(24 days)
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 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.
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.
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.
The provided text describes two influenza detection tests: the SASTM Influenza A Test (K041441) and the SASTM FluAlert A & B Test (K080380). The current submission (K132352) is primarily focused on updating the predicate devices for these tests to include sensitivity data for the H7N9 strain, rather than presenting a new clinical study with acceptance criteria for device performance. Therefore, a table of acceptance criteria and device performance as typically understood for a novel device's clinical study is not explicitly provided in this document.
The document primarily focuses on analytical sensitivity (Limit of Detection) and cross-reactivity for the H7N9 strain, rather than clinical performance metrics like sensitivity and specificity in patient cohorts.
Here's a breakdown of the information that can be extracted, addressing your points where possible:
Acceptance Criteria and Study Details for SASTM Influenza A Test and SASTM FluAlert A & B Test
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit acceptance criteria for clinical performance (e.g., sensitivity, specificity thresholds) are not provided in this document. The studies described are analytical studies for the H7N9 strain.
Analytical Performance for both devices (SASTM Influenza A Test and SASTM FluAlert A & B Test) for H7N9:
| Criterion | Acceptance Criteria (Not Explicitly Stated as "Acceptance Criteria") | Reported Device Performance (Analytical Sensitivity - Limit of Detection (LoD)) |
|---|---|---|
| H7N9 Detection LoD | Implied: Detect the H7N9 strain at relevant concentrations. | 1.0 x 10^8 EID50/mL (for A/Anhui/1/2013) |
| Cross-Reactivity | Implied: No cross-reactivity with other common respiratory viruses and non-target influenza strains on the "B" portion for FluAlert A & B. | No cross-reactivity observed on the "B" portion of the SAS™ FluAlert A&B Test with H7N9. (Many other viruses tested as Negative, see tables in submission) |
Note on Clinical Performance: The document explicitly states: "Performance characteristics for detecting the 2013 H7N9 influenza virus from human specimens have not been established." and "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." This indicates that the presented data is entirely analytical, not clinical.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The test sets for the analytical sensitivity studies consisted of serial dilutions of cultured viral strains. The exact number of replicates for each dilution is not specified, but the results for the Limit of Detection are provided. For the cross-reactivity study, various cultured viral strains were tested at specific concentrations. The exact number of specimens (or "samples") is not individually quantified beyond the listed strains and their concentrations.
- Data Provenance: The viral strains used (e.g., A/Anhui/1/2013 H7N9, various H1N1, H3N2, Influenza B strains) were obtained from ATCC and the CDC. The data is prospective in the sense that the experiments were conducted for this submission (analytical studies), but they used cultured isolates, not retrospective or prospective human clinical samples. The country of origin for the data is implied to be the United States (where SA Scientific is based and the CDC/ATCC are located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the studies are analytical (laboratory-based detection of cultured viruses), not clinical studies requiring expert ground truth interpretation of patient data. The "ground truth" here is the known presence and concentration of the virus in the cultured samples. The CDC provided the H7N9 strain with a known titer, though SA Scientific did not independently verify this titer.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies are analytical and do not involve human interpretation or adjudication of clinical outcomes. The results are based on the visual detection of a pink line on the rapid immunoassay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- This is not applicable. The device is an immunoassay (a rapid test strip), not an AI-powered diagnostic imaging or interpretive device. There is no AI component or human-reader performance improvement study described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable. The device is a rapid immunoassay, which is a standalone test in itself (it provides a visible result without external computational algorithms). There is no "algorithm" in the context of AI being tested. The human "in-the-loop" is simply reading the visual result.
7. The Type of Ground Truth Used
- The ground truth used was the known presence and concentration of specific cultured viral strains. For example, for the H7N9 strain, it was A/Anhui/1/2013, with a known titer provided by the CDC. This is a form of analytical ground truth derived from laboratory-established viral cultures.
8. The Sample Size for the Training Set
- This is not applicable. As a rapid immunoassay (not an AI model), there is no "training set" in the context of machine learning. The device's design and antibodies are developed through traditional biological and chemical means, not by training on a dataset.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the reasons stated above (not an AI model).
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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 QuailSan Antonio, TX 78240210-699-8800 | |
|---|---|---|
| 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 AdvisoryCommittee: | 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 viralnucleoproteins. The SASTM Influenza A test begins with an extraction of TypeA nucleoproteins. After the extraction has been completed, the sample is placedinto the sample well of the test. The specimen is absorbed and migrates viacapillary action through membranes that contain dried gold conjugated antibody,which is specific for influenza A viral nucleoproteins. If these nucleoproteinsare present, a "half-sandwich" immunocomplex is formed. The membranecontains 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 linedevelops in the specimen zone of the test device. In the absence of an influenzaA antigen, a "sandwich" immunocomplex is not formed and a negative result isindicated. To serve as a procedural control, a pink-colored control line willalways appear in the control zone of each strip regardless of the presence orabsence of influenza A nucleoproteins. | |
| Intended Use: | SASTM Influenza A Test is a visual and rapid assay for the presumptive in-vitroqualitative detection of influenza A viral nucleoprotein antigens from nasalwashes and nasal aspirates of symptomatic patients. The test is not intended forthe detection of Influenza Type B viral antigen or Influenza Type C viralantigen. This test is for professional use only. |
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| Negative results do not preclude infection with influenza A and should not beused as the sole basis for treatment or other patient management decisions. It isrecommended 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. Itis recommended that external quality controls be assayed following the user'slaboratory'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 utilizingimmunochromatographic technology for the visualization of influenza Aantigen. Each utilizes an antibody conjugated to colored particles and anantibody printed onto a membrane. The chemistry of the predicate device andthe proposed device is identical; the only difference is that the new insertsinclude sensitivity data for H7N9. |
| Performance Summary: | This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) viruscultured from a positive human specimen however, the performancecharacteristics of this test with clinical specimens that are positive for the 2009HINI influenza virus have not been established. The SAS FluAlert A Test candetect 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.
