(526 days)
Not Found
No
The device description details a lateral flow immunoassay based on antibody binding and visual line development, with no mention of AI, ML, image processing, or computational analysis of results.
No
This device is for diagnosis (detection of influenza antigens), not for therapy (treatment of a disease).
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "presumptive in-vitro qualitative detection of influenza A and influenza B viral nucleoprotein antigens," which is a diagnostic purpose.
No
The device description clearly outlines a physical test kit that utilizes antibodies and membranes to produce a visible result. This involves hardware components and chemical reactions, 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 SAS™ FluAlert A & B Test is for the "presumptive in-vitro qualitative detection of influenza A and influenza B viral nucleoprotein antigens". The term "in-vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the body.
- Device Description: The description details how the test works by detecting specific antigens in a sample (nasal washes and aspirates) using antibodies and producing a visual result. This is characteristic of an in-vitro diagnostic assay.
- Sample Type: The test is performed on biological samples (nasal washes and nasal aspirates) collected from patients.
- Purpose: The purpose is to aid in the diagnosis of influenza A and B infections by detecting the presence of viral antigens.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SASTM FluAlertA&B Test is a visual and rapid assay for the presumptive in- vitro qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only.
Negative results do not preclude infection with influenza A or B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
The SAS™ FluAlert A & B Test utilizes antibodies against influenza type A and influenza type B viral nucleoproteins. After the extraction has been completed, the sample is placed into two separate sample wells. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for either influenza A or influenza B viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A or influenza B nucleoproteins, respectively, which bind the "half sandwich" complex. Thus, in the presence of influenza nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A or influenza B nucleoproteins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal washes and nasal aspirates
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only.
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
Four clinical trial sites, in Texas and South Dakota, tested four hundred sixty one (461) nasal clinical specimens blindly and prospectively comparing the SAS™ Influenza A Test and The SAS™ FluAlert A&B (combined) Test performance.
Four clinical trial sites, in Texas and South Dakota, tested four hundred sixty one (461) nasal clinical specimens blindly and prospectively comparing the SASTM Influenza B Test and the SAS™ FluAlert A&B (combined) Test performance.
The SASTM FluAlert A&B Test combines the immunoassay test strips from the individual SASTM Influenza A and SASTM Influenza B Tests into one side-by-side plastic cassette. There are no other changes made to this test. In these studies, the users compared the combined test to the individual tests for evaluation of user interpretations.
Clinical sites collected the nasal wash samples from an approximately equal mix of adult (>21 years) and pediatric patients (0-21 years). The nasal aspirate samples were collected predominately from pediatric patients.
To supplement the prospective study, 191 frozen, archived, nasal wash samples from a children's hospital in Texas were blindly assayed comparing the individual SAS™ Influenza A Test and the individual SASTM Influenza B Test to the SAS™ FluAlert A&B (combined) Test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Summary: The SASTM FluAlert A&B test performed substantially equivalent to the predicate devices, SAS™ Influenza A and SAS Influenza Flu B Tests mentioned above. This was verified by comparison to freshly collected nasal wash and nasal aspirate specimens. Cross-reactivity and interference studies were performed on viral and bacterial strains commonly found in the human respiratory tract. None of the organisms interfered or cross-reacted with the performance of the SASTM FluAlert A& B test.
Clinical Summary:
Prospective Clinical Study:
The SAS™ Influenza A Test and SAS™ FluAlert A&B Test had a positive percent agreement of 97.2% and a negative percent agreement of 99.7%. Thirteen samples yielded invalid results. These data were not included in the totals.
The SASTM Influenza B test and SASTM FluAlert A&B Test had a positive percent agreement of 98.7% and a negative percent agreement of 99.7%.
