(209 days)
Not Found
No
The device is a simple chemical indicator that changes color based on a chemical reaction, with no mention of AI or ML in the description or performance studies.
No.
The device is a chemical indicator used to determine the concentration of peracetic acid in another solution, not a device intended to provide therapy or treatment for a medical condition.
No
This device is a chemical indicator used to determine the concentration of peracetic acid in a solution, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "qualitative, single use, reagent chemical indicator made up of a 0.20-inch square indicator pad... affixed to one end of a 3.25 inch by 0.20-inch white opaque plastic handle." This describes a physical, hardware-based device, not software.
Based on the provided information, the QwikCheck™ Chemical Indicator is likely considered an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to determine the concentration of peracetic acid in a solution (CS Medical's TD-12 Solution). This solution is used for disinfection, and testing its concentration is a critical step in ensuring the effectiveness of the disinfection process. While not directly testing a human sample, it's testing a reagent used in a process that impacts patient care.
- Device Description: It's a chemical indicator designed to react with a specific substance (peracetic acid) to provide a qualitative result (above or below the MRC). This aligns with the nature of many IVD tests that detect the presence or concentration of substances in a sample.
- Performance Studies: The performance studies focus on metrics like sensitivity, specificity, and stability, which are standard for evaluating the performance of IVD devices.
- Predicate Device: The predicate device listed (Serim® GUARDIAN™ Peracetic Acid Test Strips) is also a chemical indicator for peracetic acid, and it is likely regulated as an IVD.
In summary, the QwikCheck™ Chemical Indicator fits the general description and regulatory considerations of an IVD because it is a test used to evaluate a critical component of a process that directly impacts patient safety and care, even though it's not directly testing a human biological sample. It's a test performed "in vitro" (outside the body) to provide information relevant to a medical process.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
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.
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)
Summary of Non-Clinical Performance Data: The performances of the QwikCheck™ Chemical 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.
Study: Dynamic Range
Results: Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive responses at higher concentrations.
Description: 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.
Study: Instructions for Use Validation
Results: Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive responses at higher concentrations.
Description: The instructions for use of the QwikCheck Chemical 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.
Study: Closed Bottle Shelf-Life Stability
Results: Met Acceptance Criteria: Met specifications after storage of labeled shelf life of 12 months (unopened).
Description: 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.
Study: Open Bottle Use-Life Stability
Results: Met Acceptance Criteria: Met specification for 3 months (opened).
Description: 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.
Study: Comparative Sensitivity and Specificity
Results: Met Acceptance Criteria: Comparative sensitivity and specificity of 1
Description: The QwikCheck Chemical Indicators were compared 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.
Study: Analytic Specificity - Bioburden
Description: The sensitivity of the QwikCheck Chemical Indicators 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.
Study: Analytic Specificity – Other Disinfectants
Description: The sensitivity of the QwikCheck Chemical Indicators 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Comparative sensitivity of 100% and comparative specificity of 100%.
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.
Serim® GUARDIAN™ Peracetic Acid Test Strips, Serim Research Corporation, P/N 5106; K910320.
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
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) |
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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.