Who is the manufacturer of QwikCheck Chemical Indicators?

Serim Research Corporation filed the 510(k) submission for QwikCheck Chemical Indicators (K192445).

What is the FDA product code for QwikCheck Chemical Indicators?

JOJ. It is classified under 21 CFR 880.2800 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for QwikCheck Chemical Indicators?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like QwikCheck Chemical Indicators?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QwikCheck Chemical Indicators

Q: What are the predicate devices for QwikCheck Chemical Indicators?

Serim® GUARDIAN™ Peracetic Acid Test Strips (K910320).

K192445 · Serim Research Corporation · JOJ · Apr 2, 2020 · General Hospital

Device Facts

Record ID	K192445
Device Name	QwikCheck Chemical Indicators
Applicant	Serim Research Corporation
Product Code	JOJ · General Hospital
Decision Date	Apr 2, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2800
Device Class	Class 2

Indications for Use

The QwikCheck™ Chemical Indicator is a qualitative chemical indicator dedicated for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical's TD-12 Solution, is above or below the established Minimum Recommended Concentration (MRC) according to the solution manufacturer.

Device Story

QwikCheck™ Chemical Indicator is a single-use, qualitative reagent strip for monitoring peracetic acid (PAA) concentration in CS Medical's TD-12 high-level disinfectant solution. The device consists of a 0.2-inch square indicator pad treated with starch, potassium iodide, sodium thiosulfate, and a pH buffer, affixed to a plastic handle. Operation involves dipping the pad into the disinfectant solution; a two-step chemical reaction occurs. Sodium thiosulfate neutralizes PAA up to the 1750 ppm MRC. If PAA exceeds 1750 ppm, excess PAA oxidizes iodide to iodine, which complexes with starch to produce a brown color change on the pad within 30 seconds. A brown pad indicates a 'PASS' (concentration > 1750 ppm), while a pad color similar to the 'FAIL' block indicates concentration ≤ 1750 ppm. The device is used by healthcare personnel to verify disinfectant potency, ensuring effective high-level disinfection. It provides a visual, binary result to inform clinical decisions regarding the reuse or disposal of the disinfectant solution, thereby ensuring patient safety during instrument reprocessing.

Clinical Evidence

Bench testing only. Performance evaluated across concentrations below, at, and above the 1750 ppm MRC. Results demonstrated 100% sensitivity and 100% specificity compared to the predicate device. Stability testing confirmed a 12-month closed-bottle shelf-life and 3-month open-bottle use-life. Testing confirmed consistent performance in the presence of bioburden (fetal bovine serum) and specificity against other disinfectants (hydrogen peroxide, sodium hypochlorite).

Technological Characteristics

Single-use reagent strip; 0.2" x 0.2" indicator pad on plastic handle. Chemistry: starch, potassium iodide, sodium thiosulfate, pH buffer. Principle: two-step redox reaction (neutralization followed by iodine-starch complexation). Qualitative visual readout. Shelf-life: 12 months (closed), 3 months (open).

Indications for Use

Indicated for determining whether the concentration of peracetic acid in CS Medical's TD-12 Solution is above or below the manufacturer's established Minimum Recommended Concentration (MRC) of 1750 ppm.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

