510(k) · Cleared
Recalled · 2003Hybrid Capture II CT-ID Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digene Corp. · LSK Dna-Reagents, Chlamydia
Cleared on Oct 25, 1999 after a 293-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). It has been recalled once.
- Decided
- Oct 25, 1999
- Review
- 293 days
- Class
- Class I
- Product code
- LSK
- Recalls
- 1
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 LSK? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K920378 | FDA’s K920378 is Pace 2 System for Chlamydia Trachomatis Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2003 | Not classified | Z-0657-03 | Other | In Vitro diagnostic test kit may produce false positive patient results |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LSK devicesLSK Dna-Reagents, Chlamydia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSK
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LSK
Too few LSK 510(k)s in any year since 2007 to give a median.
Recalls per year · LSK
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSK
No MAUDE report names LSK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Digene HCII CT-ID Test is an in-vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of C. trachomatis DNA in cervical specimens collected using the Digene Cervical Sampler™ (Cervical Brush and Specimen Transport Medium) and in cervical specimens collected using the Digene Swab Specimen Collection Kit (Dacron® swab and Specimen Transport Medium). The Digene HCII CT-ID Test…
Read the full statement (114 words)
The Digene HCII CT-ID Test is an in-vitro nucleic acid hybridization assay with signal
amplification using microplate chemiluminescence for the qualitative detection of C.
trachomatis DNA in cervical specimens collected using the Digene Cervical Sampler™
(Cervical Brush and Specimen Transport Medium) and in cervical specimens collected
using the Digene Swab Specimen Collection Kit (Dacron® swab and Specimen
Transport Medium). The Digene HCII CT-ID Test is indicated for use with symptomatic
or asymptomatic women as evidence of infection with C. trachomatis.
The HCII CT-ID Test may be used alone or as a supplemental test to the Digene HCII
CT/GC Test to detect C. trachomatis DNA 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/K990023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990023: Hybrid Capture II CT-ID Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990023
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026