(160 days)
No
The summary describes a biological indicator system and an auto-reader that detects fluorescence. The software change mentioned relates to incubation time and temperature, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the document.
No.
This device is designed to monitor sterilization cycles for medical instruments, not to provide therapy to a patient.
Yes
The device diagnoses whether a steam sterilization process has failed based on a change indicating fluorescence, which is a diagnostic function.
No
The device description clearly details physical components like medical index cards, biological indicators, chemical integrators, and a process indicator, in addition to the software change being addressed.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "qualify or monitor dynamic-air-removal steam sterilization cycles." This is a quality control process for sterilization equipment, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device contains a biological indicator and a chemical integrator, which are used to assess the effectiveness of a sterilization process. The auto-reader detects a fluorescent change in the biological indicator, which indicates a "steam sterilization process failure." This is about monitoring the sterilization equipment, not diagnosing a condition in a patient.
- No mention of biological samples: The text does not mention the device being used with any biological samples (blood, urine, tissue, etc.) from a patient. IVDs are specifically designed to test such samples.
Therefore, the device described is a sterilization process monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
Product codes
FRC
Device Description
The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V are specifically designed to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 1496V and 41482V Challenge Packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device. Each 1496V Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V while the 41482V Challenge Pack contains a 1492V BI and a 3M™ SteriGage™ Steam Chemical Integrator (Type 5 Integrating Indicators as categorized by ISO 11140-1:2014). The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3M™ Attest™ 1492V BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.
This submission is addressing a software change to the 3M™ Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1492V BI from 1 hour to 24 minutes, and to change the incubation temperature from 56°C to 60°C making the 490 Auto-reader identical to the 490H Auto-reader (software version 4.0.0 or greater). The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V are the same design as the previously cleared devices of the same model numbers. The ComplyTM SteriGage™ Steam Chemical Integrators contained within the 41482V challenge pack are the same as those in the predicate device. The device has the same materials and fundamental scientific technology.
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)
The functionality of the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 and the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C was demonstrated in the following tests:
- Resistance of the Challenge Pack as compared to AAMI 16 Towel PCD: Challenge Pack is at least as resistant as the biological indicator AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79: 2017. Results: Passed
- Resistance of the Challenge Pack as compared to the Biological Indicator alone: Challenge Pack provides a greater resistance than the Biological Indicator alone. Results: Passed
- Auto-reader Maintenance of Incubation Temperature: Auto-reader maintains incubation temperature of 60 ± 2 ℃ over a period of 7 days. Results: Passed
The results of these evaluations showed that the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V present a challenge to the sterilization process equivalent to the biological indicator AAMI 16 Towel PCD described in ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
The Attest™ Auto-readers were tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1 (2010) 3rd Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements, and
- IEC 61010-2-010 (2014) 3rd Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials
In addition the 3M™ Attest™ Auto-readers 490 and 490H have been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- USA Title 47, Code of Federal Regulations for:
- Radiated Emissions (FCC Part 15, Subpart B, Class A)
- Conducted Emissions (FCC Part 15, Subpart B, Class A), and
- IEC 61326-1:2012 Electrical Equipment for Measurement, Control, and Laboratory Use – EMC Requirements
No clinical data was included in this premarket application submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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April 23, 2018
3M Company Hilary Hovde Regulatory Affairs Associate 3M Center, Building 275-5W-06 St Paul, Minnesota 55144
Re: K173519
Trade/Device Name: 3M Attest Super Rapid Readout Steam Challenge Pack 1496V, 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 19, 2018 Received: March 22, 2018
Dear Hilary Hovde:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V, 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H
Indications for Use (Describe)
Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
| 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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3
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510(k) Summary for 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V 3M™ Attest™ Auto-reader 490 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater)
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Hilary B. Hovde Regulatory Affairs Associate Phone Number: (651) 736-0364 FAX Number: (651) 737-5320
Submission Date: April 19, 2018
4
Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Proprietary Name: | 3MTM AttestTM Super Rapid Readout Steam Challenge Pack 1496V |
| 3MTM AttestTM Super Rapid 5 Steam-Plus Challenge Pack 41482V | |
| 3MTM AttestTM Auto-reader 490 | |
| 3MTM AttestTM Auto-reader 490H | |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR § 880.2800(a)) | |
| Device Classification: | Class II |
| Product Code: | FRC |
Predicate Device:
- 3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V, 3MTM . Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and 3MTM Attest™ Auto-reader 490, K121593
Reference Device:
- 3MTM Attest™ Auto-reader 490H, K171003 .
Description of Device:
The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V are specifically designed to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 1496V and 41482V Challenge Packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device. Each 1496V Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V while the 41482V Challenge Pack contains a 1492V BI and a 3M™ SteriGage™ Steam Chemical Integrator (Type 5 Integrating Indicators as categorized by ISO 11140-1:2014). The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3M™ Attest™ 1492V BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from vellow to brown or darker when exposed to steam.
5
This submission is addressing a software change to the 3M™ Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1492V BI from 1 hour to 24 minutes, and to change the incubation temperature from 56°C to 60°C making the 490 Auto-reader identical to the 490H Auto-reader (software version 4.0.0 or greater). The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V are the same design as the previously cleared devices of the same model numbers. The ComplyTM SteriGage™ Steam Chemical Integrators contained within the 41482V challenge pack are the same as those in the predicate device. The device has the same materials and fundamental scientific technology.
