(199 days)
Not Found
Not Found
No
The device is a simple chemical test strip that changes color based on pH, with no mention of AI/ML in the description or performance studies.
No.
This device is a test strip intended for monitoring pH in dialysate and water, not for directly treating a medical condition.
No
The device is used to monitor the pH of dialysate and water, which are components used in dialysis machines, not to diagnose a medical condition in a patient.
No
The device description explicitly states it is a "reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Dialysate or Water respectively. The pad is attached to a plastic strip for handling." This describes a physical, chemical-based test strip, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the test strips are for "monitoring of pH in Dialysate and Water." Dialysate is a solution used in hemodialysis, which is a medical procedure. While the test is performed on the dialysate and water outside of the patient's body, it is directly related to a medical treatment and the quality of the materials used in that treatment.
- Device Description: The device is a "reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Dialysate or Water." This describes a chemical reaction used to analyze a sample in vitro (outside the living body).
- Performance Studies: The performance studies evaluate the device's ability to accurately measure pH in "acid/bicarbonate dialysate, bicarbonate concentrate and water." This further reinforces its use in analyzing substances related to a medical procedure.
- Predicate Device: The predicate device listed is "SERIM® BICARB PH REAGENT STRIPS," which is also likely an IVD used for similar purposes.
In summary, the device is designed to perform a test on a sample (dialysate or water) outside of the body to provide information relevant to a medical treatment (hemodialysis). This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessing Products Corporation Test Strips are intended for use in the monitoring of pH in Dialysate and Water.
The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water.
- pH Test Strips are comprised of two different pH . ranges:
- . pH = 6.8-8.5 (K100-0117) is for acid/bicarbonate dialysate, bicarbonate concentrate and water
- pH = 0-14 (K100-0104) is for water used to . make up dialysate.
Product codes (comma separated list FDA assigned to the subject device)
MSY, MNV
Device Description
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Dialysate or Water respectively. The pad is attached to a plastic strip for handling.
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 data confirm that the product consistently generates color changes which match the color blocks for the Reference solution pH. Reference solutions were used to evaluate pH performance between 6.8 and 8.5 in acid/bicarbonate dialysate, bicarbonate concentrate and water, and the pH performance between 0 and 14 in water used to prepare dialysate. These data demonstrate appropriate performance for use in hemodialysis dialysate and water.
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.
0
K101750 Page 1 of 2
510(k) SUMMARY
JAN - 7 2011
| Prepared: | December 14, 2010 | |
|---|---|---|
| Submitter: | Reprocessing Products Corporation | |
| Address: | 3655 N. Oracle Road | |
| Tucson, AZ 85705 | ||
| Phone: | 520-888-5551 | |
| Fax: | (Fax) 520-888-5557 | |
| Contact: | Michael Honstein, Chief Operating Officer | |
| Device Trade Name: | Two ranges: | |
| 0-14 pH Test Strips (K100-0104) and 6.8- | ||
| 8.5 pH Test Strips (K100-0117) | ||
| Common or Usual Name: | pH Test Strips | |
| Device Classification Name: | Strip, Test, Reagent, Dialysate, Water | |
| Product Code: | MSY | |
| Class: | II | |
| Regulation Number: | 876.5665 | |
| Substantial Equivalence: | The Reprocessing Products Corporation | |
| pH Test Strips are substantially equivalent | ||
| to the SERIM® BICARB PH REAGENT | ||
| STRIPS | ||
| Device Description: | Device is semi-quantitative, reagent test | |
| strip comprised of a pad impregnated with | ||
| chemicals which change color upon | ||
| contact with Dialysate or Water | ||
| respectively. The pad is attached to a | ||
| plastic strip for handling. | ||
| Intended Use: | The Reprocessing Products Corporation | |
| Test Strips are intended for use in the | ||
| monitoring of pH in Dialysate and Water. | ||
| Technological Characteristics: | pH test strips are comprised of two | |
| different pH ranges: The K100-0117 test | ||
| Strips will determine the pH in the range | ||
| of 6.8 -8.5 for acid/bicarbonate dialysate, | ||
| bicarbonate concentrate and water used to | ||
| prepare dialysate. The K100-0104 test | ||
| strips will determine the in the range of 0- | ||
| 14 pH for water used to prepare dialysate. | ||
| The test strip contains a specialized | ||
| chemical formulation that reacts with the | ||
| Hydrogen ion concentration in solutions of | ||
| dialysate and water. The reaction results in | ||
| a color change which is correlatable to the | ||
| concentration of Hydrogen ions in the | ||
| solution. | ||
| The color change is interpreted by the use | ||
| of color blocks on two separate (ranges) | ||
| color charts. Gradations for 6.8-8.5 pH | ||
| Test Strips (K100-0117) include 6.8, 7.0, | ||
| 7.2, 7.4, 7.6, 7.8, 8.0, and 8.5. Gradations | ||
| for the 0-14 pH test strips (K100-0104) | ||
| include 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, | ||
| 12, 13, and 14. | JAN - 7 | |
| Performance: | The data confirm that the product | |
| consistently generates color changes which | ||
| match the color blocks for the Reference | ||
| solution pH. Reference solutions were | ||
| used to evaluate pH performance between | ||
| 6.8 and 8.5 in acid/bicarbonate dialysate, | ||
| bicarbonate concentrate and water, and the | ||
| pH performance between 0 and 14 in water | ||
| used to prepare dialysate. These data | ||
| demonstrate appropriate performance for | ||
| use in hemodialysis dialysate and water. | ||
| Conclusion: | The Reprocessing Products Corporation | |
| pH test strips have the same intended use | ||
| as the predicate device. Test strips measure | ||
| the hydrogen ion concentration in | ||
| acid/bicarbonate dialysate or water. The | ||
| Reprocessing Products Corporation pH | ||
| Test Strips have no characteristics which | ||
| raise new types of safety and effectiveness | ||
| questions. The Reprocessing Products | ||
| Corporation pH Test Strips can be used to | ||
| monitor the pH (hydrogen ion | ||
| concentration) present in water and/or | ||
| dialysate. |
.
1
K101750 Page 2 of 2
2011
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
7 2011 JAN
Reprocessing Products Corp. c/o Mr. Walter B. Jansen MedReg Consulting 8662 Comstock Lane N. . MAPLE GROVE MN 55311-1436
Re: K101750
Trade/Device Name: RPC E-Z CHEK® pH TEST STRIPS Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: MNV Dated: January 5, 2011 Received: January 5, 2011
Dear Mr. Jansen:
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 adulteration. Please note: CDRH does not evaluate information related to contract liability v warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
3
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default:htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the letters "RPC" in a bold, sans-serif font. The letters are black and stand out against a white background. To the left of the letters "RPC" is the letters "RP" inside of a square. There is an arrow pointing up between the letters "R" and "P".
4 Statement of Indications for Use:
Indications for Use
JAN - 7 2011
510(k) Number (if known): K101750
RPC E-Z CHEK® pH TEST STRIPS Device Name: Indications for Use: The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water.
- pH Test Strips are comprised of two different pH . ranges:
- . pH = 6.8-8.5 (K100-0117) is for acid/bicarbonate dialysate, bicarbonate concentrate and water
- pH = 0-14 (K100-0104) is for water used to . make up dialysate.
Prescription Use X AND/OR Over the Counter Use (Part 21 CFR 801 Subpart D) (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
form m Nha
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101756