(24 days)
Not Found
No
The device description details a lateral flow immunoassay that relies on chemical reactions and visual interpretation of colored lines. There is no mention of any computational analysis, algorithms, or learning processes.
No.
The device is described as a rapid assay for the qualitative detection of influenza A and B viral antigens, indicating it is a diagnostic tool, not a therapeutic device.
Yes
The device is intended for the "presumptive in-vitro qualitative detection of influenza A viral nucleoprotein antigens" which directly relates to diagnosing the presence of influenza A. Additionally, the text states that negative results "should not be used as the sole basis for treatment or other patient management decisions," implying its role in diagnostic processes, albeit not as the definitive sole diagnostic tool.
No
The device description clearly outlines a physical test strip that utilizes antibodies and capillary action to produce a visible line, indicating the presence of influenza antigens. This is a hardware-based in-vitro diagnostic device, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in-vitro qualitative detection of influenza A viral nucleoprotein antigens" and "in-vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens". The term "in-vitro" is a key indicator of an IVD.
- Device Description: The description details a test that analyzes a biological sample (nasal washes and nasal aspirates) outside of the body to detect specific substances (viral nucleoprotein antigens). This is the core function of an IVD.
- Anatomical Site: The sample source is from the patient's body (nasal washes and aspirates), which is typical for IVD tests.
- Professional Use: The indication for "professional use only" is common for IVD devices used in a clinical setting.
The device performs a diagnostic test on a biological sample in vitro (outside the living organism) to provide information about a patient's health status (presence of influenza A and/or B). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SASTM Influenza A Test: SASTM Influenza A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only. Negative results do not preclude infection with influenza A 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.
SASTM FluAlert A & B Test: 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 and/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.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
SASTM Influenza A Test: The SASTM Influenza A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM Influenza A test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A 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 A 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 nucleoproteins.
SASTM FluAlert A & B Test: The SASTM 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SASTM Influenza A Test:
Analytical Sensitivity (Limit of Detection): The analytical sensitivity of the SASTM FluAlert A Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. Each strain was serially diluted in SASTM Influenza A extraction buffer. Results for A/Anhui/1/2013 are included in the summary table below.
- H1N1 A/PR/3/34: LoD TCID50/0.2 ml = 1.2 x 10^5
- H3N2 A/Aichi/2/68: LoD TCID50/0.2 ml = 5.6 x 10^2
- H3N2 A/Hong Kong/8/6/8: LoD TCID50/0.2 ml = 3.5 x 10^3
- H1N1 A/FM/147: LoD TCID50/0.2 ml = 7.9 x 10^3
- H3N2 A/Victoria/3/75: LoD TCID50/0.2 ml = 4.5 x 10^5
- H1N1 A/California/04/09: LoD TCID50/0.2 ml = 1.4 x 10^3
- H7N9 A/Anhui/1/2013: LoD EID50/mL = 1.0 x 10^8
Key Results: This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen. However, the performance characteristics of this test with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established. The SAS FluAlert A Test can detect influenza A virus, but cannot differentiate influenza subtypes. Conclusion: The information presented in the premarket notification demonstrates that the SAS™ Influenza A Test reacts with a cultured strain of 2013 H7N9 (Influenza A/Anhui/1/2013). Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS Influenza A Test can detect influenza A viruses, but cannot differentiate influenza subtypes. This viral strain used in this study was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer.
SASTM FluAlert A & B Test:
Analytical Sensitivity (Limit of Detection): The analytical sensitivity for the SAS™ FluAlert A&B Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. The strain was received from the CDC with a known EIDso concentration but was not verified by SA Scientific. The strain was serially diluted in SAS™ FluAlert extraction buffer and assayed using the SAS™ FluAlert A&B Test. Results for A/Anhui/1/2013 are included in the summary table below.
