(30 days)
Not Found
No
The device is a chemical indicator that changes color based on physical conditions (temperature and air presence) in a sterilizer. There is no mention of computational analysis, algorithms, or learning processes.
No
This device is a chemical indicator used to test the performance of steam sterilizers, ensuring they effectively remove air and achieve proper sterilization conditions. It does not directly treat or diagnose a medical condition in a patient.
No
This device is a sterility assurance product used to monitor steam sterilizers, not to diagnose a medical condition in a patient.
No
The device is a physical card with indicator ink and lamination, designed to be placed in a steam sterilizer. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to detect the presence of residual air in steam sterilizers. This is a quality control measure for a sterilization process, not a test performed on a biological sample from a human or animal to diagnose a condition, monitor a treatment, or screen for a disease.
- Device Description: The device is a chemical indicator designed to respond to specific sterilization conditions (temperature and air removal). It does not interact with biological specimens.
- Performance Studies: The performance studies focus on the device's ability to accurately indicate the presence or absence of air in the sterilizer, according to standards for sterilization indicators. They do not involve testing against clinical samples or evaluating diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers.
The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.
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)
Performance testing was conducted to verify that the proposed Green Card Bowie-Dick Test meets the applicable portions of ANSI/AAMI/ISO 11140-5 Sterilization of health care products — Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests.
Performance Testing of 3 manufactured lots of Green Card Bowie-Dick Test was conducted with the following results:
- Uniform Color Change (Pass Test)-ANSI/AAMI/ISO 111140-5 Annex B: PASS
- Non-Uniform Color Change (Fail Test)- ANSI/AAMI/ISO 11140-5 Annex F: PASS
- Dry Heat Testing - ANSI/AAMI/ISO 11140-5 Annex C: PASS
- Color Density Test- ANSI/AAMI/ISO 11140-5 Annex A: PASS
- Indicator Color Stability: PASS
- Shelf-Life Stability: PASS
The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K250172, the modified Green Card Bowie-Dick Test, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared in K024293, Class II Indicator, physical/chemical sterilization process (21 CFR 880.2800), JOJ.
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).
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February 20, 2025
SteriTec Products, Inc. (a Getinge Company) % Barb Smith Principal Regulatory Affairs Specialist Getinge 75 Barbour Pond Wayne, New Jersey 07470
Re: K250172
Trade/Device Name: Green Card Bowie-Dick Test (BD115) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 17, 2025 Received: January 21, 2025
Dear Barb Smith:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Division Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K250172
Device Name
Green Card Bowie-Dick Test (BD115)
Indications for Use (Describe)
The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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SteriTec Products, Inc. 74 Inverness Drive East Englewood, CO 80112 (303) 660-4201
510(k) Summary for the Green Card Bowie-Dick Test
Page 1 of 5
510(k) Summary K250172
Date Prepared: February 17, 2025
Applicant Information
SteriTec Products Manufacturing CO INC (a Getinge Group company) 74 Inverness Drive East Englewood, CO 80112 U.S. Ph: 303-660-4201
Contact: Barb Smith Principal Requlatory Affairs Specialist Ph: 585-370-6101 e-mail: barb.smith@getinge.com
-
- Device Name
| Trade Name: | Green Card Bowie-Dick Test (BD115) |
|---|---|
| Device Classification: | Class II |
| Common/Usual Name: | Indicator, physical/chemical sterilization process |
| Classification Name: | Indicator, physical/chemical sterilization process (21 CFR 880.2800, JOJ) |
-
- Predicate Device
SteriTec Bowie-Dick Mini Pak (K024293). SteriTec Products, Manufacturing Co. Inc.
- Predicate Device
3. Description of Device
The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers.
The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and K250172
5
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510(k) Summary for the Green Card Bowie-Dick Test
displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.
4. Intended Use/Indications for Use:
The Green Card Bowie-Dick Test Card is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes.
