The Drawbridge Health NanoDrop Lancet Device is a sterile, single-use, disposable lancet for capillary blood sampling. The device incorporates two (2) stainless steel needles with blade tips to make two (2) small incisions in the skin. The device is made of a gray plastic housing base that has a molded outer rim and a bowl-shaped cavity. The outer rim is covered by a hydrogeladhesive to better attach the device to the skin, with a cover over the hydrogel adhesive pad for its protection. The bowl shape provides space for the skin to be drawn up as slight controlled vacuum pressure is applied, and for the needle blades to access the skin after piercing through a septum and vacuum chamber foil. There are two (2) clearly marked gray push buttons on the device:

The gray button marked "I" is for activation of the vacuum; and
The gray button marked "II" is for deployment of the needle blades.
There is a yellow removable plastic locking feature to prevent accidental activation of the button that deploys the needle blades(gray button marked "II"). There is also a white vacuum chamber lid securely attached on top of the base, over the gray lancet enclosure, where the two needle blades are held in a clear plastic needle holder, along with the main spring and retraction spring, and into which they automatically retract after use, with no access to this gray lancet enclosure possible. This prevents the lancet from being used more than once, and it keeps the blades retracted for sharps injury prevention safety and for disposal. A permanent plug obstructs the port and mitigates unintended connection of a collection container.
The single model number is FD004.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NanoDrop Lancet device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The following performance testing met all acceptance criteria" but does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and a general statement of meeting criteria. Thus, I will list the tests and the general performance statement where specific metrics are not provided.

Acceptance Criteria (Implied)	Reported Device Performance
Non-clinical Performance	Met all acceptance criteria
Pain levels and preferred method of obtaining blood (User Study)	Met all acceptance criteria
Lancet Cut (Penetration) Depth	Met all acceptance criteria
Applied Vacuum Lower Bound Test	Met all acceptance criteria
Lancet Needle Blade Diameter	Met all acceptance criteria
Device Length and Width	Met all acceptance criteria
Device Redeployment Testing	Met all acceptance criteria
Lancet Retraction Distance	Met all acceptance criteria
Pull Force Testing of Needle from Holder	Met all acceptance criteria
Sharps Injury Prevention Feature Drop Testing	Met all acceptance criteria
Pull Force and Mechanical Testing of Permanent Plug	Met all acceptance criteria
Permanent Plug Leak Test	Met all acceptance criteria
Hydrogel Ring and Bloodborne Pathogen Barrier	Met all acceptance criteria
USP-NF: 2020 Chapter <788> Testing for Particulates in Solutions or Medical Devices	Met all acceptance criteria
Biocompatibility	Successfully completed
ISO 10993-1: Biological Evaluation of Medical Devices-Part 1: Evaluation and testing within a risk management process	Successfully completed
ISO 10993-3: Biological Evaluation of Medical Devices- Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity	Successfully completed
ISO 10993-4: Biological Evaluation of Medical Devices-Part 4: Selection of tests for interaction with blood	Successfully completed
ISO 10993-5: Biological Evaluation of Medical Devices-Part 5: Test for in vitro cytotoxicity	Successfully completed
ISO 10993-10: Biological Evaluation of Medical Devices-Part 10: Test for irritation and skin sensitization	Successfully completed
ISO 10993-11: Biological Evaluation of Medical Devices-Part 11: Test for systemic toxicity; Material-mediated Pyrogenicity	Successfully completed
USP-NF 2018 USP <161>: USP Limulus Amebocyte Lysate (LAL) Test - Kinetic-Turbidimetric Method	Successfully completed
Sterilization/Shelf-life/Shipping Testing	Passed
Sterilization Method	Radiation (electron beam)
Sterility Assurance Level	SAL 10-6
ANSI/AAMI/ISO 11137-1, -2, -3	Passed
ASTM F1980-16 (Accelerated Aging)	Passed
ASTM 4169-16 (Shipping Containers)	Passed
ASTM F2096-11 (Gross Leaks)	Passed
ASTM F88/F88M-15 (Seal Strength)	Passed
Clinical Performance	Met all acceptance criteria
Safety and Use of NanoDrop Lancet Device	Met all acceptance criteria
User's opinion regarding handling characteristics	Met all acceptance criteria

