(693 days)
Not Found
No
The device description details a standard immuno-chromatographic test with visual interpretation of colored lines, and there is no mention of AI, ML, image processing, or any computational analysis of the results.
No
The device is an in vitro diagnostic test used to detect influenza antigens, aiding in diagnosis, but it does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the BioSign® Flu A+B test "is intended to aid in the rapid differential diagnosis of influenza A and B viral infections."
No
The device description clearly outlines a physical, immuno-chromatographic test device that uses chemical reactions and migration of fluids to produce a result. This involves hardware components and is not solely software.
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 BioSign® Flu A+B test is an "in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngcal aspirate/wash specimens obtained from patient with signs and symptoms of respiratory infection." The phrase "in vitro" is a key indicator of an IVD, meaning it is used to test samples taken from the body, outside of the body.
- Device Description: The description details how the test works by analyzing a specimen (nasal swab, etc.) in a test device, which is characteristic of an in vitro diagnostic test.
- Specimen Type: The test uses biological specimens (nasal swab, nasopharyngeal swab, and nasopharyngcal aspirate/wash specimens) obtained from patients. This is a defining characteristic of IVDs.
- Purpose: The test is intended to "aid in the rapid differential diagnosis of influenza A and B viral infections," which is a diagnostic purpose performed on a sample outside the body.
- Intended User: The test is intended for "professional and laboratory use," which aligns with the typical use of IVDs in clinical settings.
All of these points confirm that the BioSign® Flu A+B test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioSign® Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngcal aspirate/wash specimens obtained from patient with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
BioSign® Flu A+B is an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B. The test device has two test lines, thereby allowing the separate identification of type A and/or type B viral antigens from the same specimen.
In the test procedure, a specimen is collected and placed into the Extraction Well of the test device containing extraction solution for one minute, during which time antigen is extracted from disrupted virus particles. The test device is then raised, tapped and laid back down onto a level surface to allow the solution in the Extraction Well to migrate through the pads containing lyophilized detector antibodies conjugated to gold dye and then through the test membrane. If influenza antigens are present in the specimen, they will react with anti-influenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized anti-influenza antibody on the membrane, and generate a colored line in the Test line position (A and/or B). The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position, where antibody to the antiinfluenza antibody is immobilized, and anti-influenza antibody-unbound/bound dye complexes form the Control line (internal procedural control).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash specimens
Indicated Patient Age Range
The total number of patients tested was 862, of which 30% were 5 and younger, 38% were 6-21 years old, and the rest were older than 21.
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
A prospective clinical study was conducted from January 2007 to March 2008 and during March and April 2009 to determine the performance of BioSign® Flu A+B for aspirate, nasopharyngeal swab, and nasal swab specimens. The samples were collected at 5 sites in the USA from patients who visited physicians' offices and clinics with signs and symptoms of respiratory infection during the study period. All collected samples were tested with BioSign® Flu A+B, and were cultured to confirm the results of BioSign® Flu A+B. The total number of patients tested was 862. The samples that produced discrepant results between BioSign® Flu A+B and viral culture were further analyzed with proFLU plus by Prodesse (real time RT-PCR, PCR hereafter).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study:
A prospective clinical study was conducted from January 2007 to March 2008 and during March and April 2009. The total number of patients tested was 862.
- Nasopharyngeal Aspirate Sample (N=253 participants):
- Flu A: Sensitivity: 95.3% (95% CI: 92.1-98.5%), Specificity: 85.7% (95% CI: 83.3-88.1%)
- Flu B: Sensitivity: 91.6% (95% CI: 83.6-99.6%), Specificity: 97.5% (95% CI: 96.5-98.5%)
- Nasopharyngeal Sample (N=251 participants):
- Flu A: Sensitivity: 89.6% (95% CI: 84.0-95.2%), Specificity: 77.0% (95% CI: 74.2-79.8%)
- Flu B: Sensitivity: 86.8% (95% CI: 81.4-92.2%), Specificity: 92.9% (95% CI: 91.2-94.6%)
- Nasal Swab Sample (N=358 participants):
- Flu A: Sensitivity: 91.7% (95% CI: 78.2-97.1%), Specificity: 75.2% (95% CI: 70.2-79.6%)
- Flu B: Sensitivity: 82.4% (95% CI: 59.0-93.8%), Specificity: 88.3% (95% CI: 84.4-91.3%)
Archived Sample Test:
- Aspirate Sample (N=80 frozen archived samples): Agreement 100% for both Flu A and Flu B.