| InfluenzaViral Strain | ATCC | LoDTCID50/0.2 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/HongKong/8/6/8 | VR-544 | $3.5 \times 10^3$ |
| H1N1 A/FM/147 | VR-97 | $7.9 \times 10^3$ |
| H3N2A/Victoria/3/75 | VR-822 | $4.5 \times 10^5$ |
| H1N1A/California/04/09 | NR-13658 | $1.4 \times 10^3$ |
| H7N9A/Anhui/1/2013 | CDC ID2013759189 | $1.0 \times 10^8$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.
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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.
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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 QuailSan Antonio, TX 78240210-699-8800 |
|---|---|
| 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 AdvisoryCommittee: | Microbiology |
| Product Code: | GNX |
| Substantial Equivalence: | Substantially equivalent to the SASTM FluAlert A&B Test, manufactured by SAScientific, Ltd., San Antonio, TX. |
| Device Description: | The SASTM FluAlert A & B Test utilizes antibodies against influenza type A andinfluenza type B viral nucleoproteins. After the extraction has been completed,the sample is placed into two separate sample wells. The specimen is absorbedand migrates via capillary action through membranes that contain dried goldconjugated antibody, which is specific for either influenza A or influenza B viralnucleoproteins. If these nucleoproteins are present, a "half-sandwich"immunocomplex is formed. The membrane contains immobilized antibody toinfluenza A or influenza B nucleoproteins, respectively, which bind the "halfsandwich" complex. Thus, in the presence of influenza nucleoproteins, a"whole sandwich" immunocomplex is formed and a visible, pink-colored linedevelops in the specimen zone of the test device. In the absence of an influenzaantigen, a "sandwich" immunocomplex is not formed and a negative result isindicated. To serve as a procedural control, a pink-colored control line willalways appear in the control zone of each strip regardless of the presence orabsence 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 nucleoproteinantigens from nasal washes and nasal aspirates of symptomatic patients. Thetest is not intended for the detection of Influenza Type C viral antigen. This testis for professional use only. |
| Negative results do not preclude infection with influenza A and/or influenza Band should not be used as the sole basis for treatment or other patientmanagement decisions. It is recommended that negative results be confirmed bycell culture. | |
| Conditions for Use: | For prescription use only. |
| Quality Controls: | The SASTM Influenza A & Influenza B Test provides two (2) internal proceduralquality controls. It is recommended that external quality controls be assayedfollowing the user's laboratory's standard quality control procedures and inconformance with local, state and federal regulations or accreditationorganizations as applicable |
| Device comparison: | The SASTM FluAlert A&B Test is a rapid immunoassay tests utilizingimmunochromatographic technology for the visualization of Influenza A &Influenza B viral nucleoprotein antigens. Each utilizes an antibody conjugatedto colored particles and an antibody printed onto a membrane. The chemistry ofthe predicate devices and the proposed device is identical; the only difference isthat the new inserts include sensitivity data for H7N9. |
| Performance Summary: | This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) viruscultured from a positive human specimen. However, the performancecharacteristics of this test with clinical specimens that are positive for the 2013H7N9 influenza virus have not been established. The SAS FluAlert A&B Testcan distinguish between influenza A and B viruses, but cannot differentiateinfluenza subtypes. |
| Clinical Summary: | Please see K080380 for Clinical Summary |
:
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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.
| InfluenzaViral Strain | ATCC | LoDTCID50/0.2 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/HongKong/8/6/8 | VR-544 | $3.5 x 10^3$ |
| H1N1 A/FM/147 | VR-97 | $7.9 x 10^3$ |
| H3N2A/Victoria/3/75 | VR-822 | $4.5 x 10^5$ |
| H1N1A/California/04/09 | NR-13658 | $1.4 x 10^3$ |
| *H7N9A/Anhui/1/2013 | CDC ID2013759189 | ** $1.0 X 10^8$EID50/mL |
| Influenza BB/Lee/40 | VR-101 | $9.9 x 10^4$ |
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| Influenza BB/Allen/45 | VR-102 | $5.6 x 10^2$ |
|---|---|---|
| Influenza BB/Mass/3/66 | VR-523 | $4.5 x 10^2$ |
| Influenza BB/Taiwan/2/62 | VR-295 | $3.5 x 10^1$ |
| Influenza BB/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 ofthe SASTMFluAlert A&B | "B" portion ofthe SASTMFluAlert 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 /0.2ml | Neg | Neg |
| RSV B | VR1400 | 0.1 x $10^{5.25}$ TCID50 /0.2ml | Neg | Neg |
| Influenza BAllen | 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 BMaryland | VR296 | 1 x $10^4$ TCID50 /0.2 ml | Neg | |
| Influenza BTaiwan | 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) HongKong | 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 ID2013759189 | 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.
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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 __
§ 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.