BinaxNOW™ COVID-19 Antigen Self Test
FDA 510(k) clearance K243518 · decided 2025-02-11
Clearance details
- K-number
- K243518
- Device name
- BinaxNOW™ COVID-19 Antigen Self Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-13
- Decision date
- 2025-02-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QYT
- Device class
- 2
- Regulation number
- 866.3984
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test (K260754) | Assure Tech., LLC | 2026-06-05 |
| Heal-Check Rapid COVID-19 Antigen Self-Test (K260095) | Healgen Scientific,, LLC | 2026-04-13 |
| GenBody COVID-19 Ag Home Test (K251916) | Genbody.Inc. | 2026-03-13 |
| COVID-19 Detect Rapid Self -Test (K251595) | InBios International, Inc. | 2025-10-12 |
| GenaCheck COVID-19 Rapid Self-Test (K251753) | Genabio Diagnostics, Inc. | 2025-09-05 |
| OHC COVID-19 Antigen Self Test (K241313) | Osang, LLC | 2025-05-30 |
| CareSuperb™ COVID-19 Antigen Home Test (K241915) | Access Bio, Inc. | 2025-01-29 |
| Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (K241317) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-09-30 |
| CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (K240728) | CorDx, Inc. | 2024-06-21 |
| iHealth COVID-19 Antigen Rapid Test (K233842) | Ihealth Labs, Inc. | 2024-05-31 |
| Flowflex® Plus COVID-19 Home Test (K233373) | ACON Laboratories, Inc. | 2024-04-19 |
| QuickVue COVID-19 Test (K231795) | Quidel Corporation | 2024-03-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |