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.

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.

AI/ML Overview

The QwikCheck™ Chemical Indicator is a qualitative chemical indicator designed to determine if the concentration of peracetic acid (PAA) in CS Medical's TD-12 Solution is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study	Acceptance Criteria	Reported Device Performance
Dynamic Range	Negative response at concentrations at or below MRC, positive responses at higher concentrations.	100% FAIL results at and below the MRC and PASS results above the MRC.
Instructions for Use Validation	Negative response at concentrations at or below MRC, positive responses at higher concentrations.	Acceptable performance with an immediate dip/removal from solution time, a 5 ± 1 second side blot time, a time to blot of ≤ 1 second, and a 30 ± 5 second read time. 100% FAIL results at and below the MRC and PASS results above the MRC.
Closed Bottle Shelf-Life Stability	Met specifications after storage of labeled shelf life of 12 months (unopened).	Acceptable performance out to a minimum 15 months shelf-life from ambient room temperature up to 32°C, with data collection ongoing. 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	Met specification for 3 months (opened).	Acceptable performance out to a minimum 5 months open bottle use-life, with data collection ongoing. 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 Specificity	Comparative sensitivity and specificity of 1 (implicitly 100% agreement with predicate).	Comparative sensitivity of 100% and comparative specificity of 100% was found for both devices (QwikCheck and predicate). There was 100% overall agreement with values for prepared samples in both cases.
Analytic Specificity - Bioburden	Negative response at concentrations at or below MRC, positive responses at higher concentrations (when challenged with bioburden).	100% FAIL results at and below the MRC and PASS results above the MRC even with the presence of fetal bovine serum (bioburden).
Analytic Specificity – Other Disinfectants	100% FAIL results for all conditions tested when exposed to other disinfectants (i.e., not reacting to other disinfectants).	100% FAIL results for all conditions tested when exposed to hydrogen peroxide and sodium hypochlorite, indicating no false positives due to other disinfectants.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test set within the "Summary of Non-Clinical Performance Data." It indicates that the performance was evaluated "in a range of concentrations below, at, and above the MRC" and that "data collection [is] ongoing" for stability studies. The provenance of the data is not specified (e.g., country of origin). The studies are non-clinical, meaning they were conducted in a laboratory setting. The data appears to be prospective in nature, as tests were performed to evaluate the device's performance under various conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of human experts to establish ground truth for the test set. Given that this is a chemical indicator designed for objective colorimetric assessment of peracetic acid concentration, the ground truth would likely be established through precise chemical analytical methods (e.g., spectrophotometry, titration) to determine the exact PAA concentration in the prepared solutions.

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned, as human interpretation and multi-reader review are not applicable to the evaluation of a chemical indicator. The device's output (color change indicating PASS/FAIL) is compared directly against the known chemical concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or other human-interpreted medical devices where the variability of human perception is a factor. The QwikCheck Chemical Indicator is a passive device with a direct chemical reaction indicating a result.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies conducted are standalone evaluations of the chemical indicator's performance. The "device performance" refers to the indicator's ability to accurately change color (PASS/FAIL) in response to specific PAA concentrations, without human intervention in determining the PAA concentration itself (which is the ground truth from chemical analysis). The "read time" and "blot time" mentioned in the Instructions for Use Validation refer to user interaction, but the core performance being validated is the chemical reaction of the indicator.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on known chemical concentrations of peracetic acid in TD-12 Solution. These concentrations are precisely prepared "below, at, and above the MRC" (1750 ppm). For example, a solution known to be below 1750 ppm should result in a "FAIL" indication, and a solution known to be above 1750 ppm should result in a "PASS" indication.

8. The Sample Size for the Training Set

The document does not specify a "training set" or "sample size for the training set." Chemical indicators are typically developed through chemical formulation and optimization, rather than machine learning algorithms that require distinct training sets. The studies described are performance validation studies, not training exercises.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set for an algorithm, the concept of establishing ground truth for a training set is not applicable here. The ground truth for validating the device's accuracy would have been established through analytical chemistry methods to create solutions with verified concentrations of peracetic acid.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K192445

Device Name

QwikCheck™ Chemical Indicators

Indications for Use (Describe)

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)

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SERIM Research Corporation 510(k) Premarket Notification QwikCheck™ Chemical Indicators

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510(K) SUMMARY

510(k):	K192445
Prepared:	March 30, 2020
Submitter:	Serim Research Corporation
Address:	3506 Reedy DriveElkhart IN 46514
Phone:Fax:	574-264-3440574-266-6222
Contact:	Jackie NelsonDirector of Regulatory Operations
Device Trade Name:	QwikCheck™ Chemical Indicators
Common or Usual Name:	Indicator for peracetic acid (PAA) highleveldisinfectant
Device Classification Name:	Chemical Indicators for Liquid Chemical Germicide.(b) Class II (Physical/Chemical Sterilization ProcessIndicator).
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, reagentchemical indicator made up of a 0.20-inch squareindicator pad that has been chemically treated to detectperacetic acid above or below the MinimumRecommended Concentration. The indicator pad isaffixed to one end of a 3.25 inch by 0.20-inch whiteopaque plastic handle.