Fresh Prospective Nasal Aspirates (n=182):
- Influenza A: Positive % Agreement: 97.8% (95% CI 87-100%), Negative % Agreement: 100% (97% CI 95-100%)
- Influenza B: Positive % Agreement: 100% (95% CI 97-100%), Negative % Agreement: 100% (95 % CI 88-100%)
Fresh Prospective Nasal Washes (n=279):
- Influenza A: Positive % Agreement: 96.3% (95% CI 79-100%), Negative % Agreement: 99.6% (95%CI 97-100%)
- Influenza B: Positive % Agreement: 97.6% (95% CI 86-100%), Negative % Agreement: 99.6% (95% CI 97-100%)
Total Fresh Nasal Washes and Aspirates (n=461):
- Influenza A: Positive % Agreement: 97.2% (95% CI 89-100%), Negative % Agreement: 99.7% (95% CI 98-100%)
- Influenza B: Positive % Agreement: 98.7% (95% CI 92-100%), Negative % Agreement: 99.7% (95% CI 98-100%)
Retrospective Study (n=191 frozen, archived, nasal wash samples):
- Influenza A: Positive % Agreement: 100% (95% CI 84-100%), Negative % Agreement: 99.3% (95% CI 96-100%)
- Influenza B: Positive % Agreement: 94.7% (95% CI 81-99%), Negative % Agreement: 98.0% (95% CI 94-99%)
Reproducibility (n=approximately 30 aliquots each of 6 panel members, across 3 clinical sites):
Total Agreement with Expected Result:
- Influenza A High Negative: 95.6%
- Influenza A Low Positive: 88.8%
- Influenza A Moderate Positive: 98.9%
- Influenza B High Negative: 95.4%
- Influenza B Low Positive: 96.7%
- Influenza B Moderate Positive: 100%
Analytical Sensitivity (Limit of Detection): Determined for 5 influenza A and 5 influenza B viral strains. (Results in table format in the original document)
Cross Reactivity Study: Tested 22 virus strains, one yeast, and fourteen bacterial strains. All showed Negative results for both "A" and "B" portions of the test.
Interference Study:
- "A" Portion (with Influenza Whole Virus Strain A/FM/147): All 22 viral, 1 yeast, and 14 bacterial strains tested positive.
- "B" Portion (with Influenza Whole Virus Strain B/Mass/3/66): All 22 viral, 1 yeast, and 14 bacterial strains tested positive.
Conclusion of Performance Data: The performance agreement of all clinical samples for the predicate devices and the proposed new device, FluAlert A&B, is 98% for the positive samples for influenza A, and >99% for negative samples, and is > 97% for the positive samples for influenza B is and >99% for negative samples, indicating that the new device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive % Agreement, Negative % 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.
SASTM Influenza A Test (K044141), SAS™ Influenza B Test (K041439)
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 OF SAFETY AND EFFECTIVENESS SAS™ FluAlert A & B Test
.
This 510(k) summary of safety and effectiveness submission is in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitted by: | SA Scientific, Ltd.
4919 Golden Quail
San Antonio, TX 78240
210-699-8800 | JUL 23 2009 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Establishment Reg. No: | 1645225 | |
| Contact Person: | Robbi Perry | |
| Date Prepared: | July 20, 2009 | |
| Proprietary Name: | SASTM FluAlert A & B Test | |
| Classification Name: | Antigens, CF (including CF control), Influenza virus A, B, C | |
| Device Classification: | 21 CFR Part 866.3330 | |
| Regulatory Class: | Class II | |
| Classification Advisory
Committee: | Microbiology | |
| Product Code: | GNX | |
| Substantial Equivalence: | Substantially equivalent to the SASTM individual devices-SASTM Influenza A
Test (K044141) and SAS™ Influenza B Test (K041439), manufactured by SA
Scientific, Ltd., San Antonio, TX. | |
| Device Description: | The SAS™ FluAlert A & B Test utilizes antibodies against influenza type A and
influenza type B viral nucleoproteins. After the extraction has been completed,
the sample is placed into two separate sample wells. The specimen is absorbed
and migrates via capillary action through membranes that contain dried gold
conjugated antibody, which is specific for either influenza A or influenza B viral
nucleoproteins. If these nucleoproteins are present, a "half-sandwich"
immunocomplex is formed. The membrane contains immobilized antibody to
influenza A or influenza B nucleoproteins, respectively, which bind the "half
sandwich" complex. Thus, in the presence of influenza nucleoproteins, a
"whole sandwich" immunocomplex is formed and a visible, pink-colored line
develops in the specimen zone of the test device. In the absence of an influenza
antigen, a "sandwich" immunocomplex is not formed and a negative result is
indicated. To serve as a procedural control, a pink-colored control line will
always appear in the control zone of each strip regardless of the presence or
absence of influenza A or influenza B nucleoproteins. | |
| Intended Use: | SASTM FluAlertA&B Test is a visual and rapid assay for the presumptive in-
vitro qualitative detection of influenza A and influenza B viral nucleoprotein
antigens from nasal washes and nasal aspirates of symptomatic patients.
