The single-use safety lancets are hand-held disposable devices intended to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.

Device Description

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes.

The Unistik® 3 safety lancets are available in five different variants, each with a different needle gauge (18G, 21G, 23G, 28G, 30G) to facilitate appropriate blood flow rates from the skin puncture. There are two high flow variants (18G, 21G) one medium flow variant (23G) and two low flow variants (28G, 30G). The Unistik® 3 Value devices are identical to the equivalent gauge of Unistik® 3 devices, except for the colour of the plastic body housings. The Unistik® 3 Value devices all have a vanilla body housing colour, whereas the Unistik® 3 devices have a different colour for each gauge.

The Abbott SF sterile single-use safety lancets are available in a single configuration only (28G needle).

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are designed for prescription and over-the-counter use and to be used by self-testing patients, caregivers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for care-givers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are sterile single-use devices with integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are used by first twisting off the end cap, the needle tip is then exposed but remains safely shielded within the device housing. The user then presses the end face of the device against the sampling site, then activates the device by pressing the release button on the side of the lancet needle is then automatically propelled forward by the internal pre-loaded spring to lance the skin and also automatically retracted by the spring back inside the device housing, where it is then automatically locked to prevent re-use. After firing, the locked position of the needle tip inside the device ensures that it remains safely shielded, and the device can be safely disposed of into an appropriate sharps receptacle.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets consist of a stainless steel lancet needle moulded into a plastic lancet holder component. which in turn is assembled into a moulded plastic outer housing with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded.

The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Unistik® 3, Unistik® 3 Value, and Abbott SF sterile single-use safety lancets), not an AI/ML powered device. As such, information regarding AI/ML specific criteria like MRMC studies, standalone algorithm performance, number of experts for ground truth, or training set details are not applicable and are not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with relevant standards for a traditional medical device (blood lancets).

Below is the information regarding the acceptance criteria and study as presented in the document for the non-AI medical device.

1. Table of acceptance criteria and the reported device performance

Test	Requirement	Reported Device Performance
Integrity of device	Internal test specification	Meets specification
Test firing protocol	Internal test specification	Meets specification
Environmental testing	Internal test specification	Meets specification
Cap removal torque and needle retention	Internal test specification	Meets specification
Needle penetration measurement	Internal test specification	Meets specification
Drop test	Internal test specification	Meets specification

Additionally, the document states: "All additional performance tests met the acceptance criteria."

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each of the bench tests mentioned. The "data provenance" (e.g., country of origin of the data, retrospective or prospective) is also not explicitly stated, but the tests were conducted as part of the design verification for the devices by the manufacturer, Owen Mumford Ltd (United Kingdom). These would be considered prospective design verification tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a physical medical device (lancet), not an AI/ML diagnostic system requiring expert-established ground truth for a test set. The acceptance criteria are based on internal test specifications and engineering requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for a physical medical device where performance is evaluated through objective bench tests against technical specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the device is a physical medical device (lancet) and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a physical medical device (lancet) and does not involve an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" or reference against which the device performance was measured were the internal test specifications. These specifications define the expected performance parameters (e.g., integrity, firing protocol, cap removal torque, needle penetration depth, environmental resilience, drop test). Biocompatibility was assessed against ISO 10993-1, and sterility against ISO 11137 with a Sterility Assurance Level (SAL) of 10^-6.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device (lancet) and does not involve a "training set" in the AI/ML context.

9. How the ground truth for the training set was established

This question is not applicable as the device is a physical medical device (lancet) and does not involve a "training set" or "ground truth" for training purposes.

Summary

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August 12, 2022

Owen Mumford Ltd Darren Mansell Regulatory Affairs Manager Brook Hill Woodstock. Oxfordshire OX20 1TU United Kingdom

Re: K221126

Trade/Device Name: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 8, 2022 Received: July 12, 2022

Dear Darren Mansell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Jessica Carr -S

for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221126

Device Name

Unistik® 3, sterile single-use safety lancets Unistik® 3 Value, sterile single-use safety lancets Abbott SF sterile single-use safety lancets

Indications for Use (Describe)

The single-use safety lancets are hand-held disposable devices intended to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Submitter

Prepared by:	Owen Mumford LtdTel: +44(0)1993 812021Fax: +44(0)1993 813466
Prepared for:	Owner/ OperatorOwen Mumford LtdBrook HillWoodstockOxfordshireOX20 1TUUnited KingdomEstablishment Registration Number: 3003348846
Contact Person:	Darren MansellRegulatory Affairs ManagerOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email: darren.mansell@owenmumford.com
Date Prepared:	08 July 2022
2. Device
Name of Device:	Unistik® 3, sterile single-use safety lancets,
	Unistik® 3 Value, sterile single-use safety lancets,
	Abbott SF sterile single-use safety lancets
Common Name:	Blood lancets
Classification Name:feature	Single use only blood lancet with an integral sharps injury prevention feature
Regulatory Class:	II
Product Code:	FMK
3. Predicate Devices
Predicate Device Name:	SurgiLance® Safety Lancet, under 510k number K101145.

