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Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be in dicative of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is an immunological test for both professional and over the counter use.

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a qualitative, sandwich colloidal gold conjugate immunoassay for the determination of human hemoglobin in feces. The method employs a unique combination of monoclonal antibodies to selectively identify hemoglobin in test sample with a high degree of sensitivity. In less than 5 minutes, elevated levels of human hemoglobin as low as 50 ng/ml can be detected, and positive results for high levels of hemoglobin can be seen in the test as early as two to three minutes. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to another anti-hemoglobin antibody in the positive reaction zone and produces a pink-ross color band when hemoglobin concentration is greater than 50 ng/ml. In the absence of hemoglobin, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative control zone. Unbind conjugate binds to the reagents in the negative control zone, producing a pink rose color band, demonstrating that the reagents and device are functioning correctly.

A NEGATIVE specimen produces one distinct color bands in control area. A POSITIVE specimen produces two color band in the control and test area. There is no meaning attributed to color or its intensity for either line.

Here's an analysis of the provided text regarding the Forsure One Step Fecal Occult Blood (FOB) Screen Card Test, focusing on acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Data for K063693

The 510(k) summary for K063693 focuses on demonstrating substantial equivalence to a predicate device (WHPM Hemosure One Step Fecal Occult Blood (FOB) Test, K041202) through comparison of intended use and physical properties. It does not provide detailed performance characteristics from a specific study with acceptance criteria in the typical format of sensitivity, specificity, and accuracy for diagnostic devices, nor does it detail a clinical trial.

Instead, the provided text emphasizes the device's analytical performance (detection limit) and then asserts "substantial equivalence" based on similar characteristics to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission, actual "acceptance criteria" for a study in terms of clinical performance metrics (sensitivity, specificity) are not explicitly stated or provided in the document as would be found in a detailed clinical evaluation report. The document, instead, focuses on analytical performance.

Note: The above table reflects the analytical performance claims and the basis for substantial equivalence as presented in the 510(k) summary. It does not contain clinical performance metrics (sensitivity, specificity, etc.) that would typically be derived from a clinical study with explicitly stated acceptance criteria.

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

The provided 510(k) summary does not mention or describe a specific test set sample size used for performance evaluation that would lead to clinical sensitivity or specificity data. The "substantial equivalence" claim is based on comparisons of intended use, physical properties, and analytical performance (detection limit and speed), rather than a clinical comparison study on a patient cohort.

Therefore, details such as:

• Sample size: Not specified for a clinical test set.
• Data provenance: Not specified.
• Retrospective or prospective: Not applicable as a clinical test set is not described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a clinical study where experts established a ground truth for a test set. The evaluation is focused on analytical capabilities and equivalence to a predicate, not on a new clinical performance assessment requiring expert consensus on diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As there is no described clinical test set requiring expert ground truth, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done according to the provided 510(k) summary. The submission focuses on device characteristics and analytical performance, not on evaluating human reader performance with or without the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself, the Forsure One Step Fecal Occult Blood (FOB) Screen Card Test, is a standalone test. It's a "visually-read single use device" that produces a result (positive/negative) without further algorithmic interpretation. The "algorithm" here is the immunochromatographic reaction itself, yielding a visual output. The performance described (detecting 50 ng/ml hemoglobin, producing a result in

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