K261045 · Promisemed Hangzhou Meditech Co., Ltd. · FMK · May 1, 2026 · General, Plastic Surgery
Device Facts
Record ID
K261045
Device Name
Verifine Safety Lancets
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
Product Code
FMK · General, Plastic Surgery
Decision Date
May 1, 2026
Decision
SESE
Submission Type
Special
Regulation
21 CFR 878.4850
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The VeriFine Safety Lancet is intended for capillary blood sampling.
Device Story
Sterile, single-use, spring-loaded lancet for capillary blood sampling; used in home and professional healthcare settings by lay persons or clinicians. Device features dual-spring mechanism: first spring drives needle into skin; second spring immediately retracts needle into protective shield post-activation to prevent needlestick injuries. Activation occurs via push-button on top of device. Available in various needle gauges (17G-33G) and blade configurations to accommodate different blood volume requirements. Provides safe, simple method for obtaining capillary blood samples for diagnostic testing.
Clinical Evidence
No clinical data. Bench testing only, including physical characterization, mechanical testing (bond strength, spring elasticity, puncture performance), corrosion resistance, and sterilization validation (SAL 10^-6).
Technological Characteristics
Dual-spring mechanism for needle deployment/retraction. Materials: Stainless steel (X5CrNi18-10) needle, Polypropylene (PP) shield, POM push button, PE safety tab. Sterilization: Irradiation (ISO 11137-1/2). Standards: ISO 9626:2016, USP-NF M98810_01_01.
Indications for Use
Indicated for capillary blood sampling in pediatric patients over 6 months of age (greater than 10 kg), adolescents, and adults. Contraindicated for neonates and newborns.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*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.
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 1, 2026
Promisemed Hangzhou Meditech Co., Ltd.
Zearou Yang
Regulatory Affairs Manager
No. 1388 Cangxing Street
Cangqian Community, Yuhang District
Hangzhou City, 311121
China
RE: K261045
Trade/Device Name: Verifine Safety Lancets
Regulation Number: 21 CFR 878.4850
Regulation Name: Blood Lancets
Regulatory Class: Class II
Product Code: FMK
Dated: April 2, 2026
Received: April 2, 2026
Dear Zearou Yang:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261045 - Zearou Yang
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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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K261045 - Zearou Yang
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assistance/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,
Colin K. Chen -S
Digitally signed by
Colin K. Chen -S
Date: 2026.05.01
15:39:46 -04'00'
Colin Kejing Chen, Ph.D.
Acting 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
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K261045 | |
| Device Name Verifine Safety Lancet | |
| Indications for Use (Describe) The VeriFine Safety Lancet is intended for capillary blood sampling. | |
| Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ 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 | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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Promisemed
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, P. R. China
# K261045-510(k) Summary
Date prepared: 2026-05-01
| 1. Manufacturer [21 CFR 807.92 (a) (1)] | |
| --- | --- |
| Name | Promisemed Hangzhou Meditech Co., Ltd. |
| Address | No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China. |
| Contact Person | Zearou Yang |
| Phone | 86 571 88772985 |
| Email | zearou.yang@promisemed.ca |
| 2. Device [21 CFR 807.92 (a) (2)] | |
| Name | VeriFine Safety Lancet |
| Common Name | Blood Lancet |
| Classification Name | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Regulation Number | 21 CFR 878.4850 |
| Class | Class II |
| Product Code | FMK |
| 3. Legally Marketed Predicate Device [21 CFR 807.92 (a) (3)] | |
| Predicate Name | Verifine Safety Lancets |
| 510(k) Number | K221368 |
| Product Code | FMK |
| Reference Devices | No reference devices were used in this submission. |
| 4. Device Description [21 CFR 807.92 (a) (4)] | |
| The VeriFine Safety Lancet is a sterile, single use, spring-loaded devices designed for capillary blood sampling. The device is available in two configurations: needle type and blade type. The lancets feature precision-sharpened needles designed to provide maximum comfort and optimal blood flow during use. The safety lancets are designed to make capillary blood sampling simple and safe. The device is activated when the user presses the button on top of the lancet. Once activated, the needle penetrates the skin and immediately retracts into the body of the device, reducing the risk of needlestick injury from an exposed needle. A dual-spring mechanism controls this action: the first spring releases the needle into the skin, and the second spring withdraws the needle back into the protective shield. The VeriFine Safety Lancets (with push button) are available in multiple gauge and length options to accommodate different patient populations and blood volume requirements. Only the needle component within the lancet body is provided sterile. The sterilization process has been validated according to ISO 11137-1:2006. | |
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Promisemed
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, P. R. China
5. Indication for use [21 CFR 807.92 (a) (5)]
It is intended for capillary blood sampling.
