510(k) · Cleared
Recalled · 2004Roche Amplicor CT/NG Test for Neisseria Gonorrhoeae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · LSL Dna-Reagents, Neisseria
Cleared on Dec 1, 1999 after a 733-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 1, 1999
- Review
- 733 days
- Class
- Class II
- Product code
- LSL
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974503 Roche Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Molecular Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK070172 Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Diagnostics Corporation · 2007
Most influential descendants
Showing 1 of 1 · See all- K070172Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Diagnostics Corporation · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974503 | Roche Amplicor CT/NG Test for Neisseria Gonorrhoeae | Roche Molecular Systems, Inc. | 1999 | — |
| +1 | K070172 | Amplicor CT/NG Test for Neisseria Gonorrhoeae | Roche Diagnostics Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070172 | Amplicor CT/NG Test for Neisseria Gonorrhoeae | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2004 | Not classified | Z-1361-04 | Other | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070172 (Roche Diagnostics Corporation, 2007) has gone furthest, with 0 descendants 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.
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 Neisseria gonorrhoeae is a qualitative in vitro test for the detection of Neisseria gonorrhoeae in clinical specimens. The test utilizes polymerase chain reaction (PCR) for the multiplex nucleic acid amplification of Neisseria gonorrhoeae and Chlamydia trachomatis DNA in endocervical and male urethral swab specimens and in male and female urine specimens from symptomatic and asymptomatic patients, and target-specific probe hybridization capture for the detection of the amplified Neisseria gonorrhoeae DNA.
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/K974503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974503: Roche 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/K974503
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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