(87 days)
No
The device description and performance studies focus on mechanical function and safety features, with no mention of AI or ML.
No
The device is intended to produce a capillary blood sample for testing, which is a diagnostic purpose, not a therapeutic one. It facilitates the collection of a sample that can then be used for diagnosis, but it does not treat or cure a disease.
No
This device is intended to produce a capillary blood sample for testing, not to perform the test or diagnose a condition itself. It is a tool for sample collection.
No
The device description clearly states it is a "lancing device," which is a physical, mechanical device used for blood sampling. The performance studies also describe "mechanical design verification and validation testing."
Based on the provided information, the Accu-Chek Safe-T-Pro Uno lancing device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to produce a capillary blood sample. It does not perform any diagnostic testing on the blood sample itself.
- Device Description: It's a lancing device for obtaining a sample, not a device that analyzes the sample.
- Lack of Diagnostic Function: There is no mention of any analytical or diagnostic function performed by the device. It's purely a tool for sample collection.
- Performance Studies: The performance studies described are related to mechanical function and safety (sharps injury prevention), not diagnostic accuracy.
IVD devices are those intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. The Accu-Chek Safe-T-Pro Uno lancing device is a tool used to obtain the specimen, not to perform the diagnostic examination.
N/A
Intended Use / Indications for Use
The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (adults and children 1 year and older)
Heel (child under 1 year)
Indicated Patient Age Range
Adults and children 1 year and older, or, if the patient is a child under 1 year.
Intended User / Care Setting
Healthcare professionals and consumers
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)
Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification and validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device.
Clinical Testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified.
The Accu-Chek Safe-T-Pro Uno Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices.
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.
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
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
November 13, 2023
Roche Diabetes Care, Inc. Kacia Mills Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250
Re: K232509
Trade/Device Name: Accu-Chek Safe-T-Pro Uno Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 17, 2023 Received: August 18, 2023
Dear Kacia Mills:
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" (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).
1
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.
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 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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.13 14:40:24 -05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232509
Device Name Accu-Chek Safe-T-Pro Uno Lancing Device
Indications for Use (Describe)
The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Contact Details [21 CFR 807.92(a)(1)] Applicant Name: Roche Diabetes Care, Inc. Applicant Address: 9115 Hague Road Indianapolis, IN 46250-0457; United States of America Applicant Contact Telephone: +1 317-709-4223 Applicant Contact: Mrs. Kacia Mills Applicant Contact Email: kasey.mills@roche.com
Device Name [21 CFR 807.92(a)(2)]
Device Trade Name: Accu-Chek Safe-T-Pro Uno Lancing Device Common Name: Blood Lancets Classification Names: Single use only blood lancet with an integral sharps injury prevention feature Regulation Number: 878.4850, Class II Product Code: FMK
Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]
Predicate #1: K220364 Predicate Trade Name: Accu-Chek Safe-T-Pro Uno Lancing Device Product Code: FMK
Legally Marketed Reference Devices [21 CFR 807.92(a)(3)]
Reference #1: K222090 Predicate Trade Name: Safety Lancet Product Code: FMK Reference #2: K221433 Predicate Trade Name: Facet 28G Universal Lancet Product Codes: QRK, QRL
Device Description Summary [21 CFR 807.92(a)(4)]
The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.
4
| | Predicate Device - Accu-
Chek Safe-T-Pro Uno
Lancing Device | Candidate Device - Accu-
Chek Safe-T-Pro Uno
Lancing Device | Reference Device 1 -
Safety Lancet (K222090) | Reference Device 2 - Facet
28G Universal Lancet
(K221433) | | Predicate Device – Accu-
Chek Safe-T-Pro Uno
Lancing Device | Candidate Device - Accu-
Chek Safe-T-Pro Uno
Lancing Device | Reference Device 1 –
Safety Lancet (K222090) | Reference Device 2 - Facet
28G Universal Lancet
(K221433) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The Accu-Chek Safe-T-Pro
Uno lancing device is a
needle used for capillary
blood sampling for use in
diagnostic testing.
The Accu-Chek Safe-T-Pro
Uno lancing device
contains a sharps injury
prevention feature where
the lancet is retracted and
concealed before and after
use. Once the lancet is
used, it is rendered
inoperative. The device is
designed for single use
only. | The Accu-Chek Safe-T-Pro
Uno lancing device is a needle
used for capillary blood
sampling for use in diagnostic
testing.