6. Indications for Use Comparison [21 CFR 807.92 (a) (5)]
The Indications for Use statement for the VeriFine Safey Lancet is identical to that of the predicate device (K221368). Both devices have the same intended use for obtaining capillary blood samples for diagnostic testing purposes.
7. Comparison of Technological Characteristic [21 CFR 807.92 (a) (6)]
The VeriFine Safety Lancets are substantially equivalent to the predicate device, K221368. Both devices have the same intended use for capillary blood sampling. The basic technological and operating principles are the same for both devices, utilizing a dual-spring mechanism for needle deployment and retraction. Both the subject and predicate devices are disposable, sterile, single-patient-use devices.
While certain technological differences exist between the subject and predicate devices, these differences do not raise different questions of safety and effectiveness and do not affect the fundamental design principles or safe usage of the device.
| Item of description | Predicate device (K221368) | Subject device | Similarities/ Differences | Safety/Effectiveness Statement |
| --- | --- | --- | --- | --- |
| Common name | VeriFine Safety Lancet | VeriFine Safety Lancet | N/A | N/A |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Hangzhou Meditech Co., Ltd. | Same | All produced by the same manufacturer. |
| Intended use | It is intended for capillary blood sampling. | It is intended for capillary blood sampling. | Same | No new concerns. |
| Indications for use | It is intended for capillary blood sampling. | It is intended for capillary blood sampling. | Same | No new concerns. |
| Target population | Not defined. | Infants (Over 6 months and Greater than 10 kg), children, adolescents, adults. | Different | The applicable population for the Verifine® Safety Lancets is adults and pediatric patients over 6 months of age (excluding neonates and newborns), as defined in accordance with the WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy (WHO, 2010). Specifically, Section 7.1.1 and Table 7.1 of the Guidelines establish age- and weight-based criteria for capillary sampling site and procedure selection, and Section 7.1.2 specifies recommended maximum lancet penetration depths by patient population — 1.5 mm for children over 6 months and under 8 years of age, and 2.4 mm for children over 8 years of age and adults. The penetration depth specifications of the Verifine® Safety Lancets are consistent with these recommended ranges for the defined population. Neonates and newborns are excluded from the intended use population, as this population requires shallower penetration depths, dedicated sharps injury prevention features, and prescription-only |
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Promisemed
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, P. R. China
| | | | | devices, none of which are characteristics of the subject device. |
| --- | --- | --- | --- | --- |
| Anatomical site | Finger | Finger | Same | No new concerns. |
| Where used | Home environment, Professional Healthcare Facility | Home environment, Professional Healthcare Facility | Same | No new concerns. |
| Intended Users | Lay person, healthcare professional users | Lay person, healthcare professional users | Same | No new concerns. |
| Design | It is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield. | It is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are activated when you press the button on top. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield. | Similar | The subject device is activated by pressing push button on top, while the predicate device is activated by pressing device against finger. The fundamental technology and operation remain the same. |
| Materials (tissue-contacting) | Needle: Stainless steel; Shield: ABS; Trigger: POM; Lancet body, cap: PE; | Needle: Stainless steel (X5CrNi18-10); Shield: Polypropylene (PP); Push button: POM; Safety tab: Polyethylene (PE) | Similar | The PP shield contacts intact skin for less than one minute. PP has been used in marketed devices (e.g., K193273) and does not introduce new biocompatibility risks. |
| Needle gauge | 18G, 21G, 23G, 25G, 26G, 28G, 30G. | Needle type: 17G, 18G, 19G, 20G, 21G, 23G, 25G, 26G, 28G, 29G, 30G, 31G, 32G, 33G. Blade type: 21G(0.8mm), 20G(0.9mm), 19G(1.1mm, 18G(1.2mm), 17G(1.5mm). | Similar | Broader needle selection provides more clinical options without introducing new risks, as the fundamental technology and operation remain the same. |
