An occult blood test is a laboratory test used to detect hidden (occult) blood in stool, urine, or other bodily fluids. It is primarily used to screen for conditions such as colorectal cancer, gastrointestinal bleeding, ulcers, or polyps.

Intended Use of Occult Blood Test

An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination).

Intended Use

It is a Fecal Immunochemical Test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. This test is used to aid in the detection of lower gastrointestinal bleeding.

Device Description

This device is a driven flow chromatographic immunoassay consisting of a test strip housed in a plastic cassette.

It detects human hemoglobin in stool samples to screen for hidden blood, which may indicate colorectal cancer or other gastrointestinal issues. The test is designed for at-home collection, where users use a brush to take a small toilet water sample and apply it to a test card, which is then sent to a laboratory for analysis. The lab develops and tests the sample for human hemoglobin. The kit includes instructions, a test card, brushes, a waste bag, and a return envelope. Additional components, such as developer kits and control kits, are used in the lab to process and verify results. These kits are available in different packaging options to meet customer needs.

Automated Occult Blood Analyzer

Intended use

The test system is intended for the qualitatitve detection of fecal occult blood in feces by professional laboratories. The automated test is used for the measurement of fecal occult blood and is useful as an aid to detect blood in stool when lower gastrointestinal bleeding may be suspected.

Device Description

An automated system for detecting fecal occult blood in human stool samples. It uses an immunochemical method with monoclonal and polyclonal antibodies to identify human hemoglobin. A positive result appears as a pink-rose color band, while no band indicates a negative result.

The system processes up to 100 samples per hour. Samples are collected in a tube, which is then placed in the test cartridge on the sample tray. The instrument punctures the tube’s seal, releasing the sample onto a test strip. Results—positive, negative, or invalid—are displayed on a touchscreen and printed within five minutes.

• Precision/Reproducibility
• Prozone effect study
• Stability study
• Analytical sensitivity
• Cross reactivity
• Interfering substance
• Sample collection study
• Specimen stability studies
• Assay cut-off

Clinical Testing

No Guidance available  for 510k submission