(175 days)
No
The device description and performance studies focus on mechanical and usability aspects of a lancing device, with no mention of AI or ML technologies.
No
Explanation: This device is used to obtain a blood sample for diagnostic testing (blood glucose testing), not for treating a disease or condition. Therapeutic devices are designed for treatment, mitigation, or prevention of disease.
No
Explanation: The device is a lancing device intended to collect a blood sample, not to perform a diagnostic test itself. The collected blood is then used for "blood glucose testing or other tests that require small amounts of blood," implying that the diagnostic function resides in a separate blood glucose monitoring system or other testing apparatus.
No
The device description clearly states it is a "reusable lancing device" and mentions "mechanical robustness verification testing," indicating it is a physical hardware device used to obtain blood samples. There is no mention of software as the primary or sole component.
Based on the provided information, the Multi-Lancet Device 2 and ReliOn Premier Lancing Device are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. The lancing device itself does not perform any diagnostic test on the blood sample.
- The lancing device is a tool used to obtain the blood sample. The blood sample is then used with an IVD (like a blood glucose meter and test strips) for testing.
- The description explicitly states the device is used "to obtain a capillary blood sample... for blood glucose testing or other tests that require small amounts of blood." This highlights its role in sample collection, not analysis.
Therefore, the lancing device is a medical device used in conjunction with an IVD, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are reusable lancing devices intended to be used with sterile, single-use compatible lancet blades to obtain a capillary blood sample from the fingertip or alternate sites for blood glucose testing or other tests that require small amounts of blood. The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are intended for single person use only.
Product codes
QRL
Device Description
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are used with a compatible single-use lancet to puncture the skin and release a small amount of blood. The products are distributed individually or packaged together with blood glucose monitoring systems to obtain capillary whole blood samples required for testing blood glucose levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip Palm Forearm Thigh Calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home setting
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
Non-Clinical bench testing was performed per the special controls (878.4850). Cleaning/Disinfecting and Mechanical Robustness verification testing was completed to ensure the safety and usability for the duration of the claimed service life.
Clinical testing is not required for this device. The risk analysis contained in the Risk Management Report confirms that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable and communicated in the instructions for use.
Performance testing on the proposed Multi-Lancet Device 2 and ReliOn Premier Lancing Device demonstrate that the devices meet the performance requirements for their intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 17, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Arkray, Inc. % Maddi Myers Regulatory Affairs and Quality Systems Project Manager Arkray Factory USA Inc. 5182 West 76th Street Minneapolis, Minnesota 55439
Re: K221175
Trade/Device Name: Multi-Lancet Device 2, ReliOn Premier Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: April 22, 2022 Received: April 25, 2022
Dear Maddi Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
Long Chen, 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
Enclosure
2
Indications for Use
510(k) Number (if known) K221175
Device Name Multi-Lancet Device 2 Relion Premier Lancing Device
Indications for Use (Describe)
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are reusable lancing devices intended to be used with sterile, single-use compatible lancet blades to obtain a capillary blood sample from the fingertip or alternate sites for blood glucose testing or other tests that require small amounts of blood. The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are intended for single person use only.
| 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
Administrative Information
| Applicant's Name
and Address | ARKRAY Factory, Inc.
1480 Koji, Konan-cho
Koka-shi, Shiga 520-3306 Japan
Establishment Registration #
3003422726 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Joe Dempsey
Regulatory Affairs and Quality
Systems Project Manager |
| Phone | 952-746-2622 |
| Fax | 952-646-3230 |
| Email | dempseyj@arkrayusa.com |
Regulatory Information
| Trade Name | Multi-Lancet Device 2, ReliOn Premier Lancing
Device |
|--------------------------|----------------------------------------------------------|
| Classification
Name | Multiple Use Blood Lancet For Single Patient Use
Only |
| Common Name | Blood Lancet |
| Product Code | QRL |
| Classification
Panel | 79 - General & Plastic Surgery |
| Device
Classification | 21 CFR § 878.4850 |
Predicate Device Information
| Predicate Device Name | Predicate Device 510(k) Number |
|---|---|
| Accu-Chek Softclix Blood Lancing System | K214022 |
4
Device Description
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are used with a compatible single-use lancet to puncture the skin and release a small amount of blood. The products are distributed individually or packaged together with blood glucose monitoring systems to obtain capillary whole blood samples required for testing blood glucose levels.
Image /page/4/Figure/3 description: The image shows a technical drawing of a medical device, with labels pointing to different parts. The device has a body, a finger cap, and an AST cap that is transparent. Other labeled parts include a depth adjust dial, a puncture button, a release lever, and a reset lever.
Image /page/4/Figure/4 description: The image shows the text "Figure 1: Device Design Image". The text is black and is on a white background. The text is centered in the image.
Image /page/4/Figure/5 description: The image shows a medical device with several labels pointing to different parts. The finger cap and puncture button are labeled as ivory, while the Arkray symbol mark is gray. The body and reset lever are dark gray, and the device is 83 mm long.
Figure 2: Multi-Lancet Device 2 Color Design Image
5
Image /page/5/Figure/1 description: The image shows a close-up of a ReliOn device, with annotations pointing out the colors of different parts. The body and reset lever of the device are navy blue. The ReliOn logo is white.
Figure 3: ReliOn Premier Lancing Device Color Design Image
Image /page/5/Picture/3 description: The image shows a medical device, possibly a blood glucose meter, with the brand name "arkray" visible on its side. The device is primarily dark blue and has a clear plastic component at one end. It features a sleek, cylindrical design with rounded edges, and there are button-like indentations on the body of the device.