The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met, and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
5. Technological Characteristics
The chart below compares the technological characteristics of the subject device, to that of the predicate device:
| Feature | Predicate Device | Subject/Modified Device | Comparison |
|---|---|---|---|
| SteriTec Bowie-Dick Mini Pak | |||
| (K024293) | Green Card Bowie-Dick Test | ||
| Intended | |||
| Use/ | |||
| Indications | |||
| for Use | SteriTec Bowie-Dick Mini Pak is | ||
| designed to detect the presence | |||
| of residual air in pre-vacuum | |||
| steam sterilizers operating at 132° | |||
| C for 3.5 minutes. |
The indicator will demonstrate a
uniform color change from purple
to green when the proper
sterilization conditions are met,
and no air is present. If enough
air is present to create a 2° C or
greater temperature difference in
a standard Bowie-Dick test towel
pack, the indicator will
demonstrate a non-uniform color
change. | The Green Card Bowie-Dick Test
Card is designed to detect the
presence of residual air in pre-
vacuum steam sterilizers
operating at 270°F (132°C) and
273°F (134°C) for 3.5 minutes.
The indicator will demonstrate a
uniform color change from purple
to green when the proper
sterilization conditions are met,
and no air is present. If enough
air is present to create a 2°C or
greater temperature difference in
a standard Bowie-Dick test towel
pack, the indicator will
demonstrate a non-uniform color
change. | The Intended Use of the
modified device is the same
as the predicate.
This submission proposes
the monitoring of an
additional exposure
temperature and time to the
Indications for Use of:
• 134°C 3.5 minutes
In addition, the name was
changed from Bowie-Dick
Mini Pak to Green Card
Bowie-Dick Test. |
| Device
Design | Card measuring 3.5"x1.85" with
indicator ink printed on one side
and laminated with a polyester
film on both sides.
Identification/record label is on
the back side opposite the
indicator side.
Indicator area will turn uniformly
from purple to green when a | Card measuring 3.5"x1.91" with
indicator ink printed on one side
and laminated with a polyester
film on both sides.
Identification/record label is on
the back side opposite the
indicator side.
Indicator area will turn uniformly
from purple to green when a | Minor change in card
dimension. |
| successful Bowie-Dick test is
performed. If a significant amount
of air is present in the sterilizer
chamber during the test, the
indicator will have a non-uniform
color change with purple still
present.
The card is placed inside a holder
assembly prior to placement in
the sterilizer. The holder is open
on both sides allowing the
unrestricted flow of steam and air
removal around the card. The
holder acts as a weight to keep
the indicator card from blowing
around during the test. The holder
does not have any functionality
regarding the test itself. | successful Bowie-Dick test is
performed. If a significant amount
of air is present in the sterilizer
chamber during the test, the
indicator will have a non-uniform
color change with purple still
present.
The card is placed inside a holder
assembly prior to placement in
the sterilizer. The holder is open
on both sides allowing the
unrestricted flow of steam and air
removal around the card. The
holder acts as a weight to keep
the indicator card from blowing
around during the test. The holder
does not have any functionality
regarding the test itself. | | |
| Sterilization
methods
and cycles | Steam sterilizer Bowie-Dick test
132°C 3.5 minutes | Steam sterilizer Bowie-Dick test
132°C 3.5 minutes and 134°C 3.5
minutes | This submission proposes
the monitoring of additional
exposure temperature and
time to the Indications for
Use of:
• 134°C 3.5 minutes |
| Indicator
Agent | Proprietary | Proprietary | Same |
| Color
Change | The indicator area will change
from purple to green when
exposed to steam sterilization
cycle with acceptable vacuum
cycles. | The indicator area will change
from purple to green when
exposed to steam sterilization
cycle with acceptable vacuum
cycles. | Same |
| Interpretati
on | If no significant amount of
residual air is present, the
indicator will show a uniform
green color change. If the
indicator shows a purple color in
the center, this indicates the
presence of residual air. | If no significant amount of
residual air is present, the
indicator will show a uniform
green color change. If the
indicator shows a purple color in
the center, this indicates the
presence of residual air. | Same |
| Shelf Life | 2 Years | 2 Years | Same |
6
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SteriTec Products, Inc.