Serim® GUARDIAN™ Peracetic Acid Test Strips (K910320)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 2, 2020 Serim Research Corporation Jackie Nelson Director Of Quality Operations 3506 Reedy Drive Elkhard, Indiana 46514 Re: K192445 Trade/Device Name: Qwikcheck™ Chemical Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: February 26, 2020 Received: February 27, 2020 Dear Jackie Nelson: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192445 Device Name QwikCheck™ Chemical Indicators #### Indications for Use (Describe) The QwikCheck™ Chemical Indicator is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical's TD-12 Solution, is above or below the manufacturer's established Minimum Recommended Concentration (MRC) of 1750 ppm. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ SERIM Research Corporation 510(k) Premarket Notification QwikCheck™ Chemical Indicators Image /page/3/Picture/1 description: The image shows the logo for Serim Research Corp. The word "Serim" is in a large, bold, serif font. Below the word "Serim" is the phrase "Research Corp" in a smaller, sans-serif font. Above the word "Serim" is a blue rectangle with a white, flame-like shape in the center. ## 510(K) SUMMARY | 510(k): | K192445 | | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Prepared: | March 30, 2020 | | | Submitter: | Serim Research Corporation | | | Address: | 3506 Reedy Drive Elkhart IN 46514 | | | Phone: Fax: | 574-264-3440 574-266-6222 | | | Contact: | Jackie Nelson Director of Regulatory Operations | | | Device Trade Name: | QwikCheck™ Chemical Indicators | | | Common or Usual Name: | Indicator for peracetic acid (PAA) high level disinfectant | | | Device Classification Name: | Chemical Indicators for Liquid Chemical Germicide. (b) Class II (Physical/Chemical Sterilization Process Indicator). | | | Product Code: | JOJ | | | Class: | II | | | Regulation Number: | 21 CFR 880.2800 | | | Predicate Device: | Serim® GUARDIAN™ Peracetic Acid Test Strips, Serim Research Corporation, P/N 5106; K910320. | | | Device Description: | The device is a qualitative, single use, reagent chemical indicator made up of a 0.20-inch square indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration. The indicator pad is affixed to one end of a 3.25 inch by 0.20-inch white opaque plastic handle. | | {4}------------------------------------------------ | Intended Use: | The QwikCheck™ Chemical Indicator is a qualitative chemical indicator dedicated for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical's TD-12 Solution, is above or below the established Minimum Recommended Concentration (MRC) according to the solution manufacturer. | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The QwikCheck™ Chemical Indicator is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical's TD-12 Solution, is above or below the manufacturer's established Minimum Recommended Concentration (MRC) of 1750 ppm. | | Technological Characteristics: | The QwikCheck™ Chemical Indicators contains two reacting chemicals, a reducing agent, and other non-reactive compounds. The reaction process involved with the test pad is based on a two-step reaction. The first step involves a reaction in which the reducing agent reacts with peracetic acid at a concentration equivalent to 1750 ppm (MRC) to neutralize it. A second reaction then occurs in which PAA at levels above 1750 ppm reacts with one chemical and then complexes with a second chemical, resulting in a brown pad coloration. The device will reliably indicate if the PAA concentration is above or below the MRC level of 1750 ppm PAA. Refer to Table 1 for more information. | | Parameters | QwikCheck™ Chemical Indicator (K192445) | Serim® GUARDIAN™ Peracetic Acid Test Strip (K910320) | Comparison | |-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Analyte | Peracetic acid in TD-12 Solution | Peracetic acid in dialyzer reuse solutions | Similar | | Indicator strip | 0.2" x 0.2" test paper attached to a plastic handle | 0.2" x 0.2" test paper attached to a plastic handle | Same | | Parameters | QwikCheck™ Chemical Indicator (K192445) | Serim® GUARDIANTM Peracetic Acid Test Strip (K910320) | Comparison | | Chemistry | Sodium thiosulfate reacts with PAA up to the minimum recommended concentration (MRC) and neutralizes it. If the PAA concentration in the solution is > MRC, iodide reacts with excess PAA, creating iodine which then complexes with starch to create a colored complex and causes a color change of the test pad. | Sodium thiosulfate reacts with PAA up to the minimum recommended concentration (MRC) and neutralizes it. If the PAA concentration in the solution is > MRC, iodide reacts with excess PAA, creating iodine which then complexes with starch to create a colored complex and causes a color change of the test pad. | Same | | Indicator Agent(s) | Starch and iodide. | Starch and iodide. | Same | | Chemicals Present in Device | Starch, potassium iodide, sodium thiosulfate, and pH buffer. | Starch, iodide, sodium thiosulfate, and pH buffer. | Similar | | Minimum Time of Color Change | 30 seconds. | 10 seconds. | Different | | Details of Chemical Formulation | Sodium thiosulfate reacts with PAA up to the minimum recommended concentration (MRC) and neutralizes it. Excess PAA then oxidizes the iodide forming iodine, which then complexes with starch to produce a brown coloration. The pH buffer provides the appropriate pH conditions for the reaction. | Sodium thiosulfate reacts with PAA up to the minimum recommended concentration (MRC) and neutralizes it. Excess PAA then oxidizes the iodide forming iodine, which then complexes with starch to produce a black/blue coloration. The pH buffer provides the appropriate pH conditions for the reaction. | Similar | | Parameters | QwikCheck™ Chemical Indicator (K192445) | Serim® GUARDIAN™ Peracetic Acid Test Strip (K910320) | Comparison | | Results | A test pad which is similar in color to the FAIL color block indicates the solution is ≤ 1750 ppm. If the color of the test pad is similar to the PASS block, the