droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.

Device Description

droplet® personal lancet is made of steel needle placed inside the plastic body lancet with plastic protective cap.

The lancet remains sterile until the cap is removed. There are two versions of droplet® personal lancets which differ in the needle diameter: 28G and 30G. These two versions differ in lancet body color. The version 28G is available in pink and blue colors, and version 30G is available in violet version.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for droplet® personal lancets outlines the device's technical characteristics and studies performed. However, it does not contain detailed acceptance criteria tables, specific performance metrics, sample sizes, or information typically associated with AI/software-based medical devices (such as clinical study design, ground truth establishment, expert adjudication, or MRMC studies).

The document states: "Clinical data is not required." and focuses on non-clinical performance data for physical device characteristics and compatibility.

Therefore, the following response is based solely on the information available in the provided text, and will highlight what is present while explicitly stating what information is not provided as per the request.

Acceptance Criteria and Study Proving Device Meets Criteria for droplet® personal lancets

The droplet® personal lancets are mechanical medical devices (blood lancets) and as such, the acceptance criteria and study data relate to physical and functional attributes rather than diagnostic or analytical performance metrics typical of AI/software devices. The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests performed and states that "All tests were passed and met the predefined acceptance criteria." However, it does not provide a specific table of these "predefined acceptance criteria" or the quantitative reported performance values. It lists the categories of tests conducted.

Acceptance Criteria Category	Reported Device Performance
Product Specifications:
Color and aesthetics	Passed (met predefined criteria)
Presence of one raw needle	Passed (met predefined criteria)
Orientation of raw needle	Passed (met predefined criteria)
Point sharpness	Passed (met predefined criteria)
Lancet length (raw needle protrusion)	Passed (met predefined criteria)
Lancing Device Compatibility:
Installation in lancing device	Evaluated for compatibility with selected lancing devices; results used to establish compatible device list.
Stability in lancing device	Evaluated for compatibility with selected lancing devices; results used to establish compatible device list.
Proper closing of lancing device	Evaluated for compatibility with selected lancing devices; results used to establish compatible device list.
Loading and activating lancing device	Evaluated for compatibility with selected lancing devices; results used to establish compatible device list.
Lancet rotation when twisting off cap	Evaluated for compatibility with selected lancing devices; results used to establish compatible device list.
Needle protrusion from lancing device	Evaluated for compatibility with selected lancing devices; results used to establish compatible device list.
Needle retraction from lancing device	Evaluated for compatibility with selected lancing devices; results used to establish compatible device list.
Other Non-Clinical Data:
Biocompatibility	Conforms to ISO 10993-1 (stated as a technological characteristic)
Sterilization (SAL)	SAL=10^-6 (stated as a technological characteristic)
Shelf life	5 years (stated as a technological characteristic)
Transport tests (shipper, primary boxes integrity, product integrity after hazards)	All components complete; product not poured out; product meets predefined requirements; device not damaged; did not lose technological performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the non-clinical performance tests.

Data Provenance: The tests were conducted internally by HTL-Strefa S.A.'s quality control and presumably in their home country (Poland), as indicated by the company's address. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. The droplet® personal lancets are physical medical devices, and their performance evaluation relies on engineering, material science, and functional testing, not expert interpretation of outputs like in AI/imaging devices. Ground truth for properties like sharpness or needle protrusion would be established via metrology and physical testing methods, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus ground truth in clinical evaluations, particularly for subjective assessments or borderline cases, which is not relevant to the described non-clinical testing of a lancet.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC study was not conducted and is not applicable. This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks, typically within imaging or pathology. The droplet® personal lancets are standalone devices used for blood sampling, not for diagnostic interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm was not conducted and is not applicable. This device does not involve an algorithm. The reported non-clinical performance data represents the "standalone" performance of the physical device on its own against specified criteria.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be based on:

Manufacturer's Predefined Product Specifications: For physical attributes like color, aesthetics, needle presence, orientation, sharpness, and length.
Engineering/Functional Test Standards: For compatibility with lancing devices (e.g., proper fit, function, retraction).
International Standards: For biocompatibility (ISO 10993-1) and sterilization (SAL).
Simulated Environmental Conditions: For transport tests.

