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 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 method specific 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sofia® Strep A FIA and Sofia Analyzer:

Note: The provided text lacks the explicit "acceptance criteria" and the full "study that proves the device meets the acceptance criteria" in terms of specific performance targets (e.g., sensitivity, specificity thresholds). It outlines the studies performed and then states a conclusion of "substantial equivalence" based on these studies. Therefore, the table below will present the reported device performance, and the "acceptance criteria" part will reflect an inferred benchmark based on the predicate device and the general aim of demonstrating substantial equivalence.

Acceptance Criteria and Device Performance Study for Sofia® Strep A FIA and Sofia Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Sensitivity	To be substantially equivalent to the predicate device (QuickVue Dipstick Strep A Test, K011097) in detecting Group A Streptococcal antigens.	"A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity and specificity were calculated using throat swab specimens." (Actual numerical values for sensitivity are not provided in this summary.)
Specificity	To be substantially equivalent to the predicate device (QuickVue Dipstick Strep A Test, K011097) in distinguishing Group A Streptococcal antigens from other substances.	"A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity and specificity were calculated using throat swab specimens." (Actual numerical values for specificity are not provided in this summary.)
Reproducibility	Consistent results across different operators, laboratories, and varying concentrations.	"A reproducibility study was performed to demonstrate intra- and inter-operator reproducibility and intra- and inter-laboratory reproducibility with a panel of test samples at various Strep A concentrations." (Specific results or acceptance thresholds are not provided.)
Analytical Studies	Satisfactory performance in various analytical aspects (e.g., accurate detection limit, no significant cross-reactivity, stability under various conditions).	"Analytical studies included Limit of Detection, analytical inclusivity, cross-reactivity, interfering substances, operating temperature, transport stability, inter-analyzer precision, calibration cycle, and various flex studies." (Specific results or acceptance thresholds are not provided.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "A multi-center field clinical study" and "throat swab specimens" for sensitivity and specificity calculations. However, the exact number of specimens or sample size used for the clinical test set is not specified in this summary.
Data Provenance: The document states "A multi-center field clinical study." The country of origin is not explicitly stated, but being a 510(k) submission to the FDA, it is highly probable that at least a significant portion, if not all, of the clinical data was collected in the United States. The study was prospective, as it was a "field clinical study" to document performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
However, for Strep A immunological tests, the ground truth is typically established by bacterial culture, which is considered the gold standard for diagnosis. Therefore, experts involved would likely be clinical microbiologists or laboratory personnel experienced in bacterial culture techniques and interpretation.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the ground truth for Strep A is generally established by bacterial culture, a consensus among human readers for image interpretation (as implied by adjudication in radiology studies) is not typically applicable in this context. The culture result itself serves as the definitive reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done as described for AI assistance in image interpretation. This device is an in vitro diagnostic (IVD) test that automates the reading of a lateral-flow immunoassay. It does not involve human readers interpreting images with or without AI assistance in the traditional sense of an MRMC study. The Sofia Analyzer is the "AI" or automated reader, replacing manual visual interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The Sofia Strep A FIA, when used with the Sofia Analyzer, is designed for automated analysis. The "Read Results" feature states "Read results on instrument screen or print with optional printer" and "Automated Analysis: Yes." The analytical and clinical studies were performed to demonstrate the performance of this automated system directly, without a human-in-the-loop for result interpretation, beyond simply reading the result the analyzer provides.

7. The Type of Ground Truth Used

The ground truth used for establishing clinical performance (sensitivity and specificity) was bacterial culture. The intended use statement explicitly directs: "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." This indicates that bacterial culture is the definitive reference method.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. For IVD devices like this, the "algorithm" is embedded in the Sofia Analyzer. While the algorithms would have been developed and refined using internal data, this summary focuses on the validation of the final device within clinical and analytical studies, not the development phase.

9. How the Ground Truth for the Training Set Was Established

As with the training set sample size, the document does not provide details on how the ground truth for any potential training set was established. Assuming there was an internal development phase, the ground truth for training data would likely also have been established using bacterial culture as the gold standard, similar to the method for the clinical validation studies.