- Swab Sample (N=80 frozen archived samples): Agreement 100% for both Flu A and Flu B.
Reproducibility Study:
Conducted at two Physicians' Offices and one laboratory using a panel of 180 coded specimens for each site. Results obtained at each site agreed 100% with expected results.
Analytical Sensitivity - Limit of Detection (LOD):
All four viral strains tested were detected 96.7% of the time in 60 replicates.
- A/PR/8/34(H1N1): 1.05 x 10^2 TCID50/mL, 96.7% Positive
- A/Victoria/3/75(H3N2): 9.95 x 10^1 TCID50/mL, 96.7% Positive
- B/Taiwan/2/62: 1.58 x 10^3 TCID50/mL, 96.7% Positive
- B/Maryland/1/59: 1.99 x 10^1 TCID50/mL, 96.7% Positive
2009 H1N1 influenza virus clinical sample evaluation (N=66):
Detected 71% (47/66) of the CDC RT-PCR test positive specimens. The detection rate was 91% with the higher tittered specimens and 38% with the lower tittered specimens.
Analytical Specificity - Cross-reactivity:
Tested non-influenza respiratory pathogens and other microorganisms. None of the organisms or viruses listed gave a positive result at the tested concentration.
Interference Study:
Conducted using medically relevant concentrations of potentially interfering substances. Each substance had no inhibitory effect on the BioSign® Flu A+B test at the listed concentration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Nasopharyngeal Aspirate Sample (Flu A): Sensitivity: 95.3%, Specificity: 85.7%
Nasopharyngeal Aspirate Sample (Flu B): Sensitivity: 91.6%, Specificity: 97.5%
Nasopharyngeal Sample (Flu A): Sensitivity: 89.6%, Specificity: 77.0%
Nasopharyngeal Sample (Flu B): Sensitivity: 86.8%, Specificity: 92.9%
Nasal Swab Sample (Flu A): Sensitivity: 91.7%, Specificity: 75.2%
Nasal Swab Sample (Flu B): Sensitivity: 82.4%, Specificity: 88.3%
Archived Sample Test: 100% Agreement
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.
K053146: QuickVue Influenza A+B Test by Quidel Corp.
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
§ 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is: K083746
-
- Date of Summary: August 17, 2010
-
- Submitted by: Princeton BioMeditech Corporation 4242 U.S. Hwy 1, Monmouth Jct., NJ 08852 Phone: 732-274-1000 Fax: 732-274-1010
Contact Person: Jemo Kang, Ph.D., j.kang@pbmc.com Alternate Contact Person: Kyung-ah Kim, Ph.D., kakim@pbmc.com
-
- Device Name: Trade Names: BioSign® Flu A+B Status™ Flu A & B Common or Usual Name: Influenza test Classification Name: Influenza virus serological reagents (21CFR 866.3330)
-
- Identification of legally marketed devices to which claims of equivalence are made: K053146: QuickVue Influenza A+B Test by Quidel Corp.
-
- Device Description:
BioSign® Flu A+B is an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B. The test device has two test lines, thereby allowing the separate identification of type A and/or type B viral antigens from the same specimen.
In the test procedure, a specimen is collected and placed into the Extraction Well of the test device containing extraction solution for one minute, during which time antigen is extracted from disrupted virus particles. The test device is then raised, tapped and laid back down onto a level surface to allow the solution in the Extraction Well to migrate through the pads containing lyophilized detector antibodies conjugated to gold dye and then through the test membrane. If influenza antigens are present in the specimen, they will react with anti-influenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized anti-influenza antibody on the membrane, and generate a colored line in the Test line position (A and/or B). The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position, where antibody to the antiinfluenza antibody is immobilized, and anti-influenza antibody-unbound/bound dye complexes form the Control line (internal procedural control).
-
- Intended Use:
The BioSign® Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngcal aspirate/wash specimens obtained from patient with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it is recommended these results be confirmed by viral
- Intended Use:
1
culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
7. Technological Characteristics
Both BioSign® Flu A+B and the predicate, QuickVue® Influenza A+B tests are in virro rapid qualitative tests that detect influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens. The scientific principle of both tests is a solid phase chromatographic immunoassay. Both tests are lateral flow rapid assays that employ specific antibodies immobilized onto solid phases to capture and visualize influenza nucleoprotein antigens.
