Search Results

hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

hema-screen ER XCEL™ in its original concept as slides and tape was designed to offer the hospital, mass screening programs and clinical laboratories a convenient rapid method for handling fecal specimens in testing for occult blood. hema-screen ER XCEL™ is especially useful for mass screening programs as its enhanced readability feature facilitates the technicians' ability to make a determination.

hema-screen ER XCEL™ eliminates the mess and odors associated with the collection and transport of fecal specimens. Slides can be prepared at the patient's bedside and placed in a sealed envelope or by the patient at home and mailed to the hospital or laboratory in an inoffensive manner for development and evaluation.

hema-screen ER XCEL™ single slides are convenient for use when single stool specimens are to be tested. A single test is indicated when blood loss in the gastrointestinal tract is strongly suspected, for example, in persons with symptoms of ulcers, anemia, black stools or postoperative patients.

hema-screen ER XCEL™ Enhanced Readability Patient Packs are to be utilized so the patient can serially collect specimens at home over the course of three bowel movements. Patients should be instructed to follow the directions exactly, as the potential for false positive results exists due to improper diet, blood on the hands, hemorrhoids or if the test is used during menstrual bleeding. After all three slides are prepared, the slides may be sent back to the hospital laboratory for developing and evaluation. Preparation of three consecutive slides is recommended for screening asymptomatic patients by the American Cancer Society.

When stool specimens containing occult blood are applied hema-screen ER XCEL™ test paper, the hemoglobin portion of the occult blood comes in contact with the guaiac. When the hema-screen ER XCEL™ peroxide developing solution is added, a guaiac-peroxidase like reaction occurs. The chemical reaction becomes visible by the appearance of a blue-green color between 30 seconds and 60 seconds if occur blood is present.

This document describes the hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test, which is a qualitative method for detecting occult blood in stool. The application is a 510(k) premarket notification claiming substantial equivalence to the predicate device hema-screen™ ER (K102664).

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values. The substantial equivalence claim is based on the assertion that the "fundamental scientific technology of the modified device has not changed" and "There is no change in analytical sensitivity of the new device." The changes primarily involve the addition of an optional patient sampling slide with a GRID design for enhanced readability and ease of use, rather than a change in the underlying diagnostic performance.

2. Sample Size Used for the Test Set and Data Provenance:

   The document does not provide details on a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The application relies on demonstrating that the modified device's analytical sensitivity has not changed compared to the predicate device, which would imply that its performance characteristics are comparable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

   The document does not specify the number or qualifications of experts used to establish ground truth. As this is a 510(k) for a modification (addition of a GRID design for readability) to a previously cleared device, the focus is on maintaining existing performance rather than re-establishing ground truth for diagnostic accuracy with a new study.

4. Adjudication Method for the Test Set:

   No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   No MRMC comparative effectiveness study is mentioned. The device is a qualitative test for occult blood, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study:

   The document does not describe a standalone (algorithm only) performance study as this is not an AI/algorithm-based device. The device itself is a qualitative chemical test. The "enhanced readability" feature refers to the physical design of the sampling slide.

7. Type of Ground Truth Used:

   The document implies that the ground truth for establishing the performance of the original predicate device (and by extension for demonstrating no change in the modified device) would be related to the presence or absence of occult blood, likely confirmed by established clinical methods or laboratory techniques. However, specific details on how this ground truth was used or established are not provided in this summary.

8. Sample Size for the Training Set:

   The document does not mention a training set sample size, as this is a chemical diagnostic test and not a machine learning or AI-based device that would typically involve a training set.

9. How Ground Truth for the Training Set Was Established:

   Not applicable, as no training set is described for this type of device.

Summary of Device Modification and Basis for Substantial Equivalence:

The primary change in the hema-screen ER XCEL™ device from its predicate (hema-screen™ ER) is the addition of an optional patient sampling slide with a GRID design. The manufacturer states:

• "The fundamental scientific technology of the modified device has not changed."
• "The internal guaiac paper has neither been modified nor reformulated."
• "There is no change in analytical sensitivity of the new device."
• The modified design simply features a smaller surface area (small circles) on the outer cardboard to help prevent oversampling and ease of use for the patient, which facilitates readability for technicians.

Therefore, the application argues for substantial equivalence based on the technological characteristics being identical for the core diagnostic mechanism and that the design change related to readability does not impact the scientific principle, materials, intended use, operating principle, basic design, shelf life, or enhanced developing solution. The risk analysis indicated that the modifications were satisfactory and did not raise new issues of safety or effectiveness.

Ask a specific question about this device

hema-screen™ ER is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

Not Found

The provided text is an FDA 510(k) clearance letter for the Hema Screen™ ER occult blood test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process and does not delve into the technical validation studies of the device itself.

Ask a specific question about this device