(234 days)
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No
The device description details a simple paper-based dry chemistry reagent strip that relies on visual comparison to color blocks for quantitative estimation. There is no mention of any computational processing, algorithms, or learning capabilities.
No
This device is a test strip used to measure the concentration of a disinfectant solution, not to directly treat a medical condition or disease.
No
The device is described as an "efficacy test strip for measuring effective levels of peroxide in Renalin® disinfectant solution," and is used to monitor the concentration of a disinfectant, not to diagnose a medical condition in a patient.
No
The device description explicitly states it is a "paper based dry chemistry reagent strip" with a "plastic handle," indicating it is a physical, hardware-based device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to measure the concentration of peroxide in a disinfectant solution (Renalin®). This measurement is performed in vitro (outside of the body) on a sample of the disinfectant solution.
- Purpose: The measurement is used to assess the efficacy of the disinfectant solution for reprocessing kidney units. This directly relates to ensuring the safety and effectiveness of a medical procedure (dialysis).
- Device Description: It's a "dry chemistry reagent strip" that interacts with the solution to produce a color change, which is then interpreted to determine the concentration. This is a common format for IVD tests.
The key characteristic of an IVD is that it's used to examine specimens derived from the human body or to provide information about a physiological state, a disease, or a congenital abnormality. While this specific test isn't directly testing a human specimen, it's testing a solution used in a medical process that directly impacts human health. The result of the test (the peroxide concentration) provides critical information about the safety and effectiveness of the reprocessing procedure, which is essential for patient care.
Therefore, the High Range Peroxide™ Test Strip fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
High Range Peroxide™ Strip is intended to be used to measure Renalin concentration and to confirm the presence of 1 % or higher of Renalin® solution in the reprocessed kidney units. Since the strip measures actual Renalin8 concentration from 0.2 to 3.0 % without dilution, it gives a better indication and easier management in kidney reprocessing.
High Range Peroxide™ Test Strip is intended for use as an efficacy test strip for measuring effective levels of peroxide in Renalin® disinfectant solution. Each time when the kidney unit is reprocessed with peroxide disinfectant solution such as Renalin® , the reprocessing solution should be monitored with the High Range Peroxide™ Test Strip to assure that Renaline concentration is 3% as it is intended to be. After the kidney is placed under storage until next use, the Renaling concentration in the disinfectant solution should be checked again before rinsing with the strip to assure that Renalins concentration has been maintained at 1% or higher. If the Renaling concentration drops below 1%, the kidney unit has to be either reprocessed or discarded.
Product codes (comma separated list FDA assigned to the subject device)
78 FKP, LIF
Device Description
High Range Peroxide™ Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. It is a self-contained, ready to use dip-andread reagent strip without additional reagent. The strip is packaged in 50 or 100's in bottles. Color blocks corresponding to Renalin8 concentrations of 0.2, 0.5, 1.0, 2.0 and 3.0 % are printed on the bottle label. Quantitative estimation of Renalink concentration can be made by comparing the strip color to the color blocks.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
0
510(k) SUMMARY
JUN | 6 1997
High Range Peroxide Test Reagent Strip for Testing Potency of Renalin' Solution
SUBMITTER:
| Name: | Wen H. Wu, Ph. D. | Date Prepared: | October 24, 1996 |
|---|---|---|---|
| Address: | 2931 Moose Trail | ||
| Elkhart, IN 46514 | |||
| Phone: | (219) 264-0025 | ||
| Fax: | (219) 264-2787 |
Wen H. Wu, Ph. D. Contact:
Device Name:
| Trade Name: | High Range Peroxide™ Strip |
|---|---|
| Common Name: | Reagent Strip for RenalinR Peroxide |
| Classification Name: | 876.5820 Hemodialysis System Accessories |
COMPARATIVE PRODUCT:
Renalin Perassay™ 500 - Marketed by Renal System, Minneapolis, MN 55447
DESCRIPTION OF THE NEW DEVICE:
High Range Peroxide™ Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. It is a self-contained, ready to use dip-andread reagent strip without additional reagent. The strip is packaged in 50 or 100's in bottles. Color blocks corresponding to Renalin8 concentrations of 0.2, 0.5, 1.0, 2.0 and 3.0 % are printed on the bottle label. Quantitative estimation of Renalink concentration can be made by comparing the strip color to the color blocks.
INTENDED USE:
High Range Peroxide™ Strip is intended to be used to measure Renalin concentration and to confirm the presence of 1 % or higher of Renalin® solution in the reprocessed kidney units. Since the strip measures actual Renalin8 concentration from 0.2 to 3.0 % without dilution, it gives a better indication and easier management in kidney reprocessing.
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1
TECHNOLOGICAL COMPARISON:
Both the IBT High Range Peroxide™ strips and Renalin Perassay™ 500 strips are based on the oxidation of iodide to iodine by peroxide. In the case of Renalin Perassay™ 500 strip, threshold reactivity is modulated so that the strip will turn black blue only when Renaling concentration is 1% or higher. It can only provide qualitative indication of Positive (1 % or higher) or Negative (less than 1%). In the case of High Range Peroxide™ Test, a coupler is used where the strip reactivity is modulated to provide a continuous reaction range with Renalin from 0.2 to 3.0 % or equivalent peroxide levels from 100 to 1,500 ppm. It can be used as a quantitative test for Renalink or other peroxide disinfectants.
SUBSTANTIAL EQUIVALENCY STATEMENT:
Both the IBT High Range Peroxide™ Test and Renalin Perassay™ 500 Test are equally effective in detecting Positive, i.e., 1 % or higher, of Renalin® concentration in the kidney reprocessing solution. Renalin Perassay™ 500 Test, however, can only provide qualitative Positive or Negative indication of Renalin® concentration above or below 1 %. IBT High Range Peroxide™ test, on the other hand, will give quantitative results and provide more accurate indication of effective Renalin8 concentration.
Submitter: Wen H. Wu, Ph. D. Date: Oct 30. 46
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICE - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 16 1997
Wen H. Wu, Ph.D. President Integrated Biomedical Technology, Inc. 2931 Moose Trail Elkhart, Indiana 46514
Re: K964264
High Range Peracid Test Strips . .. . . . . . . Dated: March 15, 1997 Received: March 18, 1997 Regulatory class: II 21 CFR §876.5820/Product codes: 78 FKP and LIF
कु Dear Dr. Wu:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Kiliai Yi
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_1_of_1_
5100k) Number (if known): K964264
Devicc Name: High Range Perqxide_Reagent Strip
Indications For Use:
Indications for Use:
High Range Peroxide™ Test Strip is intended for use as an efficacy test strip for measuring effective levels of peroxide in Renalin® disinfectant solution. Each time when the kidney unit is reprocessed with peroxide disinfectant solution such as Renalin® , the reprocessing solution should be monitored with the High Range Peroxide™ Test Strip to assure that Renaline concentration is 3% as it is intended to be. After the kidney is placed under storage until next use, the Renaling concentration in the disinfectant solution should be checked again before rinsing with the strip to assure that Renalins concentration has been maintained at 1% or higher. If the Renaling concentration drops below 1%, the kidney unit has to be either reprocessed or discarded.
10-30-96
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Roter Athing (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K964264 |
Prescription Use_L (Por 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)