74 Inverness Drive East Englewood, CO 80112 (303) 660-4201
510(k) Summary for the Green Card Bowie-Dick Test
Page 3 of 5
7
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Page 4 of 5
510(k) Summary for the Green Card Bowie-Dick Test
6. Non-Clinical Performance Testing
Performance testing was conducted to verify that the proposed Green Card Bowie-Dick Test meets the applicable portions of ANSI/AAMI/ISO 11140-5 Sterilization of health care products — Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests.
The following table summarizes the performance testing that was completed, with acceptance criteria and results to demonstrate that performance of the Green Card Bowie-Dick Test is as safe and effective as the predicate device. This testing confirms and demonstrates that the proposed device meets the requirements of its pre-determined acceptance criteria in its claimed intended steam sterilization cycles.
| Performance Testing of 3
manufactured lots of Green
| Card Bowie-Dick Test | Pre-Determined Acceptance Criteria | Results |
|---|---|---|
| Uniform Color Change (Pass | ||
| Test)-ANSI/AAMI/ISO 111140-5 | ||
| Annex B | The Standard Test Pack must demonstrate | |
| no greater than a 0.5° C difference between | ||
| the inside of the Standard Test Pack and the | ||
| drain temperature and shall remain so for the | ||
| duration of the exposure time exclusive of a | ||
| 15 second equilibration time. This should be | ||
| demonstrated with a thermocouple graph. | ||
| The SteriTec Green Card Bowie-Dick Test | ||
| Card indicator cards must demonstrate a | ||
| uniform color change to green | PASS | |
| Non-Uniform Color Change (Fail | ||
| Test)- ANSI/AAMI/ISO 11140-5 | ||
| Annex F | The Standard Test Pack must demonstrate a | |
| 2° C (+1°/-0°C) temperature difference | ||
| between the towel pack and the drain | ||
| temperatures for the last one minute of the | ||
| three and half minute sterilization cycle. This | ||
| should be demonstrated with a thermocouple | ||
| graph. | ||
| The SteriTec Green Card Bowie-Dick Test | ||
| Card indicator cards must demonstrate a non- | ||
| uniform color change with a purple area in the | ||
| center and the rest of the indicator green. | PASS | |
| Dry Heat Testing - ANSI/AAMI/ISO | ||
| 11140-5 Annex C | The SteriTec Green Card Bowie-Dick Test | |
| Card shall show either no change or a change | ||
| that is markedly different from the change | ||
| occurring after exposure to a steam | ||
| sterilization process. | PASS | |
| Color Density Test- | ||
| ANSI/AAMI/ISO 11140-5 Annex A | Difference in color density between the | |
| substrate and indicator should be not less | ||
| than 0.3. | PASS | |
| Indicator Color Stability | Verify that the Green Card Indicator sample | |
| end color has not changed to any other color | ||
| and has remained green after 18 months or | ||
| longer from steam sterilization exposure. | PASS |
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SteriTec Products, Inc. 74 Inverness Drive East Englewood, CO 80112 (303) 660-4201
510(k) Summary for the Green Card Bowie-Dick Test
Page 5 of 5
| | Verify that the Green Card Indicator sample
fail point color has not changed to any other
color and has remained purple in center of
card after 18 months or longer from steam
sterilization exposure. | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Shelf-Life Stability | The following tests will be performed at 24
months of shelf life or longer.
● The pass cycle samples shall exhibit
complete color change to green.
● The fail cycle samples shall exhibit
incomplete color change. This
presents as a purple spot in the
center of the test card. | PASS |
7. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K250172, the modified Green Card Bowie-Dick Test, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared in K024293, Class II Indicator, physical/chemical sterilization process (21 CFR 880.2800), JOJ.