| Nominal needle length | 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm. | Needle type: 1.2 mm, 1.5 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.2 mm, 2.4 mm, 2.8 mm, 3.0 mm. Blade type: 1.0 mm, 1.2 mm, 1.5 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.2 mm, 2.4 mm. | Similar | Broader needle selection provides more clinical options without introducing new risks, as the fundamental technology and operation remain the same. |
| Sterilization method | Irradiation | Irradiation | Same | No new concerns. |
| Sterility | SAL of 10-6 | SAL of 10-6 | Same | No new concerns. |
| Single use | Yes | Yes | Same | No new concerns. |
| Biocompatibility | Biocompatibility established | Biocompatibility established | Same | No new concerns. |
| Standards met | - ISO 9626:2016; - ISO 11137-1:2006; - ISO 11137-2:2013 - USP-NF M98810_01_01; | - ISO 9626:2016; - ISO 11137-1:2006; - ISO 11137-2:2013 - USP-NF M98810_01_01; | Same | No new concerns. |
| Compatibility with the environment and other devices | Not applicable | Not applicable | Same | No new concerns. |
| Energy used and/or delivered | Not applicable | Not applicable | Same | No new concerns. |
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Promisemed
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, P. R. China
| Electrical safety | Not applicable | Not applicable | Same | No new concerns. |
| --- | --- | --- | --- | --- |
| Mechanical safety | Not applicable | Not applicable | Same | No new concerns. |
| Chemical safety | Not applicable | Not applicable | Same | No new concerns. |
| Thermal safety | Not applicable | Not applicable | Same | No new concerns. |
| Radiation safety | Not applicable | Not applicable | Same | No new concerns. |
| Labeling | Labeling requirement listed in blood lancet reclassification final order (86 FR 66180) such as hand washing instruction and warning statement are supplemented. | Labeling requirement listed in blood lancet reclassification final order (86 FR 66180) such as hand washing instruction and warning statement are supplemented. | Same | No new concerns. |
The subject device has the same intended use as the predicate device (K221368) for capillary blood sampling. While the subject device shares the same fundamental technological characteristics as the predicate device, certain technological differences exist as described below:
- Activation Mechanism
Push-button activation versus pressure-against-finger activation;
- Shield Material
Polypropylene (PP) versus Acrylonitrile Butadiene Styrene (ABS);
- Needle Gauge and Length Options
Broader range of specifications;
These differences do not alter the fundamental operating principle, which relies on a dual-spring mechanism for needle deployment and retraction. Performance testing has demonstrated that the subject device is as safe and as effective as the predicate device.
# 8. Nonclinical test [21 CFR 807.92 (b) (1)]
The subject device has been evaluated through comprehensive nonclinical performance testing, including physical characterization (appearance, color coding, and dimensional verification per ISO 7864), mechanical testing (bond strength, spring elasticity and puncture performance per ISO 9626, and safety mechanism functionality), corrosion resistance of the stainless steel needle material, sterility testing with sterilization validation as per ISO 11137-1, ISO 11137-2, and USP $< 71>$ achieving a sterility assurance level of $10^{-6}$ . All testing met pre-established acceptance criteria based on applicable standards and device specifications, with no deviations observed. Puncture performance testing demonstrated equivalent performance between the subject device and the predicate device (K221368). Based on the nonclinical testing results, the subject device is as safe and effective as, and performs as well as, the predicate device.
# 9. Clinical test [21 CFR 807.92 (b) (2)]
No clinical testing was conducted for this submission.
# 10. Conclusion [21 CFR 807.92 (b) (3)]
Based on the nonclinical performance testing described above, the VeriFine Safety Lancet (subject device) has been demonstrated to be substantially equivalent to the predicate device (K221368). The subject device has the same intended use as the predicate device. While certain technological differences exist (activation mechanism, shield material, and range of gauge/length options), these differences do not raise different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device and is appropriate for clearance under the 510(k) pathway.
