(103 days)
Not Found
No
The device description and performance summary indicate a simple chemical reaction-based test strip with visual comparison to a color chart, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is a diagnostic testing reagent strip used to detect blood leaks in dialysate, not to treat a condition or disease.
Yes
The device provides a "means of checking the presence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor," and its output (color change) is interpreted to indicate the "presence of significant blood leak," which are diagnostic functions.
No
The device is a physical reagent strip with a chemically treated pad, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "testing for occult blood in dialysate" and "checking the presence of Blood in dialysate". This involves analyzing a sample (dialysate) taken from a patient's treatment process to provide information about the patient's condition (presence of blood leak).
- Device Description: The device is a "reagent strip" with a "chemically treated" pad designed to "detect the presence of blood in the dialysate solution". This is a classic description of an in vitro diagnostic test.
- Mechanism of Action: The device works by a chemical reaction that produces a color change based on the presence of blood components in the dialysate sample. This is an in vitro process.
- Performance Studies: The performance studies describe testing the device with "suspensions of whole blood in dialysate and solutions of human hemoglobin in dialysate". This further confirms that the device is designed to analyze biological substances in a sample outside of the body.
- Predicate Devices: The predicate devices listed are also "Blood Leak Test Strips", which are typically classified as IVDs.
The device is used to analyze a sample (dialysate) outside of the body to provide information relevant to the patient's treatment and potential complications (blood leak). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
78-FJD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of SteriChek® Blood Leak Reagent Strips and Serim™ Blood Leak Test Strips were analyzed with suspensions of whole blood in dialysate and solutions of human hemoglobin in dialysate. The hemoglobin was measured with the Drabkin spectrophotometric method. The sensitivity of the reagent strip methods was equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SteriChek Blood Leak Reagent Strips detect very low levels of blood in dialysate. The reagent strips give positive readings at 1.5 mg/dL of hemoglobin. The reagent strips are more sensitive than the AAMI recommended setting of 5.5 mg/dL for blood leak monitors.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Serim™ Blood Leak Test Strips, 510(k) No. K012115 and K990206
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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page 1 of 2
DEC = 7 2004
510(k) SUMMARY
| Prepared: | November 13, 2004 |
|---|---|
| Submitter: | Hach Company |
| Address: | 23575 County Road 106 |
| Elkhart, IN 46514 | |
| U.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 Common | |
| Name: | 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 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. | |
| Intended Use: | SteriChek Blood Leak Reagent Strips provide a quick convenient means |
| of testing for occult blood in dialysate. |
1
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 of
detecting blood in the dialysate. In the alarm condition the detector shall
initiate audible and visual alarms. The high alarm limit shall be not more
than 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 of
hemoglobin in the dialysate, assuming a hematocrit of 25% and a dialysate
flow of 0.5 L/minute). For many years, Hemodialysis technicians have
used reagent strips to assist in differentiating an actual blood leak from a
false alarm to avoid unnecessary interruption of the Hemodialysis
procedure. A confirmed blood leak requires termination of the dialysis
session and restarting with a new dialyzer. Interrupting a dialysis session
can be very stressful to the patient. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SteriChek Blood Leak Reagent Strips detect very low levels of blood in
dialysate. The reagent strips give positive readings at 1.5 mg/dL of
hemoglobin. The reagent strips are more sensitive than the AAMI
recommended setting of 5.5 mg/dL for blood leak monitors. This
increased sensitivity of the reagent strips provides a safety margin. |
| Technological
Characteristics: | Reagent strip method to test for occult blood by color change resulting
from a reaction between an indicator and an oxidant when hemoglobin
from red blood cells is present. |
| Assessment of
Performance: | The performance characteristics of SteriChek® Blood Leak Reagent Strips and
Serim™ Blood Leak Test Strips were analyzed with suspensions of whole blood
in dialysate and solutions of human hemoglobin in dialysate. The hemoglobin was
measured with the Drabkin spectrophotometric method. The sensitivity of the
reagent 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 called
cyanmethemoglobin by adding the blood sample to alkaline "Drabkin's solution".
Drabkin's solution contains potassium ferricyanide, potassium cyanide, sodium
bicarbonate and a surfactant. The absorbance of the stable pigment is measured at
540 nm with a spectrophotometer. The absorbance value is a measure of the
hemoglobin present in the sample. |
| Conclusion: | The SteriChek® Blood Leak Reagent Strips have the same intended use as
the predicate device. The SteriChek® Blood Leak Reagent Strips have no
technological characteristics that raise new types of safety or effectiveness
questions. |
2
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.
3
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
4
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
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