8. Performance Summary
Clinical Study
A prospective clinical study was conducted from January 2007 to March 2008 and during March and April 2009 to determine the performance of BioSign® Flu A+B for aspirate, nasopharyngeal swab, and nasal swab specimens. The samples were collected at 5 sites in the USA from patients who visited physicians' offices and clinics with signs and symptoms of respiratory infection during the study period. All collected samples were tested with BioSign® Flu A+B, and were cultured to confirm the results of BioSign® Flu A+B. The total number of patients tested was 862, of which 30% were 5 and younger, 38% were 6-21 years old, and the rest were older than 21. Forty eight (48) percent were male and 52% were female.
The combined data from all sites of the prospective study are presented in the tables below.
The samples that produced discrepant results between BioSign® Flu A+B and viral culture were further analyzed with proFLU plus by Prodesse (real time RT-PCR, PCR hereafter). These results are presented in the footnote below each table.
| Reference (Virus Culture)
Results | | | | | Reference (Virus Culture)
Results | | | | |
|--------------------------------------|-------------------|-------------------|-------|-------------------------------------------------|--------------------------------------|-------------------|-------------------|-------|----------------------------------------------------|
| BioSign
Flu A+ B | Flu A
Positive | Flu A
Negative | Total | Performance | BioSign
Flu A+ B | Flu B
Positive | Flu B
Negative | Total | Performance |
| Flu A
Positive | 41 | 30* | 71 | Sensitivity:
95.3%
95% CI: 92.1-
98.5% | Flu B
Positive | 11 | 6* | 17 | Sensitivity:
91.6%
95%
CI: 83.6-
99.6% |
| Flu A
Negative | 2** | 180 | 182 | Specificity:
85.7%
95% CI: 83.3-
88.1% | Flu B
Negative | 1** | 235 | 236 | Specificity:
97.5%
95% CI:
96.5-98.5% |
| Total | 43 | 210 | 253 | | Total | 12 | 241 | 253 | |
Nasopharyngeal Aspirate Sample ... .
- Of 30 discrepant results, 22 were positive by both BioSign and PCR ; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ** Of 2 discrepant results, 1 was negative by both BioSign and PCR
** The discrepant sample was positive by PCR
2
Nasopharyngeal Sample
| Reference (Virus Culture) Results | ||||
|---|---|---|---|---|
| BioSign | ||||
| Flu A+ B | Flu A Positive | Flu A Negative | Total | Performance |
| Flu A | ||||
| Positive | 26 | 51* | 77 | Sensitivity: |
| 89.6% | ||||
| 95% CI: 84.0-95.2% | ||||
| Flu A | ||||
| Negative | 3** | 171 | 174 | Specificity: |
| 77.0% | ||||
| 95% CI: 74.2-79.8% | ||||
| Total | 29 | 222 | 251 | |
| Reference (Virus Culture) Results | ||||
| BioSign | ||||
| Flu A+ B | Flu B | |||
| Positive | Flu B | |||
| Negative | Total | Performance | ||
| Flu B | ||||
| Positive | 33 | 15* | 48 | Sensitivity: |
| 86.8% | ||||
| 95% CI: 81.4- | ||||
| 92.2% | ||||
| Flu B | ||||
| Negative | 5** | 198 | 203 | Specificity: |
| 92.9% | ||||
| 95% CI: 91.2- | ||||
| 94.6% | ||||
| Total | 38 | 213 | 251 |
*Of 51 discrepant results, 41 were positive by both BioSign and PCR ** Of 3 discrepant results, 1 was negative by both BioSign and PCR
*Of the 15 discrepant results, 8 were positive by both BioSign and PCR
** Of the 5 discrepant results, 2 were negative by both BioSign and PCR
| | | Reference (Virus Culture) | | | Reference (Virus Culture)
Results | | | | |
|---------------------|-------------------|---------------------------|-------|-------------------------------------------------|--------------------------------------|-------------------|-------|-------------|----------------------------------------------------|
| | | Results | | BioSign
Flu A+ B | Flu B
Positive | Flu B
Negative | Total | Performance | |
| BioSign
Flu A+ B | Flu A
Positive | Flu A
Negative | Total | Performance | Flu B
Positive | 14 | 40* | 54 | Sensitivity:
82.4%
95%
CI: 59.0–
93.8% |
| | | | | | Flu B
Negative | 3** | 301 | 304 | Specificity:
88.3%
95% CI: 84.4–
91.3% |
| Flu A
Positive | 33 | 80* | 113 | Sensitivity:
91.7%
95% CI: 78.2-
97.1% | Total | 17 | 341 | 358 | |
| Flu A
Negative | 3** | 242 | 245 | Specificity:
75.2%
95% CI: 70.2-
79.6% | | | | | |
| Total | 36 | 322 | 358 | | | | | | |
Nasal Swab Sample
.
