The FS & A Device is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The ADC Freestyle Lancing Device II variant is sold for use with ADC 'Freestyle' single-use lancets; these are not included in this submission. The OM Autolet variant is sold for use with Unilet Lancets and as 'universally compatible with most lancets'. The lancets are disposed of after each use and the device is maintained by using isopropyl alcohol or soap to wipe the outside of the device. The FS & A Device is for use only on a single patient.

The Autolet Lite is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The device was designed for use as a system with Unilet Lancets (and as 'universally compatible with most lancets') which are included in this 510(k) The Unilet Lancets feature 3 lancet gauges, 3 with labelling "Unilet Lancets" and the same 3 lancet gauges labelled "Unilet ComforTouch Lancets". These lancets have different gauge sizes and styling but are functionally identical and for the purpose of this 510(k), all references to "Unilet Lancets" can be considered to apply to Unilet Lancets and Unilet ComforTouch Lancets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Owen Mumford Ltd.'s Freestyle Lancing Device II, Autolet, Autolet Lite, and Unilet Lancets. The goal of the submission is to demonstrate substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System (K214022).

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states: "Design verification testing of the FS & A has been carried out to evaluate the performance of the devices against defined acceptance criteria." and "The objective of the design verification testing conducted was to verify that the submission devices met the pre-determined specifications, to support the conclusion that they are fit for purpose and are considered safe and effective for the intended use."

However, the specific "acceptance criteria" (e.g., numerical targets for depth of penetration accuracy, load/fire mechanism reliability) are not explicitly listed in a detailed table or described quantitatively for each test. The table below summarizes the general acceptance and reported performance.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Design Input IDs (FS & A Device)	Passed all 20 design input IDs testing and verification.
Design Inputs (Autolet Lite)	Passed all 12 design inputs testing and verification.
Design Inputs (Unilet Lancets)	Passed all 12 design inputs testing and verification.
Biocompatibility
Cytotoxicity	All skin contact materials tested for cytotoxicity in accordance with ISO 10993-5:2009. All materials scored 0 (lowest level achievable), indicating non-cytotoxicity. Expert toxicological review concluded no irritation or sensitization risk.
Sterilization (Unilet Lancets)
Sterility Assurance Level (SAL)	10^-6 achieved.
Dose Range	25-50 kGy.
Shelf Life
FS & A Device	Designed to last for 2 years.
Autolet Lite	Designed to last for no less than 3000 complete uses.
Unilet Lancets	Sterile shelf life of 5 years.

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

The document does not specify the sample sizes used for the "design verification testing" for the specific tests (e.g., how many devices were tested for mechanical performance, how many samples for biocompatibility).

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond the fact that the testing was carried out as part of the design verification internally by Owen Mumford Ltd. (UK-based company). The Toxicologist for biocompatibility assessment was from Medwise International Consultancy Limited, York, UK.

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

This information is not applicable as the document describes technical performance testing and biocompatibility assessments, not a diagnostic device involving expert interpretation or "ground truth" establishment in a clinical sense. For biocompatibility, an "Expert toxicological review" was conducted by a toxicologist from Medwise International Consultancy Limited, York, UK. Their specific qualifications (e.g., years of experience) are not detailed.

4. Adjudication method for the test set

This information is not applicable for the type of technical and biocompatibility testing described.

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 information is not applicable. The submission is for lancing devices and lancets, which are mechanical devices for capillary blood sampling, not AI-powered diagnostic tools requiring MRMC studies.

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

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the technical performance tests, the "ground truth" or reference was the pre-determined specifications and design input IDs for the devices. For biocompatibility, the ground truth was established against ISO 10993-1:2009 and ISO 10993-5:2009 standards and an expert toxicological review. For sterilization, it was against ISO 11137 standards.

8. The sample size for the training set

This information is not applicable as the submission is for a physical medical device (lancing devices and lancets), not a machine learning or AI model that requires a 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 a physical medical device.

