ALERE I INFLUENZA A & B— 510(k) K141520
Substantially EquivalentAlere Scarborough, Inc D/B/A Binax, Inc.
FDA 510(k) clearance K141520 for ALERE I INFLUENZA A & B, Substantially Equivalent on 2014-06-13. Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc D/B/A Binax, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
Recent devices under product code OCC
view allMore clearances from Alere Scarborough, Inc D/B/A Binax, Inc.
view allAdverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K141520
K-number listed on FDA's recall record- Z-1231-2017 — Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests
- Z-2095-2015 — Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
- Z-1677-2015 — Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141520.
Data sourced from openFDA. This site is unofficial and independent of the FDA.