Negative results should be confirmed via culture. This test is not intended for | |
| | the detection of Influenza Type C viral antigen. This test is for professional use only. | |
| | Negative results do not preclude infection with influenza A or B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture. | |
| Conditions for Use: | For prescription use only. | |
| Quality Controls: | The SAS™ Influenza A & Influenza B Test provides two (2) internal procedural quality controls. It is recommended that external quality controls be assayed following the user's laboratory's standard quality control procedures and in conformance with local, state and federal regulations or accreditation organizations as applicable | |
| Device comparison: | The SAS™ Influenza A & Influenza B tests are rapid immunoassay tests utilizing immunochromatographic technology for the visualization of Influenza A & Influenza B viral nucleoprotein antigens. Each utilizes an antibody conjugated to colored particles and an antibody printed onto a membrane. The chemistry of the predicate devices and the proposed device is identical; the only differnce is the plastic cassette. | |
| Performance Summary: | The SASTM FluAlert A&B test performed substantially equivalent to the predicate devices, SAS™ Influenza A and SAS Influenza Flu B Tests mentioned above. This was verified by comparison to freshly collected nasal wash and nasal aspirate specimens. | |
| | Cross-reactivity and interference studies were performed on viral and bacterial strains commonly found in the human respiratory tract. None of the organisms interfered or cross-reacted with the performance of the SASTM FluAlert A& B test. | |
| Clinical Summary: | | |
| Prospective Clinical Study: | The SASTM FluAlert A&B Test combines the immunoassay test strips from the individual SASTM Influenza A and SASTM Influenza B Tests into one side-by-side plastic cassette. There are no other changes made to this test. In these studies, the users compared the combined test to the individual tests for evaluation of user interpretations. Please see: "Results Summary: SASTM Influenza A and SAS™ Influenza B Individual Devices compared to cell culture or DFA" chart for comparison of the individual tests to cell culture/DFA. | |
| | Four clinical trial sites, in Texas and South Dakota, tested four hundred sixty one (461) nasal clinical specimens blindly and prospectively comparing the SAS™ Influenza A Test and The SAS™ FluAlert A&B (combined) Test performance. The SAS™ Influenza A Test and SAS™ FluAlert A&B Test had a positive percent agreement of 97.2% and a negative percent agreement of 99.7%. Thirteen samples yielded invalid results. These data were not included in the totals. | |
| | Four clinical trial sites, in Texas and South Dakota, tested four hundred sixty one (461) nasal clinical specimens blindly and prospectively comparing the SASTM Influenza B Test and the SAS™ FluAlert A&B (combined) Test performance. The SASTM Influenza B test and SASTM FluAlert A&B Test had a positive percent agreement of 98.7% and a negative percent agreement of 99.7%. | |
1
:
2
Clinical sites collected the nasal wash samples from an approximately equal mix of adult (>21 years) and pediatric patients (0-21 years). The nasal aspirate samples were collected predominately from pediatric patients.