It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product and does not involve AI/machine learning, therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

FDA 510(k) Clearance Letter - droplet® personal lancets

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 1, 2025

HTL-Strefa S.A.
Justyna Zemigala
Regulatory Affairs Manager
Adamówek 7
Ozorków, 95-035
Poland

Re: K250016
Trade/Device Name: droplet® personal lancets
Regulation Number: 21 CFR 878.4850
Regulation Name: Blood Lancets
Regulatory Class: Class II
Product Code: QRK
Dated: January 3, 2025
Received: January 3, 2025

Dear Justyna Zemigala:

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"

Page 2

K250016 - Justyna Zemigala Page 2

(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 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 QS 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 (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 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.

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-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).

Page 3

K250016 - Justyna Zemigala Page 3

Sincerely,

James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.07.01 08:16:15 -04'00'

James Jang
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

Page 4

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)
K250016

Device Name
droplet® personal lancets

Indications for Use (Describe)
droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users 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."

Page 5

HTL-Strefa S.A.
Traditional 510(k) for droplet® personal lancets
Submitted Under 21 CFR § 807.87

Confidential and Proprietary
© 2025 HTL-Strefa S.A.
Page 1 of 5

510(k) Summary

As required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR §807.92(a).

Summary

[807.92 (a)(1,2)]

Date prepared: January 3rd, 2025

Submitted by: HTL-Strefa S.A.
ul. Adamówek 7
95-035 Ozorków
Poland

Primary Contact: Justyna Żemigała
Regulatory Affairs Manager
phone number +48 42 270 02 06
email: justyna.zemigala@htl-strefa.pl

Secondary Contact: Szymon Skurzyński
Senior Regulatory Affairs Specialist
phone number: +48 42 270 02 06
email: szymon.skurzynski@htl-strefa.pl

Trade Name: droplet® personal lancets
Common Name: blood lancets
Regulation Number: 21 CFR § 878.4850
Product Code: QRK
Device Classification: Class II
Review Panel: General and Plastic Surgery

K250016

Page 6

HTL-Strefa S.A.
Traditional 510(k) for droplet® personal lancets
Submitted Under 21 CFR § 807.87

Confidential and Proprietary
© 2025 HTL-Strefa S.A.
Page 2 of 5

Predicate Device:

[807.92 (a)(3)]

The legally marketed device to which substantial equivalence is claimed is:

Manufacturer Name	Trade Name	510(k) Number
SteriLance Medical (Suzhou) Inc.	Disposable Blood Lancet	K221507

Description of Device:

[807.92 (a)(4)]

droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling. The patient target population of this device is the population from children to adults.

droplet® personal lancet is made of steel needle placed inside the plastic body lancet with plastic protective cap.

Principles of Operation:

The droplet® personal lancets cooperate with lancing device. The protective cap of the lancet is twisted and removed to expose the needle. The lancing device loaded by lancet is placed against the puncture site and activated. Pressure is applied near to the puncture site (if necessary, intermittently) to obtain the required blood sample. The lancet is disposed in an appropriate biohazard container after use. Lancing device holds a lancet firmly, and when triggered, moves the lancet linearly ahead to prick the skin in a controlled manner. Lancing device can be adjusted to alter the depth that the lancet goes into the skin. The purpose is to obtain a small amount of capillary blood for testing.

Indications for Use:

[807.92 (a)(5)]

droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.

