(88 days)
Not Found
Not Found
No
The device description and performance studies indicate a simple chemical reagent strip, with no mention of AI or ML.
No.
The device is a peroxide reagent strip used to measure the concentration of peroxide in water for rinsing dialysate lines and dialyzers, not for direct therapeutic treatment on a patient.
No
The device is used to measure residual peroxide in water used for rinsing dialysate lines and dialyzers, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a physical strip with a reagent pad, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure the concentration of peroxide remaining in water used for rinsing dialysate lines and dialyzers. This is a test performed on the water itself, not on a biological sample from a patient.
- Device Description: The device is a reagent strip designed to react with chemicals in the water. It does not interact with or analyze biological specimens.
- Lack of Biological Sample Analysis: IVDs are specifically designed to perform tests on biological samples (like blood, urine, tissue, etc.) to provide information about a person's health or condition. This device does not do that.
Therefore, the SteriChek™ Residual Peroxide Reagent Strips fall under the category of a chemical test for water quality, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SteriChek™ Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid. The chemically treated pad changes color relative to the amount of peroxide remaining in the rinse.
SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.
Product codes (comma separated list FDA assigned to the subject device)
78 LIF
Device Description
The device is made up of a 0.20 square inch off-white reagent pad that is chemically treated to detect peroxide in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
The concentration of peroxide in rinse water is obtained by comparing the color of the reagent pad with color blocks on the label. The color blocks are calibrated in terms of peroxide concentration in parts per million (ppm). The device is used as a rapid screening method to detect levels of less than 1.0 ppm, or as a quantitative method to allow estimation of peroxide concentration between 0 and 10 ppm.
SteriChek™ Peroxide Reagent Strips contain 4-Residual aminoantipyrine (4AAP) and 8-amino-2-naphthalene sulfonic acid (ANS), two colorless compounds which serve as the indicator system, peroxidase and a pH buffer. The reaction of the indicator reagents with hydrogen peroxide is catalyzed by peroxidase. This reaction of the indicators gives rise to a red-purple color. The intensity of the color is proportional to the concentration of the peroxide.
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 predicate device has been manufactured by Environmental Test Systems, Inc. since its introduction by Serim Research Corporation. ETS will manufacture the SteriChek™ Residual Peroxide Reagent Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name. The change in formulation provides for different color development but follows the same test principles as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for ETS, which stands for Educational Testing Service. The logo is in black and white and features the letters "ETS" in a bold, stylized font. There are two horizontal lines above and below the letters.
Environmental Test Systems, Inc.
PInz
¥974798
MAR 20 1998
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | December 12, 1997 |
|---|---|
| Submitter: | Environmental Test Systems, Inc. |
| Address: | 23575 County Road 106 |
| Elkhart, IN 46514-0659 | |
| U.S.A. | |
| (219) 262-2060 | |
| Contact: | Bruce G. Piekarski, Director-Business Development |
| Device Trade/ | |
| Proprietary Name: | SteriChek™ Residual Peroxide Reagent Strips |
| Device Common | |
| Name: | ETS Peroxide Reagent Strips |
| Classification Name: | Class II |
| CH | |
| Predicate Device: | Serim™ Peroxide Reagent Strips |
| Manufactured by Environmental Test Systems, Inc. (for Serim | |
| Research Corporation) | |
| Device Description: | The device is made up of a 0.20 square inch off-white reagent pad that |
| is chemically treated to detect peroxide in water. The pad is affixed to | |
| one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. | |
| Intended Use: | SteriChek™ Peroxide Reagent Strips provide a convenient means for |
| measuring the concentration of peroxide remaining in water being | |
| used to rinse out dialysate lines and dialyzers following disinfection | |
| with peroxide/peracetic acid. The chemically treated pad changes | |
| color relative to the amount of peroxide remaining in the rinse. |
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1
K974798
P2012
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SteriChek Residual Peroxide Reagent Strips 510(k) Safety and Effectiveness Summary - December 12, 1997 Environmental Test Systems, Inc. (Page 2 of 2)
The concentration of peroxide in rinse water is obtained by comparing Technological the color of the reagent pad with color blocks on the label. The color Characteristics: blocks are calibrated in terms of peroxide concentration in parts per million (ppm). The device is used as a rapid screening method to detect levels of less than 1.0 ppm, or as a quantitative method to allow estimation of peroxide concentration between 0 and 10 ppm.
SteriChek™ Peroxide Reagent Strips contain 4-Residual aminoantipyrine (4AAP) and 8-amino-2-naphthalene sulfonic acid (ANS), two colorless compounds which serve as the indicator system, peroxidase and a pH buffer. The reaction of the indicator reagents with hydrogen peroxide is catalyzed by peroxidase. This reaction of the indicators gives rise to a red-purple color. The intensity of the color is proportional to the concentration of the peroxide.
Assessment of The predicate device has been manufactured by Environmental Test Systems, Inc. since its introduction by Serim Research Corporation. Performance: ETS will manufacture the SteriChek™ Residual Peroxide Reagent Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name. The change in formulation provides for different color development but follows the same test principles as the predicate device.
The SteriChek™ Residual Peroxide Reagent Strips have the same Conclusion: intended use as the predicate device. There will be no changes in the design, materials or other features compared to the predicate device, other than the change of indicators and the trade or proprietary name of the device. The SteriChek™ Residual Peroxide Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 20 1998
Mr. Bruce G. Piekarski Director - Business Development Environmental Test Systems, Inc. P.O. Box 4659 Elkhart, IN 46514-0659
Re: K974798
SteriChek™ Residual Peroxide Reagent Strips Dated: December 19, 1997 Received: December 22, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 LIF
Dear Mr. Piekarski:
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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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) 594-4613. 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/cdrb/dsmamain.html".
Sincerely vours
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
SteriChek Residual Peroxide Reagent Strips 510(k) Submission - December 12, 1997 Environmental Test Systems, Inc.
510(k) Number (if known)
Device Name: SteriChek™ Residual Peroxide Regent Strips
Indications for Use:
SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use | (Per 21 CFR 801.109)
Over-The Counter Use
OR