(246 days)
Serim™ Bicarb pH II Test Strips
Not Found
No
The device description explicitly states that the color of the pad is "visually compared to a color chart" to determine the pH, indicating a manual, non-AI/ML process. There are no mentions of AI, ML, or related concepts in the summary.
No
The device is described as a reagent strip used to check the pH of bicarbonate solutions for dialysate preparation, not for direct therapeutic use on a patient. Its function is to provide information for the preparation of a therapeutic solution, not to directly treat a medical condition.
No
This device measures the pH of a bicarbonate solution used for preparing dialysate, which is a quality control check for a medical process, not a measurement of a biological parameter to diagnose a disease in a patient.
No
The device description clearly states it is a physical strip with a reagent pad, which is a hardware component. The pH determination is done by visual comparison to a color chart, not through software analysis.
Based on the provided information, the SteriChek® Bicarb pH Reagent Strips are an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended for checking the pH of bicarbonate solutions used in the preparation of dialysate. This involves testing a sample (the bicarbonate solution) outside of the human body to provide information relevant to a medical process (dialysis).
- Device Description: It's a reagent strip designed to react chemically with the sample and produce a visually interpretable result (color change). This is a common format for IVD tests.
- Performance Studies: The description includes performance studies comparing the device to a predicate device and a standard reference method, which is typical for demonstrating the analytical performance of an IVD.
While the device doesn't involve image processing, AI, or specific patient information, its core function of testing a sample in vitro to provide information for a medical procedure clearly places it within the definition of an IVD.
N/A
Intended Use / Indications for Use
SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of the bicarbonate solution of used to prepare dialysate or concentrated bicarbonate solution used in the preparation of dialysate. The color that develops in the pad after exposure to the sample according to the directions is compared to a color chart to determine the pH of the sample.
SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate solutions used in the preparation of dialysate.
Product codes
78 MNV
Device Description
The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the pH of the bicarbonate solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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® Bicarb pH Reagent Strips and Serim™ Bicarb pH II Test Strips were analyzed with acid/bicarbonate solutions and concentrated bicarbonate solutions. Acid/bicarbonate solutions were prepared through adjustment of acidic and basic components to give discrete pH levels. Concentrated bicarbonate solutions were prepared through progressive conversion of the sodium bicarbonate to its carbonate form by aging. A standard reference method with calibration based on NIST traceable standard reference material was used to determine the reference pH values. The performance was equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Serim™ Bicarb pH II Test Strips
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
SteriChek™ Bicarb pH Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
·
510(k) SAFETY AND EFFECTIVENESS SUMMARY
DEC 2 3 2003
| Prepared: | April 18, 2003 |
|---|---|
| Submitter: | Environmental Test Systems, Inc. |
| 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® Bicarb pH Reagent Strips |
| Device Common | |
| Name: | Bicarb pH Reagent Strips |
| Classification Name: | Class II |
| CH | |
| Predicate Device: | Serim™ Bicarb pH II Test Strips |
| Device Description: | The device is made up of a 0.20 inch square off-white reagent pad that has |
| been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch | |
| white opaque polystyrene strip. The reagent pad is activated by exposing | |
| it to the sample. The color of the pad is visually compared to a color chart | |
| to determine the pH of the bicarbonate solution. | |
| Intended Use: | SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of |
| checking the pH of the bicarbonate solution of used to prepare dialysate or | |
| concentrated bicarbonate solution used in the preparation of dialysate. The | |
| color that develops in the pad after exposure to the sample according to the | |
| directions is compared to a color chart to determine the pH of the sample. | |
| Technological | |
| Characteristics: | The pH of the bicarbonate solution or bicarbonate concentrate is obtained |
| by comparing the color of the reagent pad with color blocks on the label. |
1
K0312407
SteriChek™ Bicarb pH Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
The color blocks are calibrated in terms of pH values. The device is used to measure the pH of bicarbonate solutions and concentrated bicarbonate solutions.
SteriChek® Bicarb pH Reagent Strips contains the indicators, Cresol Red and Phenol Red. The indicators undergo a color change that is dependent on the pH or hydrogen ion concentration of the sample.
Assessment of The performance characteristics of SteriChek® Bicarb pH Reagent Strips and Performance: Serim™ Bicarb pH II Test Strips were analyzed with acid/bicarbonate solutions and concentrated bicarbonate solutions. Acid/bicarbonate solutions were prepared through adjustment of acidic and basic components to give discrete pH levels. Concentrated bicarbonate solutions were prepared through progressive conversion of the sodium bicarbonate to its carbonate form by aging. A standard reference method with calibration based on NIST traceable standard reference material was used to determine the reference pH values. The performance was equivalent.
Conclusion: The SteriChek® Bicarb pH Reagent Strips have the same intended use as the predicate device. The predicate device's indicator system is different than that of the Bicarb pH Reagent Strips. However, both systems effectively measure the pH or hydrogen ion concentration of bicarbonate solutions. The SteriChek® Bicarb pH 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
David A. Morris, Ph.D. Director, Research Environmental Test Systems, Inc. P.O. Box 4659 ELKHART IN 46514-0659
Re: K031267
Trade/Device Name: SteriChek® Bicarb pH Reagent Strips Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 MNV Dated: August 29, 2003 Received: September 29, 2003
Dear Dr. Morris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct forth in the quality systems (QS) 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) I his lotter will and w you to co co finding of substantial equivalence of your device to a legally promaticated predicated. " ce 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), please If you desire spoolite at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Other of Othphanes as ( endification" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
SteriChek™ Bicarb pH Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
510(k) Number (if known) K031267
Device Name: SteriChek® Bicarb pH Reagent Strips.
Indications for Use:
SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate solutions used in the preparation of dialysate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﻠﻴ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
David A. Leyva
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Device
Number K031267
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