510(k) · Cleared
ClearedAbbott Multi-Collect Specimen Collection Kit, Abbott Real Time CT/NG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · LSL Dna-Reagents, Neisseria
Cleared on May 9, 2014 after an 86-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 9, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK140354 Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time CT/NGAbbott Molecular, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK202977 Alinity m STI AssayAbbott Molecular, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK222379 Alinity m STI AssayAbbott Molecular, Inc. · 2023 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140354 | Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time CT/NG | Abbott Molecular, Inc. | 2014 | — |
| +1 | K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022 | — |
| +2 | K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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 LSL? 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 LSL device
- #1 K231329 Aptima Neisseria gonorrhoeae Assayscore 6.7 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Abbott RealTime CT/NG (List No. 8L07) Named without a submission number | |
| * | — | Abbott multi-Collect Specimen Collection Kit (List No. 9K12) Named without a submission number | |
| * | — | Abbott multi-Collect Specimen Collection Kit Swab (5W260) Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202977 | Alinity m STI Assay | 2022 | 1 |
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?
- Of its descendants, K202977 (Abbott Molecular, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LSL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSL
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSL
41in 2025
MAUDE reports naming product code LSL, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 62 | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 3 | 86 | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 1 | 10 |
| 2018 | 3 | 90 | 0 | 7 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Abbott Realtime CT/NG assay isan invitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chiamydia trachomatis and the genomic DNA of Neisseria gonorrtoeaa. The assay may be used to test the following specimens from symptomatic individuals: female endoorvicai swab, clinician-collected vaginal swab, and patient-dallected vaginal swab specimens; male urethral swab specimens; and female and male urine…
Read the full statement (146 words)
The Abbott Realtime CT/NG assay isan invitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chiamydia trachomatis and the genomic DNA of Neisseria gonorrtoeaa. The assay may be used to test the following specimens from symptomatic individuals: female endoorvicai swab, clinician-collected vaginal swab, and patient-dallected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens.
The Abbott multi-Collect Specimen Collection Kit isintended for the collection and transportation of male and female swab and urine specimens for the detection of Chiamydia traohomatis and Neisserta gononrhoeae per instructions provided. Refer to the specimen collection procedure in the package insert for the specimen collection instructions for specific sample types.
Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140354: Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time CT/NG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140354
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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