# K981485: Hybrid Capture II GC-ID

- Pathway: 510(k) (Traditional)
- Applicant: Digene Corp.
- Decided: Nov 29, 1999 after 584 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920301 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920301: Pace 2 Neisseria Gonorrhoeae Probe Confirm. Assay, Gen-Probe, Inc. (1994) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K981485
Methodology: https://510kreport.com/methodology