence to detect influenza<br>A and influenza B viral nucleoprotein<br>antigens in nasal swab, nasopharyngeal<br>swab, and nasopharyngeal aspirate/wash<br>specimens taken directly from<br>symptomatic patients. This qualitative<br>test is intended for use as an aid in the<br>rapid differential diagnosis of acute<br>influenza A and influenza B viral<br>infections. The test is not intended to<br>detect influenza C antigens. A negative<br>test is presumptive and it is<br>recommended these results be confirmed<br>by virus culture or an FDA-cleared<br>influenza A and B molecular assay.<br>Negative results do not preclude<br>influenza virus infections and should not<br>be used as the sole basis for treatment or<br>other management decisions. The test is<br>intended for professional and laboratory<br>use.<br>Performance characteristics for influenza<br>A and B were established during<br>February through March 2011 when<br>influenza viruses A/California/7/2009<br>(2009 HINI), A/Perth/16/2009 (H3N2),<br>and B/Brisbane/60/2008 (Victoria-Like)<br>were the predominant influenza viruses<br>in circulation according to the Morbidity<br>and Mortality Weekly Report from the<br>CDC entitled "Update: Influenza<br>Activity--United States, 2010-2011<br>Season, and Composition of the 2011-<br>2012 Influenza Vaccine". Performance<br>characteristics may vary against other<br>emerging influenza viruses.<br>If infection with a novel influenza virus<br>is suspected based on current clinical and<br>epidemiological screening criteria<br>recommended by public health<br>authorities, specimens should be<br>collected with appropriate infection<br>control precautions for novel virulent<br>influenza viruses and sent to state or<br>local health department for testing. Virus<br>culture should not be attempted in these<br>cases unless a BSL 3+ facility is<br>available to receive and culture<br>specimens. |
| Item<br>Features | Proposed Device | Predicate Device for Assay | Predicate Device for Analyzer |
| FDA File<br>Number | Sofia Analyzer and Strep A<br>FIA | QuickVue Dipstick Strep A<br>Test | Sofia Analyzer and Influenza<br>A+B FIA |
| FDA File<br>Number | TBD | K011097 | K112177 |
| Manufacturer | Quidel Corporation and LRE | Quidel Corporation | Quidel Corporation and LRE |
| Regulation<br>Number | 21 CFR 866.3740 and 21<br>CFR 866.2560 | 21 CFR 866.3740 | 21 CFR 866.3330 and 21 CFR<br>866.2560 |
| Classification<br>Product Code | GTY and KHO | GTY | GNX and KHO |
| Instrument | Sofia Analyzer | None | Sofia Analyzer |
| Analyte | Group A Streptococcal | Group A Streptococcal | Influenza A and Influenza B |
| Automated<br>Analysis | Yes | No | Yes |
| Read Results | Read results on instrument<br>screen or print with optional<br>printer | Visual read for presence or<br>absence of control and test<br>lines | Read results on instrument screen or<br>print with optional printer |
| Calibrator | Yes – Calibration Cassette<br>and QC Card provided | Not Applicable | Yes - Calibration Cassette and QC<br>Card provided |
| Read Result<br>Time | 5 Minutes | 5 Minutes | 15 Minutes |
| Specimen<br>Types | Throat swab | Throat swab or culture<br>colonies | Nasal swab, nasopharyngeal swab,<br>and nasopharyngeal aspirate/wash |
| Qualitative | Yes | Yes | Yes |
| Test Principle | Immunofluorescence Device | Immunoassay | Immunofluorescence Device |
| Format | Lateral-flow Test Cassette | Lateral-flow dipstick | Lateral-flow Test Cassette |
| Antibodies<br>Used | Polyclonal rabbit antibodies<br>that are specific to Group A<br>Streptococcus | Polyclonal rabbit antibodies<br>that are specific to Group A<br>Streptococcus | Monoclonal antibodies to influenza<br>A nucleoprotein and monoclonal<br>antibodies to influenza B<br>nucleoprotein |
| Detection<br>Particle | Polystyrene microparticles<br>dyed with Europium chelate | Polystyrene microparticles<br>dyed with red colorant | Polystyrene microparticles dyed<br>with Europium chelate |
| Storage | Room Temperature | Room Temperature | Room Temperature |
| Reagent | One reagent bottle containing<br>sodium nitrite and acetic acid<br>in glass ampoule | Two reagent bottles: one<br>containing sodium nitrite and<br>one containing acetic acid | Lyophilized buffer containing<br>detergents |
| Transfer<br>Device | Fixed volume pipette used to<br>transfer patient sample mixed<br>with reagent into Test<br>Cassette | Directly add dipstick to test<br>tube containing patient<br>sample mixed with reagent | Fixed volume pipette used to<br>transfer patient sample mixed with<br>reagent into Test Cassette |
| External<br>Controls | Test kit contains Positive and<br>Negative Control Swabs | Test kit contains Positive and<br>Negative Liquid Controls | Test kit contains Positive and<br>Negative Control Swabs…
