510(k) · Cleared
ClearedHybrid Capture II GC-ID
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 Nov 29, 1999 as substantially equivalent to K920301 (Gen-Probe, Inc., 1994) after a 584-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 29, 1999
- Review
- 584 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920301 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK920301 Pace 2 Neisseria Gonorrhoeae Probe Confirm. AssayGen-Probe, Inc. · 1994
- This deviceK981485 Hybrid Capture II GC-IDDigene Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920301 | Pace 2 Neisseria Gonorrhoeae Probe Confirm. Assay | Gen-Probe, Inc. | 1994 | — |
| 0 (this device) | K981485 | Hybrid Capture II GC-ID | Digene Corp. | 1999 | — |
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 |
|---|---|---|---|
| * | K920301 | Pace 2 Neisseria Gonorrhoeae Probe Confirm. AssaySummary page 1…2 test is a legally marketed device made available for commercial distribution in the United States as of April 26, 1994 after FDA cleared 510(k) premarket notification K920301. Both the Pace 2 test and the Digene Hybrid Capture® Il GC-ID Test share the same intended use. Analytical and clinical data have… | 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 GC-ID Test is a nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of N. gonorrhoeae DNA in cervical specimens collected using the Digene Cervical Sampler™ (Digene cervical brush and Digene Specimen Transport Medium) and in cervical specimens collected using the Digene Swab Specimen Collection Kit ([Swab SCK] Dacron® swab and Digene Specimen Transport Medium). The…
Read the full statement (119 words)
The Digene HCII GC-ID Test is a nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of N. gonorrhoeae DNA in cervical specimens collected using the Digene Cervical Sampler™ (Digene cervical brush and Digene Specimen Transport Medium) and in cervical specimens collected using the Digene Swab Specimen Collection Kit ([Swab SCK] Dacron® swab and Digene Specimen Transport Medium). The Digene HCII GC-ID Test is indicated for use as an aid in diagnosing infection with N. gonorrhoeae in symptomatic or asymptomatic females.
The HCII GC-ID Test may be used alone or as a supplemental test to the Digene HCII CT/GC Test to detect N. gonorrhoeae in specimens that are positive by the HCII CT/GC Test.
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/K981485 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981485: Hybrid Capture II GC-ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981485
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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