E-Z CHEK BLOOD LEAK TEST STRIPS

K123805 · Reprocessing Products Corp · FJD · Mar 20, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123805
• Device Name: E-Z CHEK BLOOD LEAK TEST STRIPS
• Applicant: Reprocessing Products Corp
• Product Code: FJD · Gastroenterology, Urology
• Decision Date: Mar 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

The Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips are designed to indicate the presence or absence of blood in dialysate during the hemodialysis procedure. The test strips will measure equal to 0 mg HGB/dL and 0.25 mg HGB/dL in dialysate.

Device Story

E-Z Chek Blood Leak Test Strips are semi-quantitative, reagent-impregnated pads attached to plastic strips. Used during hemodialysis procedures to detect blood leaks in dialysate. Principle of operation: pseudoperoxidative activity of hemoglobin and myoglobin catalyzes oxidation of an indicator by organic hydroperoxide, resulting in a color change. User compares strip color to provided color blocks to determine hemoglobin concentration (0 mg HGB/dL vs 0.25 mg HGB/dL). Provides immediate visual feedback to clinicians regarding dialysate integrity; helps identify potential blood leaks during treatment.

Clinical Evidence

Bench testing only. Performance evaluated using reference solutions between 0 mg HGB/dL and 0.25 mg HGB/dL in Bicarbonate/Acetate dialysate. Data confirmed consistent color change matching reference color blocks.

Technological Characteristics

Semi-quantitative reagent test strip. Detection principle: pseudoperoxidative activity of hemoglobin/myoglobin catalyzing oxidation of an indicator by organic hydroperoxide. Form factor: reagent pad on plastic handle. Visual colorimetric readout.

Indications for Use

Indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.

Regulatory Classification

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.

Predicate Devices

• Serim® Blood Leak Test Strips

Submission Summary (Full Text)

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## 510(k) SUMMARY

## MAR 20 2013

Page 1 of 2

| Prepared: | November 30, 2012 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 1643 W. Modern Court<br>Tucson, AZ 85705 |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Michael Honstein, Chief Operating Officer |
| Device Trade Name: | E-Z Chek® Blood Leak Test Strips K100-<br>0114 |
| Common or Usual Name: | Blood Leak Test Strips |
| Device Classification Name: | Strip, Dialysate, Hemodialysis Water,<br>Blood Leak indicator |
| Product Code: | FJD |
| Class: | II |
| Regulation Number: | 875.5665, 876.5820 |
| Substantial Equivalence: | The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Blood Leak Test Strips<br>are substantially equivalent to the Serim®<br>Blood Leak Test Strips. |
| Device Description: | Device is semi-quantitative, reagent test<br>strip comprised of a pad impregnated with<br>chemicals which change color upon contact<br>with blood in dialysate. The pad is attached<br>to a plastic strip for handling. |
| Intended Use: | The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Blood Leak Test Strips<br>are designed to indicate the presence or<br>absence of blood in dialysate during the<br>hemodialysis procedure. The test strips will<br>measure equal to 0 mg HGB/dL and 0.25<br>mg HGB/dL in dialysate. |
| Technological Characteristics: | The detection is based on the<br>pseudoperoxidative activity of hemoglobin<br>and myoglobin, which catalyze the<br>oxidation of an indicator by an organic<br>hydroperoxide producing a color change<br>consistent with the color blocks provided in<br>the labeling. |
| Performance: | The data confirm the product consistently<br>generates color change which meets the<br>color block for the reference solution<br>concentration. Reference solutions were<br>used to evaluate performance between 0<br>mg HGB/dL and 0.25 mg HGB/dL<br>Bicarbonate/Acetate dialysate used for<br>hemodialysis treatment. These data<br>demonstrate appropriate performance for<br>use in hemodialysis dialysate used in<br>treatment. |
| Conclusion: | The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Blood Leak Test Strips<br>have the same intended use as the predicate<br>device. Both test strips are designed to<br>detect the presence or absence of blood in<br>dialysate during hemodialysis treatments.<br>The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Blood Leak Test Strips<br>has no characteristics which raise new<br>types of safety and effectiveness questions.<br>The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Blood Leak Test Strips<br>can be used to detect the presence or<br>absence of blood in dialysate during<br>hemodialysis treatment. |

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Traditional 510k Premarket Notification E-Z Chek® Blood Leak Test Strips 22805

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2013

Reprocessing Products Corporation % Mr. Ted Williams Quality Assurance/Regulatory Affairs Director P.O. Box 35849 TUCSON AZ 85740

Re: K123805

Trade/Device Name: E-Z Chek® Blood Leak Test Strips (K100-0114) Regulation Number: 21 CFR& 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJD Dated: January 29, 2013 Received: February 7, 2013

Dear Mr. Williams:

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 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.

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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 (reporting of medical device-related 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P.Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510k Premarket Notification E-Z Chek® Blood Leak Test Strips

Page 1 of 1

Statement of Indications for Use: 4.

> 510k Number (if known): K123805

E-Z Chek® Blood Leak (K100-0114) Device Name:

Indications for Use: The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.

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)

Herbert Lerner -S

dve. Gastro-Renal, and