# K962873: Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration Dna Probe

- Pathway: 510(k) (Traditional)
- Applicant: Vysis
- Decided: Jan 13, 1997 after 174 days
- Product code: OVQ (Chronic Lymphocytic Leukemia Fish Probe Kit)
- Device class: 2
- Regulation: 21 CFR 866.6040
- Recalls of this device: none
- 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 FDA summary names no predicate by number.

## Indications for use
The CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA. Probe Kit is designed to be an adjurict to standard cytogenetic analysis for in vitro diagrostic use in identifying and enumerating chromosome 12 via fluorescence in sifu hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with chronic lymphocytic leukemia (CLL). Results from the CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Kit are intended for use in conjunction with standard cytogenetics and for further assessing the trisomy 12 status in normal and abnormal tissue specimens characterized by standard cytogenetics, in patients with and/or without clinical symptoms of CLL. It is not intended to be a stand alone assay for test reporting.

Source page: https://510kreport.com/device/K962873
Methodology: https://510kreport.com/methodology