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Intended Use:	The QwikCheck™ Chemical Indicator is a qualitativechemical indicator dedicated for use in determiningwhether the concentration of peracetic acid, the activeingredient in CS Medical's TD-12 Solution, is aboveor below the established Minimum RecommendedConcentration (MRC) according to the solutionmanufacturer.
Indications for Use:	The QwikCheck™ Chemical Indicator is a chemicalindicator for use in determining whether theconcentration of peracetic acid, the active ingredient inCS Medical's TD-12 Solution, is above or below themanufacturer's established Minimum RecommendedConcentration (MRC) of 1750 ppm.
Technological Characteristics:	The QwikCheck™ Chemical Indicators contains tworeacting chemicals, a reducing agent, and other non-reactive compounds. The reaction process involvedwith the test pad is based on a two-step reaction. Thefirst step involves a reaction in which the reducingagent reacts with peracetic acid at a concentrationequivalent to 1750 ppm (MRC) to neutralize it. Asecond reaction then occurs in which PAA at levelsabove 1750 ppm reacts with one chemical and thencomplexes with a second chemical, resulting in abrown pad coloration. The device will reliably indicateif the PAA concentration is above or below the MRClevel of 1750 ppm PAA. Refer to Table 1 for moreinformation.

Intended Use:

The QwikCheck™ Chemical Indicator is a qualitativechemical indicator dedicated for use in determiningwhether the concentration of peracetic acid, the activeingredient in CS Medical's TD-12 Solution, is aboveor below the established Minimum RecommendedConcentration (MRC) according to the solutionmanufacturer.

Indications for Use:

The QwikCheck™ Chemical Indicator is a chemicalindicator for use in determining whether theconcentration of peracetic acid, the active ingredient inCS Medical's TD-12 Solution, is above or below themanufacturer's established Minimum RecommendedConcentration (MRC) of 1750 ppm.

Technological Characteristics:

The QwikCheck™ Chemical Indicators contains tworeacting chemicals, a reducing agent, and other non-reactive compounds. The reaction process involvedwith the test pad is based on a two-step reaction. Thefirst step involves a reaction in which the reducingagent reacts with peracetic acid at a concentrationequivalent to 1750 ppm (MRC) to neutralize it. Asecond reaction then occurs in which PAA at levelsabove 1750 ppm reacts with one chemical and thencomplexes with a second chemical, resulting in abrown pad coloration. The device will reliably indicateif the PAA concentration is above or below the MRClevel of 1750 ppm PAA. Refer to Table 1 for moreinformation.

