Atlas FDA

ALERE I INFLUENZA A & B

FDA 510(k) clearance K141520 · decided 2014-06-13

Clearance details

K-number
K141520
Device name
ALERE I INFLUENZA A & B
Applicant
Alere Scarborough, Inc D/B/A Binax, Inc.
Decision
Substantially Equivalent
Date received
2014-06-09
Decision date
2014-06-13
Days to decision
4 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Scarborough, ME, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Alere Scarborough

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BioCode® Respiratory Pathogen Panel (RPP) (K254139)Applied BioCode, Inc.2026-05-01
NxTAG® Respiratory Pathogen Panel (K242613)Luminex Molecular Diagnostics, Inc.2024-10-02
ID NOW Influenza A & B 2 (K232775)Abbott Diagnostics Scarborough, Inc.2023-10-10
Panther Fusion AdV/hMPV/RV Assay (K231017)Hologic, Inc.2023-05-05
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822)Roche Molecular Systems, Inc.2022-07-06
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (K210234)Roche Molecular Systems, Inc.2021-02-16
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (K201505)Diasorin Molecular, LLC2020-08-22
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System (K200065)Roche Molecular Systems, Inc.2020-02-10
BioCode Respiratory Pathogen Panel (RPP) (K192485)Applied BioCode, Inc.2019-12-23
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167)Luminex Molecular Diagnostics, Inc.2019-12-11
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729)Roche Molecular Systems, Inc.2019-07-24
ID NOW Influenza A & B 2 (K191534)Abbott Diagnostics Scarborough, Inc.2019-07-11

Recalls involving this device

RecordFirmDate
Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each pack recall (Z-1231-2017)Quidel Corporation2017-02-22
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influen recall (Z-2095-2015)Alere Scarborough, Inc. dba Binax, Inc.2015-07-16
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on t recall (Z-1677-2015)Alere Scarborough, Inc. dba Binax, Inc.2015-05-26