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510(k) Data Aggregation
(103 days)
STERICHEK BLOOD LEAK REAGENT STRIPS
SteriChek® Blood Leak Reagent Strips provide a quick convenient means of testing for occult blood in dialysate.
SteriChek® Blood Leak Reagent Strips provide a quick convenient means of checking the presence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor of the Hemodialysis machine.
The device is made up of a 0.20 inch square yellow reagent pad that has been chemically treated to detect the presence of blood in the dialysate solution used in Hemodialysis. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. To use the reagent strip, the reagent pad is immersed in the sample, removed immediately and allowed to react for 60 seconds. The reagent pad is then compared with the color blocks on the bottle label. The Negative color block is yellow with small blue-green speckles. If a reagent pad has a similar yellow color 60 seconds after reaction with dialysate, then the dialysate does not contain significant blood. The Positive color block is green. A reagent pad with color equal to or darker than the Positive color block indicates the presence of significant blood leak. The speckles on the color blocks represent the reaction image that might be left by intact red blood cells that might land on the reagent pad.
Acceptance Criteria and Device Performance Study
The information provided describes the SteriChek® Blood Leak Reagent Strips, a device designed to detect occult blood in dialysate. The acceptance criteria and the study proving the device meets these criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| AAMI Recommended High Alarm Limit: Not more than 0.35 mL/minute for a fixed alarm limit at a hematocrit of 25% (0.25), which calculates to 5.5 mg/dL of hemoglobin in the dialysate (assuming a dialysate flow of 0.5 L/minute). | Device Sensitivity: Positive readings at 1.5 mg/dL of hemoglobin. |
| Equivalence to Predicate Device: The device should have equivalent performance characteristics to the Serim™ Blood Leak Test Strips. | Study Finding: The sensitivity of the reagent strip methods (SteriChek® vs. Serim™) was equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set in terms of the number of individual blood samples. However, it mentions that the performance characteristics were analyzed with suspensions of whole blood in dialysate and solutions of human hemoglobin in dialysate.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth for hemoglobin concentration was established using a standardized laboratory method.
4. Adjudication Method for the Test Set
Not applicable. The study primarily focused on comparing the sensitivity of the device to a predicate device and a quantitative laboratory method rather than expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study described is a comparison of the device's sensitivity to a predicate device and a laboratory standard.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study appears to evaluate the device in a standalone manner. The "device performance" refers to the chemical reaction and color change of the reagent strip itself, which is then visually compared to color blocks. While a human is involved in the visual comparison, the core "performance" attributed to the device is its ability to react to and indicate the presence of blood at certain concentrations.
7. The Type of Ground Truth Used
The ground truth used was measured hemoglobin concentration using the Drabkin spectrophotometric method. This is described as "the standard used in most laboratories" where hemoglobin is converted to a stable pigment (cyanmethemoglobin) and its absorbance is measured at 540 nm with a spectrophotometer. The absorbance value directly measures the hemoglobin present.
8. The Sample Size for the Training Set
The document does not describe a "training set" as this device is a chemical reagent strip, not a machine learning or AI-driven system that typically involves training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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