Atlas FDA

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

FDA 510(k) clearance K220801 · decided 2022-06-24

Clearance details

K-number
K220801
Device name
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Applicant
Abbott Diagnostics Scarborough, Inc.
Decision
Substantially Equivalent
Date received
2022-03-18
Decision date
2022-06-24
Days to decision
98 days
Clearance type
Special
Product code
OZE
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 Abbott Diagnostics Scarborough

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

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
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (K243274)Centers for Disease Control and Prevention2025-07-11
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (K243931)Centers for Disease Control and Prevention2025-03-14
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) (K241110)Centers for Disease Control and Prevention2024-05-21
Lyra Influenza A+B Assay (K230236)Quidel Corporation2023-03-03
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit (K200370)Centers for Disease Control and Prevention2020-03-10
FluChip-8G Influenza A+B Assay (K182513)Indevr, Inc.2019-04-22
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit (K190302)Centers for Disease Control and Prevention2019-03-27
ID NOW Influenza A & B 2 (K190204)Alere Scarborough, Inc.2019-03-18
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, (K181736)Centers For Disease Control and Prevention (CDC)2018-07-30
Accula Flu A/Flu B Test (K171641)Mesa Biotech, Inc.2018-02-06
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit (K172091)Centers for Disease Control and Prevention2017-08-09
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (K161556)Centers For Disease Control and Prevention (CDC)2016-06-30

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NMP22 BladderChek Test (P940035/S017)Abbott Diagnostics Scarborough, Inc.2022-07-12
Alere NMP22 BladderChek Test (P940035/S016)Abbott Diagnostics Scarborough, Inc.2021-06-15
Alere NMP22 BladderChek Test (P940035/S015)Abbott Diagnostics Scarborough, Inc.2018-05-17
MATRITECH NMP22(TM) TEST KIT (P940035/S014)Abbott Diagnostics Scarborough, Inc.2017-02-27
Alere NMP22 BladderChek Test (P940035/S013)Abbott Diagnostics Scarborough, Inc.2016-09-08
ALERE NMP22(TM) TEST (P940035/S012)Abbott Diagnostics Scarborough, Inc.2016-05-06
ALERE NMP22 BLADDERCHEK TEST (P940035/S011)Abbott Diagnostics Scarborough, Inc.2015-07-28
ALERE NMP22 TEST (P940035/S010)Abbott Diagnostics Scarborough, Inc.2013-07-16