Fresh Prospective Nasal Aspirates:
| SAS Influenza A | Total | |||
|---|---|---|---|---|
| SAS | ||||
| A/B | ||||
| Combo | + | - | ||
| + | 44 | 0 | 44 | |
| - | 1 | 137 | 138 | |
| Total | 45 | 137 | 182 | |
| Positive % Agreement: 97.8% (95% CI 87- | ||||
| 100%) | ||||
| Negative % Agreement: 100% (97% CI 95- | ||||
| 100%) |
| SAS Influenza B | Total | |||
|---|---|---|---|---|
| SAS | ||||
| A/B | ||||
| Combo | + | |||
| + | 37 | 0 | 37 | |
| 0 | । 45 | 145 | ||
| Total | 37 | । 45 | 182 | |
| Positive % Agreement: 100% (95% | ||||
| CI 97-100%) | ||||
| Negative % Agreement: 100% (95 % CI | ||||
| 88-100%) |
Fresh Prospective Nasal Washes:
| SAS Influenza A | Total | |||
|---|---|---|---|---|
| + | ||||
| SAS | ||||
| A/B | + | ટર્ભ | l | 27 |
| Combo | 1 | 251 | 252 | |
| Total | 27 | 252 | 279 | |
| Positive % Agreement: 96.3% (95% CI 79- | ||||
| 100%) | ||||
| Negative % Agreement: 99.6% (95%CI 97- | ||||
| 100%) |
3
| SAS Influenza B | Total | |||
|---|---|---|---|---|
| SAS | ||||
| A/B | ||||
| Combo | + | |||
| + | 40 | 1 | 41 | |
| 1 | 237 | 238 | ||
| Total | 41 | 238 | 279 | |
| Positive % Agreement: 97.6% (95% CI 86- | ||||
| 100%) | ||||
| Negative % Agreement: 99.6% (95% CI 97- | ||||
| 100%) |
Results Summary: Fresh Nasal Washes and Aspirates:
| SAS Influenza A | Total | |||
|---|---|---|---|---|
| SAS | ||||
| A/B | ||||
| Combo | + | 70 | 1 | 71 |
| - | 2 | 388 | 390 | |
| Total | 72 | 389 | 461 | |
| Positive % Agreement: 97.2% (95% CI 89- | ||||
| 100%) | ||||
| Negative % Agreement: 99.7% (95% CI 98- | ||||
| 100%) |
| SAS Influenza B | Total | |||||
|---|---|---|---|---|---|---|
| SAS | ||||||
| A/B | ||||||
| Combo | + | |||||
| + | 77 | 1 | 78 | |||
| 1 | 382 | 383 | ||||
| Total | 78 | 383 | 461 | |||
| Positive % Agreement: 98.7% (95% CI 92- | ||||||
| 100%) | ||||||
| Negative % Agreement: 99.7% (95% CI 98- | ||||||
| 100%) |
Note: Performance characteristics for detecting the 2009 H1N1 influenza virus from human specimens have not been established
4
Demographics of Fresh Samples:
| Age (years) | Number of Nasal
Wash specimens | % of Total
NW
Specimens | Number of Nasal
Aspirate
Specimens | % of Total
NA Specimens |
|----------------|-----------------------------------|-------------------------------|------------------------------------------|----------------------------|
| 0-5 | 16 | 5.7% | 73 | 40.1% |
| 6-21 | 21 | 7.5% | 108 | 59.3% |
| 22 - 65 | 25 | 9.0% | 1 | 0.6% |
| >65 | 9 | 3.2% | 0 | |
| Not Determined | 208 | 74.5% | 0 | |
| Total | 279 | | 182 | |
Retrospective Study:
To supplement the prospective study, 191 frozen, archived, nasal wash samples from a children's hospital in Texas were blindly assayed comparing the individual SAS™ Influenza A Test and the individual SASTM Influenza B Test to the SAS™ FluAlert A&B (combined) Test. For these samples, the positive percent agreement with the Influenza A Test is 100% and negative percent agreement is 99.3%, while positive percent agreement with the Influenza B Test was 94.7% and negative percent agreement is 98.0%
| | SAS™ Influenza
A Test | | |
|---------------------------------------------|--------------------------|-----|-----|
| | + | - | |
| SAS™ Flu Alert A&B
Combined Test | 27 | 1 | 28 |
| - | 0 | 163 | 163 |
| Total | 27 | 164 | 191 |
| Positive % Agreement: 100% (95% CI 84-100%) | | | |
Negative % Agreement: 99.3% (95% CI 96-100%)
| | SASTM Influenza
B Test | | | |
|---------------------------------------|---------------------------|----|-----|-----|
