# K140354: Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time CT/NG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: May 9, 2014 after 86 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott RealTime CT/NG (List No. 8L07): named in the summary without a submission number
- (no number) Abbott multi-Collect Specimen Collection Kit (List No. 9K12): named in the summary without a submission number
- (no number) Abbott multi-Collect Specimen Collection Kit Swab (5W260): named in the summary without a submission number

## Most influential descendants
- K202977: Alinity m STI Assay (2022), 1 descendant of its own
- K222379: Alinity m STI Assay (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K140354
Methodology: https://510kreport.com/methodology