K250016

Page 7

HTL-Strefa S.A.
Traditional 510(k) for droplet® personal lancets
Submitted Under 21 CFR § 807.87

Technological Characteristics:

[807.92 (a)(6)]

A comparison characteristics of droplet® personal lancets and predicate device is shown in the table below:

Feature	Subject Device	Predicate Device	Conclusion
510(k) Number	pending	K221507	510(k) number for Subject Device is pending
Classification	Class II	Class II	The same
Regulation number	21 CFR § 878.4850	21 CFR § 878.4850	The same
Product Code	QRK	QRK	The same
Type of use	Over-The-Counter Use (OTC)	Over-The-Counter Use (OTC)	The same
Indications for Use	droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling	Disposable Blood Lancet is used for capillary blood collection	The same
Patient target population	From children to adults	Adult and pediatric	The same
Reuse durability	Single use	Single use	The same
Sterilization method and SAL	Sterilized by irradiation SAL=10-6	Sterilized by irradiation SAL=10-6	The same
Shelf life	5 years	5 years	The same
Biocompatibility	Conforms to ISO 10993-1	Conforms to ISO 10993-1	The same
Components	Needle, lancet body, protective cap	Needle, lancet body, protective cap	The same
Needle diameter	28G, 30G	21G, 23G, 26G, 28G, 30G, 32G, 33G	The same. Needle diameters 28G and 30G of the subject device are within the diameter range

K250016

Page 8

HTL-Strefa S.A.
Traditional 510(k) for droplet® personal lancets
Submitted Under 21 CFR § 807.87

Feature	Subject Device	Predicate Device	Conclusion
Materials	Needle: stainless steel; lancet body and protective cap: polyethylene	Needle: stainless steel, lancet body and protective cap: polyethylene	of the predicate device. The same

Based upon the above comparisons to the predicate device, droplet® personal lancets do not raise any new issues of safety and effectiveness.

Non-Clinical Performance Data:

[807.92 (b)(1)]

The safety and effectiveness studies for droplet® personal lancets were performed to demonstrate compliance with the established requirements by manufacturer as per product specifications. These tests were conducted by quality control and included: color and aesthetics, presence of one raw needle in the lancet, orientation of raw needle in the lancet, point sharpness and lancet length without the needle protective cap (raw needle protrusion from the molding). All tests were passed and met the predefined acceptance criteria.

The cooperation of the droplet® personal lancets with lancing devices was tested. The aim of the tests was to evaluate the compatibility of droplet® personal lancets manufactured by HTL-Strefa S.A. with selected commercially available lancing devices from different manufacturers. The following test parameters were assessed: possibility to install the lancet in the lancing device and stability of the lancet in the lancing device; properly closing of the lancing device after inserting the lancet; possibility of the loading and activating the lancing device with inserted lancet; rotating the lancet in the lancing device when twisting off the protective cap; lancet needle protrusion from the lancing device; retraction of the lancet needle when activating the lancing device. The results of the above tests were used to establish the current list of lancing devices cooperating with droplet® personal lancets, as a part of the information provided with the product.

Additionally non-clinical performance data were obtained after carrying out biocompatibility, sterilization and transport tests.

During the transport tests, the devices were exposed to mechanical hazards to check whether the pre-determined packaging method is appropriate for their transporting to distribution centers, customers and secures the devices from damage. The aim of the test was to verify the integrity of the shipper, primary boxes and also correctness of the finished product subjected to transport exposure hazards. Tests imitate the extreme exposures that the product can be subjected during packaging, transport and storage activities. After performed tests, all product components are complete. The product is not being poured out of the transport. After transport exposures, the product meets the predefined requirements. The device was not damaged and did not lose its technological performance.

K250016

Page 9

HTL-Strefa S.A.
Traditional 510(k) for droplet® personal lancets
Submitted Under 21 CFR § 807.87

Clinical Performance Data:

[807.92 (b)(2)]

Clinical data is not required.

Conclusion:

[807.92 (b)(3)]

The droplet® personal lancets are concluded to be substantially equivalent in the intended use, technology/principle of operation, materials and performance to the legally marketed predicate device cleared under K221507.

K250016

Regulation Number and Section

§ 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.