- H1N1 A/PR/3/34: LoD TCID50/0.2 ml = 1.2 x 10^5
- H3N2 A/Aichi/2/68: LoD TCID50/0.2 ml = 5.6 x 10^2
- H3N2 A/Hong Kong/8/6/8: LoD TCID50/0.2 ml = 3.5 x 10^3
- H1N1 A/FM/147: LoD TCID50/0.2 ml = 7.9 x 10^3
- H3N2 A/Victoria/3/75: LoD TCID50/0.2 ml = 4.5 x 10^5
- H1N1 A/California/04/09: LoD TCID50/0.2 ml = 1.4 x 10^3
- H7N9 A/Anhui/1/2013: LoD EID50/mL = 1.0 x 10^8
- Influenza B B/Lee/40: LoD TCID50/0.2 ml = 9.9 x 10^4
- Influenza B B/Allen/45: LoD TCID50/0.2 ml = 5.6 x 10^2
- Influenza B B/Mass/3/66: LoD TCID50/0.2 ml = 4.5 x 10^2
- Influenza B B/Taiwan/2/62: LoD TCID50/0.2 ml = 3.5 x 10^1
- Influenza B B/Maryland/1/59: LoD TCID50/0.2 ml = 1.6 x 10^2
Cross Reactivity Study:
The cross-reactivity for the SAS™ FluAlert A&B Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. The cultured viral strain was tested on the SASTM FluAlert A&B Test at the indicated concentrations. The cross-reactivity of A/Anhui/1/2013 in the "B" potion of the SAS™ FluAlert A&B Test was added to the summary table below.
- Adenovirus 5 (1.2 x 10^10): Neg in "A" and "B" portion.
- Adenovirus 7 (3.2 x 10^3 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- Adenovirus 10 (3.2 x 10^3 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- CoxsackieA9 (3.2 x 10^2 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- CoxsackieB5 (3.2 x 10^6 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- Cytomegalovirus (20 µg/ml): Neg in "A" and "B" portion.
- Echovirus 11 (NA): Neg in "A" and "B" portion.
- Echovirus3 (1 x 10^4 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- Echovirus 6 (3.2 x 10^6 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- HSV-1 (15 µg/ml): Neg in "A" and "B" portion.
- HSV-2 (15 µg/ml): Neg in "A" and "B" portion.
- Varicella zoster (12 µg/ml): Neg in "A" and "B" portion.
- Parainfluenza 1 (5.6 x 10^6 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- Parainfluenza 2 (1.8 x 10^5 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- Parainfluenza 3 (3.2 x 10^6 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- RSV Long (0.1 x 10^5.5 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- RSV B (0.1 x 10^5.25 TCID50 /0.2 ml): Neg in "A" and "B" portion.
- Influenza B Allen (3.2 x 10^3 TCID50 /0.2 ml): Neg in "A" portion.
- Influenza B Lee (3.2 x 10^6 TCID50 /0.2 ml): Neg in "A" portion.
- Influenza B Mass (1.8 x 10^3 TCID50 /0.2 ml): Neg in "A" portion.
- Influenza B Maryland (1 x 10^4 TCID50 /0.2 ml): Neg in "A" portion.
- Influenza B Taiwan (5.6 x 10^2 TCID50 /0.2 ml): Neg in "A" portion.
- Influenza A (H1N1) PR (1.8 x 10^4 TCID50 /0.2 ml): Neg in "B" portion.
- Influenza A (H3N2) Aichci (1.8 x 10^6 TCID50/0.2 ml): Neg in "B" portion.
- Influenza A (H3N2) Hong Kong (5.6 x 10^4 TCID50 /0.2 ml): Neg in "B" portion.
- Influenza A FM (3.2 x 10^4 TCID50 /0.2 ml): Neg in "B" portion.
- Influenza A (H3N2) Victoria (1.8 x 10^6 TCID50 /0.2 ml): Neg in "B" portion.
- Influenza A (H1N1) California/04/09 (1.1 x 10^4 TCID50 /0.2 ml): Neg in "B" portion.
