# K990023: Hybrid Capture II CT-ID Test

- Pathway: 510(k) (Traditional)
- Applicant: Digene Corp.
- Decided: Oct 25, 1999 after 293 days
- Product code: LSK (Dna-Reagents, Chlamydia)
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K920378: Pace 2 System for Chlamydia Trachomatis, Gen-Probe, Inc. (1992). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Feb 7, 2003 · Not classified · Z-0657-03: In Vitro diagnostic test kit may produce false positive patient results

## Indications for use
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.

Source page: https://510kreport.com/device/K990023
Methodology: https://510kreport.com/methodology