SAS INFLUENZA A & B TEST

K080380 · Sa Scientific, Inc. · PSZ · Jul 23, 2009 · Microbiology

Device Facts

• Record ID: K080380
• Device Name: SAS INFLUENZA A & B TEST
• Applicant: Sa Scientific, Inc.
• Product Code: PSZ · Microbiology
• Decision Date: Jul 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

Intended 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 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.

Device Story

The SAS™ FluAlert A & B Test is a rapid, visual, lateral-flow immunoassay for professional use in clinical settings. It processes nasal wash or nasal aspirate samples to detect influenza A and B viral nucleoproteins. The device utilizes two separate test strips housed in a single side-by-side plastic cassette. Sample extraction occurs before application to the test wells. The assay relies on capillary action to migrate the sample across membranes containing gold-conjugated antibodies. If influenza antigens are present, a 'whole sandwich' immunocomplex forms, resulting in a visible pink line in the specimen zone. A procedural control line appears on each strip to verify proper flow. The test provides qualitative results to assist clinicians in patient management, though negative results do not rule out infection and require confirmation via cell culture.

Clinical Evidence

Prospective clinical study (n=461) and retrospective study (n=191) compared combined device to individual predicates. Prospective study showed 97.2% positive agreement and 99.7% negative agreement for Influenza A; 98.7% positive agreement and 99.7% negative agreement for Influenza B. Historical clinical sensitivity/specificity for individual tests vs. cell culture/DFA: Influenza A (76% sensitivity, 97.9% specificity); Influenza B (90.5% sensitivity, 100% specificity).

Technological Characteristics

Lateral-flow immunochromatographic assay. Utilizes gold-conjugated antibodies specific to influenza A and B nucleoproteins. Form factor is a side-by-side plastic cassette containing two test strips. Manual, point-of-care test requiring no external energy source or connectivity. Qualitative visual readout.

Indications for Use

Indicated for the presumptive in-vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens in nasal washes and nasal aspirates from symptomatic patients. For professional use only. Not indicated for Influenza Type C detection. Negative results require confirmation by cell culture.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SAS™ Influenza A Test (K044141)
• SAS™ Influenza B Test (K041439)

Submission Summary (Full Text)

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K080380

## 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.<br>4919 Golden Quail<br>San Antonio, TX 78240<br>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<br>Committee: | Microbiology | |
| Product Code: | GNX | |
| Substantial Equivalence: | Substantially equivalent to the SASTM individual devices-SASTM Influenza A<br>Test (K044141) and SAS™ Influenza B Test (K041439), manufactured by SA<br>Scientific, Ltd., San Antonio, TX. | |
| Device Description: | The SAS™ FluAlert A & B Test utilizes antibodies against influenza type A and<br>influenza type B viral nucleoproteins. After the extraction has been completed,<br>the sample is placed into two separate sample wells. The specimen is absorbed<br>and migrates via capillary action through membranes that contain dried gold<br>conjugated antibody, which is specific for either influenza A or influenza B viral<br>nucleoproteins. If these nucleoproteins are present, a "half-sandwich"<br>immunocomplex is formed. The membrane contains immobilized antibody to<br>influenza A or influenza B nucleoproteins, respectively, which bind the "half<br>sandwich" complex. Thus, in the presence of influenza nucleoproteins, a<br>"whole sandwich" immunocomplex is formed and a visible, pink-colored line<br>develops in the specimen zone of the test device. In the absence of an influenza<br>antigen, a "sandwich" immunocomplex is not formed and a negative result is<br>indicated. To serve as a procedural control, a pink-colored control line will<br>always appear in the control zone of each strip regardless of the presence or<br>absence of influenza A or influenza B nucleoproteins. | |
| Intended Use: | SASTM FluAlertA&B Test is a visual and rapid assay for the presumptive in-<br>vitro qualitative detection of influenza A and influenza B viral nucleoprotein<br>antigens from nasal washes and nasal aspirates of symptomatic patients.<br>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%. | |

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:

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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<br>A/B<br>Combo | | + | - | |
| | + | 44 | 0 | 44 |
| | - | 1 | 137 | 138 |
| Total | | 45 | 137 | 182 |
| Positive % Agreement: 97.8% (95% CI 87-<br>100%) | | | | |
| Negative % Agreement: 100% (97% CI 95-<br>100%) | | | | |

| | SAS Influenza B | | | Total |
|-------------------------------------------------|-----------------|----|------|-------|
| SAS<br>A/B<br>Combo | | + | | |
| | + | 37 | 0 | 37 |
| | | 0 | । 45 | 145 |
| Total | | 37 | । 45 | 182 |
| Positive % Agreement: 100% (95% | | | | |
| CI 97-100%) | | | | |
| Negative % Agreement: 100% (95 % CI<br>88-100%) | | | | |

## Fresh Prospective Nasal Washes:

| | SAS Influenza A | | | Total |
|--------------------------------------------------|-----------------|------|-----|-------|
| | | + | | |
| SAS<br>A/B | + | ટર્ભ | l | 27 |
| Combo | | 1 | 251 | 252 |
| Total | | 27 | 252 | 279 |
| Positive % Agreement: 96.3% (95% CI 79-<br>100%) | | | | |
| Negative % Agreement: 99.6% (95%CI 97-<br>100%) | | | | |

