STERICHEK BICARB PH REAGENT STRIPS

K031267 · Environmental Test Systems, Inc. · MNV · Dec 23, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031267
• Device Name: STERICHEK BICARB PH REAGENT STRIPS
• Applicant: Environmental Test Systems, Inc.
• Product Code: MNV · Gastroenterology, Urology
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

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.

Device Story

Device consists of 0.20-inch square reagent pad affixed to 3.25-inch white opaque polystyrene strip. Reagent pad contains Cresol Red and Phenol Red indicators. User exposes pad to bicarbonate solution sample; color change occurs based on pH/hydrogen ion concentration. User visually compares pad color to calibrated color chart on label to determine pH. Used in clinical settings for monitoring dialysate preparation. Provides rapid, convenient pH verification to ensure proper solution concentration.

Clinical Evidence

Bench testing only. Performance compared against Serim™ Bicarb pH II Test Strips using acid/bicarbonate and concentrated bicarbonate solutions. Reference pH values determined via standard method calibrated with NIST traceable reference material. Performance found to be equivalent.

Technological Characteristics

Reagent pad on polystyrene strip. Indicators: Cresol Red and Phenol Red. Sensing principle: colorimetric pH-dependent indicator reaction. Form factor: 3.25" x 0.20" strip. Manual visual readout via color chart comparison.

Indications for Use

Indicated for checking the pH of bicarbonate solutions and concentrated bicarbonate solutions used in the preparation of dialysate.

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™ Bicarb pH II Test Strips

Submission Summary (Full Text)

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K031267

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<br>Elkhart, IN 46514<br>U.S.A.<br>[phone] |
| Contact: | David A. Morris, Ph.D.<br>Director of Technology |
| Device Trade/<br>Proprietary Name: | SteriChek® Bicarb pH Reagent Strips |
| Device Common<br>Name: | Bicarb pH Reagent Strips |
| Classification Name: | Class II<br>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<br>been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch<br>white opaque polystyrene strip. The reagent pad is activated by exposing<br>it to the sample. The color of the pad is visually compared to a color chart<br>to determine the pH of the bicarbonate solution. |
| Intended Use: | SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of<br>checking the pH of the bicarbonate solution of used to prepare dialysate or<br>concentrated bicarbonate solution used in the preparation of dialysate. The<br>color that develops in the pad after exposure to the sample according to the<br>directions is compared to a color chart to determine the pH of the sample. |
| Technological<br>Characteristics: | The pH of the bicarbonate solution or bicarbonate concentrate is obtained<br>by comparing the color of the reagent pad with color blocks on the label. |

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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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