- Influenza A (H7N9) Anhui/1/2013 (1.0 X 10^9 EID50/ ml): Neg in "B" portion.
Key Results: This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen. However, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. Conclusion: The information presented in the premarket notification demonstrates that the SASTM FluAlert A&B Test reacts with a cultured strain of 2013 H7N9 (FluA/Anhui/1/2013). There is no cross-reactivity observed on the "B" portion of the SAS™ FluAlert A&B Test. Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. This viral strain used in this study was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
K132B52
510(k) SUMMARY SASTM Influenza A Test K041441
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 | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Establishment Reg. No: | 1645225 | |
| Contact Person: | Nelson Torres | AUG 2 2 2013 |
| Date Prepared: | July 22, 2013 | |
| Proprietary Name: | SASTM Influenza A Test | |
| Classification Name: | Antigens, CF (including CF control), Influenza virus A, B, C | |
| Device Classification: | 21 CFR Part 866.3330 | |
| Regulatory Class: | Class I | |
| Classification Advisory
Committee: | Microbiology | |
| Product Code: | GNX | |
| Substantial Equivalence: | SASTM Influenza A Test, manufactured by SA Scientific, Ltd., San Antonio, TX. | |
| Device Description: | The SASTM Influenza A Test utilizes antibodies against influenza type A viral
nucleoproteins. The SASTM Influenza A test begins with an extraction of Type
A nucleoproteins. After the extraction has been completed, the sample is placed
into the sample well of the test. The specimen is absorbed and migrates via
capillary action through membranes that contain dried gold conjugated antibody,
which is specific for influenza A viral nucleoproteins. If these nucleoproteins
are present, a "half-sandwich" immunocomplex is formed. The membrane
contains immobilized antibody to influenza A nucleoproteins, which binds the
"half sandwich" complex. Thus, in the presence of influenza A 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
A 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 nucleoproteins. | |
| Intended Use: | SASTM Influenza A Test is a visual and rapid assay for the presumptive in-vitro
qualitative detection of influenza A viral nucleoprotein antigens from nasal
washes and nasal aspirates of symptomatic patients. The test is not intended for
the detection of Influenza Type B viral antigen or Influenza Type C viral
antigen. This test is for professional use only. | |
1
| | Negative results do not preclude infection with influenza A 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 SASTM Influenza A Test provides an internal procedural quality control. 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 SASTM Influenza A is a rapid immunoassays utilizing
immunochromatographic technology for the visualization of influenza A
antigen. Each utilizes an antibody conjugated to colored particles and an
antibody printed onto a membrane. The chemistry of the predicate device and
the proposed device is identical; the only difference is that the new inserts
include sensitivity data for H7N9. |
| Performance Summary: | This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus
cultured from a positive human specimen however, the performance
characteristics of this test with clinical specimens that are positive for the 2009
HINI influenza virus have not been established. The SAS FluAlert A Test can
detect influenza A virus, but cannot differentiate influenza subtypes. |
| Clinical Summary: | Please see K041441 for Clinical Summary |
Note: Performance characteristics for detecting the 2013 H7N9 influenza virus from human specimens have not been established
Analytical Sensitivity
(Limit of Detection):
The analytical sensitivity of the SAS™ FluAlert A Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. Each strain was serially diluted in SAS™ Influennza A extraction buffer. Results for A/Anhui/1/2013 are included in the summary table below.
| Influenza
Viral Strain | ATCC | LoD
TCID50/0.2 ml |
|----------------------------|----------------------|-------------------------------|
| H1N1 A/PR/3/34 | VR-95 | $1.2 \times 10^5$ |
| H3N2 A/Aichi/2/68 | VR-547 | $5.6 \times 10^2$ |
| H3N2 A/Hong
Kong/8/6/8 | VR-544 | $3.5 \times 10^3$ |
| H1N1 A/FM/147 | VR-97 | $7.9 \times 10^3$ |
| H3N2
A/Victoria/3/75 | VR-822 | $4.5 \times 10^5$ |
| H1N1
A/California/04/09 | NR-13658 | $1.4 \times 10^3$ |
| H7N9
A/Anhui/1/2013 | CDC ID
2013759189 | $1.0 \times 10^8$
EID50/mL |
*This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen however, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS Influenza A Test can detect influenza A viruses, but cannot differentiate influenza subtypes.