Summary

{0}------------------------------------------------

K123793

510(k) SUMMARY

JUN 11, 7, 2013 11:51 PM

Submitted By:	Quidel Corporation10165 McKellar CourtSan Diego, California 92121Telephone: 858-552-7908Fax: 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, K011097Sofia Analyzer, K112177
Device Classification/Name:	21 CFR 866.3740 / Streptococcus Group A serologicalreagents
Intended Use:	The Sofia Strep A FIA employs immunofluorescencetechnology to detect Group A Streptococcal antigens fromthroat swabs of symptomatic patients. All negative testresults should be confirmed by bacterial culture becausenegative results do not preclude Group A Strep infectionand should not be used as the sole basis for treatment. Thetest is intended for professional and laboratory use as an aidin the diagnosis of Group A Streptococcal infection.

{1}------------------------------------------------

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.

{2}------------------------------------------------

Device Comparison:

Note: The shaded cells in the table below identify where there are differences between the proposed and predicate devices.

ItemFeatures	Proposed Device	Predicate Device for Assay	Predicate Device for Analyzer
	Sofia Analyzer and Strep AFIA	QuickVue Dipstick Strep A Test	Sofia Analyzer and InfluenzaA+B FIA
Intended Use	The Sofia Strep A FIAemploysimmunofluorescencetechnology to detect GroupA Streptococcal antigensfrom throat swabs ofsymptomatic patients. Allnegative test results shouldbe confirmed by bacterialculture because negativeresults do not precludeGroup A Strep infection andshould not be used as thesole basis for treatment. Thetest is intended forprofessional and laboratoryuse as an aid in the diagnosisof Group A Streptococcalinfection.	The QuickVue DipstickStrep A is a sensitiveimmunoassay for thequalitative detection ofGroup A Streptococcal,antigen from throat swabspecimens or confirmation ofpresumptive Group AStreptococcal colonies fromculture. This test is to beused to aid in the diagnosisof disease caused by GroupA Streptococcus.	The Sofia Influenza A+B FIA employsimmunofluorescence to detect influenzaA and influenza B viral nucleoproteinantigens in nasal swab, nasopharyngealswab, and nasopharyngeal aspirate/washspecimens taken directly fromsymptomatic patients. This qualitativetest is intended for use as an aid in therapid differential diagnosis of acuteinfluenza A and influenza B viralinfections. The test is not intended todetect influenza C antigens. A negativetest is presumptive and it isrecommended these results be confirmedby virus culture or an FDA-clearedinfluenza A and B molecular assay.Negative results do not precludeinfluenza virus infections and should notbe used as the sole basis for treatment orother management decisions. The test isintended for professional and laboratoryuse.Performance characteristics for influenzaA and B were established duringFebruary through March 2011 wheninfluenza viruses A/California/7/2009(2009 HINI), A/Perth/16/2009 (H3N2),and B/Brisbane/60/2008 (Victoria-Like)were the predominant influenza virusesin circulation according to the Morbidityand Mortality Weekly Report from theCDC entitled "Update: InfluenzaActivity--United States, 2010-2011Season, and Composition of the 2011-2012 Influenza Vaccine". Performancecharacteristics may vary against otheremerging influenza viruses.If infection with a novel influenza virusis suspected based on current clinical andepidemiological screening criteriarecommended by public healthauthorities, specimens should becollected with appropriate infectioncontrol precautions for novel virulentinfluenza viruses and sent to state orlocal health department for testing. Virusculture should not be attempted in thesecases unless a BSL 3+ facility isavailable to receive and culturespecimens.
ItemFeatures	Proposed Device	Predicate Device for Assay	Predicate Device for Analyzer
FDA FileNumber	Sofia Analyzer and Strep AFIA	QuickVue Dipstick Strep ATest	Sofia Analyzer and InfluenzaA+B FIA
FDA FileNumber	TBD	K011097	K112177
Manufacturer	Quidel Corporation and LRE	Quidel Corporation	Quidel Corporation and LRE
RegulationNumber	21 CFR 866.3740 and 21CFR 866.2560	21 CFR 866.3740	21 CFR 866.3330 and 21 CFR866.2560
ClassificationProduct 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
AutomatedAnalysis	Yes	No	Yes
Read Results	Read results on instrumentscreen or print with optionalprinter	Visual read for presence orabsence of control and testlines	Read results on instrument screen orprint with optional printer
Calibrator	Yes – Calibration Cassetteand QC Card provided	Not Applicable	Yes - Calibration Cassette and QCCard provided
Read ResultTime	5 Minutes	5 Minutes	15 Minutes
SpecimenTypes	Throat swab	Throat swab or culturecolonies	Nasal swab, nasopharyngeal swab,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
AntibodiesUsed	Polyclonal rabbit antibodiesthat are specific to Group AStreptococcus	Polyclonal rabbit antibodiesthat are specific to Group AStreptococcus	Monoclonal antibodies to influenzaA nucleoprotein and monoclonalantibodies to influenza Bnucleoprotein
DetectionParticle	Polystyrene microparticlesdyed with Europium chelate	Polystyrene microparticlesdyed with red colorant	Polystyrene microparticles dyedwith Europium chelate
Storage	Room Temperature	Room Temperature	Room Temperature
Reagent	One reagent bottle containingsodium nitrite and acetic acidin glass ampoule	Two reagent bottles: onecontaining sodium nitrite andone containing acetic acid	Lyophilized buffer containingdetergents
TransferDevice	Fixed volume pipette used totransfer patient sample mixedwith reagent into TestCassette	Directly add dipstick to testtube containing patientsample mixed with reagent	Fixed volume pipette used totransfer patient sample mixed withreagent into Test Cassette
ExternalControls	Test kit contains Positive andNegative Control Swabs	Test kit contains Positive andNegative Liquid Controls	Test kit contains Positive andNegative Control Swabs
ItemFeatures	Proposed Device	Predicate Device for Assay	Predicate Device for Analyzer
QualityControlFeatures	Sofia Analyzer and Strep AFIABuilt-in features include:Built-in procedural control zone scanned by the analyzer to determine whether adequate flow occurred Analyzer prevents used or expired cartridge from being read by the reader Cassette properly inserted	QuickVue Dipstick Strep ATestBuilt-in procedural control line interpreted by the operator to determine whether adequate flow occurred and clearing of background	Sofia Analyzer and InfluenzaA+B FIABuilt-in features include:Built-in procedural control zone scanned by the analyzer to determine whether adequate flow occurred Analyzer prevents used or expired cartridge from being read by the reader Cassette properly inserted Built-in negative control line scanned by the analyzer to measure degree of non-specific binding

