510(k) · Cleared
ClearedHybrid Capture II CT/GC Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digene Corp. · LSL Dna-Reagents, Neisseria
Cleared on Feb 29, 2000 as substantially equivalent to K940979 (Gen-Probe, Inc., 1994) after a 669-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 29, 2000
- Review
- 669 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940979 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK940979 Gen-Probe Pace 2C Syst Chlamydia Trac/Neisser GonorrGen-Probe, Inc. · 1994
- This deviceK981567 Hybrid Capture II CT/GC TestDigene Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940979 | Gen-Probe Pace 2C Syst Chlamydia Trac/Neisser Gonorr | Gen-Probe, Inc. | 1994 | — |
| 0 (this device) | K981567 | Hybrid Capture II CT/GC Test | Digene Corp. | 2000 | — |
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 |
|---|---|---|---|
| * | K940979 | Gen-Probe Pace 2C Syst Chlamydia Trac/Neisser Gonorr Our OCR of the scanned summary read K340979, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Gen-Probe Pace 2 System for Neisseria gonorrhoeae and Chlamydia…”. | 1994 |
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 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 Digene HCII CT/GC Test is an in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the combined qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA in cervical specimens collected with the Digene Cervical Sampler™ (Brush) and the Digene Swab Specimen Collection Kit (Swab). Follow-up testing using the Digene HCII CT-ID and HCII GC-ID Tests is required to identify…
Read the full statement (109 words)
The Digene HCII CT/GC Test is an in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the combined qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA in cervical specimens collected with the Digene Cervical Sampler™ (Brush) and the Digene Swab Specimen Collection Kit (Swab). Follow-up testing using the Digene HCII CT-ID and HCII GC-ID Tests is required to identify the organism(s) present in HCII CT/GC DNA Test positive specimens. The HCII CT/GC DNA Test is indicated for use as an initial test to identify symptomatic or asymptomatic women with Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) infection.
For In Vitro Diagnostic 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/K981567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981567: Hybrid Capture II CT/GC Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981567
Report an extraction error
Are you the manufacturer?
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