** This viral strain was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer.
2
Conclusion:
The information presented in the premarket notification demonstrates that the SAS™ Influenza A Test reacts with a cultured strain of 2013 H7N9 (Influenza A/Anhui/1/2013). Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS Influenza A Test can detect influenza A viruses, but cannot differentiate influenza subtypes. This viral strain used in this study was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer.
3
510(k) SUMMARY SAS™ FluAlert A & B Test K080380
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 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Reg. No: | 1645225 |
| Contact Person: | Nelson Torres |
| Date Prepared: | July 22, 2013 |
| 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 I |
| Classification Advisory
Committee: | Microbiology |
| Product Code: | GNX |
| Substantial Equivalence: | Substantially equivalent to the SASTM FluAlert A&B Test, manufactured by SA
Scientific, Ltd., San Antonio, TX. |
| Device Description: | The SASTM 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: | 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 and/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. |
| Conditions for Use: | For prescription use only. |
| Quality Controls: | The SASTM 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 SASTM FluAlert A&B Test is a 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 difference is
that the new inserts include sensitivity data for H7N9. |
| Performance Summary: | This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus
cultured from a positive human specimen. However, the performance
characteristics of this test with clinical specimens that are positive for the 2013
H7N9 influenza virus have not been established. The SAS FluAlert A&B Test
can distinguish between influenza A and B viruses, but cannot differentiate
influenza subtypes. |
| Clinical Summary: | Please see K080380 for Clinical Summary |
:
4
Note: Performance characteristics for detecting the 2013 H7N9 influenza virus from human specimens have not been established
Analytical Sensitivity
(Limit of Detection):
The analytical sensitivity for the SAS™ FluAlert A&B Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. 'The strain was received from the CDC with a known EIDso concentration but was not verified by SA Scientific. The strain was serially diluted in SAS™ FluAlert extraction buffer and assayed using the SAS™ FluAlert A&B Test. Results for A/Anhui/1/2013 are included in the summary table 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 | $4.5 x 10^5$ |
| H1N1
A/California/04/09 | NR-13658 | $1.4 x 10^3$ |
| *H7N9
A/Anhui/1/2013 | CDC ID
2013759189 | ** $1.0 X 10^8$
EID50/mL |
| Influenza B
B/Lee/40 | VR-101 | $9.9 x 10^4$ |
5
| 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 | $1.6 x 10^2$ |
*This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen however, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes.