| | + | - | | |
| SASTM FluAlert A & B
Combined Test | + | 36 | 3 | 39 |
| | - | 2 | 150 | 152 |
| Total | | 38 | 153 | 191 |
Positive % Agreement: 94.7% (95% CI 81-99%) Negative % Agreement: 98.0% (95% CI 94-99%)
Reproducibility:
The reproducibility of the SASTM FluAlert A&B Test was evaluated at three clinical sites. Three or four non-professional users per site tested the SASTM FluAlert A&B Test against a panel of approximately 30 aliquots each of six (6) panel members over a two-week period. Specimens were comprised of pooled nasal aspirates and included two (2) levels of positives for influenza A and two (2) for influenza B and two (2) negatives. The low and medium positives for influenza A contained H3N2 A/Hong Kong/8/68 and the low and medium positives for influenza B contained B/Allen/45. Negative specimens for influenza A contained H3N2 A/Hong Kong/8/68 and negative specimens for influenza B contained B/Allen/45, but both were in concentrations below the
5
limit of detection. Although 30 aliquots of each were prepared, in some cases the total number was fewer than 30 because of spillage or pipetting errors.
| | Panel Member | Influenza
A
High
Negative | Influenza A
Low Positive | Influenza A
Moderate
Positive | Influenza
B
High
Negative | Influenza B
Low Positive | Influenza B
Moderate
Positive |
|----------------------------|---------------------------------------------------------|------------------------------------|-----------------------------|-------------------------------------|------------------------------------|-----------------------------|-------------------------------------|
| | Viral Titer
Final
Concentration
TCID50/0.2 ml. | $1.8 x 10^3$ | $7 x 10^3$ | $1.4 x 10^4$ | $2.8 x 10^2$ | $1.1 x 10^3$ | $2.2 x 10^3$ |
| Agreement | Site 1 | 29 Neg/30
96.7% | 26 Pos/30
86.6% | 29 Pos/30
96.7% | 28 Neg/29
96.6% | 29 Pos/30
96.7% | 29 Pos/29
100% |
| with
Expected
Result | Site 2 | 29 Neg/30
96.7% | 26 Pos/29
89.7% | 29 Pos/29
100% | 30 Neg/30
100% | 29 Pos/30
96.7% | 30 Pos/30
100% |
| | Site 3 | 28 Neg/30
93.3% | 27 Pos/30
90.0% | 30 Pos/30
100% | 26 Neg/29
89.7% | 29 Pos/30
96.7% | 30 Pos/30
100% |
| | Total
Agreement | 95.6% | 88.8% | 98.9% | 95.4% | 96.7% | 100% |
Analytical Sensitivity (Limit of Detection):
The limit of detection (LOD) for the SAS™ FluAlert A&B Test was determined for five (5) each influenza A and Influenza B viral strains. Each strain was received from ATCC with a known TCID50 concentration. Each strain was serially diluted in SASTM FluAlert extraction buffer. Strains were assayed in triplicate using the SAS™ FluAlert A&B Test until no positive signal could be seen. Results are summarized below.
| Influenza
Viral Strain | ATCC | LoD
TCID50/0.2 ml |
|--------------------------------|--------|----------------------|
| H1N1 A/PR/3/34 | VR-95 | $1.2 x 10^5$ |
| H3N2 A/Aichi/2/68 | VR-547 | $5.6 x 10^2$ |
| H3N2 A/Hong
Kong/8/6/8 | VR-544 | $3.5 x 10^3$ |
| H1N1 A/FM/147 | VR-97 | $7.9 x 10^3$ |
| H3N2
A/Victoria/3/75 | VR-822 | $4.5 x 10^5$ |
| Influenza B
B/Lee/40 | VR-101 | $9.9 x 10^4$ |
| Influenza B
B/Allen/45 | VR-102 | $5.6 x 10^2$ |
| Influenza B
B/Mass/3/66 | VR-523 | $4.5 x 10^2$ |
| Influenza B
B/Taiwan/2/62 | VR-295 | $3.5 x 10^1$ |
| Influenza B
B/Maryland/1/59 | VR-296 | $1.6 x 10^2$ |
6
Cross Reactivity Study:
Twenty-two virus strains were obtained from ATCC or other commercial sources. Each cultured viral strain was tested on the SAS™ FluAlert A&B Test in these concentrations. The results are summarized below.