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| | SAS Influenza B | | | Total |
|--------------------------------------------------|-----------------|----|-----|-------|
| SAS<br>A/B<br>Combo | | + | | |
| | + | 40 | 1 | 41 |
| | | 1 | 237 | 238 |
| Total | | 41 | 238 | 279 |
| Positive % Agreement: 97.6% (95% CI 86-<br>100%) | | | | |
| Negative % Agreement: 99.6% (95% CI 97-<br>100%) | | | | |

Results Summary: Fresh Nasal Washes and Aspirates:

| | SAS Influenza A | | Total | |
|--------------------------------------------------|-----------------|----|-------|-----|
| SAS<br>A/B<br>Combo | + | 70 | 1 | 71 |
| | - | 2 | 388 | 390 |
| Total | | 72 | 389 | 461 |
| Positive % Agreement: 97.2% (95% CI 89-<br>100%) | | | | |
| Negative % Agreement: 99.7% (95% CI 98-<br>100%) | | | | |

| | SAS Influenza B | | | Total | | |
|--------------------------------------------------|-----------------|----|-----|-------|--|--|
| SAS<br>A/B<br>Combo | | + | | | | |
| | + | 77 | 1 | 78 | | |
| | | 1 | 382 | 383 | | |
| Total | | 78 | 383 | 461 | | |
| Positive % Agreement: 98.7% (95% CI 92-<br>100%) | | | | | | |
| Negative % Agreement: 99.7% (95% CI 98-<br>100%) | | | | | | |

Note: Performance characteristics for detecting the 2009 H1N1 influenza virus from human specimens have not been established

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### Demographics of Fresh Samples:

| Age (years) | Number of Nasal<br>Wash specimens | % of Total<br>NW<br>Specimens | Number of Nasal<br>Aspirate<br>Specimens | % of Total<br>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<br>A Test | | |
|---------------------------------------------|--------------------------|-----|-----|
| | + | - | |
| SAS™ Flu Alert A&B<br>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<br>B Test | | | |
|---------------------------------------|---------------------------|----|-----|-----|
| | + | - | | |
| SASTM FluAlert A & B<br>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

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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<br>A<br>High<br>Negative | Influenza A<br>Low Positive | Influenza A<br>Moderate<br>Positive | Influenza<br>B<br>High<br>Negative | Influenza B<br>Low Positive | Influenza B<br>Moderate<br>Positive |
|----------------------------|---------------------------------------------------------|------------------------------------|-----------------------------|-------------------------------------|------------------------------------|-----------------------------|-------------------------------------|
| | Viral Titer<br>Final<br>Concentration<br>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<br>96.7% | 26 Pos/30<br>86.6% | 29 Pos/30<br>96.7% | 28 Neg/29<br>96.6% | 29 Pos/30<br>96.7% | 29 Pos/29<br>100% |
| with<br>Expected<br>Result | Site 2 | 29 Neg/30<br>96.7% | 26 Pos/29<br>89.7% | 29 Pos/29<br>100% | 30 Neg/30<br>100% | 29 Pos/30<br>96.7% | 30 Pos/30<br>100% |
| | Site 3 | 28 Neg/30<br>93.3% | 27 Pos/30<br>90.0% | 30 Pos/30<br>100% | 26 Neg/29<br>89.7% | 29 Pos/30<br>96.7% | 30 Pos/30<br>100% |
| | Total<br>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<br>Viral Strain | ATCC | LoD<br>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<br>Kong/8/6/8 | VR-544 | $3.5 x 10^3$ |
| H1N1 A/FM/147 | VR-97 | $7.9 x 10^3$ |
| H3N2<br>A/Victoria/3/75 | VR-822 | $4.5 x 10^5$ |
| Influenza B<br>B/Lee/40 | VR-101 | $9.9 x 10^4$ |
| Influenza B<br>B/Allen/45 | VR-102 | $5.6 x 10^2$ |
| Influenza B<br>B/Mass/3/66 | VR-523 | $4.5 x 10^2$ |
| Influenza B<br>B/Taiwan/2/62 | VR-295 | $3.5 x 10^1$ |
| Influenza B<br>B/Maryland/1/59 | VR-296 | $1.6 x 10^2$ |

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## 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<br>SASTM FluAlert<br>A&B | "B" portion of the<br>SASTM FluAlert<br>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<br>SASTM FluAlert<br>A&B | "B" portion of the<br>SASTM FluAlert<br>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<br>the SASTM<br>FluAlert<br>A&B | "B" Portion of<br>the SASTM<br>FluAlert<br>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<br>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)<br>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<br>SAS™ FluAlert<br>A&B | "B" portion of the<br>SAS™ FluAlert<br>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

{9}------------------------------------------------

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.

{10}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{11}------------------------------------------------

# 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<br>510(k)_<br>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<br>CHANDER CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION C<br>And States of Construction | |
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