510(k) · Cleared
ClearedAbbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Cleared on Jul 10, 2008 as substantially equivalent to K043224 (Gen-Probe, Inc., 2005) and 4 other predicates after a 115-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jul 10, 2008
- Review
- 115 days
- Class
- Class I
- Product code
- MKZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K003395 (2001). 8 ancestors in all, the oldest P950039 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003395 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2001 | 1 |
| −1 | K032554 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2003 | — |
| 0 (this device) | K080739 | Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit | Abbott Molecular, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 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 MKZ? 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 MKZ device
- #1 K230451 Aptima® Chlamydia trachomatis Assayscore 6.4 · 1 generation · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K043224 | Gen-Probe Aptima Combo 2 AssaySummary page 1…390 (Neisseria), 866.3120 (Chlamydia) Dgvice Class: 2 (Neisseria), | (Chlamydia Substantially Equivalent Devices: GEN-PROBE® APTIMA® Combo 2 Assay (Assigned 510(k) No. K043224); Becton Dickenson ProbeTec” ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (Assigned 510(k) No. K012351);… | 2005 |
| * | K012351 | Bdprobetec ET CT/GC Amplified Dna AssaySummary page 1…APTIMA® Combo 2 Assay (Assigned 510(k) No. K043224); Becton Dickenson ProbeTec” ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (Assigned 510(k) No. K012351); Gen-Probe® APTIMA™ Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens (K043224); Gen-Probe APTI… | 2001 |
| * | K043144 | Gen-Probe Aptima Assay for Neisseria GonorrhoeaeSummary page 1…men Collection Kit for Endocervical and Urethral Swab Specimens (K043224); Gen-Probe APTIMA Urine Specimen Collection Kit for Male and Female Urine (Assigned 510(k) No. 043144); Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit (Assigned 510(k) No. K032554); BD ProbeTec ET Urine Processing Kit Assi… | 2005 |
| * | K032554 | Gen-Probe Aptima Combo 2 AssaySummary page 1…APTIMA Urine Specimen Collection Kit for Male and Female Urine (Assigned 510(k) No. 043144); Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit (Assigned 510(k) No. K032554); BD ProbeTec ET Urine Processing Kit Assigned 510(k) No. (K052224). Abbott RealTime CT/NG // awlti-Collect Specimen Collection… | 2003 |
| * | K052224 | BD Probe Tec Urine Preservative TransportSummary page 1…igned 510(k) No. 043144); Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit (Assigned 510(k) No. K032554); BD ProbeTec ET Urine Processing Kit Assigned 510(k) No. (K052224). Abbott RealTime CT/NG // awlti-Collect Specimen Collection Kit Volume | March 2008 Section 2 Sce 2 $10(k) Summary_mw9 Page |… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K043224.
How does its category compare?
All MKZ devicesMKZ Dna Probe, Nucleic Acid Amplification, Chlamydia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MKZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MKZ
Too few MKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MKZ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKZ
1in 2025
MAUDE reports naming product code MKZ, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may…
Read the full statement (162 words)
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine.
The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhéac per instructions provided. Refer to the specimen collection procedure in the package insert for 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/K080739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080739: Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080739
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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