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510(k) Data Aggregation
(99 days)
FJD
The Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips are designed to indicate the presence or absence of blood in dialysate during the hemodialysis procedure. The test strips will measure equal to 0 mg HGB/dL and 0.25 mg HGB/dL in dialysate.
The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with blood in dialysate. The pad is attached to a plastic strip for handling.
The provided document describes the Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips. Here's an analysis of the acceptance criteria and the study outlined:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative pass/fail format typical for medical device verification. Instead, it describes the intended performance and the study's findings regarding that performance.
| Acceptance Criteria (Implied from Intended Use) | Reported Device Performance |
|---|---|
| Indicate the presence or absence of blood in dialysate. | The product consistently generates color change which meets the color block for the reference solution concentration. |
| Measure equal to 0 mg HGB/dL (no blood). | Reference solutions were used to evaluate performance between 0 mg HGB/dL and 0.25 mg HGB/dL Bicarbonate/Acetate dialysate. The data confirm the product meets the color block for this concentration. |
| Measure 0.25 mg HGB/dL (presence of blood at a specific detectable threshold). | Reference solutions were used to evaluate performance between 0 mg HGB/dL and 0.25 mg HGB/dL Bicarbonate/Acetate dialysate. The data confirm the product meets the color block for this concentration. |
| Appropriate performance for use in hemodialysis dialysate during treatment. | These data demonstrate appropriate performance for use in hemodialysis dialysate used in treatment. |
| Technological characteristics: Detection based on pseudoperoxidative activity of hemoglobin and myoglobin, catalyzing oxidation of an indicator by an organic hydroperoxide, producing a color change consistent with color blocks. | Confirmed through the performance study where the device generates color change that meets the color block for reference solutions, implying the underlying technological principle is functional and produces the expected visual outcome. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Reference solutions" were used, and "data confirm the product consistently generates color change," but it doesn't quantify the number of tests performed or the sample size of distinct reference solutions/concentrations tested.
- Data Provenance: Not explicitly stated. The study appears to be a laboratory-based performance evaluation using reference solutions, rather than human clinical data from a specific country. It is almost certainly retrospective in the sense that the test strips were manufactured and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is established by the known concentrations of hemoglobin (HGB) in the prepared reference solutions, not by expert human interpretation. The "color block" comparison itself would be a visual assessment, but the ground truth is the chemical concentration.
4. Adjudication Method for the Test Set
Not applicable. The performance is evaluated by observing a color change and comparing it to a visual "color block" corresponding to known HGB concentrations. There is no mention of human adjudication for the results beyond this direct comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test strip where performance is assessed by comparison to reference color blocks, not by interpretation by multiple human readers. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this appears to be a standalone performance evaluation. The device's performance is determined by its inherent color-changing reaction to blood in dialysate, and its comparison to established color blocks. There is no "human-in-the-loop" aspect to its fundamental operation or the evaluation method described beyond visually comparing the strip's color to a reference.
7. The Type of Ground Truth Used
The ground truth used is known concentrations of hemoglobin (HGB) in prepared reference solutions. These solutions serve as the objective standard against which the test strip's color-changing reaction is evaluated.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent test strip, not an AI or machine learning algorithm that requires a "training set." Its chemical formulation dictates its performance, which is then verified.
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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(103 days)
FJD
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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(147 days)
FJD
Serim Blood Leak Test Strips – 2 provide a rapid and convenient means for testing dialysate for occult blood leaks that may occur during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.
The SERIM Blood Leak Test Strips-2 consist of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the SERIM™ Blood Leak Test Strips-2:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity: Positive reading for 1.5 mg/dL hemoglobin (corresponding to approximately 0.1 mL/minute blood loss, well below AAMI recommended limit of 0.35 mL/minute or 5.5 mg/dL hemoglobin) | 100% Sensitivity: Sixty positive strip readings were obtained with dialysis buffer containing non-hemolyzed blood at 1.5 mg/dL hemoglobin (as determined by the cyanmethemoglobin method). |
| Specificity: Negative reading for dialysate without significant blood. | 100% Specificity: Sixty negative strip readings were obtained with dialysis buffer without blood. |
| Clear distinction between Positive and Negative color blocks. | Two color blocks on the bottle label (yellow for Negative, green for Positive) provide a clear distinction. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 60 negative samples and 60 positive samples (totaling 120 samples).
- Data Provenance: The document does not specify the country of origin. The data appears to be from a controlled laboratory study, not directly referenced as prospective or retrospective patient data. It describes "blind studies" using "blood standards" in "dialysis buffer."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that positive ground truth was defined as "1.5 mg/dL hemoglobin, determined by the cyanmethemoglobin method." This implies reliance on a laboratory assay rather than human expert interpretation for the quantitative ground truth. The color block comparison is manual, but the underlying "true" hemoglobin levels were determined by a standard analytical method.