Summary

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

10/3/2022

Owen Mumford Ltd % Patty Cronan Quality Manager Owen Mumford USA Inc. 1755 West Oak Commons Ct. Marietta, Georgia 30062

Re: K221613

Trade/Device Name: Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: Mav 30, 2022 Received: June 3, 2022

Dear Patty Cronan:

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

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

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 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,

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) K221613

Device Name

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

Indications for Use (Describe)

Freestyle Lancing Device II: Use with compatible lancets for capillary blood sampling.

Autolet: Use with compatible lancets for capillary blood sampling.

Autolet Lite: Use with compatible lancets for capillary blood sampling.

Unilet Lancets: Use with compatible lancing device for capillary blood sampling.

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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SECTION 5.0

510(k) SUMMARY

1.Submitter

Prepared by:	Matthew WilloughbyRegulatory Affairs OfficerOwen Mumford Ltd.Tel: +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.comPaul SmithHead of QualityOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email:paul.smith@owenmumford.com
Date Prepared:	16 AUG 2022

Section 5-1

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2. Device

Name of Device:	Freestyle Lancing Device II
	Autolet
	Autolet Lite
	Unilet Lancets
Common Name:	Home-use Lancing Device
Classification Name:	Multiple Use Blood Lancet for Single Patient Use Only
Product Code:	QRL
Subsequent Product Code:	QRK
FDA Classification:	Class II

3.Predicate Devices

Predicate Device Name: Accu-Chek Softclix Blood Lancing System, 510(k) number K214022.

4. Description of The Device

The purpose of this 510(k) Premarket Notification is to obtain FDA clearance for the following devices:

. Freestyle Lancing Device II
. Autolet
. Autolet Lite
Unilet Lancets

The intended use for these devices remains the same as the predicate device.

The Autolet design is an Owen Mumford branded variant of the "Freestyle Lancing Device II". The sole difference is the moulded branding on the outer of the rear body component, the component is functionally identical and made of the same material. Therefore, much of the information for the Freestyle Lancing Device II and Autolet devices is the same and they can be considered variants of the same device.

For brevity, in the sections within this submission pertaining to both the "Freestyle Lancing Device II" and "Autolet" devices, they will be referred to as the "FS & A Device". When information provided is specific to one variant, its full name will be used. Additionally, any reference within the documentation referring to 'Perceval' can be considered as pertaining to the FS & A Device, as the original design work was performed under the project name Perceval.

The FS & A Device is intended to be used by patients with medical conditions who require frequent capillary blood sampling, such as diabetics. Frequency of use will depend greatly on the patients need for using the device, although typically diabetics may monitor their blood qlucose levels several times per day. The primary site for lancing is the finger, although an 'alternate site adapter' is provided, so lancing can be performed on sites other than the fingers as necessary.

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5.Indications for Use

Freestyle Lancing Device II: Use with compatible lancets for capillary blood sampling.

Autolet: Use with compatible lancets for capillary blood sampling.

Autolet Lite: Use with compatible lancets for capillary blood sampling.

Unilet Lancets: Use with compatible lancing device for capillary blood sampling.

6. Technological Characteristics

The Autolet, Freestyle Lancing Device II device and the Autolet Lite and Unilet Lancets are substantially equivalent to the predicate device, the Accu-Chek Softclix Blood Lancing System, 510(k) number K214022.

A comparison of the intended uses and technological characteristics is summarized in the table 5.1 below.

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0(k) Number: K221

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1613てK2Number:

0(k)
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Device Characteristic	Accu-Chek Softclix Blood Lancing System	Submission Device - FS & A Device	Autolet Lite and Unilet Lancets
Indications for Use	The Accu-Chek Softclix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.	Freestyle Lancing Device II: Use with compatible lancets for capillary blood sampling.Autolet: Use with compatible lancets for capillary blood sampling.	Autolet Lite: Use with compatible lancets for capillary blood sampling.Unilet Lancets: Use with compatible lancing device for capillary blood sampling.
	The sterile, single-use lancets are to be used with the resuseable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
	This system if for use only on a single patient in a home setting.
	This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Number of Uses	Base (lancing device): multiple useLancet: single use	Base (lancing device): multiple useLancet: single use	Base (lancing device): multiple useLancet: single use
Depth Adjustment	11 levels by twisting cap	Levels 1-5, with half settings for a total of 9 different settings, set by twisting dial.	10 different settings, set by twisting cap
Depth of Penetration	Minimum depth of penetration: 0.8mmMaximum depth of penetration: 2.3mm	Minimum depth of penetration: 0.5mmMaximum depth of penetration: 2.5mm	Minimum depth of penetration: 0.60mmMaximum depth of penetration: 1.95mm

