FDA product code PHP: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
PHP is the FDA product code for system, colorectal neoplasia, dna methylation and hemoglobin detection. It is a Class III device, reviewed by the Pathology panel. Devices under PHP reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 2 recalls for PHP devices.
Definition
The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening.
Classification
| Field | Value |
|---|---|
| Device name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PHP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-02.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code PHP?
PHP is the FDA product code for system, colorectal neoplasia, dna methylation and hemoglobin detection. It is a Class III device, reviewed by the Pathology panel.
What device class is PHP?
Class III. Typical premarket route: PMA.
Have PHP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code PHP
- Run a recall and safety report across every PHP manufacturer
- Watch product code PHP 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times