Summary of Nonclinical Testing
As the change is to the 3M™ Attest™ Auto-reader software, testing was conducted on the biological indicators and the challenge packs following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- . ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General Requirements
- . ISO 11138-3:2017 Sterilization of health care products – Biological indicators, Part 3: Biological indicators for moist heat sterilization processes
- ANSI/AAMI/ISO 18472:2006 Sterilization of Health Care Products – Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and . Chapter Biological Indicators - Resistance Performance Tests
6
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V 3MTM Attest™ Auto-reader 490 and 490H
The functionality of the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 and the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C was demonstrated in the following tests:
| Test | Acceptance Criteria | Results |
|---|---|---|
| Resistance of the | ||
| Challenge Pack as | ||
| compared to AAMI 16 | ||
| Towel PCD | Challenge Pack is at least as resistant as the | |
| biological indicator AAMI 16 Towel Process | ||
| Challenge Device (PCD) described in ANSI/AAMI | ||
| ST79: 2017 | Passed | |
| Resistance of the | ||
| Challenge Pack as | ||
| compared to the | ||
| Biological Indicator | ||
| alone | Challenge Pack provides a greater resistance than | |
| the Biological Indicator alone | Passed | |
| Auto-reader Maintenance | ||
| of Incubation | ||
| Temperature | Auto-reader maintains incubation temperature of | |
| $60 \pm 2$ ℃ over a period of 7 days | Passed |
The results of these evaluations showed that the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V present a challenge to the sterilization process equivalent to the biological indicator AAMI 16 Towel PCD described in ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
The Attest™ Auto-readers were tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1 (2010) 3rd Edition; Safety requirements for electrical equipment for . measurement, control, and laboratory use – Part 1: General requirements, and
- . IEC 61010-2-010 (2014) 3rd Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials
In addition the 3M™ Attest™ Auto-readers 490 and 490H have been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- USA Title 47, Code of Federal Regulations for:
- Radiated Emissions (FCC Part 15, Subpart B, Class A) O
- o Conducted Emissions (FCC Part 15, Subpart B, Class A), and
- . IEC 61326-1:2012 Electrical Equipment for Measurement, Control, and Laboratory Use – EMC Requirements
7
No clinical data was included in this premarket application submission.
Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Autoreader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
8
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V 3M™ Attest™ Auto-reader 490 and 490H
Comparison to Predicate Device
| | Submission Device:
3MTM Attest™ | Predicate Device (K121593):
3MTM Attest™ |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Super Rapid Readout
Steam Challenge Pack 1496V and
3MTM AttestTM Super Rapid 5 | Super Rapid Readout
Steam Challenge Pack 1496V and
3MTM Attest™ Super Rapid 5 |
| | Steam-Plus Challenge Pack 41482V | Steam-Plus Challenge Pack 41482V |
| Indications for use | Use the 3MTM Attest™ Super Rapid Readout
Steam Challenge Pack 1496V and the 3MTM
Attest™ Super Rapid 5 Steam-Plus Challenge
Pack 41482V in conjunction with the 3MTM
AttestTM Auto-reader 490 or 3MTM AttestTM
Auto-reader 490H having software version 4.0.0
or greater to qualify or monitor dynamic-air- | Use the 3M™ Attest™ Super Rapid
Readout Steam Challenge Pack 1496V
and the 3MTM Attest™ Super Rapid 5
Steam-Plus Challenge Pack 41482V in
conjunction with the 3MTM AttestTM
Auto-reader 490 to qualify or monitor
dynamic-air-removal (pre-vacuum)
steam sterilization cycles 270°F
(132°C) at 4 minutes and 275°F
(135°C) at 3 minutes. |
| | removal steam sterilization cycles of 4 minutes
at 270°F (132°C) and 3 minutes at 275°F
(135°C). | The 3MTM Attest™ Super Rapid
Readout Biological Indicator 1492V
contained in the challenge pack
provides a final fluorescent result in 1
hour. An optional visual pH color
change result is observed in 48 hours. |
| General Design | Layers of medical index cards, some of which
are die-cut to contain indicators, overwrapped
and secured with a label. | Identical |
| Biological Indicator | 3MTM Attest™ Super Rapid Readout Biological
Indicator 1492V | Identical |
| Biological Indicator
Incubation
temperature | 60 ± 2°C | 56 ± 2°C |
| Biological Indicator
Readout time | 24 minute final fluorescent result in both the 490
and 490H Auto-readers having software versions
4.0.0 or greater.
1 hour final fluorescent result in 490 Auto-
readers having software versions less than 4.0.0. | 1 hour final fluorescent result in 490
Auto-readers. |
| Resistance
Comparison to the
AAMI ST79
16 Towel PCD | Equivalent in resistance to the AAMI ST79
16 Towel PCD | Identical |
| Chemical Integrator | The 3M™ Attest™ Super Rapid Readout Steam
Challenge Pack 1496V does not contain a
chemical integrator.
The 3MTM Attest™ Super Rapid 5 Steam-Plus
Challenge Pack 41482V contains a 3M™
SteriGage™ Chemical Integrator | Identical |
| External Chemical
Process Indicator | Turns from yellow to brown or darker upon
steam exposure | Identical |
| Shelf-life | 21 months | Identical |
9
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the 3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, the 3MTM Attest™ Auto-reader 490, and the 3MTM Attest™ Autoreader 490H are as safe, as effective, and perform as well as or better than the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Auto-reader 490 (K121593).