(406 days)
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No
The device description details a chemical reaction resulting in a color change, which is then compared to a color scale. There is no mention of any computational analysis, learning algorithms, or image processing that would indicate the use of AI/ML.
No.
The device is a test strip intended to detect residual peracetic acid, not to directly treat or diagnose a medical condition. It is used as part of a quality assurance program for reprocessed dialyzers.
No
The device is described as a "semi-quantitative test of the residual presence of peracetic acid in dialyzers after reprocessing." It tests the residual presence of a chemical, not a health condition or disease in a patient.
No
The device description clearly states it is a physical test strip with a test pad and color indicator, which are hardware components.
Based on the provided information, the Micro-X Residual Test Strips are an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for testing the "residual presence of peracetic acid in dialyzers after reprocessing." This involves testing a sample (the solution from the dialyzer) in vitro (outside the body) to determine a characteristic of that sample.
- Device Description: The description details a test strip with a chemical reaction that produces a color change based on the presence of peracetic acid. This is a typical mechanism for an in vitro diagnostic test.
- Comparison to Predicate Device: The mention of "Renalin Residual Test Strips" as a predicate device strongly suggests that this type of product is regulated as an IVD. Predicate devices are typically other legally marketed devices of the same type, which in this context would be other IVDs for testing residual disinfectants.
While the document doesn't explicitly use the term "IVD," the intended use and device description align perfectly with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body or other sources to provide information for diagnostic, monitoring, or screening purposes. In this case, the "other source" is the dialyzer and the purpose is monitoring the reprocessing process.
N/A
Intended Use / 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.
Product codes
78 MSY
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing between Micro Xtm Residual Strips
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Renalin Residual Test Strips
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5665 Water purification system for hemodialysis.
(a)
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.(b)
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.
0
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
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
ग Page 1
い
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K974064 |
|---|---|
| --------------- | --------- |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)