(103 days)
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.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.