(28 days)
Not Found
No
The device description and performance studies focus on immunochromatographic assay technology and do not mention any AI or ML components.
No.
Explanation: This device is an in vitro diagnostic test designed to detect influenza antigens, aiding in diagnosis, not to provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to aid in the rapid differential diagnosis of influenza A and B viral infections." This clearly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines a physical immunochromatographic assay with a test strip, reaction tube, and reagents, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Clearview® Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients."
The term "in vitro" directly indicates that the test is performed outside of the living organism, which is the defining characteristic of an In Vitro Diagnostic device. The description further clarifies that it analyzes a biological specimen (nasal swab) to detect specific markers (influenza antigens) to aid in diagnosis.
N/A
Intended Use / Indications for Use
The Clearview® Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Product codes
GNX
Device Description
The Clearview Exact II Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip. Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. A Clearview Exact II Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence or absence of pink-to-purcle colored Sample Lines. The yellow Control Line turns blue in a valid test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal swab specimens, nasal cavity or nasopharynx
Indicated Patient Age Range
children (less than 18 years of age) and adults (18 years or older)
Intended User / Care Setting
Not Found
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
A total of 478 prospective specimens, collected from children (less than 18 years of age) and adults (18 years or older), were evaluated in the Clearview® Exact II Influenza A & B Test and compared to viral culture, Evaluated specimens were nasal swabs collected from patients presenting with influenza-like symptoms. Forty-four percent (44%) of the population tested was
§ 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
JAN 6 2011
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
The purpose of this Special 510(k) submission is to modify the Clinical Performance claims of the current 510(k) cleared Clearview® Exact II Influenza A & B Test (K092349).
SUBMITTER
Alere Scarborough, Inc., d/b/a Binax, Inc. 10 Southgate Road Scarborough, Maine 04074 (207) 730-5739 (Office) (207) 730-5717 (Fax) Establishment Registration Number: 1221359
CONTACT PERSON
Anne Jepson anne jepson@alere.com (email)
ALTERNATE CONTACT PERSON Angela Drysdale angela.drysdale@alere.com (email)
DATE PREPARED
(
December 8, 2010
TRADE NAME
Clearview® Exact II Influenza A & B Test
COMMON NAME
Not applicable
CLASSIFICATION NAME
Antigen, Cf (including Cf Control), Influenza Virus A, B, C (per 21 CFR 866,3330)
PREDICATE DEVICE
Clearview® Exact II Influenza A & B Test, K092349
DEVICE DESCRIPTION
The Clearview Exact II Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip.
1
Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. A Clearview Exact II Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence or absence of pink-to-purcle colored Sample Lines. The yellow Control Line turns blue in a valid test.
INTENDED USE
The Clearview Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
TECHNOLOGICAL CHARACTERISTICS
The Clearview® Exact II Influenza A & B Test, under consideration in this special 510(k) filing, is exactly the same test as the currently 510(k) cleared Clearview® Exact II Influenza A & B Test. Both use lateral flow immunochromatographic technology. Both tests are rapid immunoassays that employ specific antibodies immobilized onto solid phases to capture and visualize influenza nucleoprotein antigens.
PERFORMANCE SUMMARY
CLINICAL STUDY
Clearview® Exact II Influenza A & B Test Performance vs. Viral Culture - Prospective Study
The clinical performance of the Clearview® Exact II Influenza A & B Test was established in a multi-center. prospective, clinical study conducted at seven U.S. trial sites during the 2008-2009 respiratory season.
A total of 478 prospective specimens, collected from children (less than 18 years of age) and adults (18 years or older), were evaluated in the Clearview® Exact II Influenza A & B Test and compared to viral culture, Evaluated specimens were nasal swabs collected from patients presenting with influenza-like symptoms. Forty-four percent (44%) of the population tested was