FDA product code OXP: Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
OXP is the FDA product code for dna-probe kit, human chromosome x and y, bmt engraftment. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under OXP. The average 510(k) review took 502 days (median 502).
Definition
X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OXP clearance
Top OXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vysis | 1 | 1997-01-21 |
Most recent OXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954214 | Vysis | CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT | 1997-01-21 | 502 |
Recalls for OXP devices
openFDA lists no recalls for product code OXP.
Frequently asked questions
What is FDA product code OXP?
OXP is the FDA product code for dna-probe kit, human chromosome x and y, bmt engraftment. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Pathology panel.
What device class is OXP?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXP?
Across 1 cleared submissions the average was 502 days from receipt to decision (median 502).
Which companies have the most OXP clearances?
Vysis (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXP
- Run a recall and safety report across every OXP manufacturer
- Watch product code OXP 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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