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

Sample Size (Clinical Study): 30 subjects (each with two samples for the NanoDrop Lancet and two samples for the predicate device, totaling four samples per subject).
Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the study was retrospective or prospective, though a "clinical study was performed" generally implies a prospective design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The clinical study was focused on "safety and use" and "user's opinion," suggesting direct participant feedback rather than expert-adjudicated ground truth in the traditional sense of medical image analysis or diagnosis.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the study (safety, use, user opinion for a blood lancet), a formal adjudication method like "2+1" or "3+1" is unlikely to be applicable in the same way it would be for diagnostic device performance studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Was an MRMC study done? A clinical study was performed comparing the NanoDrop Lancet Device to a comparable cleared OTC FMK fingerstick lancet (Acti-Lance K220643) to evaluate "safety and use" and "user's opinion with regards to handling characteristics." While it involved comparison, it doesn't explicitly fit the typical definition of an MRMC study focused on diagnostic accuracy with multiple human readers interpreting cases. It's more of a comparative user experience and safety study.
Effect Size: The document does not provide specific quantitative effect sizes for how much human readers (or users, in this context) improve with the AI (device) vs. without the AI (predicate device). It only states that "All acceptance criteria were met, supporting safe and effective use of the NanoDrop Device unsupervised and self-administered by adults on the upper arm."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a medical lancet, not an AI or algorithm-driven device. Therefore, the concept of "standalone performance" for an algorithm does not apply to this product. The non-clinical performance tests (like cut depth, vacuum, redeployment, etc.) are essentially evaluating the device's standalone mechanical and functional performance, but not in the context of an "algorithm."

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was essentially:

Device safety: Observed absence of adverse events or complications.
Device effectiveness/use: Successful acquisition of capillary blood samples.
User opinion: Subjective feedback from participants regarding handling characteristics.

This isn't ground truth established by pathology or expert consensus in a diagnostic sense, but rather direct observational and subjective feedback from participants in a usability and safety context.

8. The Sample Size for the Training Set

The document describes a clinical study as a performance evaluation for market clearance, not a study to train an algorithm. As this is not an AI/ML device, there is no training set in the traditional sense.

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

As there is no training set for an AI/ML algorithm, this information is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 22, 2024

Drawbridge Health, Inc. Beth Thompson Sr. Regulatory Consultant, Lean RAQA 5949 Amberwood Dr. Naples, Florida 34110

Re: K223826

Trade/Device Name: NanoDrop Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: January 26, 2024 Received: January 29, 2024

Dear Beth Thompson:

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).

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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 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 mediation-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: 2024.02.22 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

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Indications for Use

510(k) Number (if known) K223826

Device Name NanoDrop Lancet

Indications for Use (Describe)

The NanoDrop Lancet is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.

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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Image /page/3/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a red teardrop shape on the left, followed by the words "Drawbridge" and "Health" in black font. The word "Health" is located below the word "Drawbridge".

1. APPLICANT INFORMATION

Submitter Information
Company Name:	Drawbridge Health, Inc
Address:	620 Omni Industrial BlvdSummerville, SC 29486
Phone Number:	1-631-897-5215
Establishment Registration Number	3015798231
Primary Company Contact
Name:	Jerome Scelza
Title:	Co-CEO
Phone Number:	1-631-897-5215
Email:	jscelza@dbhealth.com
Official Correspondent
Name:	Beth Thompson
Title:	Sr. Regulatory Consultant
Phone Number:	1-224-656-3620
Email:	betht@leanraqa.com

2. DATE OF PREPARATION

Date of Preparation	January 26, 2024
---------------------	------------------

3. DEVICE INFORMATION

Device Name:	NanoDrop Lancet device
Common Name:	Blood Lancet
Classification Name:	Single use only blood lancet with an integral sharpsinjury prevention feature
Model(s):	FD004
Regulation Number:	21 CFR 878.4850(a)
Product Code:	FMK
Class:	Class II

4. PREDICATE DEVICES

Predicate Type	510(k) Number	Name of Device	Name of Manufacturer
Primary Device	K223208	Safety Lancet	Suzhou Zhenwu MedicalCo., Ltd.
Reference Device	K220643	DropSafe Acti-Lance SafetyLancet	HTL-Strefa S.A.

