510(k) · Cleared
ClearedVirazyme Influenza ID Test for Influenza Types a and B Viruses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zymetx, Inc. · GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Cleared on Sep 10, 1997 after a 139-day review. The FDA summary names no predicate by number.
- Decided
- Sep 10, 1997
- Review
- 139 days
- Class
- Class I
- Product code
- GNX
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GNX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GNX devicesGNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GNX
6in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GNX
27in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GNX
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNX
93in 2025
MAUDE reports naming product code GNX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 4 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 6 | 27 | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 36 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 93 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ViraZyme® Influenza ID test is a direct specimen test indicated for use in the qualitative detection of both influenza types A and B virus from throat swab specimens. The ViraZyme® Influenza ID test may be used when a patient is suspected of having symptoms of an influenza-like illness. These symptoms can include, but are not limited to the following: fever of 38.5°C, sore throat, headache, myalgia, rhinitis, vomiting, chills, malaise, and cough. A…
Read the full statement (119 words)
The ViraZyme® Influenza ID test is a direct specimen test indicated for use in the qualitative detection of both influenza types A and B virus from throat swab specimens. The ViraZyme® Influenza ID test may be used when a patient is suspected of having symptoms of an influenza-like illness. These symptoms can include, but are not limited to the following: fever of 38.5°C, sore throat, headache, myalgia, rhinitis, vomiting, chills, malaise, and cough. A positive ViraZyme® result would indicate the presence of influenza type A or B virus. A negative result is considered presumptive and should be confirmed by culture. The ViraZyme® Influenza ID test does not detect influenza C, and is indicated for in Vitro Diagnostic Use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971494 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971494: Virazyme Influenza ID Test for Influenza Types a and B Viruses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971494
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026