MICRO X RESIDUAL TEST STRIPS

K974064 · Reprocessing Products Corp · MSY · Dec 7, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974064
• Device Name: MICRO X RESIDUAL TEST STRIPS
• Applicant: Reprocessing Products Corp
• Product Code: MSY · Gastroenterology, Urology
• Decision Date: Dec 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

Micro-X Residual Test Strips are intended for use as a semi-quantitative test of the residual 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, sanitation of water treatment systems and dialysis machine disinfection as part of an established quality assurance program.

Device Story

Micro X Residual Test Strips are chemical test strips (0.25" x 4.75") used to detect residual peracetic acid levels in reprocessed dialyzers and dialysis equipment. The test pad is impregnated with peroxidase and a chromophore color indicator. Upon contact with a solution containing peracetic acid, the peroxidase liberates oxygen, which reacts with the chromophore to produce a color change. The user compares the resulting color on the test pad to a provided color scale on the container to read the concentration in mg/L. This process ensures that residual germicide levels are within safe limits to maintain dialyzer biocompatibility prior to dialysis initiation. The device is used by clinical staff in dialysis settings as part of a quality assurance program.

Clinical Evidence

Bench testing only.

Technological Characteristics

Test strips (0.25" x 4.75") containing a test pad impregnated with peroxidase and a chromophore color indicator. Operates via chemical reaction (peroxidase-mediated oxygen liberation) resulting in a visual color change proportional to peracetic acid concentration. Results are semi-quantitative, read by visual comparison to a color scale.

Indications for Use

Indicated for semi-quantitative testing of residual peracetic acid in reprocessed dialyzers, water treatment systems, and dialysis machines following disinfection procedures.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Renalin Residual Test Strips

Submission Summary (Full Text)

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4 1998 DEC

## K974064

Page 111

## X. 510k Summary:

Trade Name - Micro Xtm Residual Test Strips

Common name - Residual test strips

Classification name - Dialyzer test strips

Substantially equivalent to Renalin Residual Test Strips

- Description Micro X 10 Residual Test Strips are approximately 0.25" x 4.75" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers.
- Intended Use -Micro Xm Residual Test Strips are intended for use in determining the level of peracetic acid present in dialyzers at the conclusion of the required rinse procedure, and prior to the initiation of dialysis. The strips are also used for the determination of residual peracetic levels present in the rinse solution of water treatment systems and dialysis machines following samitization/disinfection procedures.
- Characteristics Micro X " Test Strips have a test pad, which is impregnated with peroxidase, which liberates oxygen from peracetic acid upon contact with the solution. The oxygen reacts with the chromophore, color indicator, which is also present on the test pad, resulting in a color change. The color change is compared to the color scale on the container and the result is read directly in mg/L. This is an important characteristic as levels of peracetic acid above those indicated by the germicide manufacturer may compromise dialyzer biocompatibility. This test strip, when properly used, provides a measure of residual germicide within the fluid pathways of reprocessed dialyzers.

Test Data:

Comparative testing between Micro Xtm Residual Strips

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 7 1998

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

Re: K974064 Micro X™ Residual Test Strips Dated: September 8, 1998 Received: September 8, 1998 Regulatory Class: II CFR 21 876.5820/Procode: 78 MSY

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 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 (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 (OS) 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 regulation 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 regulations.

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 307.97). 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/dsmaldsmamain.html".

Sincerely your

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K974064

Device Name: MICRO-X RESIDUAL TEST STRIPS

## Indications For Use:

Micro-X Residual Test Strips are intended for use as a semi-quantitative test of the residual 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, sanitation of water treatment systems and dialysis machine disinfection as part of an established quality assurance program.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K974064 |
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| Prescription Use | |
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| (Per 21 CFR 801.109) | |

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