STERICHEK GLUTARALDEHYDE REAGENT STRIPS

K040660 · Hach Company · LIF · Nov 15, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040660
• Device Name: STERICHEK GLUTARALDEHYDE REAGENT STRIPS
• Applicant: Hach Company
• Product Code: LIF · Gastroenterology, Urology
• Decision Date: Nov 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

SteriChek Glutaraldehyde Reagent Strips provide a convenient means of testing the concentration of Glutaraldehyde in dialyzer disinfecting solutions. The test is not intended to replace microbiological tests or quantitative determinations of concentrations of stock solutions of Glutaraldehyde. The test may be used on a random sample of reprocessed dialyzers in order to document the presence of the agent during storage. SteriChek Glutaraldehyde Reagent Strips do not measure residual levels of Glutaraldehyde.

Device Story

Device consists of a 0.20-inch square reagent pad affixed to a 3.25-inch white opaque polystyrene strip. Pad contains dry reagents (glycine and methyl red indicator). Used by dipping in glutaraldehyde disinfecting solution; chemical reaction between glycine and glutaraldehyde releases acid, causing a pH-dependent color change on the pad. Provides qualitative concentration assessment. Used in clinical settings for reprocessed dialyzers to document presence of disinfecting agent during storage. Healthcare providers visually interpret color change to verify solution presence; does not replace quantitative stock solution testing or microbiological assays.

Clinical Evidence

Bench testing only. Performance evaluated using analytical studies of glutaraldehyde solutions at various concentrations. Reference method used for comparison was the hydroxylamine hydrochloride reaction followed by acid titration.

Technological Characteristics

Reagent strip with 0.20-inch square pad on 3.25-inch x 0.20-inch white opaque polystyrene strip. Active components: Glycine (CAS #56-40-6) and Methyl Red pH indicator (CAS #845-10-3). Principle: Colorimetric detection of pH change resulting from acid release during glycine-glutaraldehyde reaction.

Indications for Use

Indicated for testing glutaraldehyde concentration in dialyzer disinfecting solutions for reprocessed dialyzers. Not for measuring residual glutaraldehyde levels, replacing microbiological testing, or quantitative analysis of stock solutions.

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™ Glutaraldehyde Test Strips

Submission Summary (Full Text)

{0}------------------------------------------------

K040660 plofa.

NOV 1 5 2004

SteriChek® Glutaraldchyde Reagent Strips 510(k) Submission Environmental Test Systems, Inc.

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | March 4, 2004 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Hach Company/Environmental Test Systems |
| 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® Glutaraldehyde Reagent Strips |
| Device Common<br>Name: | Glutaraldehyde Reagent Strips |
| Classification Name: | Class II<br>CH |
| Predicate Device: | Serim™ Glutaraldehyde Test Strips |
| Device Description: | The device is made up of a 0.20 inch square light red reagent pad that has<br>been chemically treated to test the concentration of Glutaraldehyde in<br>solutions for disinfecting dialyzers used in Hemodialysis. The pad is<br>affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene<br>strip. |
| ntended Use: | SteriChek Glutaraldehyde Reagent Strips provide a convenient means of<br>testing the concentration of Glutaraldehyde in dialyzer disinfecting<br>solutions. The test is not intended to replace microbiological tests or<br>quantitative determinations of concentrations of stock solutions of<br>Glutaraldehyde. The test may be used on a random sample of reprocessed<br>dialyzers in order to document the presence of the agent during storage.<br>SteriChek Glutaraldehyde Reagent Strips do not measure residual levels of<br>Glutaraldehyde. |

{1}------------------------------------------------

K040660 p2§2

SteriChek® Glutaraldehyde Reagent Strip 510(k) Submissic Environmental Test Systems, In-

Technological The device is a qualitative reagent strip method to measure Glutaraldchydc Characteristics: solution by color change caused by the sample on a pad containing dry reagents and indicators. Glycine in the reagent pad reacts with Glutaraldchyde and releases acid. The resulting pH change is detected with a colorimetric indicator. The active components are the pH indicator Methyl Red (CAS #845-10-3), and Glycine (CAS #56-40-6). Assessment of The performance characteristics of SteriChek Glutaraldehyde Reagent Performance: Strips are based on analytical studies using samples of Glutaraldehyde solutions of various concentrations. The reference method for determination of Glutaraldehyde is based on the reaction of Glutaraldehyde with hydroxylamine hydrochloride followed by titration of the released acid (Aldrich Chemical Company, "Basics Assay Method for Determination of Aldehydes and Ketones".) The SteriChek® Glutaraldchyde Reagent Strips have the same intended Conclusion: use as the predicate device. The predicate device's indicator system is different than that of the SteriChek Glutaraldehyde Reagent Strips. However, both systems effectively measure the pH or hydrogen ion concentration. The SteriChek® Glutaraldehyde Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

NOV 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Dr. David A. Morris Director of Technology Hach Company/ETS 23575 County Road 106 Elkhart, Indiana 46514

Re: K040660

Trade/Device Name: SteriChek® Glutaraldehyde Reagent Strips Regulation Number: None Regulation Name: None Regulatory Class: II Product Code: LIF Dated: October 25, 2004 Received: October 28, 2004

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 adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

## Page 2 – Dr. Morris

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 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

SteriChek® Glutaraldehyde Reagent Strips 510(k) Submission Environmental Test Systems, Inc.

510(k) Number (if known)

Device Name: SteriChek® Glutaraldehyde Reagent Strips.

Indications for Use:

SteriChek® Glutaraldehyde Reagent Strips provide a convenient means of testing the concentration of Glutaraldehyde in dialyzer disinfecting solutions. The test is not intended to replace microbiological tests or quantitative determinations of concentrations of stock solutions of Glutaraldehyde. The test may be used on a random sample of reprocessed dialyzers in order to document the presence of the agent during storage. SteriChek® Glutaraldehyde Reagent Strips do not measure residual levels of Glutaraldehyde

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Luis

OR

Division Sign-Off) Division of Sign-Off
Division of Anesthesiology, General Hospital, Andelen of Anesthesiology, Infection Control, Dental D

510(k) Number: K040660

Page 6