510(k) · Cleared
ClearedAlinity m STI Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on Apr 29, 2022 as substantially equivalent to K140354 (Abbott Molecular, Inc., 2014) and 3 other predicates after a 576-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Apr 29, 2022
- Review
- 576 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K984631 (1999). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
- 2 generations backK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- 1 generation backK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
- This deviceK202977 Alinity m STI AssayAbbott Molecular, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK222379 Alinity m STI AssayAbbott Molecular, Inc. · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K222379Alinity m STI AssayAbbott Molecular, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… | Becton Dickinson Microbiology Systems | 1999 | 2 |
| −2 | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| −1 | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | 2 |
| 0 (this device) | K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022 | — |
| +1 | K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEP device
- #1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140354 | Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time CT/NGSummary page 6…edicate Devices Device Name Predicate Device 510(k) Cleared Alinity m STI Assay Abbott RealTime CT/NG K140354 5/9/14 (Primary Predicate for CT/NG) Aptima Combo 2 Assay… | 2014 |
| * | K190515 | Aptima Combo 2 Assay (Panther System)Summary page 6…ime CT/NG K140354 5/9/14 (Primary Predicate for CT/NG) Aptima Combo 2 Assay K190515 5/23/19 (Primary Predicate for CT/NG) BD Max CT/GC/TV… | 2019 |
| * | K151589 | BD Max CT/GC/TV, BD Max InstrumentSummary page 6…2 Assay K190515 5/23/19 (Primary Predicate for CT/NG) BD Max CT/GC/TV K151589 9/6/16 (Primary Predicate for TV) Aptima Mycoplasma genitalium Assay… | 2016 |
| * | DEN180047 | Aptima Mycoplasma genitalium AssaySummary page 6…T/GC/TV K151589 9/6/16 (Primary Predicate for TV) Aptima Mycoplasma genitalium Assay DEN180047 1/23/19 (Primary Predicate for MG)… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222379 | Alinity m STI Assay | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K222379 (Abbott Molecular, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QEP devicesQEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QEP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEP
268in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEP
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEP
9in 2025
MAUDE reports naming product code QEP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 5 | 85 | 0 | 0 |
| 2020 | 3 | 46 | 0 | 0 |
| 2021 | 3 | 521 | 0 | 1 |
| 2022 | 3 | 438 | 0 | 1 |
| 2023 | 3 | 325 | 0 | 8 |
| 2024 | 0 | — | 3 | 8 |
| 2025 | 4 | 268 | 0 | 9 |
| 2026 | 3 | 171 | 0 | — |
What is it indicated for?
The Alinity m STI Assay is an in vitro transcription-polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms.…
Read the full statement (213 words)
The Alinity m STI Assay is an in vitro transcription-polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes:
CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs
NG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs
TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine
MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine
A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202977: Alinity m STI Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202977
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026