*Of 80 discrepant results, 65 were positive by both BioSign and PCR ** Of 3 discrepant results, all 3 were positive by PCR
*Of 40 discrepant results, 18 were positive by both BioSign and PCR
** Of 3 discrepant results, 1 was negative by both BioSign and PCR
3
As further verification of the PCR test results shown from the samples with discrepant results between BioSign and viral culture, available archived remnant samples from the clinical studies with concordant results were also tested by PCR. The specificity for both Flu A and Flu B was 100%, while the sensitivity for Flu A was 90% and the sensitivity for Flu B was 91.7%.
Archived Sample Test
Aspirate Sample
Eighty (80) frozen archived samples originally obtained from influenza positive patients visiting Columbia NY Presbyterian Hospital and confirmed as positive for either influenza A or Influenza B by viral culture were tested with BioSign Flu A+B.
The tables below present test results with archived samples.
| Reference (Virus Culture) Results | ||||
|---|---|---|---|---|
| BioSign | ||||
| Flu A+ B | Flu A | |||
| Positive | Flu A | |||
| Negative | Total | Agreement | ||
| Flu A | ||||
| Positive | 50 | 0 | 50 | 100% |
| Flu A | ||||
| Negative | 0 | 30 | 30 | 100% |
| Total | 50 | 30 | 80 |
| Reference (Virus Culture) Results | ||||
|---|---|---|---|---|
| BioSign | ||||
| Flu A+ B | Flu B | |||
| Positive | Flu B | |||
| Negative | Total | Agreement | ||
| • Flu B | ||||
| Positive | 30 | 0 | 30 | 100% |
| Flu B | ||||
| Negative | 0 | 50 | 50 | 100% |
| Total | 30 | 50 | 80 |
Swab Sample ¨¨¨ ¨ ¨ ¨¨:
| T | Reference (Virus Culture) Results | Total | Agreement | |
|---|---|---|---|---|
| BioSign | ||||
| Flu A+ B | Flu A | |||
| Positive | Flu A | |||
| Negative | ||||
| Flu A | ||||
| Positive | 50 | 0 | 50 | 100% |
| Flu A | ||||
| Negative | 0 | 30 | 30 | 100% |
| Total | 50 | 30 | 80 |
| Reference (Virus Culture) Results | ||||
|---|---|---|---|---|
| BioSign | ||||
| Flu A+ B | Flu B | |||
| Positive | Flu B | |||
| Negative | Total | Agreement | ||
| Flu B | ||||
| Positive | 30 | 0 | 30 | 100% |
| Flu B | ||||
| Negative | 0 | 50 | 50 | 100% |
| Total | 30 | 50 | 80 |
Reproducibility Study
The reproducibility study for the BioSign® Flu A+B test was conducted at two Physicians' Offices and one laboratory using a panel of 180 coded specimens for each site. Testing was performed by two people for five days at each site following the same test protocol as would be used for fresh patient sample. The panel contained high negative, low positive and moderate positive specimens. Each specimen level was tested at each site in replicates of 15 over a period of five days.
4
The results obtained at each site agreed 100% with the expected results. No differences were observed within run (15 replicates), between runs (three different days), or between sites (three POL sites and one lab).
Analytical Sensitivity
Limit of Detection (LOD)
The LODs were determined for each of the two strains selected from the influenza type A and type B strains. The sensitivity level of each selected viral strain was tested 60 times to confirm the sensitivity level as LOD level, which gives 95% detection rate.
