Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "method specific algorithms" for processing results, which is standard for medical devices and does not indicate the use of AI or ML. There is no mention of AI, ML, deep learning, or related concepts.

Therapeutic

No
The device is an aid in the diagnosis of Group A Streptococcal infection, not a treatment itself. It detects antigens and provides a test result, which informs treatment decisions but does not perform a therapeutic function.

Diagnostic

Yes.

The device is explicitly stated to be "an aid in the diagnosis of Group A Streptococcal infection." Therefore, it serves a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a hardware component, the Sofia Analyzer, which is essential for processing the immunoassay cassette and displaying results. While software is involved in processing the fluorescent signal and displaying results, the device is not solely software.

IVD (In Vitro Diagnostic)

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 "as an aid in the diagnosis of Group A Streptococcal infection." This is a key characteristic of an IVD, as it's used to provide information for diagnostic purposes.
Specimen Type: The device uses "throat swabs of symptomatic patients," which are biological specimens collected from the human body. IVDs are designed to test such specimens.
Technology: The device employs "immunofluorescence technology to detect Group A Streptococcal antigens." This is a common method used in IVD tests to identify specific substances in biological samples.
Professional and Laboratory Use: The intended user is "professional and laboratory use," which aligns with the typical setting for performing IVD tests.

The description clearly indicates that this device is used in vitro (outside the body) to examine a biological specimen (throat swab) to aid in the diagnosis of a disease (Group A Streptococcal infection).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

GTY, KHO

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.

Mentions image processing

Not Found

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)

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.
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.
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.

These studies demonstrated the substantial equivalence of the Sofia Strep A FIA with the Sofia Analyzer to the existing products already marketed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity and specificity were calculated using throat swab specimens during the multi-center field clinical study.

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.

K011097, K112177

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

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.

Summary

0

K123793

510(k) SUMMARY

JUN 11, 7, 2013 11:51 PM

| Submitted By: | Quidel Corporation
10165 McKellar Court
San Diego, California 92121
Telephone: 858-552-7908
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
Sofia Analyzer, K112177 |
| Device Classification/Name: | 21 CFR 866.3740 / Streptococcus Group A serological
reagents |
| 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. |

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.

| Item

Features	Proposed Device	Predicate Device for Assay	Predicate Device for Analyzer
	Sofia Analyzer and Strep A
FIA	QuickVue Dipstick Strep A Test	Sofia Analyzer and Influenza
A+B FIA
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.	The QuickVue Dipstick
Strep A is a sensitive
immunoassay for the
qualitative detection of
Group A Streptococcal,
antigen from throat swab
specimens or confirmation of
presumptive Group A
Streptococcal colonies from
culture. This test is to be
used to aid in the diagnosis
of disease caused by Group
A Streptococcus.	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
specimens taken directly 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 virus 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 management decisions. The 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 HINI), 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, specimens should be
collected with appropriate infection
control precautions for novel virulent
influenza viruses and sent to state or
local health department for testing. Virus
culture should not be attempted in these
cases unless a BSL 3+ facility is
available to receive and culture
specimens.
Item
Features	Proposed Device	Predicate Device for Assay	Predicate Device for Analyzer
FDA File
Number	Sofia Analyzer and Strep A
FIA	QuickVue Dipstick Strep A
Test	Sofia Analyzer and Influenza
A+B FIA
FDA File
Number	TBD	K011097	K112177
Manufacturer	Quidel Corporation and LRE	Quidel Corporation	Quidel Corporation and LRE
Regulation
Number	21 CFR 866.3740 and 21
CFR 866.2560	21 CFR 866.3740	21 CFR 866.3330 and 21 CFR
866.2560
Classification
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
Analysis	Yes	No	Yes
Read Results	Read results on instrument
screen or print with optional
printer	Visual read for presence or
absence of control and test
lines	Read results on instrument screen or
print with optional printer
Calibrator	Yes – Calibration Cassette
and QC Card provided	Not Applicable	Yes - Calibration Cassette and QC
Card provided
Read Result
Time	5 Minutes	5 Minutes	15 Minutes
Specimen
Types	Throat swab	Throat swab or culture
colonies	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
Antibodies
Used	Polyclonal rabbit antibodies
that are specific to Group A
Streptococcus	Polyclonal rabbit antibodies
that are specific to Group A
Streptococcus	Monoclonal antibodies to influenza
A nucleoprotein and monoclonal
antibodies to influenza B
nucleoprotein
Detection
Particle	Polystyrene microparticles
dyed with Europium chelate	Polystyrene microparticles
dyed with red colorant	Polystyrene microparticles dyed
with Europium chelate
Storage	Room Temperature	Room Temperature	Room Temperature
Reagent	One reagent bottle containing
sodium nitrite and acetic acid
in glass ampoule	Two reagent bottles: one
containing sodium nitrite and
one containing acetic acid	Lyophilized buffer containing
detergents
Transfer
Device	Fixed volume pipette used to
transfer patient sample mixed
with reagent into Test
Cassette	Directly add dipstick to test
tube containing patient
sample mixed with reagent	Fixed volume pipette used to
transfer patient sample mixed with
reagent into Test Cassette
External
Controls	Test kit contains Positive and
Negative Control Swabs	Test kit contains Positive and
Negative Liquid Controls	Test kit contains Positive and
Negative Control Swabs
Item
Features	Proposed Device	Predicate Device for Assay	Predicate Device for Analyzer
Quality
Control
Features	Sofia Analyzer and Strep A
FIA
Built-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 A
Test
Built-in procedural control line interpreted by the operator to determine whether adequate flow occurred and clearing of background	Sofia Analyzer and Influenza
A+B FIA
Built-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

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·

..

100 come the comments of

・

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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:

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.

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

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