Parameters	QwikCheck™ ChemicalIndicator (K192445)	Serim® GUARDIAN™Peracetic Acid Test Strip(K910320)	Comparison
Analyte	Peracetic acid in TD-12Solution	Peracetic acid in dialyzerreuse solutions	Similar
Indicatorstrip	0.2" x 0.2" test paperattached to a plastichandle	0.2" x 0.2" test paperattached to a plastic handle	Same
Parameters	QwikCheck™ ChemicalIndicator (K192445)	Serim® GUARDIANTMPeracetic Acid Test Strip(K910320)	Comparison
Chemistry	Sodium thiosulfate reactswith PAA up to theminimum recommendedconcentration (MRC) andneutralizes it. If the PAAconcentration in thesolution is > MRC,iodide reacts with excessPAA, creating iodinewhich then complexeswith starch to create acolored complex andcauses a color change ofthe test pad.	Sodium thiosulfate reactswith PAA up to theminimum recommendedconcentration (MRC) andneutralizes it. If the PAAconcentration in thesolution is > MRC, iodidereacts with excess PAA,creating iodine which thencomplexes with starch tocreate a colored complexand causes a color changeof the test pad.	Same
IndicatorAgent(s)	Starch and iodide.	Starch and iodide.	Same
ChemicalsPresent inDevice	Starch, potassium iodide,sodium thiosulfate, andpH buffer.	Starch, iodide, sodiumthiosulfate, and pH buffer.	Similar
MinimumTime ofColorChange	30 seconds.	10 seconds.	Different
Details ofChemicalFormulation	Sodium thiosulfate reactswith PAA up to theminimum recommendedconcentration (MRC) andneutralizes it. ExcessPAA then oxidizes theiodide forming iodine,which then complexeswith starch to produce abrown coloration. ThepH buffer provides theappropriate pHconditions for thereaction.	Sodium thiosulfate reactswith PAA up to theminimum recommendedconcentration (MRC) andneutralizes it. Excess PAAthen oxidizes the iodideforming iodine, whichthen complexes withstarch to produce ablack/blue coloration. ThepH buffer provides theappropriate pH conditionsfor the reaction.	Similar
Parameters	QwikCheck™ ChemicalIndicator (K192445)	Serim® GUARDIAN™Peracetic Acid Test Strip(K910320)	Comparison
Results	A test pad which issimilar in color to theFAIL color blockindicates the solution is ≤1750 ppm. If the color ofthe test pad is similar tothe PASS block, thesolution is > 1750 ppm.	If the indicator pad ispredominantly or entirelywhite, record the result as"FAIL"; the peracetic acidconcentration is at orbelow 400 ppm. If theindicator pad ispredominantly or entirelygray/blue, black or brown,record the result as"PASS"; the peracetic acidconcentration is at orabove 800 ppm.	Different
"PASS"Indication	Dark brown.	Gray / blue, black orbrown.	Similar
Bold text indicates differences between the proposed and predicate device.

Table 1: Summary of Technological Characteristics Table

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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.

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Study	Results
Dynamic Range	Met Acceptance Criteria:Negative response at concentrations at or below MRC, positive responses at higher concentrations.
Instructions for UseValidation	Met Acceptance Criteria:Negative response at concentrations at or below MRC, positive responses at higher concentrations.
Closed Bottle Shelf-LifeStability	Met Acceptance Criteria:Met specifications after storage of labeled shelf life of 12 months (unopened).
Open Bottle Use-LifeStability	Met Acceptance Criteria:Met specification for 3 months (opened).
Comparative Sensitivityand 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.

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Closed Bottle Shelf-LifeStability:	The closed bottle shelf-life of the QwikCheckChemical Indicators was evaluated at and above theMRC with TD-12 peracetic acid high-leveldisinfectant solutions at ambient room temperature upto 32°C storage. The chemical indicator yieldedacceptable performance out to a minimum 15 monthsshelf-life from ambient room temperature up to 32°C,with data collection ongoing. The chemical indicatoryielded acceptable performance with 100% FAILresults at and below the MRC and PASS results abovethe MRC. A conservative 12-month shelf-life isclaimed.
Open Bottle Use-Life Stability:	The open bottle use-life of the QwikCheck ChemicalIndicators was evaluated at and above the MRC withTD-12 peracetic acid high-level disinfectant solutionsat constant high humidity storage (≥ 80% RH) andrepeated openings of the chemical indicator bottle.The chemical indicator yielded acceptableperformance out to a minimum 5 months open bottleuse-life, with data collection ongoing. The chemicalindicator yielded acceptable performance with 100%FAIL results at and below the MRC and PASS resultsabove the MRC. A conservative 3-month open bottleuse-life is claimed.

Closed Bottle Shelf-LifeStability:

The closed bottle shelf-life of the QwikCheckChemical Indicators was evaluated at and above theMRC with TD-12 peracetic acid high-leveldisinfectant solutions at ambient room temperature upto 32°C storage. The chemical indicator yieldedacceptable performance out to a minimum 15 monthsshelf-life from ambient room temperature up to 32°C,with data collection ongoing. The chemical indicatoryielded acceptable performance with 100% FAILresults at and below the MRC and PASS results abovethe MRC. A conservative 12-month shelf-life isclaimed.

Open Bottle Use-Life Stability:

The open bottle use-life of the QwikCheck ChemicalIndicators was evaluated at and above the MRC withTD-12 peracetic acid high-level disinfectant solutionsat constant high humidity storage (≥ 80% RH) andrepeated openings of the chemical indicator bottle.The chemical indicator yielded acceptableperformance out to a minimum 5 months open bottleuse-life, with data collection ongoing. The chemicalindicator yielded acceptable performance with 100%FAIL results at and below the MRC and PASS resultsabove the MRC. A conservative 3-month open bottleuse-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.

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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.

Regulation Number and Section

§ 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).