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Image /page/4/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a red teardrop shape on the left, followed by the words "Drawbridge" in a bold, sans-serif font. Below "Drawbridge" is the word "HEALTH" in a smaller, sans-serif font. The logo is simple and modern, and the red teardrop shape likely represents blood, which is relevant to the company's focus on health and diagnostics.

5. DEVICE DESCRIPTION

The gray button marked "I" is for activation of the vacuum; and
The gray button marked "II" is for deployment of the needle blades.

There is a yellow removable plastic locking feature to prevent accidental activation of the button that deploys the needle blades(gray button marked "II"). There is also a white vacuum chamber lid securely attached on top of the base, over the gray lancet enclosure, where the two needle blades are held in a clear plastic needle holder, along with the main spring and retraction spring, and into which they automatically retract after use, with no access to this gray lancet enclosure possible. This prevents the lancet from being used more than once, and it keeps the blades retracted for sharps injury prevention safety and for disposal. A permanent plug obstructs the port and mitigates unintended connection of a collection container.

The single model number is FD004.

6. INDICATIONS FOR USE

The NanoDrop Lancet device is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.

Device	Subject Device	Predicate Device	Remark	ReferenceDevice	Discussion
Device	Blood Lancet	Blood Lancet	Same	Blood Lancet	Same
Manufacturer	Drawbridge Health,Inc	Suzhou ZhenwuMedical Co.	Different	HTL-StrefaS.A.	Different
510(k) Number	K223826	K223208	Different	K220643	Different
Product Code	FMK	FMK	Same	FMK	Same
Classification	Class II	Class II	Same	Class II	Same
Intended Use	Intended for capillaryblood sampling	Intended for capillaryblood sampling	Same	Intended forcapillary bloodsampling	Same
HEALTH			510(k) Summary
IntendedPopulation	Adults and Pediatrics.If user is under theage of 18, the lancetmust be used by anadult or under thesupervision of anadult	Adults and Pediatrics. Ifuser is under the age of18, the lancet must beused by an adult orunder the supervisionof an adult	Same	Not stated	N/A
Number of Uses	Single use on oneperson; no more thanone use	Single use on oneperson; no more thanone use	Same	Single use onone patient	Same
Prescription orOTC Use	Over-the-counter	Over-the-counter	Same	Over-thecounter	Same
Needle Bladegauge	17G blades	Available in 21G and18G blades	Similar	17G blades	Same
Needle BladeDiameter	0.060in +/- 0.001in(1.52mm +/-0.025mm)	21G: 0.800mm-0.830mm18G: 1.200mm-1.300mm	Similar	Not stated	N/A
Needle BladeLength	0.500in +/- 0.002in	Unknown	Unknown	Not stated	N/A
Needle BladePenetrationDepth	1.9-2.0 mm	21G: 1.8, 2.0, 2.2, 2.4mm18G: 2.0, 2.2, 2.4 mm	Similar	Not stated	N/A
Usage	Single use only	Single use only	Same	Single use only	Same
Sterilization	Gamma radiation	Gamma radiation	Same	ISO 10993	Same
Sharps InjuryPreventionFeature	Only one puncture canbe made after theprotective lock andadhesive cover areremoved and the pushbuttons are activatedto start the vacuumand to release theblades. Both lancetblades automaticallyretract into the deviceafter activation.	The puncture functioncan only be used afterthe cap is pulled off.Lancet retracts into thedevice after activation.	Similar	Sharps InjuryPreventionFeature andBladeRetraction	Similar
Biocompatibility	No cytotoxicityNo irritationNo skin sensitizationNo acute systemictoxicityNo pyrogens	No cytotoxicityNo irritationNo skin sensitizationNo acute systemictoxicityNo pyrogens	Same	ISO 10993	Same
ClinicalTesting	Safety andPerformance study	None	Different	None	Different
Shelf life	19 months	5 years	Similar	5 years	Similar

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

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Drawbridge

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The characteristics of the devices present no material differences in substantial equivalence as the gauge size and number of blades does not affect performance, the difference in method of activation does not affect performance, the penetration depth falls within the range of the predicate device, and the difference in shelf life does not affect performance. The devices are substantially equivalent to each other.

