Heal-Check Rapid COVID-19 Antigen Self-Test
FDA 510(k) K260095 · Healgen Scientific,, LLC
510(k) numberK260095
Submission
- Device name
- Heal-Check Rapid COVID-19 Antigen Self-Test
- Applicant
- Healgen Scientific,, LLC
Houston, TX, US - Received
- January 13, 2026
- Decision date
- April 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYT – Over-The-Counter Covid-19 Antigen Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3984
- Specialty
- Microbiology
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Other 510(k)s with product code QYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT · Traditional | Assure Tech., LLC | 06/05/2026SE |
| K251916 | GenBody COVID-19 Ag Home TestQYT · Traditional | Genbody.Inc. | 03/13/2026SE |
| K251595 | COVID-19 Detect Rapid Self -TestQYT · Traditional | InBios International, Inc. | 10/12/2025SE |
| K251753 | GenaCheck COVID-19 Rapid Self-TestQYT · Traditional | Genabio Diagnostics, Inc. | 09/05/2025SE |
| K241313 | OHC COVID-19 Antigen Self TestQYT · Traditional | Osang, LLC | 05/30/2025SE |
| K243518 | BinaxNOW COVID-19 Antigen Self TestQYT · Traditional | Abbott Diagnostics Scarborough, Inc. | 02/11/2025SE |
| K241915 | CareSuperb COVID-19 Antigen Home TestQYT · Traditional | Access Bio, Inc. | 01/29/2025SE |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/30/2024SE |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestQYT · Traditional | CorDx, Inc. | 06/21/2024SE |
| K233842 | iHealth COVID-19 Antigen Rapid TestQYT · Traditional | Ihealth Labs, Inc. | 05/31/2024SE |
More from Ihealth Labs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug TestDJC · Traditional | 03/16/2026SE |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestNFW · Traditional | 02/12/2026SE |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 12/23/2025SE |
| K251800 | Healgen® URS Test StripsJMT · Traditional | 12/23/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | 08/15/2025SE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | 12/17/2024SE |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…NGL · Traditional | 05/13/2024SE |
| K232377 | Healgen Rapid COVID-19 Antigen TestQVF · Traditional | 04/19/2024SE |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 04/12/2024SE |
| K231045 | Healgen URS Test StripsLJX · Traditional | 06/16/2023SE |
Questions and answers
When was Heal-Check Rapid COVID-19 Antigen Self-Test cleared by the FDA?
Heal-Check Rapid COVID-19 Antigen Self-Test (K260095) received a 510(k) decision of Substantially Equivalent on April 13, 2026, 90 days after the submission was received.
What is the product code of K260095?
The FDA product code is QYT – Over-The-Counter Covid-19 Antigen Test, a Class II (moderate risk) device regulated under 21 CFR 866.3984.