(184 days)
Not Found
No
The device description details a qualitative immunoassay based on antibody-antigen binding and chromatographic migration, with no mention of AI or ML technologies. The performance studies are based on traditional metrics like sensitivity and specificity, not metrics typically associated with AI/ML performance evaluation.
No.
This device is an in vitro diagnostic test designed to detect Influenza A/B viral antigens to aid in the diagnosis of Influenza infections, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This test is intended for professional in vitro diagnostic use to aid in the diagnosis of Influenza infections..."
No
The device description clearly outlines physical components such as swabs, reaction cups, test strips, and reagent solutions, indicating it is a hardware-based in vitro diagnostic test, not software-only.
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 test is intended for "professional in vitro diagnostic use to aid in the diagnosis of Influenza infections".
- Device Description: The description details how the test works by detecting viral antigens in biological specimens (throat or nasal swabs) in vitro (outside of the body).
- Intended User / Care Setting: It specifies "professional in vitro diagnostic use", further confirming its intended purpose.
The definition of an IVD is a medical device that is used to perform tests on specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Influenza A/B Rapid Test is a qualitative immunoassay for the rapid detection of Influenza A/B viral antigens from throat or nasal swab specimens. This test is intended for professional in vitro diagnostic use to aid in the diagnosis of Influenza infections, and to gather evidemiological information for detection of Influenza outbreaks. When used for diagnosis, negative assay results should be confirmed by cell culture. This assay does not detect the presence of Influenza C viral antigens.
Product codes
GNX
Device Description
The Influenza A/B Rapid Test consists of swabs, reaction cups, test strips, and reagent solutions. The test detects the viral nucleoprotein associated with the viral nucleic acid. The nucleoprotein is released by lysing the virus envelop with the lysis/elution solution. Since the nucleoprotein is type specific only (not subtype specific), the test uses two pairs of monoclonal antibodies - one pair is specific for Influenza A, the other is specific for Influenza B. The antibody pairs are conjugated to either biotin or digoxigenin. In the presence of the viral antigen, a sandwich complex is formed, consisting of the biotin-conjugated antibody, the nucleoprotein, and the digoxigeninconjugated antibody. When the test strip is placed in the reaction cup, the complex migrates chromatographically, solubilizing colloidal gold particles incorporated in the red pad of the strip. The colloidal gold particles bind to the digoxigenin of the complex, which is then bound by the biotin to the immobilized streptavidin on the strip (positive result line). Any excess gold particles continue to migrate to the second line (control line), which then becomes visible. This indicates the correct chromatographic migration. The test reagent formulation has been modified slightly to produce improved specificity, and allow the use of nasal swab samples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat, nasal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional in vitro diagnostic 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)
Performance vs. Cell Culture
Throat Swab: Sensitivity 69.7% Specificity 93.3%
Nasal Swab: Sensitivity 77.4% Specificity 93.0%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity 69.7% for Throat Swab, 77.4% for Nasal Swab
Specificity 93.3% for Throat Swab, 93.0% for Nasal Swab
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3328 Influenza virus antigen detection test system.
(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
0
510(k) Summary
NOV 3 0 2001
KD11684
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-2000 |
| Contact Person: Luann Ochs | |
| Date Prepared: May 29, 2001. | |
| 2) Device name | Proprietary name: Roche Diagnostics Influenza A/B Rapid Test |
| Common name: Influenza virus detection reagents | |
| Classification name: Antigens, CF (including CF control), influenza virus A, B, C | |
| 3) Predicate device | We claim substantial equivalence to the previously cleared Roche Diagnostics Influenza A/B Rapid Test (K993048). |
Continued on next page
1
510(k) Summary, Continued
- Device The Influenza A/B Rapid Test consists of swabs, reaction cups, test strips, Description and reagent solutions. The test detects the viral nucleoprotein associated with the viral nucleic acid. The nucleoprotein is released by lysing the virus envelop with the lysis/elution solution. Since the nucleoprotein is type specific only (not subtype specific), the test uses two pairs of monoclonal antibodies - one pair is specific for Influenza A, the other is specific for Influenza B. The antibody pairs are conjugated to either biotin or digoxigenin. In the presence of the viral antigen, a sandwich complex is formed, consisting of the biotin-conjugated antibody, the nucleoprotein, and the digoxigeninconjugated antibody. When the test strip is placed in the reaction cup, the complex migrates chromatographically, solubilizing colloidal gold particles incorporated in the red pad of the strip. The colloidal gold particles bind to the digoxigenin of the complex, which is then bound by the biotin to the immobilized streptavidin on the strip (positive result line). Any excess gold particles continue to migrate to the second line (control line), which then becomes visible. This indicates the correct chromatographic migration. The test reagent formulation has been modified slightly to produce improved specificity, and allow the use of nasal swab samples. 5) Intended use The Influenza A/B Rapid Test is a qualitative immunoassay for the rapid detection of Influenza A/B viral antigens from throat or nasal swab specimens. This test is intended for professional in vitro diagnostic use to aid in the diagnosis of Influenza infections, and to gather evidemiological information for detection of Influenza outbreaks. When used for diagnosis, negative assay results should be confirmed by cell culture. This assay does not detect the presence of Influenza C viral antigens. Continued on next page
2
510(k) Summary, Continued
The new, modified Roche Diagnostics Influenza A/B Rapid Test is 6) Comparison substantially equivalent to other products in commercial distribution intended to predicate device for similar use. Most notably it is substantially equivalent to the previously cleared Roche Diagnostics Influenza A/B Rapid Test.
Similarities:
| Feature | RDC Influenza A/B
Rapid Test | Modified
RDC Influenza A/B
Rapid Test |
|--------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended use | Detection of Influenza
A and B viral antigen | Detection of Influenza
A and B viral antigen |
| Indication for use | Aid in the diagnosis of
influenza A or B viral
infections. | Aid in the diagnosis of
influenza A or B viral
infections. |
| Test Principle | Direct visualization of
antigen-antibody
complex binding to a
surface. | Direct visualization of
antigen-antibody
complex binding to a
surface. |
| Results | Positive or negative
qualitative results | Positive or negative
qualitative results |
| Quality control | Internal procedural
quality control, external
quality control
solutions | Internal procedural
quality control, external
quality control
solutions |
Continued on next page
3
510(k) Summary, Continued
6) Comparison to predicate device, continued
Differences
| Feature | RDC Influenza A/B Rapid Test | Modified RDC Influenza A/B Rapid Test |
|---|---|---|
| Sample type | Throat swab | Throat swab, nasal swab |
| Performance vs. Cell Culture | Sensitivity 68.4% | |
| Specificity 80.7% | Throat Swab: | |
| Sensitivity 69.7% | ||
| Specificity 93.3% | ||
| Nasal Swab: | ||
| Sensitivity 77.4% | ||
| Specificity 93.0% |
Benefits:
.
The modified test allows for the use of nasal swabs in addition to throat swabs, and shows improved specificity over the previous version.
and the contraction of the comments of the comments of the consistent of the contraction of the consistent of the contribution of the contribution of the consistent of the co
4
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 3 0 2001
Ms. Luann Ochs Director, Regulatory Submissions Roche Diagnostics Corporation Near Patient Testing 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K011684
Trade/Device Name: Roche Diagnostics Influenza A/B Rapid Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: I Product Code: GNX Dated: November 16, 2001 Received: November 19, 2001
Dear Ms. Ochs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): Device Name: Roche Diagnostics Influenza A/B Rapid Test Indications for Use:
The Influenza A/B Rapid Test is a qualitative immunoassay for the rapid detection of Influenza A/B viral antigens from throat swab or nasal swab specimens. This test is intended for professional in vitro diagnostic use to aid in the diagnosis of Influenza infections, and to gather epidemiological information for detection of Influenza outbreaks. When used for diagnosis, negative assay results should be confirmed by cell culture. This assay does not detect the presence of Influenza C viral antigens.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wordes Duboce
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011684
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Roche Diagnostics Corporation May 29, 2001
CONFIDENTIAL
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