All four viral strains tested were detected 96.7% of the time in 60 replicates at the level listed in the table below.
| Influenza Type | Viral Strain | TCID50/mL | #Positive/#Total | % Positive |
|---|---|---|---|---|
| A | A/PR/8/34(H1N1) | $1.05 \times 10^2$ | 58/60 | 96.7 |
| A | A/Victoria/3/75(H3N2) | $9.95 \times 10^1$ | 58/60 | 96.7 |
| B | B/Taiwan/2/62 | $1.58 \times 10^3$ | 58/60 | 96.7 |
| B | B/Maryland/1/59 | $1.99 \times 10^1$ | 58/60 | 96.7 |
. . . . .
Analytical Inclusivity
The analytical inclusivity was established for a total of 21 influenza strains: 11 strains of influenza A type and 10 strains of influenza B type. The results are shown in the table below
| Influenza
Type | Viral Strain | TCID50/mL | Influenza
Type | Viral Strain | TCID50/mL |
|-------------------|-----------------------------------------------------------|---------------|-------------------|------------------|-----------------|
| A | A/PR/8/34(H1N1) | $1.05 × 10^2$ | B | B/Lcc/40 | $5.00 × 10^0$ |
| A | A/FM/1/47(H1N1) | $1.73 × 10^1$ | B | B/Allen/45 | $1.58 × 10^0$ |
| A | A/NWS/33(H1N1) | $4.10 × 10^3$ | B | B/GL/1739/54 | $9.95 × 10^2$ |
| A | A/Hong Kong/8/68(H3N2) | $8.5 × 10^2$ | B | B/Taiwan/2/62 | $1.58 × 10^3$ |
| A | A/Denver/1/57(H1N1) | $7.20 × 10^0$ | B | B/Maryland/1/59 | $1.99 × 10^1$ |
| A | A/Aichi/2/68(H3N2) | $9.95 × 10^0$ | B | B/Mass/3/66 | $5.00 × 10^1$ |
| A | A/Port Chalmers/1/73 | $1.99 × 10^2$ | B | B/R22 Barbara | $1.6 × 10^{-1}$ |
| A | A/Victoria/3/75(H3N2) | $9.95 × 10^1$ | B | B/R75 | $2.94 × 10^3$ |
| A | A/New Jersey/8/76(H1N1) | $9.95 × 10^1$ | B | B/Russia/69 | $3.16 × 10^3$ |
| A | A/WS/33(H1N1) | $5.00 × 10^1$ | B | B/Hong Kong/5/72 | $2.88 × 10^1$ |
| A | A/Swine/1976/31 | $1.58 × 10^2$ | | | |
| A | 2009 H1N1 Clinical Isolate*
(Swine Origin Influenza A) | $1.00 × 10^3$ | | | |
ー ::! ・ ・ ・ i \ .: ' ' \ '', ' '', ' ! ! ・( ・;
5
| A | 2009 H1N1 Clinical Isolate*
(Swine Origin Influenza A) | $1.00 \u00d7 10^3$ | | |
|---|-----------------------------------------------------------|--------------------|--|--|
| A | A/CA/07/2009(H1N1) | $6.15 \u00d7 10^3$ | | |
| A | A/CA/08/2009(H1N1) | $9.31 \u00d7 10^3$ | | |
| A | A/NY/18/2009(H1N1) | $2.5 \u00d7 10^3$ | | |
| A | A/Mexico/4108/2009(H1N1) | $8.51 \u00d7 10^3$ | | |
| A | A/CA/07/2009 NYC, X-179A
(H1N1) | $1.08 \u00d7 10^3$ | | |
| A | A/Virginia/ATCC2/2009(H1
N1) | $2.32 \u00d7 10^3$ | | |
| A | A/Virginia/ATCC3/2009(H1
N1) | $5.00 \u00d7 10^4$ | | |
· Clinical Isolate cultured and tittered. Culture confirmed positive for 2009 H1N1 Influenza A strain using proFLU Influenza A Subtyping
The performance of BioSign® Flu A+B was evaluated with nasal and nasopharyngeal swab samples obtained from patients infected with the 2009 HIN1 influenza virus consisting of sixty six (66) frozen clinical Nasal and Nasopharyngeal samples that had previously tested positive for 2009 HIN by the cleared CDC RT-PCR test. The BioSign® Flu A+B test detected 71% (47/66) of the CDC RT-PCR test positive specimens. The detection rate was 91% with the higher tittered specimens and 38% with the lower tittered specimens.
