(149 days)
Not Found
PCD26-C, PCD26-2
No
The description focuses on biological and chemical indicators for sterilization processes and reader incubators, with no mention of AI or ML capabilities.
No
The listed devices are intended for monitoring the efficacy of sterilization processes, not for treating patients.
No
The provided text describes devices (biological indicators, chemical indicators, integrators, and incubators) used for monitoring the efficacy of sterilization processes for medical devices. These are not diagnostic devices; they assess the sterilization equipment's function, not diagnose a patient's condition or disease directly.
No
The provided text describes various physical devices used for monitoring sterilization processes, including biological indicators, chemical indicators, and reader incubators. There is no mention of any software component being the primary or sole medical device.
Based on the provided text, none of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
-
IVDs are used to examine specimens taken from the human body. The intended use of all the listed Terragene devices is to monitor the efficacy of sterilization processes (steam, ethylene oxide, vaporized hydrogen peroxide). They are used to test the sterilization equipment and process itself, not to diagnose or provide information about a patient's health based on a biological sample.
-
The devices are indicators of sterilization effectiveness. They use biological spores or chemical reactions to determine if the sterilization parameters were met. This is a quality control measure for the sterilization process, not a diagnostic test for a patient.
Therefore, these devices fall under the category of sterilization process indicators, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.
Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification processes.
Terragene Bionova® Reader Incubators (10/20FRLCD, Mini-Bio) incubate at 60° C and 37° C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 10^6 Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes.
The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %, SV37°C/75 min., SV54°C/30 min, SV55°C/28 min.
Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met.
Terragene Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Ranid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C.
Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to vellow for CD42 to indicate that the conditions of the cycle have been met.
The integrator Terragene Integron® TT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.
The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121°C for 30 minutes, 132°C for 15 minutes, 135°C for 25 minutes, 135°C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.
Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the effication processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
Autoclave/Steam Cycles
Gravity Displacement
Models: CD29, CT22, IT26-C, IT26-1YS
121° C: 30 minutes
132° C: 15 minutes, 25 minutes
135°C: 10 minutes
Models: PCD26-C, PCD26-2
121° C: 30 minutes
132° C: NA
135°C: NA
Models: BT224, PCD224-2, PCD224-C
121° C: NA
132° C: 15 minutes, 25 minutes
135°C: 10 minutes
Models: BT224, PCD224-2, PCD224-C
121° C: NA
132° C: 10 minutes
135°C: 10 minutes
Dynamic Air Removal (Vacuum Assist)
Models: BT224, PCD224-2, PCD224-C, CD29, CT22, IT26-C, IT26-1YS
121° C: NA
132° C: 4 minutes
135° C: 3 minutes
Models: PCD26-C, PCD26-2
121° C: NA
132° C: 4 minutes
135° C: NA
Vaporized Hydrogen Peroxide
Models: BT95, BT96, CT40, CD42
Cycles: STERRAD 100S 54 minutes; STERRAD Standard and Express cycles; V-Pro Max and Sterizone VP4
Models: CD40
Cycles: STERRAD 100S 54 minutes; STERRAD Standard and Express cycles; V-Pro Max
Ethylene Oxide
Models: CD16, BT110, IT12
Cycles: 55° C for 240 minutes, 600 mg/L, RH 60 %
Fluorescence Read Time and pH Color Change
Models: BT224, PCD224-2, PCD224-C
Fluorescence Read Time: 20 minutes
pH Color Change: 48 hours
Models: BT96
Fluorescence Read Time: 30 minutes
pH Color Change: 48 Hours
Models: BT95
Fluorescence Read Time: 2 Hours
pH Color Change: 48 Hours
Models: BT110
Fluorescence Read Time: 4 hours
pH Color Change: 48 Hours
Minimum Stated Values (SV) for Chemical Integrators
Autoclave/Steam Cycles
Models: IT26-C, IT26-1YS
121 °C: 16.5 minutes
132 °C: 2.0 minutes
135 °C: 1.2 minutes
Ethylene Oxide (600mg/L)
Models: IT12
37 °C: 75 minutes
54 °C: 30 minutes
55 °C: 28 minutes
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
Not Found
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)
Not Found
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.