| Virus | ATTC/Lot # | Concentration | "A" portion of the
SASTM FluAlert
A&B | "B" portion of the
SASTM FluAlert
A&B |
|------------------------------|------------|---------------------------------------|---------------------------------------------|---------------------------------------------|
| Adenovirus 5 | 10-198-000 | $1.2 \times 10^{10}$ | Neg | Neg |
| Adenovirus 7 | VR7 | $3.2 \times 10^{3}$ TCID50 /0.2 ml | Neg | Neg |
| Adenovirus 10 | VR1087 | $3.2 \times 10^{3}$ TCID50 /0.2 ml | Neg | Neg |
| CoxsackieA9 | VR186 | $3.2 \times 10^{2}$ TCID50 /0.2 ml | Neg | Neg |
| CoxsackieB5 | VR185 | $3.2 \times 10^{6}$ TCID50 /0.2 ml | Neg | Neg |
| Cytomegalovirus | 021301 | 20 µg/ml | Neg | Neg |
| Echovirus11 | VR1052 | NA | Neg | Neg |
| Echovirus3 | VR1040 | $1 \times 10^{4}$ TCID50 /0.2 ml | Neg | Neg |
| Echovirus 6 | VR1044 | $3.2 \times 10^{6}$ TCID50 /0.2 ml | Neg | Neg |
| HSV-1 | 2J30000 | 15 µg/ml | Neg | Neg |
| HSV-2 | 8J29502 | 15 µg/ml | Neg | Neg |
| Varicella zoster | 1102097 | 12 µg/ml | Neg | Neg |
| Parainfluenza 1 | VR907 | $5.6 \times 10^{6}$ TCID50 /0.2 ml | Neg | Neg |
| Parainfluenza 2 | VR92 | $1.8 \times 10^{5}$ TCID50 /0.2 ml | Neg | Neg |
| Parainfluenza 3 | VR93 | $3.2 \times 10^{6}$ TCID50 /0.2 ml | Neg | Neg |
| RSV Long | VR26 | $0.1 \times 10^{5.5}$ TCID50 /0.2 ml | Neg | Neg |
| RSV B | VR1400 | $0.1 \times 10^{5.25}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza B Allen | VR102 | $3.2 \times 10^{3}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza B Lee | VR101 | $3.2 \times 10^{6}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza B Mass | VR523 | $1.8 \times 10^{3}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza B Maryland | VR296 | $1 \times 10^{4}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza B Taiwan | VR295 | $5.6 \times 10^{2}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza A (H1N1) PR | VR95 | $1.8 \times 10^{4}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza A (H3N2) Aichci | VR547 | $1.8 \times 10^{6}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza A (H3N2) Hong Kong | VR544 | $5.6 \times 10^{4}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza A FM | VR97 | $3.2 \times 10^{4}$ TCID50 /0.2 ml | Neg | Neg |
| Influenza A (H3N2) Victoria | VR822 | $1.8 \times 10^{6}$ TCID50 /0.2 ml | Neg | Neg |
One yeast and fourteen bacterial strains were obtained from ATCC or other commercial sources. Each cultured bacterial or yeast strain was diluted to a concentration of 1 x 100 cfu/ml and tested on the SAS™ FluAlert A&B Test. The results are summarized below.
