FDA product code NTR: Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
NTR is the FDA product code for immunohistochemical reagent, antibody (monoclonal or polyclonal) to p63 protein in nucleus of prostatic basal cells. It is a Class I device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under NTR. The average 510(k) review took 29 days (median 29). FDA has posted 1 recall for NTR devices.
Definition
MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED BY NEEDLE BIOPSY OR SURGICAL PROCEDURES. THE PRESENCE OR ABSENCE OF P63 STAINING AIDS THE PATHOLOGIST IN THE DIFFERENTIAL DIAGNOSIS OF PROSTATE CANCER IN CONJUNCTION WITH MORPHOLOGICAL FINDINGS SEEN WITH HEMATOXYLIN AND EOSIN STAINING COMPLEMENTED BY PROPER CONTROLS.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells |
| Device class | Class I |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NTR clearance
Top NTR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Asymmetrx | 1 | 2005-02-09 |
Most recent NTR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050063 | Asymmetrx | PROSTATE-63 CANCER DIAGNOSTIC TEST | 2005-02-09 | 29 |
Recalls for NTR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-27.
Frequently asked questions
What is FDA product code NTR?
NTR is the FDA product code for immunohistochemical reagent, antibody (monoclonal or polyclonal) to p63 protein in nucleus of prostatic basal cells. It is a Class I device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is NTR?
Class I, regulation 21 CFR 864.1860. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NTR?
Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).
Which companies have the most NTR clearances?
Asymmetrx (1).
Have NTR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-10-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NTR
- Run a recall and safety report across every NTR manufacturer
- Watch product code NTR 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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