8. PERFORMANCE TESTING

8.1 Non-clinical performance
The following performance testing met all acceptance criteria.
Pain levels and preferred method of obtaining blood - User Study
Lancet Cut (Penetration) Depth ●
Applied Vacuum Lower Bound Test ●
Lancet Needle Blade Diameter ●
Device Length and Width
Device Redeployment Testing
Lancet Retraction Distance
Pull Force Testing of Needle from Holder
Sharps Injury Prevention Feature Drop Testing
Pull Force and Mechanical Testing of Permanent Plug
Permanent Plug Leak Test
. Hydrogel Ring and Bloodborne Pathogen Barrier
USP-NF: 2020 Chapter <788> Testing for Particulates in Solutions or Medical Devices

8.2 Biocompatibility

The following biocompatibility testing was successfully completed:

10993-1:2009	ISO	Biological Evaluation of Medical Devices-Part 1 :Evaluation and testing within a risk management process
10993-3:2014	ISO	Biological Evaluation of Medical Devices- Part 3 : Tests for genotoxicity,carcinogenicity, and reproductive toxicity
10993-4:2006	ISO	Biological Evaluation of Medical Devices-Part 4 :Selection of tests for interaction with blood
10993-5:2009	ISO	Biological Evaluation of Medical Devices-Part 5 :Test for invitro cytotoxicty
10993-10:2010	ISO	Biological Evaluation of Medical Devices-Part 10:Test for irritation and skin sensitization
10993-11:2006	ISO	Biological Evaluation of Medical Devices-Part 11 :Test for systemic toxicity; Material-mediated Pyrogenicity
USP-NF2018	USP <161>	USP Limulus Amebocyte Lysate (LAL) Test - Kinetic-Turbidimetric Method

Sterilization/Shelf-life Testing/Shipping Testing 8.3

Sterilization Method	Radiation (electron beam)
NEW YORK	drawbridgehealth.com
152 W 57th Street, 10th Floor	Info@dbhealth.com
New York NY 10017

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Sterility Assurance Level

11137-1:2006/(R)15;A1:2013	ANSI/AAMI/ISO	Sterilization of Healthcare Products-Radiation-Part 1 : Requirements fordevelopment, validation and routine control of a sterilization process formedical devices
11137-2: 2013	ANSI/AAMI/ISO	Sterilization of Healthcare Products-Radiation-Part 2 : Establishing theradiation dose
11137-3: 2017	ANSI/AAMI/ISO	Sterilization of Healthcare Products-Radiation-Part 3 : Guidance ondosimetric aspects
F1980-16	ASTM	Standard Guide for Accelerated Aging of Sterile Medical Device Packages
4169-16	ASTM	Standard Practice for Performance Testing of Shipping Containers andSystem
F2096-11	ASTM	Standard Test Method for Detecting Gross Leaks in Medical Packaging byInternal Pressurization (bubble test)
F88/F88M-15	ASTM	Standard Test Method for Seal Strength of Flexible Barrier Materials

SAL 10-6

8.4 Animal and Clinical performance data

No animal study is included in this submission.

A clinical study was performed with the aim to evaluate the safety and use of the NanoDrop Lancet Device and to evaluate the user's opinion with regards to handling characteristics of the device as compared to a comparable cleared OTC FMK fingerstick lancet (Acti-Lance K220643). The study included thirty subject with two samples for each device (four samples per subject). All acceptance criteria were met, supporting safe and effective use of the NanoDrop Device unsupervised and self-administered by adults on the upper arm.

9. CONCLUSION

The conclusions drawn from the clinical and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. They are substantially equivalent to each other.

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.