| Bacteria or Yeast | "A" portion of the
SASTM FluAlert
A&B | "B" portion of the
SASTM FluAlert
A&B |
|-----------------------------|---------------------------------------------|---------------------------------------------|
| Candida albicans | Neg | Neg |
| Chlamydia trachomatis | Neg | Neg |
| Corynebacterium diphtheriae | Neg | Neg |
| Haemophilus influenza | Neg | Neg |
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| Klebsiella pneumoniae | Neg | Neg |
|---|---|---|
| Serratia marcescens | Neg | Neg |
| Staphylococcus epidermidis | Neg | Neg |
| Staphylococcus aureus | Neg | Neg |
| Streptococcus sp gr A | Neg | Neg |
| Streptococcus sp gr F | Neg | Ncg |
| Streptococcus sp gr G | Neg | Neg |
| Streptococcus pneumoniae | Neg | Neg |
| Mycoplasma pneumoniae | Neg | Neg |
| Neisseria meningitidis | Neg | Ncg |
| Pseudomonas aeruginosa | Neg | Neg |
Interference Study:
The analytical specificity of the A portion of the SAS™ FluAlert A&B was evaluated by testing a panel of 22 viruses, 14 bacteria, and one yeast species which may be found in the respiratory tract. For the A portion of the test, Influenza Whole Virus Strain A/FM/147 (ATCC VR97) at a titer of 7.9 x 103 TCID30/0.2 ml. was added to viral cultures and viral antigens at the concentrations in the table below and bacterial and yeast cultures at concentrations of 1 x 108 cfu/ml. For the B portion of the test, Influenza Whole Virus Strain B/Mass/3/66 (ATCC VR523) at a titer of 3.2 x 10' TCIDsy/0.2 ml. was added to viral cultures in the concentrations in the table below and bacterial and yeast cultures at 1 x 10° cfu/ml.
Results are summarized below:
| Virus | ATTC/Lot # | Concentration | "A" Portion of
the SASTM
FluAlert
A&B | "B" Portion of
the SASTM
FluAlert
A&B |
|-----------------------|------------|---------------------------------|------------------------------------------------|------------------------------------------------|
| Adenovirus 5 | 10-198-000 | $1.2 x 10^{10}$ TCID50/0.2 ml | Pos | Pos |
| Adenovirus 7 | VR7 | $3.2 x 10^3$ TCID50/0.2 ml | Pos | Pos |
| Adenovirus 10 | VR1087 | $3.2 x 10^3$ TCID50/0.2 ml | Pos | Pos |
| CoxsackieA9 | VR186 | $3.2 x 10^2$ TCID50/0.2 ml | Pos | Pos |
| CoxsackieB5 | VR185 | $3.2 x 10^6$ TCID50/0.2 ml | Pos | Pos |
| Cytomegalovirus | 021301 | 20 µg/ml | Pos | Pos |
| Echovirus11 | VR1052 | NA | Pos | Pos |
| Echovirus3 | VR1040 | $1 x 10^4$ TCID50/0.2 ml | Pos | Pos |
| Echovirus6 | VR1044 | $3.2 x 10^6$ TCID50/0.2 ml | Pos | Pos |
| HSV-1 | 2J30000 | 15 µg/ml | Pos | Pos |
| HSV-2 | 8J29502 | 15 µg/ml | Pos | Pos |
| Varicella zoster | 1102097 | 12 µg/ml | Pos | Pos |
| Parainfluenza 1 | VR907 | $5.6 x 10^6$ TCID50/0.2 ml | Pos | Pos |
| Parainfluenza 2 | VR92 | $1.8 x 10^5$ TCID50/0.2 ml | Pos | Pos |
| Parainfluenza 3 | VR93 | $3.2 x 10^6$ TCID50/0.2 ml | Pos | Pos |
| RSV Long | VR26 | $0.1 x 10^{5.5}$ TCID50/0.2 ml | Pos | Pos |
| RSV B | VR1400 | $0.1 x 10^{5.25}$ TCID50/0.2 ml | Pos | Pos |
| Influenza B Allen | VR102 | $3.2 x 10^3$ TCID50/0.2 ml | Pos | |
| Influenza B Lee | VR101 | $3.2 x 10^6$ TCID50/0.2 ml | Pos | |
| Influenza B Mass | VR523 | $1.8 x 10^3$ TCID50/0.2 ml | Pos | |
| Influenza B Maryland | VR296 | $1 x 10^4$ TCID50/0.2 ml | Pos | |
| Influenza B Taiwan | VR295 | $5.6 x 10^2$ TCID50/0.2 ml | Pos | |
| Influenza A (H1N1) PR | VR95 | $1.8 x 10^4$ TCID50/0.2 ml | | Pos |
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| Influenza A (H3N2) Aichci | VR547 | $1.8 x 10^6$ TCID50/0.2 ml | Pos |
|---|---|---|---|
| Influenza A (H3N2) Hong | |||
| Kong | VR544 | $5.6 x 10^4$ TCID50/0.2 ml | Pos |