{3}------------------------------------------------

. .

100 come the comments of

・

. .

{4}------------------------------------------------

Summary of Performance Data:

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate device. These studies included the following:

1. A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity and specificity were calculated using throat swab specimens.
1. A reproducibility study was performed to demonstrate intra- and inter-operator reproducibility and intra- and inter-laboratory reproducibility with a panel of test samples at various Strep A concentrations.
1. Analytical studies included Limit of Detection, analytical inclusivity, cross-reactivity, interfering substances, operating temperature, transport stability, inter-analyzer precision, calibration cycle, and various flex studies.

Conclusion:

These studies demonstrated the substantial equivalence of the Sofia Strep A FIA with the Sofia Analyzer to the existing products already marketed. QuickVue Dipstick Strep A Test (K011097) and Sofia Analyzer/Sofia Influenza A+B FIA (K112177).

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic element resembling a bird or abstract human figure, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the graphic. The text is in uppercase letters and is oriented to follow the curve of the circle.

Public Health Service

Food and Drug Administration · 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

June 17 2013

JOHN TAMERIUS SR. VICE PRES., CLINICAL AND REGULATORY AFFAIRS QUIDEL CORPORATION 10165 MCKELLAR COURT SAN DIEGO CA 92121

Re: K123793

Trade/Device Name: Sofia® Strep A FIA and Sofia™ Analyzer Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcusspp. serological reagents Regulatory Class: I Product Code: GTY, KHO Dated: May 24, 2013 Received: May 28, 2013

Dear Dr. Tamerius:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

Page 2-Dr. Tamerius

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Sally A. Hojvat -S

Sally Hojvat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K123793

Device Name: Sofia Strep A FIA

Indications for Use:

Prescription_Use_ X __ AND/OR_ ___ Over_The=Counter_Use_ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

John Hobson -St John Hobson -5 [ -5] -- 1 ] [ ]
2013.06.14 09:06:39=04'00'

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K123793 510(K)

$\mathscr{A}$. $\mathscr{M}$.

Division Sian-C

Office of In Vitro Diagnostics and Radiological Health

510(k) K123793

Page 1 of 1

Regulation Number and Section

§ 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.