Figure 4: Image of Multi-Lancet Device 2 with AST Cap
Indications for Use
The Multi-Lancet™ Device 2 and ReliOn Premier Lancing Device are reusable lancing devices intended to be used with sterile, single-use compatible lancet blades to obtain a capillary blood sample from the fingertip or alternate sites for blood glucose testing or other tests that require small amounts of blood. The Multi-Lancet™ Device 2 and ReliOn Premier Lancing Device are intended for single person use only.
6
Substantial Equivalence Information
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are substantially equivalent to the Accu-Chek Softclix Blood Lancing System. Below Table 1 provides a comparison between the Multi-Lancet Device 2 and ReliOn Premier Lancing Device and the predicate device.
The Multi-Lancet Device 2 includes the thigh and calf as additional anatomical testing sites when compared to the predicate device. These anatomical testing sites were previously cleared under submission K120759.
| COMPONENT/
| CHARACTERISTIC | PROPOSED | PREDICATE |
|---|---|---|
| Blood Lancet | ||
| 510(k) Number | To Be Determined | K214022 |
| Device Description | The Multi-Lancet Device 2 and ReliOn | |
| Premier Lancing Device are used with | ||
| compatible single-use lancets to obtain a | ||
| drop of blood from a fingertip using the | ||
| Finger Cap or alternative sites using the | ||
| Alternative Site Testing (AST) Cap. | The Accu-Chek Softclix | |
| Lancing Device uses | ||
| compatible Accu-Chek Softclix | ||
| Lancets to obtain a drop of | ||
| blood from a fingertip or | ||
| alternative sites using the | ||
| Accu-Chek Softclix Alternative | ||
| Site Testing (AST) Cap. | ||
| Intended Use | The Multi-LancetTM Device 2 and ReliOn | |
| Premier Lancing Device are reusable | ||
| lancing devices intended to be used with | ||
| sterile, single-use compatible lancet | ||
| blades to obtain a capillary blood sample | ||
| from the fingertip or alternate sites | ||
| for blood glucose testing or other tests that | ||
| require small amounts of blood. | The Accu-Chek Softclix Blood | |
| Lancing System is intended for | ||
| the hygienic collection of | ||
| capillary blood for testing | ||
| purposes from the side of a | ||
| fingertip and from alternative | ||
| sites, such as the palm, the | ||
| upper arm, and the forearm. |
| Table 1: Similarities and Differences Between Proposed and Predicate Device | ||
|---|---|---|
| COMPONENT/ | ||
| CHARACTERISTIC | PROPOSED | PREDICATE |
| Indications for Use | The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are intended for single person use only. | The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. |
| Number of Uses | Base (lancing device): multiple use | Base (lancing device): multiple use |
| Lancet: single use | ||
| Device Images | Image: Lancing Device with Finger Cap: | |
| Image: Lancing Device with AST Cap: | ||
| Image: ReliOn Premier Lancing Device: | Image: Lancing Device (and AST Cap): | |
| Depth Adjustment | 7 settings by twisting cap | 11 settings by twisting cap |
| COMPONENT/ | ||
| CHARACTERISTIC | PROPOSED | PREDICATE |
| Lancing Depth | ||
| Range | 0.0-3.0mm | 0.8-2.3mm |
| Mechanical Loading | Spring-driven | Spring-driven |
| Load and firing | After removing the cap, load the lancet into | |
| the base. This sets the device and readies | ||
| it for firing. Fire by pressing the puncture | ||
| button on the side. | Load by pressing priming | |
| button when lancet is inserted | ||
| Fire by pressing the release | ||
| button | ||
| Reset Method | Firing mechanism is reset by pulling the | |
| reset lever. | Firing mechanism is reset by | |
| pushing the priming button. | ||
| Anatomical sites | Fingertip Palm Forearm Thigh Calf | Fingertip Ball of the band (palm) Upper arm Lower arm (forearm) |
| Sharps Injury | ||
| Prevention | Until firing, the lancet is contained within | |
| the lancing device housing. Immediately | ||
| after firing, the lancet is automatically | ||
| retracted back into housing. The eject lever | ||
| can then be slid forward for contactless | ||
| disposal of the lancet. | Lancets are covered by a | |
| sterile barrier cap until twisted | ||
| off before use. Until firing, the | ||
| lancet is contained within the | ||
| lancing device housing. | ||
| Immediately after firing, the | ||
| lancet is automatically retracted | ||
| back into housing. An ejector | ||
| sleeve can then be pulled | ||
| forward for contactless disposal | ||
| of the lancet. |
7
8
Summary of Performance Testing
Non-Clinical bench testing was performed per the special controls (878.4850). Cleaning/Disinfecting and Mechanical Robustness verification testing was completed to ensure the safety and usability for the duration of the claimed service life.
Clinical testing is not required for this device. The risk analysis contained in the Risk Management Report confirms that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable and communicated in the instructions for use.
Performance testing on the proposed Multi-Lancet Device 2 and ReliOn Premier Lancing Device demonstrate that the devices meet the performance requirements for their intended use.
9
Proposed Labeling
Labeling adequately communicates to the user the device intended use, safety precautions and directions for use. The labeling meets the requirements documented in the:
-
- Regulation for Medical Device Labeling (21 CFR § 801)
-
- Regulation for multiple use blood lancet for single patient use only (21 CFR 878.4850 (c)(vi))
Substantial Equivalence Conclusion
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are substantially equivalent to the predicate Accu-Chek Softclix Lancing Device based on comparisons of the device classifications, intended use, and technological characteristics. Non-clinical performance testing successfully confirmed the suitability of the Multi-Lancet Device 2 and ReliOn Premier Lancing Device for the intended uses and demonstrated the devices are as safe, as effective, and perform as well as the predicate device as required per 21 CFR § 807.92(b)(3).