NOTE:
The performance characteristics of the test with cultured avian influenza A subtype H5N1 virus, or with specimens from human infected with H5N1 or other avian influenza viruses has not been established. ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...
Analytical Specificity
Cross-reactivity
The potential cross-reactivity of the non-influenza respiratory pathogens and other microorganisms with which the majority of the population may be infected was tested on the BioSign® Flu A+B test at medically relevant levels, 108 cfu/mL for bacteria and 10 pfu/mL for non-flu viruses. None of the organisms or viruses listed in the table below gave a positive result with BioSign® Flu A+B at the tested concentration.
| Viruses Tested | |
|---|---|
| Adenovirus* | Measles** |
| Human coronavirus** | Human metapneumovirus** |
| Cytomegalovirus** | Mumps virus** |
| Enterovirus** | Respiratory syncytial virus; Type B* |
| Epstein Barr Virus** | Rhinovirus; Type 1A** |
| Human parainfluenza; Type 1, 2 and 3* |
** In the study the virus was confirmed using commercially available PCR (not approved by FDA).
- In the study the virus was confirmed using FDA approved immuno-fluorecence assay.
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| Bacteria Tested | |
|---|---|
| Bordetella pertussis | Neisseria sp. |
| Chlamydia pneumoniae | Pseudomonas aeruginosa |
| Corynebacterium sp. | Staphylococcus aureus: Protein A Producer |
| Escherichia coli | Staphylococcus epidermidis |
| Hemophilus influenzae | Streptococcus pneumoniae |
| Lactobacillus sp. | Streptococcus pyogenes |
| Legionella spp | Streptococcus salivarius |
| Moraxella catarrhalis | |
| Mycobacterium tuberculosis avirulent | |
| Mycoplasma pneumoniae | |
| Neisseria meningitides |
Interference
The interference study was conducted using medically relevant concentrations of the potentially interfering substances listed below with two strains each of influenza type A and type B to assess the potential interference of the substances on the performance of the BioSign® Flu A+B test.
The test was conducted by spiking each substance into samples containing the lowest detectable virus level of influenza Type A or Type B for the positive interference testing and into samples without influenza virus for the negative interference testing. Each substance had no inhibitory effect on the BioSign® Flu A+B test at the concentration listed in the table below.
| Substances Tested | Concentration Tested |
|---|---|
| Mucin | 1 mg/ml |
| Whole Blood | 1 % |
| Phenylephrine | 10 mg/mL |
| Oxymetazoline | 10 mg/mL |
| Sodium Chloride with preservative | 20% |
| Beclomethasone | 1 mg/mL |
| Dexamethasone | 1 mg/mL |
| Flunisolide | 1 mg/mL |
| Triamcinolone | 1 mg/mL |
| Budesonide | 1 mg/mL |
| Mometasone | 1 mg/mL |
| Fluticasone | 0.5 mg/mL |
| Luffa opperculata, sulfur | 1% |
| Galphimia glauca | 1% |
| Histaminum hydrochloricum | 1% |
| Live intranasal influenza virus vaccine | 1% |
| Benzocaine | 1 mg/mL |
| Menthol | 1 mg/mL |
| Zanamivir | 1 mg/mL |
| Mupirocin | 1 mg/mL |
| Tobramycin | 1 mg/mL |
ﺮ ﺩﺭ ۱۰۰۰
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 - Room 5645 Silver Spring. MD 20993-0002
Dr. Kyung-ah Kim Associate Director Princeton BioMeditech Corporation 4242 U.S Route 1 Monmouth Junction, NJ 08852-1905
NOV 1 0 2010
Re: K083746
Trade/Device Name: BioSign Flu A+B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: November 8, 2010 Received: November 9, 2010
Dear Dr. Kyung-ah Kim:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely yours,
Jauzaotgn
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K083746 NOV 1 0 2010
Device Name: BioSign® Flu A+B, Status Flu A & B
Indications For Use:
The BioSign® Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash specimens of patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
・・・・・・・・・・・・・
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) a consideraria por use
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
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510(k) K083746