POTENCY TEST STRIPS, INDICATOR TEST STRIPS

K974426 · Reprocessing Products Corp · LIF · Feb 10, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K974426
• Device Name: POTENCY TEST STRIPS, INDICATOR TEST STRIPS
• Applicant: Reprocessing Products Corp
• Product Code: LIF · Gastroenterology, Urology
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

Micro X Potency Test Strips are intended for use in verifying the presence of peracetic acid at the conclusion of the required exposure period for the germicide during dialyzer reprocessing, water treatment sanitization and machine disinfection.

Device Story

Micro-X Potency Test Strips are 0.25" x 2.0" indicator strips used to verify peracetic acid presence during dialyzer reprocessing, water treatment sanitization, and machine disinfection. The strips are impregnated with an indicator solution that undergoes a visual color change upon contact with peracetic acid. This provides a qualitative YES/NO indication of the presence of an appropriate germicide level, distinguishing peracetic acid from other clear solutions like saline or water. The device is used by clinical staff in a reprocessing environment to ensure adequate germicide exposure. The output is a visual color change, which informs the user whether the dialyzer has been properly sanitized, thereby preventing the use of improperly reprocessed equipment.

Clinical Evidence

Bench testing only. Comparative performance testing between Micro-X Potency Test Strips and the predicate Renalin Indicator Test Strips demonstrated identical performance.

Technological Characteristics

Indicator test strips (0.25" x 2.0"). Impregnated with a chemical indicator solution activated by peracetic acid. Provides visual color change for qualitative (YES/NO) detection of peracetic acid above a minimum threshold. Standalone, non-electronic, single-use device.

Indications for Use

Indicated for use as a semi-quantitative test to verify the presence of peracetic acid in dialyzers following reprocessing. Compatible with all peroxyacetic/peracetic acid germicides used in dialyzer reprocessing as part of a quality assurance program.

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

• Renalin Indicator Test Strips

Submission Summary (Full Text)

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## 11974426

## 510k Summary: X.

Trade Name - Micro Xtm Potency Test Strips

Common name - Indicator test strips

Classification name - Dialyzer test strips

Substantially equivalent to Renalin Indicator Test Strips

Description - Micro X = Potency Test Strips are approximately 0.25" x 2.0" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers.

Intended Use -Micro X Potency Test Strips are intended for use in verifying the presence of peracetic acid at the conclusion of the required exposure period for the germicide during dialyzer reprocessing, water treatment sanitization and machine disinfection.

Characteristics - Micro Xen Potency Test Strips are impregnated with an indicator solution which is activated by the presence of peracetic acid. The reaction results in a color change of the indicator which provides visual confirmation of the presence of peracetic acid. This is an important characteristic as peracetic acid is a clear solution and can easily be confused with saline, water or other clear solutions which may have been inadvertently added to the dialyzer in place of the peracetic acid solution

While the test is not quantitative, as it does not provide a measure of concentration, it is activated above a minimum level of peracetic acid. This characteristic is exploited to provide a YES / NO indication of the presence of an appropriate level of peracetic acid.

Test Data:

Comparative testing between Micro X " Potency Strips, Renalin Indicator Test Strips indicate identical performance among the test strips.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a family of three figures, with flowing lines suggesting movement or connection.

FEB 1 0 1999

Michael Honstein Vice President of Operations Reprocessing Products Corporation 1661 W. Prince Rd., Suite 104 Tucson, Arizona 85705

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K974426 Re: Micro-X™ Potency Test Strip Dated: October 4, 1998 Received: November 12, 1998 Regulatory class: II 21 CFR §876.5820/Product code: 78 LIF

Dear Mr. Honstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requiations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 by reference to premarket notification"(21 CFR 807.97). "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

\$

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ + or

510(k) Number (if known): UNKNOWN

Device Name: MICRO-X POTENCY TEST STRIPS

Indications For Use:

Micro-X Potency Test Strips are intended for use as a semi-quantitative test of the presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers as part of an established quality assurance program.

(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)

OR

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT.

Division of Reproductive, Abdominal, and Radiological De 510(k) Number