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13ਹਵਟK2
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10(k)ம்

Device Characteristic	Accu-Chek Softclix Blood LancingSystem	Submission Device – FS & ADevice	Autolet Lite and Unilet Lancets
Load and firing	Load by pressing priming button when lancet is inserted Fire by pressing the release button	Load by pulling back grey slider until it clicks (after lancet has been inserted) Fire by pressing the lancing button	Load by inserting the lancet into the lancet holder and pushing down until fully seated Fire by pressing the release button
Mechanical Loading	Spring-driven	Spring-driven	Spring-driven
Lancet Sterility	Yes, gamma irradiation	Yes, gamma irradiation	Yes, Gamma irradiation
Lancet Dimensions	28G, 0.4mm wide, beveled cut with 3 facets. Needle length not known.	N/A – this column covers the devices only.	Unilet Lancets: 23G 0.64mm wide, 28G 0.36mm wide, 30G 0.31mm wideAll lancets have the same needle length 3.2mm (+-0.3mm)
			Needle drawings can be found in section 11 – Device Description, of this submission.

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7.Performance Data

Non-clinical performance data:

Design verification testing of the FS & A 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:

The objective of the design verification testing conducted was to verify that the submission devices met the pre-determined specifications, to support the conclusion that they are fit for purpose and are considered safe and effective for the intended use.

Submission Device	Design Verification Testing	Results
FS & A Device	Yes – 20 Design Input IDsTested and Verified	Passed all testing andverification
Autolet Lite	Yes – 12 Design InputsTested and Verified	Passed all testing andverification
Unilet Lancets	Yes – 12 Design InputsTested and Verified	Passed all testing andverification

Biocompatibility:

All patient contact materials of the FS & A Device were assessed against the requirements of ISO 10993-1:2009. All skin contact materials used in the device were tested for cytotoxicity in accordance with ISO 10993-5:2009. These results along with base material and master-batch data sheets, the proposed material application, the device assembly process and any examples of current usage were used by the Toxicologist (Medwise International Consultancy Limited, York UK) to assess the suitability of the materials for their intended use and provide a biocompatibility evaluation. All contact materials were found to be non-cytotoxic according to the test method stipulated in ISO 10993-5:2009: Each material scored 0; the lowest level achievable. Expert toxicological review for the materials concluded that "it is inconceivable that transient daily skin contact with the device would result in any incidence of irritation or sensitization" to users and therefore the requirements of ISO 10993 are met without the need for further animal testing.

Results of the testing and toxicological assessment demonstrate the materials of the FS & A Device are biocompatible and do not pose a biological risk to the user, therefore, safe for use.

Sterilization:

Unilet Lancets are the only device in this submission that is provided sterile.

Sterilization Method: Gamma radiation

Radiation dose range: 25-50 kGy

Sterility assurance level (SAL): 10-6

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Description of the method used to validate the sterilization cycle:

Sterilization validation (Dose mapping) was conducted in accordance with Section 9 of ISO 11137: "Sterilization of Healthcare Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices."

The verification dose for the Unilet Lancets manufactured by Tianjin Huahong Technology Co., Ltd is 6.5kGy and the minimum exposure dose has been determined as 25kGy.

Shelf life

The FS & A Device is designed to last for 2 years as per the design verification for the device.

Unilet Lite is designed to last for no less than 3000 complete uses.

Unilet Lancets have a sterile shelf life of 5 years.

8.Conclusion

In summary, the differences between the FS & A Device, Autolet Lite and Unilet Lancets and the predicate 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.