Not Found
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2019
Terragene SA % Raymond Kelly Consultant Licensale Inc 68 Southwoods Terrace Southbury, Connecticut 06488
Re: K191021
Trade/Device Name: Terragene Bionova® SCBI (BT95, BT96, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-1 YS, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40) Regulation Number: 21 CFR 880.2800
Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: August 13, 2019 Received: August 16, 2019
Dear Raymond Kelly:
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
1
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 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 medical devices and radiation-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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191021
Device Name
Terragene Bionova® SCBI (BT95, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-1YS, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)
Indications for Use (Describe)
Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.
Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification processes.
Terragene Bionova® Reader Incubators (10/20FRLCD, Mini-Bio) incubate at 60° C and 37° C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 106 Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes.
The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %, SV37°C/75 min., SV54°C/30 min, SV55°C/28 min.
Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met.
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)
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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191021
Device Name
Terragene Bionova® SCBI (BT95, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-1YS, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)
Indications for Use (Describe)
Terragene Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Ranid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C.
Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to vellow for CD42 to indicate that the conditions of the cycle have been met.
The integrator Terragene Integron® TT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.
The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121°C for 30 minutes, 132°C for 15 minutes, 135°C for 25 minutes, 135°C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min..
| 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)
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
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191021
Device Name
Terragene Bionova® SCBI (BT95, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)
Indications for Use (Describe)
Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the effication processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
| Autoclave/Steam Cycles | |||
|---|---|---|---|
| Gravity Displacement | |||
| Models | 121° C | 132° C | 135°C |
| CD29, CT22, IT26-C, IT26-1YS | 30 minutes | 15 minutes, 25 minutes | 10 minutes |
| PCD26-C, PCD26-2 | 30 minutes | NA | NA |
| BT224, PCD224-2, PCD224-C | NA | 15 minutes, 25 minutes | 10 minutes |
| BT224, PCD224-2, PCD224-C | NA | 10 minutes | 10 minutes |
| Dynamic Air Removal (Vacuum Assist) | |||
| Models | 121° C | 132° C | 135° C |
| BT224, PCD224-2, PCD224-C, CD29, CT22, IT26-C, IT26-1YS | NA | 4 minutes | 3 minutes |
| PCD26-C, PCD26-2 | NA | 4 minutes | NA |
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)
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
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191021
Device Name
Terragene Bionova® SCBI (BT95, BT96, BT110, BT224); Terragene Bionova® PCD (PCD224-C); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)
Indications for Use (Describe)
| Vaporized Hydrogen Peroxide | |||
|---|---|---|---|
| Models | Cycles | ||
| BT95, BT96, CT40, CD42 | STERRAD 100S 54 minutes | ||
| STERRAD Standard and Express cycles | |||
| V-Pro Max and Sterizone VP4 | |||
| CD40 | STERRAD 100S 54 minutes | ||
| STERRAD Standard and Express cycles | |||
| V-Pro Max | |||
| Ethylene Oxide | |||
| Models | Cycles | ||
| CD16, BT110, IT12 | 55° C for 240 minutes, 600 mg/L, RH 60 % | ||
| Fluorescence Read Time and pH Color Change | |||
| Models | Fluorescence Read Time | pH Color Change | |
| BT224, PCD224-2, PCD224-C | 20 minutes | 48 hours | |
| BT96 | 30 minutes | 48 Hours | |
| BT95 | 2 Hours | 48 Hours | |
| BT110 | 4 hours | 48 Hours | |
| Minimum Stated Values (SV) for Chemical Integrators | |||
| Autoclave/Steam Cycles | |||
| Models | 121 °C | 132 °C | 135 °C |
| IT26-C, IT26-1YS | 16.5 minutes | 2.0 minutes | 1.2 minutes |
| Ethylene Oxide (600mg/L) | |||
| Models | 37 °C | 54 °C | 55 °C |
| IT12 | 75 minutes | 30 minutes | 28 minutes |
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)
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