4. Adjudication Method for the Test Set
- The document does not mention an adjudication method. The test strips are designed for visual comparison to distinct positive and negative color blocks. The 100% sensitivity and specificity reported suggest no ambiguity in interpretation for the tested samples, implying direct comparison to the color blocks was sufficient, without needing further adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the device and its comparison to a predicate device's chemical properties. The document does not discuss human reader performance, either with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone performance study was conducted. The "SERIM Blood Leak Test Strips-2" themselves are a standalone diagnostic device. The reported sensitivity and specificity demonstrate the performance of the device independent of human interpretation ambiguity, beyond simply visual classification after the test is run. The device is the "algorithm" in this context (chemical reaction leading to a visual output).
7. Type of Ground Truth Used
- The ground truth for positive samples was established using a quantitative laboratory method: "1.5 mg/dL hemoglobin, determined by the cyanmethemoglobin method."
- The ground truth for negative samples was "dialysis buffer without blood."
8. Sample Size for the Training Set
- The document does not describe a training set or a machine learning algorithm. This device is a chemical test strip, not an AI-based system. Therefore, the concept of a "training set" is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
- As the device is a chemical test strip and not an AI-based system, there is no "training set," and therefore, no process for establishing its ground truth.
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(90 days)
FJD
SERIM Blood Leak Test Strips provide a rapid and convenient means for testing spent dialysate for blood in hemodialysis clinics. The presence of blood in dialysate indicates a leak in the dialysis membrane.
The SERIM Blood Leak Test Strip consists of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.
Here's a breakdown of the acceptance criteria and study detailed in the provided document for the SERIM™ Blood Leak Test Strips:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specificity: 100% (no false positives) for dialysis buffer without blood. | 100 negative strip readings (100% specificity) obtained with dialysis buffer without blood. |
| Sensitivity: 100% (all true positives detected) for dialysis buffer containing 1.5 mg/dL hemoglobin. | 100 positive strip readings (100% sensitivity) obtained with dialysis buffer containing non-hemolyzed blood at 1.5 mg/dL hemoglobin. |
| Agreement with predicate device (Chemstrip occult blood test) for 101 dialysate samples (negative for blood leaks). | Both SERIM strips and Chemstrip occult blood test gave negative readings for blood leaks in all 101 dialysate samples. |
| Agreement with predicate device for spiked dialysate samples (33 samples spiked with 1.5 mg/dL hemoglobin). | All 33 spiked samples gave positive blood leak readings with both types of strips (SERIM and Chemstrip). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- 100 negative samples (dialysis buffer without blood).
- 100 positive samples (dialysis buffer with 1.5 mg/dL hemoglobin).
- 101 dialysate samples collected at a dialysis clinic.
- 33 of the 101 dialysate samples were spiked with blood.
- Data Provenance: The document does not explicitly state the country of origin, but given the FDA submission, it is likely US-based. The study appears to be a prospective evaluation of the strips against defined standards and collected dialysate samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions that "12 participants" used the SERIM Blood Leak Test Strips to test blood standards in "blind studies." It does not specify their qualifications or if they are considered "experts" in the sense of establishing ground truth.
For the ground truth of the blood concentrations (1.5 mg/dL hemoglobin), it was "determined by the cyanmethemoglobin method," which is a laboratory assay. This implies chemical validation rather than expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for disagreements. The results are presented as direct counts of positive and negative readings. Since it's a diagnostic strip interpreted against a color chart, the "adjudication" (if any) would likely be an intrinsic part of the 12 participants' individual interpretations, though this isn't explicitly detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This study evaluates a diagnostic test strip, which is a standalone device interpreted by a user, not an AI system assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the study evaluates the SERIM Blood Leak Test Strips as a standalone diagnostic device. The "algorithm" here is the chemical reaction on the strip leading to a color change, which is then visually compared to a reference color chart on the bottle label by the user. The performance reported (specificity and sensitivity) is for this standalone function (device + user interpretation). The "12 participants" are the human-in-the-loop for interpretation, but the focus is on the device's ability to produce the correct color change.
7. The Type of Ground Truth Used
The ground truth used was a combination of:
- Laboratory Assay/Known Concentration: For the 100 positive samples, the hemoglobin concentration of 1.5 mg/dL was "determined by the cyanmethemoglobin method." For the negative samples, it was dialysis buffer without blood, representing a known absence.
- Comparator Device Performance (for clinical samples): For the 101 dialysate samples and the 33 spiked samples, the performance of the SERIM strips was compared to "Chemstrip occult blood strips" (the predicate device). While not a standalone "ground truth" in terms of direct pathology or outcomes data, the agreement with an established, legally marketed equivalent device serves as a strong comparator for substantial equivalence.
8. The Sample Size for the Training Set
The document does not mention a training set for the device. This is a diagnostic test strip that relies on chemical reactions and visual interpretation, not a machine learning or AI-based device that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable for this type of device, this question is not relevant to the provided documentation.
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