** This viral strain was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer.
Cross Reactivity Study:
The cross-reactivity for the SAS™ FluAlert A&B Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. The cultured viral strain was tested on the SASTM FluAlert A&B Test at the indicated concentrations. The cross-reactivity of A/Anhui/1/2013 in the "B" potion of the SAS™ FluAlert A&B Test was added to the summary table 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 | $1.2 x 10^{10}$ | Neg | Neg |
| Adenovirus 7 | VR7 | 3.2 x $10^3$ TCID50 /0.2 ml | Neg | Neg |
| Adenovirus 10 | VR1087 | 3.2 x $10^3$ TCID50 /0.2 ml | Neg | Neg |
| CoxsackieA9 | VR186 | 3.2 x $10^2$ TCID50 /0.2 ml | Neg | Neg |
| CoxsackieB5 | VR185 | 3.2 x $10^6$ TCID50 /0.2 ml | Neg | Neg |
| Cytomegalovirus | 021301 | 20 µg/ml | Neg | Neg |
| Echovirus 11 | VR1052 | NA | Neg | Neg |
| Echovirus3 | VR1040 | 1 x $10^4$ TCID50 /0.2 ml | Neg | Neg |
| Echovirus 6 | VR1044 | 3.2 x $10^6$ 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 x $10^6$ TCID50 /0.2 ml | Neg | Neg |
| Parainfluenza 2 | VR92 | 1.8 x $10^5$ TCID50 /0.2 ml | Neg | Neg |
| Parainfluenza 3 | VR93 | 3.2 x $10^6$ TCID50 /0.2 ml | Neg | Neg |
| RSV Long | VR26 | 0.1 x $10^{5.5}$ TCID50 /0.2
ml | Neg | Neg |
| RSV B | VR1400 | 0.1 x $10^{5.25}$ TCID50 /0.2
ml | Neg | Neg |
| Influenza B
Allen | VR102 | 3.2 x $10^3$ TCID50 /0.2 ml | Neg | |
| Influenza B Lee | VR101 | 3.2 x $10^6$ TCID50 /0.2 ml | Neg | |
| Influenza B Mass | VR523 | 1.8 x $10^3$ TCID50 /0.2 ml | Neg | |
| Influenza B
Maryland | VR296 | 1 x $10^4$ TCID50 /0.2 ml | Neg | |
| Influenza B
Taiwan | VR295 | 5.6 x $10^2$ TCID50 /0.2 ml | Neg | |
| Influenza A
(H1N1) PR | VR95 | 1.8 x $10^4$ TCID50 /0.2 ml | | Neg |
6
| Influenza A
| (H3N2) Aichci | VR547 | $1.8 x 10^6$ TCID50/0.2 ml | Neg |
|---|---|---|---|
| Influenza A | |||
| (H3N2) Hong | |||
| Kong | VR544 | $5.6 x 10^4$ TCID50 /0.2 ml | Neg |
| Influenza A FM | VR97 | $3.2 x 10^4$ TCID50 /0.2 ml | Neg |
| Influenza A | |||
| (H3N2) Victoria | VR822 | $1.8 x 10^6$ TCID50 /0.2 ml | Neg |
| Influenza A | |||
| (H1N1) | |||
| California/04/09 | NR-13658 | $1.1 x 10^4$ TCID50 /0.2 ml | Neg |
| Influenza A | |||
| (H7N9) | |||
| Anhui/1/2013 | CDC ID | ||
| 2013759189 | 1.0 X $10^9$ EID50/ ml | Neg |
*This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen however, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes.
** This viral strain was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer.
,
Conclusion:
The information presented in the premarket notification demonstrates that the SASTM FluAlert A&B Test reacts with a cultured strain of 2013 H7N9 (FluA/Anhui/1/2013). There is no cross-reactivity observed on the "B" portion of the SAS™ FluAlert A&B Test. Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. This viral strain used in this study was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer.
7
Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W()666-(i609 Silver Spring, MI) 20993-0002
NELSON TORRES QA/RA SPECIALIST SA SCIENTIFIC 4919 GOLDEN QUAIL SAN ANTONIO TX 78240
August 22,2013
Re: K132352
Trade/Device Names: SAS " Influenza A and SAS" FluAlert A & B Tests Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: 1 Product Code: GNX Dated: July 22, 2013 Received: August 2, 2013
Dear Mr. Torres:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, subject to the general approvisions 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA `s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
8
Page 2-Mr. Torres
If you desire specific advice for your devices on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sally A. Hojvat -S
Sally Hojvat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
Indications for Use Form
510(k) Number: __ K132352
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
SASTM 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 and/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 (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 OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2013.08.20 15:36:18 -04'00'
Page 1 of 1 -
10
Indications for Use Form
510(k) Number: K132352
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
SASTM Influenza A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only.
Negative results do not preclude infection with influenza A 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 (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 OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2013.08.20 15:38:43 -04'00'
Page 1 of 1 __