(126 days)
Not Found
No
The device is a simple chemical indicator test strip and the summary contains no mention of AI, ML, or any related technologies.
No
The device is a test strip used to determine the concentration of glutaraldehyde in a disinfectant solution, not for medical treatment.
No
The device is a chemical indicator test strip used to determine the concentration of glutaraldehyde in a disinfectant solution, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "reagent test strip made up of a 0.40-inch square reagent pad... affixed to one end of a 3.25 inch by 0.40-inch white opaque polystyrene strip," indicating it is a physical, hardware-based device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to determine the concentration of glutaraldehyde in a solution (CIDEXPLUS 28 Day Solution). This is a test performed in vitro (outside the body) on a sample (the solution).
- Device Description: The description details a reagent test strip designed to detect a chemical in a solution. This aligns with the nature of IVD devices which are used to analyze samples.
- Comparison to Predicate Device: The performance studies compare the device to a "CIDEXPLUS Solution Test Strip," which is also likely an IVD used for a similar purpose.
The key characteristic of an IVD is that it is used to examine specimens derived from the human body or other sources to provide information for diagnostic, monitoring, or screening purposes. While this specific device is testing a disinfectant solution, the principle of testing a sample in vitro to gain information about its properties falls under the broad category of IVD devices, particularly those used in healthcare settings for quality control or monitoring of sterilization processes.
N/A
Intended Use / Indications for Use
The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.40-inch square reagent pad that has been chemically treated to detect glutaraldehyde in CIDEXPLUS 28 Day solutions. The pad is affixed to one end of a 3.25 inch by 0.40-inch white opaque polystyrene strip.
The Serim® Disintek GTA 2.1% Test Strips contain three Technological Characteristics: reacting chemicals, and a background dye. The visual response given by the indicator pad of the test strip is based on the following chemical reactions. Glutaraldehyde reacts with sodium sulfite to form a colorless addition product and a base. The base then reacts with a pH indicator producing a purple color. The indicator pad also contains sodium bisulfite, which reacts with both glutaraldehyde and with the base. When glutaraldehyde concentration is above the 2.1% level (MEC), enough base is produced to result in an irreversible and distinct color change of the indicator pad. Testing of freshly activated Cidex® Plus solutions always results in a solid purple color on the indicator pad. When the glutaraldehyde concentration is at or approaching the MEC level, the base is neutralized by the sodium bisulfite and the indicator pad will display a distinctly blotched yellow and purple appearance. The test pad size of 0.4" x 0.4" and a color block showing a representative color change for the MEC level allows for easy interpretation of the change in color. As the glutaraldehyde concentration approaches 1.5%, the indicator pad will appear mostly yellow. The device will reliably indicate if the glutaraldehyde concentration is above or below the MEC level of 2.1% in CIDEXPLUS 28 Day solutions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Serim Disintek GTA 2.1% Test Performance: Strips was evaluated in split samples blind studies and compared to test results obtained with CIDEXPLUS Solution Test Strips. The performance of the Serim Disintek GTA 2.1% Test Strips is substantially equivalent to the predicate device, CIDEXPLUS Solution Test Strips.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%
۰۰ ۰۰۰ ۰
CONFIDENTIAL
510 (K) SUMMARY
MAR 1 6 2009
| Prepared: | November 6, 2008 |
|---|---|
| Submitter: | Serim Research Corporation |
| Address | P.O. Box 4002 |
| Elkhart IN 46514 | |
| Phone: | |
| Fax: | 574-264-3440 |
| 574-266-6222 | |
| Contact: | Patricia A. Rupchock |
| Director of Regulatory Affairs | |
| Device Trade Name: | Serim® DISINTEK™ GTA 2.1% |
| Common or Usual Name: | Indicator for CIDEXPLUS glutaraldehyde disinfectant |
| solutions. | |
| Device Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Product Code: | JOJ |
| Class: | II |
| Regulation Number: | 21CFR 880.2800 |
| Substantial Equivalence: | The Serim® DISINTEK™ GTA 2.1% is substantially |
| equivalent to CIDEXPLUS Solution test strips ; K981054 | |
| Device Description: | The device is a qualitative, single use, reagent test strip |
| made up of a 0.40-inch square reagent pad that has been | |
| chemically treated to detect glutaraldehyde in | |
| CIDEXPLUS 28 Day solutions. The pad is affixed to one | |
| end of a 3.25 inch by 0.40-inch white opaque polystyrene | |
| strip. | |
| Intended Use: | The Serim® Disintek GTA 2.1% Test Strip is a chemical |
| indicator for use in determining whether the concentration | |
| of glutaraldehyde the active ingredient in CIDEXPLUS | |
| 28 Day Solution, is above or below the minimum | |
| effective concentration (MEC) established for | |
| CIDEXPLUS 28 Day Solution |
: ·
1
SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%
The Serim® Disintek GTA 2.1% Test Strips contain three Technological Characteristics: reacting chemicals, and a background dye. The visual response given by the indicator pad of the test strip is based on the following chemical reactions. Glutaraldehyde reacts with sodium sulfite to form a colorless addition product and a base. The base then reacts with a pH indicator producing a purple color. The indicator pad also contains sodium bisulfite, which reacts with both glutaraldehyde and with the base. When glutaraldehyde concentration is above the 2.1% level (MEC), enough base is produced to result in an irreversible and distinct color change of the indicator pad. Testing of freshly activated Cidex® Plus solutions always results in a solid purple color on the indicator pad. When the glutaraldehyde concentration is at or approaching the MEC level, the base is neutralized by the sodium bisulfite and the indicator pad will display a distinctly blotched yellow and purple appearance. The test pad size of 0.4" x 0.4" and a color block showing a representative color change for the MEC level allows for easy interpretation of the change in color. As the glutaraldehyde concentration approaches 1.5%, the indicator pad will appear mostly yellow. The device will reliably indicate if the glutaraldehyde concentration is above or below the MEC level of 2.1% in CIDEXPLUS 28 Day solutions. The performance of the Serim Disintek GTA 2.1% Test Performance: Strips was evaluated in split samples blind studies and compared to test results obtained with CIDEXPLUS Solution Test Strips. The performance of the Serim Disintek GTA 2.1% Test Strips is substantially equivalent to the predicate device, CIDEXPLUS Solution Test Strips. Conclusion: The Serim Disintek GTA 2.1% Test Strips have the same intended use as the predicate device. Both test strips measure the potency of GTA in CIDEXPLUS 28 Day Solution, above or below the Minimum Effective Concentration of 2.1%. The Serim Disintek GTA 2.1% Test Strips do not raise any new safety or effectiveness issues.
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). The seal features the department's name encircling a symbol. The symbol is a stylized eagle with three overlapping wings, representing health, services, and people. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
MAR 1 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation 3506 Reedy Drive Elkhart, Indiana 46514
Re: K083295
Trade/Device Name: Scrim® DISINTEK™ GTA 2.1% Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 23, 2009 Received: February 26, 2009
Dear Ms. Rupchock:
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 - Ms. Rupchock
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sutte y. Michael Davis.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Serim® DISINTEK™ GTA 2.1%
Indications For Use: The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.
K
Prescription Use Over-The-Counter Use AND / OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shala A Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083245
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