solution is > 1750 ppm. | If the indicator pad is predominantly or entirely white, record the result as "FAIL"; the peracetic acid concentration is at or below 400 ppm. If the indicator pad is predominantly or entirely gray/blue, black or brown, record the result as "PASS"; the peracetic acid concentration is at or above 800 ppm. | Different | | "PASS" Indication | Dark brown. | Gray / blue, black or brown. | Similar | | Bold text indicates differences between the proposed and predicate device. | | | | Table 1: Summary of Technological Characteristics Table {5}------------------------------------------------ {6}------------------------------------------------ The QwikCheck™ Chemical Indicators have the same intended use as the predicate device. Both devices measure the potency of peracetic acid (PAA) in disinfectant solution, to determine whether it is above or below the Minimum Recommended Concentration. The difference between the proposed PAA indicator and the predicate device is the use in different concentrations of commercial preparations of PAA. Summary of Non-Clinical The performances of the QwikCheck™ Chemical Performance Data: Indicators were evaluated in non-clinical tests in a range of concentrations below, at, and above the MRC. The results show that the proposed device is an effective monitor of the concentration of TD-12 solution when used as directed by the manufacturer. Table 2 summarizes the non-clinical testing performed Serim Research to demonstrate safety and bv effectiveness of the QwikCheck Chemical Indicators in monitoring the concentration of TD-12 peracetic acid high-level disinfectant solutions. A further discussion of each individual study follows the table. {7}------------------------------------------------ | Study | Results | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Dynamic Range | Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive responses at higher concentrations. | | Instructions for Use Validation | Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive responses at higher concentrations. | | Closed Bottle Shelf-Life Stability | Met Acceptance Criteria: Met specifications after storage of labeled shelf life of 12 months (unopened). | | Open Bottle Use-Life Stability | Met Acceptance Criteria: Met specification for 3 months (opened). | | Comparative Sensitivity and Specificity | Met Acceptance Criteria: Comparative sensitivity and specificity of 1 | ### Table 2: Performance Testing Summary Dynamic Range: The dynamic range of the QwikCheck Chemical Indicators was evaluated below, at, and above the TD-12 peracetic acid MRC using high-level disinfectant solutions. The chemical indicator yielded acceptable performance with 100% FAIL results at and below the MRC and PASS results above the MRC. - Instructions for Use The instructions for use of the QwikCheck Chemical Validation: Indicators were evaluated at and above the MRC using TD-12 peracetic acid high-level disinfectant solutions. The chemical indicator yielded a acceptable performance with an immediate dip/removal from solution time, a 5 ± 1 second sideblot time, a time to blot of ≤ 1 second, and a 30 ± 5 second read time. The chemical indicator yielded acceptable performance with 100% FAIL results at and below the MRC and PASS results above the MRC. {8}------------------------------------------------ | Closed Bottle Shelf-Life Stability: | The closed bottle shelf-life of the QwikCheck Chemical Indicators was evaluated at and above the MRC with TD-12 peracetic acid high-level disinfectant solutions at ambient room temperature up to 32°C storage. The chemical indicator yielded acceptable performance out to a minimum 15 months shelf-life from ambient room temperature up to 32°C, with data collection ongoing. The chemical indicator yielded acceptable performance with 100% FAIL results at and below the MRC and PASS results above the MRC. A conservative 12-month shelf-life is claimed. | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Open Bottle Use-Life Stability: | The open bottle use-life of the QwikCheck Chemical Indicators was evaluated at and above the MRC with TD-12 peracetic acid high-level disinfectant solutions at constant high humidity storage (≥ 80% RH) and repeated openings of the chemical indicator bottle. The chemical indicator yielded acceptable performance out to a minimum 5 months open bottle use-life, with data collection ongoing. The chemical indicator yielded acceptable performance with 100% FAIL results at and below the MRC and PASS results above the MRC. A conservative 3-month open bottle use-life is claimed. | Comparative Sensitivity and The QwikCheck Chemical Indicators were compared Specificity: to the predicate device, Serim GUARDIAN Peracetic Acid test strips using comparison studies. A comparative sensitivity of 100% and comparative specificity of 100% was found for both devices. There was 100% overall agreement with values for prepared samples in both cases. - Analytic Specificity -The sensitivity of the QwikCheck Chemical Indicators Bioburden: to bioburden was evaluated at and above the MRC using TD-12 peracetic acid high-level disinfectant solutions and fetal bovine serum. The chemical indicator yielded acceptable performance with 100% FAIL results at and below the MRC and PASS results above the MRC. {9}------------------------------------------------ Analytic Specificity – Other The sensitivity of the QwikCheck Chemical Indicators Disinfectants: to other disinfectants was evaluated at and above the MRC using TD-12 peracetic acid high-level disinfectant solutions and the following disinfectants: hydrogen peroxide and sodium hypochlorite. The chemical indicator yielded 100% FAIL results for all conditions tested. Conclusion: Based on the non-clinical tests performed, the subject device, QwikCheck™ Chemical Indicator is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Serim® GUARDIAN™ Peracetic Acid Test Strips, K910320, Class II (21CFR 880.2800), Product code JOJ.

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