The Accu-Chek Safe-T-Pro
Uno lancing device contains a
sharps injury prevention
feature where the lancet is
retracted and concealed before
and after use. Once the lancet
is used, it is rendered
inoperative. The device is
designed for single use only. | Safety Lancet, could be
divided into Model XY,
Model XH, and Model XA
according to the design
features and key functional
elements. The device is
sterilized by Gamma ray
(Co-60 or e-beam) and for
single use. The shelf life is 5
years. | The Facet 28G Universal Lancet
(Facet Lancet) is a sterile, single
use, blood sampling device used
to obtain a sample of capillary
blood for diagnostic purposes,
primarily for blood glucose
monitoring in diabetic patients. | Number of
Uses | Single use only with
integral sharps injury
prevention feature | Same | Same | Single Use Only Blood Lancet
Without An Integral Sharps
Injury Prevention Feature and
Multiple Use Blood Lancet For
Single Patient Use Only |
| Indications
for Use | The Accu-Chek Safe-T-Pro
Uno lancing device is a
sterile, single-use,
disposable lancing device
intended to be used by
healthcare professionals. It
is designed for capillary
blood sampling from the
fingertip of adults and
children 1 year and older
or, if the patient is a child
under 1 year, from the heel. | The Accu-Chek Safe-T-Pro
Uno lancing device is intended
to produce a capillary blood
sample for testing utilizing
small amounts of blood. | Safety Lancet is intended to
be used to obtain capillary
blood sample to perform
medical testing, including
blood glucose monitoring
and for tests using small
amounts of blood. | The Facet 28G Universal Lancet
is a sterile, disposable single use
device used to obtain a droplet of
capillary blood for subsequent
diagnostic testing from the finger
or an alternative site, such as the
palm, upper arm, or forearm.
The Lancet is to be properly
disposed of after a single use on
an individual child, adolescent,
or adult patient in home testing. | Device
images | Image: Predicate Device | Image: Candidate Device | Image: Reference Device 1
Model XY Model XH
Image: Model XY and Model XH
Model XA
Image: Model XA | Not available |
| Intended
Users | Healthcare professionals | Healthcare professionals and
consumers | Consumers | Consumers | Lancet
Sterility | Gamma irradiation | Same | Same | Same |
Similarities / Differences Between Candidate, Predicate, and Reference Devices
5
6
| | Predicate Device – Accu-
Chek Safe-T-Pro Uno
Lancing Device | Candidate Device - Accu-
Chek Safe-T-Pro Uno
Lancing Device | Reference Device 1 –
Safety Lancet (K222090) | Reference Device 2 – Facet
28G Universal Lancet
(K221433) |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Needle
Gauge and
Depth levels | 28 Gauge needle – 1.5 mm
depth | 28 Gauge needle – 1.5 mm
depth | Model XY Dimension/gauge:
21G,23G,25G,26G,
28G,30G (Needle
type),1.2mm (Blade
type) Penetration depth:
1.4mm-2.8mm(Needle
type), 1.6mm-2.0mm
(Blade type) Model XH Dimension/gauge:
18G,21G,23G,28G
(Needle type), 1.5mm
(Blade type) Penetration depth:
1.2mm-2.8mm
(Needle type),
1.6mm-2.0mm(Blade
type) Model XA Dimension/gauge:
21G,23G,28G
(Needle type) Penetration depth:
1.3mm/1.8mm/2.3mm,
1.5mm/2.0mm/2. 5mm
(Needle type) | 28 Gauge needle, multiple depth
options depending on multiple
use blood lancet device used
with single use only blood lancet |
| Mechanical
loading | Spring-driven | Same | Same | Same for multiple use blood
lancet device in which the single
use blood lancet is used |
| | Predicate Device - Accu-
Chek Safe-T-Pro Uno
Lancing Device | Candidate Device - Accu-
Chek Safe-T-Pro Uno
Lancing Device | Reference Device 1 –
Safety Lancet (K222090) | Reference Device 2 - Facet
28G Universal Lancet
(K221433) |
| Load and
firing | Loading / priming the
device is not required.
Press release button to
activate lancet mechanism. | Same | Same | Loading is required. |
| Anatomical
sites | Fingertip (adults and
children 1 year and older)
Heel (child under 1 year) | Same | Fingertip | Fingertip, palm, upper arm,
forearm |
| Sharps
injury
prevention | The Accu-Chek Safe-T-Pro
Uno lancing device is
designed with a sharps
injury prevention feature.
It is a passive safety
mechanism that
automatically activates after
the device is used, requiring
no action on the part of the
user. The lancet remains in
the housing before and after
use. After activation, the
single-use device cannot be
used again. | Same | Same | N/A |
7
8
Indications for Use Comparison [21 CFR 807.92(a)(5)]
The indications for use statement of the candidate device and of the predicate device are not identical. However, the intended use is the same, which is to obtain a blood sample testing. The package insert for the candidate device was updated to clearly separate indications for use and the intended test population.
Technological Comparison [21 CFR 807.92(a)(6)]
The technological characteristics of the candidate device are the same as the predicate.
Non-Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]
Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification and validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device. See more in attached Verification Summary.
Clinical Testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified. See Risk documents provided in Biocompatibility section.
The Accu-Chek Safe-T-Pro Uno Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices.