510(k) · Cleared
ClearedAmplicor CT/NG Test for Neisseria Gonorrhoeae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corporation · LSL Dna-Reagents, Neisseria
Cleared on Apr 17, 2007 as substantially equivalent to K974503 (Roche Molecular Systems, Inc., 1999) after an 89-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 17, 2007
- Review
- 89 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974503 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK974503 Roche Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Molecular Systems, Inc. · 1999 · Recalled
- This deviceK070172 Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Diagnostics Corporation · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974503 | Roche Amplicor CT/NG Test for Neisseria Gonorrhoeae | Roche Molecular Systems, Inc. | 1999 | 1 |
| 0 (this device) | K070172 | Amplicor CT/NG Test for Neisseria Gonorrhoeae | Roche Diagnostics Corporation | 2007 | — |
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? (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 |
|---|---|---|---|
| * | K974503 | Roche Amplicor CT/NG Test for Neisseria GonorrhoeaeSummary page 2…Neisseria gonorrhoeae Predicate We claim equivalence to the currently marketed AMPLICOR CT/NG test for Device Neisseriagonorrhoeae cleared under K974503. Comparison - The table below shows the similarities between the AMPLICOR CT/NG test similarities for Neisseriago… | 1999 |
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 a recall.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 AMPLICOR CT/NG test for Neisseriagonorrhoeae is a qualitative in vitro test for the detection of N gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae.N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization…
Read the full statement (174 words)
The AMPLICOR CT/NG test for Neisseriagonorrhoeae is a qualitative in vitro test for the detection of N gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae.N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target.
Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test Accessory to direct the Tecan Genesis RSP 150 Workstation Urine specimens are not indicated for use with the automated sample preparation option.
Roche Scripts for AMPLICOR CT/NG Test: The Roche Scripts for AMPLICOR CTING Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:
* AMPLICOR ® CT/NG test for Chlamydia trachomatis
* AMPLICOR ® CT/NG test for Neisseria gonorrhoeae
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070172: Amplicor CT/NG Test for Neisseria Gonorrhoeae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070172
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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