# K981567: Hybrid Capture II CT/GC Test

- Pathway: 510(k) (Traditional)
- Applicant: Digene Corp.
- Decided: Feb 29, 2000 after 669 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 K940979 (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)
- K940979: Gen-Probe Pace 2C Syst Chlamydia Trac/Neisser Gonorr, Gen-Probe, Inc. (1994). 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…”.

## Indications for use
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.

Source page: https://510kreport.com/device/K981567
Methodology: https://510kreport.com/methodology