(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.
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DEC = 7 2004
510(k) SUMMARY
| Prepared: | November 13, 2004 |
|---|---|
| Submitter: | Hach Company |
| Address: | 23575 County Road 106Elkhart, IN 46514U.S.A.(219) 262-2060 |
| Contact: | David A. Morris, Ph.D.Director of Technology |
| Device Trade/Proprietary Name: | SteriChek® Blood Leak Reagent Strips, 510(k) No. K042322 |
| Device CommonName: | Blood Leak Reagent Strips |
| Classification Name: | 21 CFR 876.5820 Hemodialysis system and accessories, Class II |
| Product Code: | 78-FJD |
| Predicate Device: | Serim™ Blood Leak Test Strips, 510(k) No. K012115 and K990206 |
| Device Description: | The device is made up of a 0.20 inch square yellow reagent pad that hasbeen chemically treated to detect the presence of blood in the dialysatesolution used in Hemodialysis. The pad is affixed to one end of a 3.25inch by 0.20 inch white opaque polystyrene strip. To use the reagentstrip, the reagent pad is immersed in the sample, removed immediatelyand allowed to react for 60 seconds. The reagent pad is then comparedwith the color blocks on the bottle label. The Negative color block isyellow with small blue-green speckles. If a reagent pad has a similaryellow color 60 seconds after reaction with dialysate, then the dialysatedoes not contain significant blood. The Positive color block is green. Areagent pad with color equal to or darker than the Positive color blockindicates the presence of significant blood leak. The speckles on the colorblocks represent the reaction image that might be left by intact red bloodcells that might land on the reagent pad. |
| Intended Use: | SteriChek Blood Leak Reagent Strips provide a quick convenient meansof testing for occult blood in dialysate. |
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CONFIDENTIAL
K042322 - 510(k) Summary
K042322 - 510(k) Summary
| The Association for the Advancement of Medical Instrumentation (AAMI)(1) recommends that all Hemodialysis systems shall have a method ofdetecting blood in the dialysate. In the alarm condition the detector shallinitiate audible and visual alarms. The high alarm limit shall be not morethan 0.35 mL/minute for a fixed alarm limit at a hematocrit of 25% (0.25).The leak rate of 0.35 mL/minute calculates to a level of 5.5 mg/dL ofhemoglobin in the dialysate, assuming a hematocrit of 25% and a dialysateflow of 0.5 L/minute). For many years, Hemodialysis technicians haveused reagent strips to assist in differentiating an actual blood leak from afalse alarm to avoid unnecessary interruption of the Hemodialysisprocedure. A confirmed blood leak requires termination of the dialysissession and restarting with a new dialyzer. Interrupting a dialysis sessioncan be very stressful to the patient. | |
|---|---|
| SteriChek Blood Leak Reagent Strips detect very low levels of blood indialysate. The reagent strips give positive readings at 1.5 mg/dL ofhemoglobin. The reagent strips are more sensitive than the AAMIrecommended setting of 5.5 mg/dL for blood leak monitors. Thisincreased sensitivity of the reagent strips provides a safety margin. | |
| TechnologicalCharacteristics: | Reagent strip method to test for occult blood by color change resultingfrom a reaction between an indicator and an oxidant when hemoglobinfrom red blood cells is present. |
| Assessment ofPerformance: | The performance characteristics of SteriChek® Blood Leak Reagent Strips andSerim™ Blood Leak Test Strips were analyzed with suspensions of whole bloodin dialysate and solutions of human hemoglobin in dialysate. The hemoglobin wasmeasured with the Drabkin spectrophotometric method. The sensitivity of thereagent strip methods was equivalent. |
| The Drabkin method is the standard used in most laboratories. In this method,hemoglobin or oxyhemoglobin is converted to a stable pigment calledcyanmethemoglobin by adding the blood sample to alkaline "Drabkin's solution".Drabkin's solution contains potassium ferricyanide, potassium cyanide, sodiumbicarbonate and a surfactant. The absorbance of the stable pigment is measured at540 nm with a spectrophotometer. The absorbance value is a measure of thehemoglobin present in the sample. | |
| Conclusion: | The SteriChek® Blood Leak Reagent Strips have the same intended use asthe predicate device. The SteriChek® Blood Leak Reagent Strips have notechnological characteristics that raise new types of safety or effectivenessquestions. |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 2004
David A. Morris, Ph.D. Director of Technology Hach® Company 23575 County Road 106 ELKHART IN 46514
Re: K042322
Trade/Device Name: SteriChek® Blood Leak Reagent Strips Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FJD Dated: November 13, 2004 Received: November 15, 2004
Dear Dr. Morris:
We have reviewed your Section 510(k) premarket notification of intent to make the device referenced in We have reviewed your Section 510(R) premarket nearcally equivalent (for the stated in the above and have detenmined the devices marketed in interstate commerce prior to the enclosure) to legally marketed predicato don't be ice Amendments, or to devices that have been May 28, 1976, the enactinent aate of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of another (PMA). You may, therefore, market the A do not require approval of a premiations of the Act. The general controls provisions of the Act device, subject to the general controls provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarker If your device is classified (see above) into entrols. Existing major regulations affecting your Approval), If may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parts 800 loca device can be found in the Sode of Perocerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat IDA S Issualice of a substance of a substances of the Act or any
FDA has made a determination that your device complies with other requirements of the FDA has made a delemination mar your do view Federal agencies. You must comply with all the rederal statues and regulations administered by other in ton and listing (21 CFR Part 807); labeling Act 's requirements, including practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing practice requirement
regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to orgin maing of substantial equivalence of your device to a legally prematication: "The PDF Intentige size in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific act 100 of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please the regaral information on your responsibilities under the Act from the 807.77). Tou may obtain curers, International and Consumer Assistance at its toll-free number (800) DVISIon of onlin Manatacarers, its Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO4a22a pg. 1041
SteriChek™ Blood Leak Reagent Strips 510(k) Submission Hach Company
510(k) Number (if known) __KO42322
Device Name: SteriChek® Blood Leak Reagent Strips.
Indications for Use:
SteriChek® Blood Leak Reagent Strips provide a quick convenient means of checking the Sterence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor of the Hemodialysis machine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy Brogdon
(Division Sign-(Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 7
§ 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.