(Cleared for: Prescription Use and Over-The-Counter Use)

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4. Description of The Device

This submission covers the following devices:

. Unistik® 3, sterile single-use safety lancets
. Unistik® 3 Value, sterile single-use safety lancets
. Abbott SF® sterile single-use safety lancets

In the remainder of this submission, the Unistik® 3 safety lancets and Unistik® 3 Value safety lancets will both be referred to as "the Unistik® 3 safety lancets."

The Abbott SF sterile single-use safety lancets are available in a single configuration only (28G needle).

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The purpose of this 510(k) application is to obtain both prescription-only clearance and overcounter clearance for the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile singleuse safety lancets. The intended use for the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets remains the same as the predicate device.

5. Indications for Use

The single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.

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6. Technological Characteristics

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are substantially equivalent to the predicate device, the SurgiLance® Safety Lancet.

A comparison of the intended uses and technological characteristics of the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets to the predicate SurgiLance® devices is summarised in the table below.

Device Characteristic	Predicate Device: SurgiLance® Safety Lancets – K101145.	Submission Device - Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets
Indications For Use	The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury.	Equivalent to the predicate device
Use environment	Home and clinical	Home and clinical
Operating principle	Contact-activated spring-powered automatic lancing and needle retraction.	Manually activated (side fire button) spring-powered automatic lancing and needle retraction.
Design/ construction	Stainless steel lancet needle moulded into a plastic lancet holder component, which in turn is assembled into a moulded plastic outer housing with a pre-loaded steel spring	Unchanged from the predicate device with the exception of an addition of a plastic tab functioning as a firing button which is incorporated into the external plastic outer housing.
Integral sharps injury prevention feature?	Yes	Unchanged from the predicate device
Device Characteristic		Predicate Device:SurgiLance® SafetyLancets – K101145.	Submission Device -Unistik® 3 sterile single-usesafety lancets and Abbott SFsterile single-use safety lancets
Single-use?		Yes	Unchanged from the predicatedevice
Sterility		Sterile	Unchanged from the predicatedevice
Components and Materials		Plastic external and internalcomponents, stainless steelneedle and steel spring	Unchanged from the predicatedevice, but likely that plastic andsteel specifications used differ frompredicate.
Package		Laminate pulp board cartons	Unchanged from the predicatedevice.
NeedleSpecifications	NeedleGauges(SWG)	18G, 21G	Unistik 3: 18G, 21G, 23G, 28G,30GAbbott SF: 28GThe predicate device is available in18G and 21G variants only,therefore the Unistik® 3 sterilesingle-use safety lancets andAbbott SF sterile single-use safetylancets represent an extendedrange of higher gauges (smallerneedle diameters) compared to thepredicate.
Device Characteristic	Predicate Device:SurgiLance® SafetyLancets – K101145.	Submission Device -Unistik® 3 sterile single-usesafety lancets and Abbott SFsterile single-use safety lancets
LancingDepths (mm)	1.8 mm & 2.3 mm (18G)1.0 mm, 1.8 mm, 2.2 mm &2.8 mm (21G)	Unistik 3: 1.4mm, 1.5mm. 1.8mm,2.0mmAbbott SF: 1.4mmThe Unistik® 3 sterile single-usesafety lancets and Abbott SF sterilesingle-use safety lancets lancingdepth range falls within the rangeoffered by the predicate device, i.e.1.4 mm - 2.0 mm compared to thepredicate range of1.0 mm - 2.8 mm.
Needle TipConfiguration	Not known.	2-facet chisel - 1.8 mm (18G)3-facet - 2.0 mm (21G)3-facet - 1.8 mm (23G)3-facet - 1.8 mm (28G)3-facet - 1.5 mm (30G)
Sterilisationmethod	Not known.	20-40 kGy Cobalt 60 gammaradiation validated to achieve asterility assurance level (SAL) of 10-6

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Table 6.1: Comparison of Characteristics between Submission Devices and Predicate Device

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7. Performance Data

Non-clinical performance data:

Design verification testing of the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets has been carried out to evaluate the performance of the devices against defined acceptance criteria.

The following table provides a summary of the relevant design verification testing.

Bench Testing:

Test	Requirement	Results
Integrity of device	Internal test specification	Meets specification
Test firing protocol	Internal test specification	Meets specification
Environmental testing	Internal test specification	Meets specification
Cap removal torque and needleretention	Internal test specification	Meets specification
Needle penetration measurement	Internal test specification	Meets specification
Drop test	Internal test specification	Meets specification

Table 7.1: Summary of the performance tests

Additionally, performance testing other than the above was conducted on the devices. The devices comply with the acceptance criteria established based on the specifications of the devices. All additional performance tests met the acceptance criteria.

The results from these tests demonstrate that the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are safe and effective when used as intended.

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Biocompatibility:

Biocompatibility evidence per ISO 10993-1 is available for some of the materials of the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets.

Sterilisation:

The sterility of the devices is assured using a sterilisation method validated in accordance with ISO 11137 "Medical Devices – Validation and Routine Control of Radiation Sterilisation". Through the sterilisation methods used, all devices are sterilised to provide a Sterility Assurance Level (SAL) of 10-6.

8. Conclusion

In summary, the differences between the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets and the predicate device have no impact on safety and effectiveness and the products are therefore substantially equivalent to the predicate device.

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.