510(k) · Cleared
ClearedAptima® Chlamydia trachomatis Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Cleared on Nov 16, 2023 as substantially equivalent to K063451 (Gen-Probe, Inc., 2007) after a 268-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Nov 16, 2023
- Review
- 268 days
- Class
- Class I
- Product code
- MKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063451 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK063451 Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199Gen-Probe, Inc. · 2007
- This deviceK230451 Aptima® Chlamydia trachomatis AssayHologic, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199 | Gen-Probe, Inc. | 2007 | — |
| 0 (this device) | K230451 | Aptima® Chlamydia trachomatis Assay | Hologic, Inc. | 2023 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199Summary page 4…DNA Probe, Nucleic Acid Amplification, Chlamydia Regulation Number: 866.3120 Regulatory Class: Class I Product Code: MKZ Legally Marketed Predicate Devices Predicate #: K063451 Predicate Trade Name: Aptima Assay for Chlamydia trachomatis Product Code: MKZ Device Description Summary Clearance of this pre… | 2007 |
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?
- Its one ancestor has no recall.
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. 2023, 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 Aptima Chlamydia trachomatis (CT) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Chlamydia trachomatis to aid in the diagnosis of chlamydia urogenital disease using the Panther System.
The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: patient-collected vaginal swab specimens¹ (in a clinical setting); and female and male urine specimens.
¹Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Aptima Multitest Swab Specimen Collection Kit has not been evaluated for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230451: Aptima® Chlamydia trachomatis Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230451
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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