(98 days)
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Not Found
No
The device description and intended use clearly state that the color change on the reagent strip is visually compared to a color chart by the user to determine the concentration. There is no mention of any computational analysis, learning algorithms, or automated interpretation of results.
No.
The device is used to test for total chlorine levels in water used to prepare dialysate, not to treat a medical condition or disease.
No
This device tests for chlorine in water used to prepare dialysate, which is a substance for medical use, but it does not directly diagnose a medical condition in a patient. Instead, it tests the quality of a substance used in a medical procedure.
No
The device is a physical reagent strip with a chemically treated pad, not a software-only device.
Based on the provided information, the SteriChek ™ Total Chlorine Reagent Strips are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to test for total chlorine in water used to prepare dialysate. This is a test of the water quality, not a test performed on a biological specimen from a human body for the purpose of diagnosis, monitoring, or screening of a disease or condition.
- Device Description: The device tests a water sample.
- Lack of Biological Specimen: IVDs are designed to be used with biological specimens (blood, urine, tissue, etc.). This device uses a water sample.
Therefore, while it is a diagnostic test in the sense that it diagnoses the presence and concentration of total chlorine, it does not meet the definition of an In Vitro Diagnostic device as it is not used on a human biological specimen.
N/A
Intended Use / Indications for Use
SteriChek ™ Total Chlorine Reagent Strips provide a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare 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 concentration of total chlorine present in the sample.
Product codes
78 MSY
Device Description
The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the amount of total chlorine present in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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)
The performance characteristics of SteriChek™ Total Chlorine reagent Strips Serim™ and HiSense Test Kit were analyzed with water samples in which either sodium hypochlorite or chloramines were added to give a range of free chlorine or combined chlorine levels. The performance was equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Serim ™ HiSense Test Kit
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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
994226 p. i/2
MAR 2 2 2000
SteriChek™ Total Chlorine Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | December 10, 1999 |
|---|---|
| Submitter: | Environmental Test Systems, Inc. |
| Address: | 23575 County Road 106 |
| Elkhart, IN 46514 | |
| U.S.A. | |
| (219) 262-2060 | |
| Contact: | David A. Morris, Ph.D. |
| Vice President, Technology | |
| Device Trade/Proprietary Name: | SteriChek ™ Chlorine Reagent Strips |
| Device Common Name: | Total Chlorine Reagent Strips |
| Classification Name: | Class II CH |
| Predicate Device: | Serim ™ HiSense Test Kit |
| Device Description: | The device is made up of a 0.20 inch square off-white reagent pad that has |
| been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch | |
| white opaque polystyrene strip. The reagent pad is activated by exposing | |
| it to the sample. The color of the pad is visually compared to a color chart | |
| to determine the amount of total chlorine present in the sample. | |
| Intended Use: | SteriChek ™ Total Chlorine Reagent Strips provide a quick convenient |
| means of testing for low levels of total chlorine (i.e. total chloramines plus | |
| free chlorine) in water used to prepare 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 concentration of total chlorine | |
| present in the sample. | |
| Technological Characteristics: | The concentration of chlorine in rinse water is obtained by comparing the |
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K994226 p.2/2
MAR 2 2 2000
SteriChek™ Total Chlorine Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
color of the reagent pad with color blocks on the label. The color blocks are calibrated in terms of chlorine concentration in parts per million (ppm). The device is used as a quantitative method to detect total chlorine concentrations between 0 and 3 ppm. The device will reliably measure total chlorine concentrations as low as 0.1 ppm total chlorine.
SteriChek™ Chlorine Reagent Strips contains an indicator, Michler's thioketone, an activating surfactant, and other non-reactive ingredients. Free chlorine and combined chlorine (chloramines) react with the indicator to form a blue complex. The amount of the blue complex is dependent on the concentration of free chlorine and combined chlorine in the sample.
Assessment of Performance:
The performance characteristics of SteriChek™ Total Chlorine reagent Strips Serim™ and HiSense Test Kit were analyzed with water samples in which either sodium hypochlorite or chloramines were added to give a range of free chlorine or combined chlorine levels. The performance was equivalent.
Conclusion: The SteriChek™ Total Chlorine Reagent Strips have the same intended use as the predicate device. The predicate device's indicator system (qualitative combined dry and liquid colorimetric method) is different than that of the Total Chlorine Reagent Strips. However, both systems effectively measure the total free and combined chlorine levels in water. The SteriChek™ Total Chlorine Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions.
2
Public Health Service
MAR 2 2 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David A. Morris, Ph.D. Vice President, Technology Environmental Test Systems, Inc. 23575 County Road, #106 Elkhart, IN 46514
Re: K994226 SteriChek™ Total Chlorine Reagent Strips Dated: March 1, 2000 Received: March 6, 2000 Requiatory Class: II 21 CFR $876.5665/Procode: 78 MSY
Dear Dr. Morris:
We have reviewed your Section 510K) notification of intent to market the device 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 reclassfied 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or requlations.
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 market predication 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) 594-4591. Additionally, for question 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" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
SteriChek™ Total Chlorine Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
510(k) Number (if known) K994336
Device Name: SteriChek™ Total Chlorine Reagent Strips.
Indications for Use:
:
SteriChek™ Total Chlorine Reagent Strips provide a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines and free chlorine) in water used to prepare dialysate.
(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)
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Dev 510(k) Number
Over-The-Counter Use
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