FDA product code SBB: System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
SBB is the FDA product code for system, colorectal neoplasia, rna markers and hemoglobin detection. It is a Class III device, reviewed by the Pathology panel. Devices under SBB reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for SBB devices, 1 initiated in the last five years.
Definition
The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy.
Classification
| Field | Value |
|---|---|
| Device name | System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SBB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-20.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code SBB?
SBB is the FDA product code for system, colorectal neoplasia, rna markers and hemoglobin detection. It is a Class III device, reviewed by the Pathology panel.
What device class is SBB?
Class III. Typical premarket route: PMA.
Have SBB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code SBB
- Run a recall and safety report across every SBB manufacturer
- Watch product code SBB 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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