RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

GE Lancing Device is a reusable lancing device for the single used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.

Device Description

RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device is a mechanical device holding and firing a single-use lancet linearly ahead to prick the skin to collect capillary whole blood from target sites. RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device can be adjusted for 7 levels of depth for a user collecting different amount of capillary blood.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the BIONIME Corporation's RIGHTEST Lancing Device GD500, GE Lancing Device, and iGlucose Lancing Device. It specifically focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device's performance against specific acceptance criteria for AI or diagnostic accuracy.

Therefore, many of the requested elements for an AI/diagnostic accuracy study (such as MRMC studies, effect size of human reader improvement with AI, specific ground truth methods, sample sizes for training/test sets related to AI model development, etc.) are not applicable to this document, as it pertains to a lancing device, not an AI-powered diagnostic tool.

However, I can extract the relevant information regarding the performance data and the basis for substantial equivalence for this medical device.

Device Under Review: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (reusable lancing devices for capillary blood sampling)

A table of acceptance criteria and the reported device performance:

Since this is a lancing device and not a diagnostic or AI device, the "acceptance criteria" here relate to safety, functionality, and biocompatibility, rather than diagnostic performance metrics like sensitivity/specificity. The document states that performance data demonstrated safety and efficacy but does not provide quantitative "acceptance criteria" for each test with reported values. Instead, it lists the types of tests performed.

Acceptance Criteria (Implied by regulatory requirements for lancing devices)	Reported Device Performance (Summary from document)
Biocompatibility (In vitro Cytotoxicity)	C. ISO 10993-5 In vitro Cytotoxicity A. was completed.
Biocompatibility (Skin Irritation)	A. ISO 10993-23 Skin Irritation B. was completed.
Biocompatibility (Skin Sensitization)	B. ISO 10993-10 Skin Sensitization (Maximization Test) was completed.
Functional Performance	D. Functional tests were validated and completed.
Cleaning and Disinfection Efficacy	E. The cleaning and disinfections on the materials of device were evaluated and tested.

The document concludes that the device is "substantially equivalent to predicate devices in regard to indications for use, design, and technology, without raising any safety and efficacy risks or concerns," implying that the performance tests met the necessary standards for these types of devices.

Sample size used for the test set and the data provenance:

This information is not provided in the document as it's not a study on diagnostic accuracy or AI performance. The tests mentioned (biocompatibility, functional tests) would have their own sample sizes based on standard testing protocols for medical devices. The data provenance would be from laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. Ground truth establishment by experts is relevant for diagnostic accuracy studies, especially for image interpretation. For a lancing device, "ground truth" would relate to measurable physical properties or biological responses (e.g., cytotoxicity, successful blood draw) determined by validated test methods, not expert consensus on images.
Adjudication method for the test set:

This is not applicable as there is no expert adjudication process for the performance tests of a lancing device in this context.
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 is not applicable. This document is for a lancing device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. There is no AI algorithm in this device.
The type of ground truth used:

For this type of device, the "ground truth" is defined by standardized laboratory test results for biocompatibility (e.g., cell viability assays, skin patch tests) and engineering validation for functional performance (e.g., consistency of lancing depth, successful lancet injection/retraction). It is not pathology or outcomes data in the sense of a diagnostic device.
The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:

This is not applicable. No training set is used for this type of device.

Summary of Substantial Equivalence (as reported in the document):

The submission argues for substantial equivalence based on the following:

Same "intended use/indication(s) for use": To obtain capillary blood samples for glucose monitoring or other tests requiring small amounts of blood, for single user, with depth adjustment and alternative site testing capabilities.
Similar Technological Characteristics: Both the proposed and predicate devices are mechanical devices that hold and fire a single-use lancet linearly to prick the skin, automatically inject and retract the lancet, have a clear cap for alternative site testing, retract the lancet after use to prevent sharp injury, have mechanical loading and firing functions, and eject the used lancet without touching it.
Differences noted: The primary difference is the "depth of penetration." The proposed device offers 7 different depths (0.5 mm to 1.7 mm) compared to the predicate devices' 6 different depths or interchangeable contact tips. The submission states this difference "did not raise other concerns on safety and efficacy."
Performance Data: The provided performance data (biocompatibility and functional tests) demonstrated safety and efficacy consistent with the predicate devices and regulatory requirements.