| Influenza A FM | VR97 | $3.2 x 10^4$ TCID50/0.2 ml | Pos |
| Influenza A (H3N2) | |||
| Victoria | VR822 | $1.8 x 10^6$ TCID50/0.2 ml | Pos |
One yeast and fourteen bacterial strains were obtained from ATCC or other commercial sources. Each cultured bacterial or yeast strain was diluted to a concentration of 1 x 10° cfu/ml and tested on the SAS™ FluAlert A&B Test. The results are summarized below.
| Bacteria or Yeast | "A" portion of the
SAS™ FluAlert
A&B | "B" portion of the
SAS™ FluAlert
A&B |
|-----------------------------|--------------------------------------------|--------------------------------------------|
| Candida albicans | Pos | Pos |
| Chlamydia trachomatis | Pos | Pos |
| Corynebacterium diphtheriae | Pos | Pos |
| Haemophilus influenza | Pos | Pos |
| Klebsiella pneumoniae | Pos | Pos |
| Serratia marcescens | Pos | Pos |
| Staphylococcus epidermidis | Pos | Pos |
| Staphylococcus aureus | Pos | Pos |
| Streptococcus sp gr A | Pos | Pos |
| Streptococcus sp gr F | Pos | Pos |
| Streptococcus sp gr G | Pos | Pos |
| Streptococcus pneumoniae | Pos | Pos |
| Mycoplasma pneumoniae | Pos | Pos |
| Neisseria meningitidis | Pos | Pos |
| Pseudomonas aeruginosa | Pos | Pos |
Expected Values:
Influenza prevalence varies year to year, with the highest number of cases in the fall and winter months in the US. During the period of September 30, 2007 to April 5, 2008, prevalence in the US for both influenza A and influenza B was 18.5%, with 74% of those cases attributed to influenza A and 26% attributed to influenza B. For studies conducted on the SAS™ FluAlert A&B Test, during the 2007-2008 and 2008-2009 seasons, prevalence for fresh, prospective nasal washes and nasal aspirates was 15.1% for influenza A and 16.5% for influenza B.
Conclusion of Performance Data:
The performance agreement of all clinical samples for the predicate devices and the proposed new device, FluAlert A&B, is 98% for the positive samples for influenza A, and >99% for negative samples, and is > 97% for the positive samples for influenza B is and >99% for negative samples, indicating that the new device is substantially equivalent to the predicate devices
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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines above a wavy base.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUL 2 3 2009
Robbi Perry Regulatory Affairs SA Scientific, Ltd. 4919 Golden Quail San Antonio, TX 78240
Re: K080380
Trade/Device Name: SASTM FluAlert A&B Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class II Product Code: GNX Dated: June 2, 2009 Received: June 4, 2009
Dear Ms. Perry:
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. Insting 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 (PMA), 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); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 vours.
Sally A. Ulricht, M.S., Ph.D.
A. Hoivat. M Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K080380
Device Name: SAS™ FluAlert A & B Test
Indication For Use:
SAS™ FluAlert A & B Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only.
Negative results do not preclude infection with influenza A or influenza B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Uve Schuf
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 6080380
510(k)_
TACT Status Catalogues of Canada Career of Canada Career of Canada Compares of Canadian Compares of Canadian Compares of Canadian Compares of Canadian Compares of Canadian Co
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