Alinity m STI Assay
FDA 510(k) K202977 · Abbott Molecular, Inc.
Submission
- Device name
- Alinity m STI Assay
- Applicant
- Abbott Molecular, Inc.
Des Plaines, IL, US - Received
- September 30, 2020
- Decision date
- April 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3393
- Specialty
- Microbiology
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually…
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| K243343 | BD CTGCTV2QEP · Traditional | Bd Integrated Diagnostic Solutions/Becton, | 04/22/2025SE |
| K240217 | cobas® liat CT/NG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 01/17/2025SE |
| K240197 | cobas® liat CT/NG/MG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 01/16/2025SE |
| K230267 | NeuMoDx CT/NG Assay 2.0QEP · Traditional | Neumodx Molecular, Inc. | 12/22/2023SE |
| K220407 | Visby Medical Sexual Health TestQEP · Dual Track | Visby Medical | 03/07/2023SE |
| K222379 | Alinity m STI AssayQEP · Traditional | Abbott Molecular, Inc. | 03/03/2023SE |
More from Abbott Molecular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252102 | Alinity m HCVMZP · Traditional | 09/25/2025SE |
| K243489 | Alinity m EBV (09N43-095)QLX · Traditional | 07/28/2025SE |
| K243485 | Alinity m CMVPAB · Traditional | 07/01/2025SE |
| K241921 | Alinity m BKVQMI · Traditional | 03/24/2025SE |
| K241573 | Alinity m Resp-4-PlexQOF · Traditional | 02/14/2025SE |
| K243410 | simpli-COLLECT STI TestQYA · Traditional | 01/30/2025SE |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX · Traditional | 12/06/2024SE |
| K233349 | Alinity m HSV 1 & 2 / VZVPGI · Traditional | 05/03/2024SE |
| K222379 | Alinity m STI AssayQEP · Traditional | 03/03/2023SE |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…QLX · Traditional | 07/15/2022SE |
Questions and answers
When was Alinity m STI Assay cleared by the FDA?
Alinity m STI Assay (K202977) received a 510(k) decision of Substantially Equivalent on April 29, 2022, 576 days after the submission was received.
What is the product code of K202977?
The FDA product code is QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, a Class II (moderate risk) device regulated under 21 CFR 866.3393.