The document concludes that the RIGHTEST Lancing Device GD500, GE Lancing Device, and iGlucose Lancing Device are "substantially equivalent to the predicate devices On Call Lancing Device and the Genteel Lancing Device (K113332 and K153670)."

Summary

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September 26, 2022

Bionime Corporation % I Hsin Li Regulatory Consultant Symbiosis Consulting Ltd. 11F., No.95, Sec. 2, Nanjing E. Rd., Zhongshan Dist., Taipei, 10489 Taiwan

Re: K221062

Trade/Device Name: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL Dated: August 26, 2022 Received: August 26, 2022

Dear I Hsin Li:

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

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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 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 (QS) 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).

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) K221062

Device Name BIONIME CORPORATION

Indications for Use (Describe)

RIGHTEST Lancing Device GD500

GE Lancing Device

iGlucose Lancing Device

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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K221062

SECTION 5-510(k) SUMMARY

This 510 (K) summary is being submitted in accorndance with requirements of
ithe 21,CFR Section 807.92.

A.	510(k) NUMBER	K221062
B.	DATE PREPARED	September 25th, 2022
C.	SUBMITTER	BIONIME CORPORATIONNO. 100, Section 2, Daqing Street., South District,Taichung City, Taiwan, 40242Registration Number: 3004183148FEI Number: 3004183148Tel: +886 4 23692388
D.	CONTACT PERSON	Primary Contact PersonEngineerName: Yu Chi HuangTel: +886 4 23692388#5898E-mail: Yuchi.huang@bionime.comSecond Contact PersonRegulatory ConsultantName: I Hsin LiTel: +886 2 6605 7988E-mail: contact@symbiosistw.com
E.	DEVICES	Proprietary Name: RIGHTEST Lancing Device GD500Common Name: Multiple Use Blood Lancet For Single Patient Use OnlyProduct Code: QRLRegulation Number: 21 CFR 878.4850Device Class: Class IIReview Panel: General & Plastic SurgeryProprietary Name: GE Lancing DeviceCommon Name: Multiple Use Blood Lancet For Single Patient Use OnlyProduct Code: QRLRegulation Number: 21 CFR 878.4850Device Class: Class IIReview Panel: General & Plastic Surgery
Proprietary Name:	iGlucose Lancing Device
Common Name:	Multiple Use Blood Lancet For SinglePatient Use Only
Product Code:	QRL
Regulation Number:	21 CFR 878.4850
Device Class:	Class II
Review Panel:	General & Plastic Surgery

SECTION 5-510(k) SUMMARY Page 1 of 8 pages

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RIGHTEST Lancing Device GD500 F. INDICATION(S) FOR

USE

GE Lancing Device

GE Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

iGlucose Lancing Device

SECTION 5-510(k) SUMMARY Page 2 of 8 pages

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G.	PRIMARYPREDICATE DEVICE	Proprietary Name:Common Name:Product Code:Regulation Number:510(k) Number:510(k) Submitter:Device Class:Review Panel:	On Call Lancing DeviceSingle Use Only Blood Lancet with AnIntegral Sharps Injury Prevention FeatureFMK21 CFR 878.4850K113332ACON Laboratories Inc.Class IIGeneral & Plastic Surgery
H.	SECONDARYPREDICATE DEVICE	Proprietary Name:Common Name:Product Code:Regulation Number:Regulation Name:510(k) Number:510(k) Submitter:Device Class:Review Panel:	Genteel Lancing DeviceSingle Use Only Blood Lancet with AnIntegral Sharps Injury Prevention FeatureFMK21 CFR 878.4850Blood lancetsK153670Genteel LLCClass IIGeneral & Plastic Surgery
I.	DEVICE DECRIPTION		RIGHTEST Lancing Device GD500/ GE Lancing Device/iGlucose Lancing Device is a mechanical device holding andfiring a single-use lancet linearly ahead to prick the skin tocollect capillary whole blood from target sites. RIGHTESTLancing Device GD500/ GE Lancing Device/ iGlucose LancingDevice can be adjusted for 7 levels of depth for a user collectingdifferent amount of capillary blood.
J.	COMPARISON OFTECHNOLOGICALCHARACTERISTICSWITH THEPREDICATE DEVICES		RIGHTEST Lancing Device GD500, GE Lancing Device andiGlucose Lancing Device and predicate devices (K113332 andK113618) are:1. Same "intended use/ indication(s) for use"2. Same "Puncture device to obtain micro bloodsamples"3. Same "Clear cap for testing alternative site"4. Same "Lancet retracted after use to prevent sharpinjure"5. Same "Mechanical loading and firing function"6. Same "Ejecting the used lancet Without touching theused disposable lancet"7. Different "The depth of penetration"

