FDA product code OYU: Dna-Probe Kit, Human Chromosome
OYU is the FDA product code for dna-probe kit, human chromosome. It is a Class II device, regulated under 21 CFR 866.4700 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under OYU. The average 510(k) review took 230 days (median 132). FDA has posted 1 recall for OYU devices, 1 initiated in the last five years.
Definition
Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe Kit, Human Chromosome |
| Device class | Class II |
| Regulation | 21 CFR 866.4700 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OYU clearance
Top OYU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vysis | 3 | 2001-04-13 |
Most recent OYU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010288 | Vysis | ANEUVYSION MULITICOLOR DNA PROBE KIT | 2001-04-13 | 72 |
| K972200 | Vysis | ANEUVYSION | 1997-10-20 | 132 |
| K953591 | Vysis | CEP 8 SPECTRUMORANGE DNA PROBE KIT | 1996-11-29 | 486 |
Recalls for OYU devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-01.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code OYU?
OYU is the FDA product code for dna-probe kit, human chromosome. It is a Class II device, regulated under 21 CFR 866.4700 and reviewed by the Pathology panel.
What device class is OYU?
Class II, regulation 21 CFR 866.4700. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYU?
Across 3 cleared submissions the average was 230 days from receipt to decision (median 132).
Which companies have the most OYU clearances?
Vysis (3).
Have OYU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-02-01.
Next steps
- Run an FDA pathway report with predicate devices for product code OYU
- Run a recall and safety report across every OYU manufacturer
- Watch product code OYU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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