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K221062

RIGHTEST Lancing Device GD500/GE Lancing

Device/iGlucose Lancing Device and predicate devices (K113332 and K153670) are all the same intended use/ indication(s) for use, intended population, similar technical design and functions. The varying setting in the depth of penetration between RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device and predicate devices did not raise other concerns on safety and efficacy.

BIONIME CORPORATION concluded that RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device is substantially equivalent to the predicate devices On Call Lancing Device and the Genteel Lancing Device (K113332 and K153670).

SECTION 5-510(k) SUMMARY

Page 4 of 8 pages

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K. A COMPARISON TABLE WITH PREDICATE DEVICES

Items	Proposed DeviceRIGHTEST Lancing Device GD500,GE Lancing Device and iGlucoseLancing Device	Primary Predicate DeviceOn Call Lancing Device	Secondary PredicateDeviceGenteel Lancing Device	SubstantialEquivalenceComparisonAssessment
510(k) Number	TBD	K113332	K153670	N/A
Product Code	QRL	FMK	FMK	Different
DeviceClassification	Class II	Class II	Class II	Same
Intended Use/Indication(s) for Use	RIGHTEST Lancing DeviceGD500 is a reusable lancingdevice for the single user. Itshould be used with the propersterile lancet for the capillaryblood sampling. It couldautomatically inject the lancetinto and retract it from thefingertip to obtain a capillaryblood sample for glucosemonitoring or other test thatrequire one or two drops ofblood. A depth adjustable capallows the best depth of skinpenetration for each individualuser. Alternative site testing(palm or forearm) can beperformed by installing the clearcap on the lancing device.GE Lancing Device is a reusablelancing device for the singleuser. It should be used with the	The On Call® Lancing Device isused with On Call® disposablesterile lancets to draw capillaryblood from the fingertip, palm (atthe base of the thumb) or forearm,for blood glucose testing or othertesting utilizing small amounts ofblood. The On Call® LancingDevice is intended to be used by asingle patient and should not beshared.	The Genteel lancingdevice is used withdisposable sterilelancets to drawcapillary bloodfrom the fingertip oralternate sites forblood glucosetesting or othertesting utilizingsmall amounts ofblood. The Genteellancing device is forSingle Patient UseOnly.	Same

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K22	11	062

Items	Proposed Device	Primary Predicate Device	Secondary Predicate Device	K22106SubstantialEquivalenceComparisonAssessment
	RIGHTEST Lancing Device GD500,GE Lancing Device and iGlucoseLancing Device	On Call Lancing Device	Genteel Lancing Device
	proper sterile lancet for thecapillary blood sampling. Itcould automatically inject thelancet into and retract it from thefingertip to obtain a capillaryblood sample for glucosemonitoring or other test thatrequire one or two drops ofblood. A depth adjustable capallows the best depth of skinpenetration for each individualuser. Alternative site testing(palm or forearm) can beperformed by installing the clearcap on the lancing device.
	iGlucose Lancing Device is areusable lancing device for thesingle user. It should be usedwith the proper sterile lancet forthe capillary blood sampling. Itcould automatically inject thelancet into and retract it from thefingertip to obtain a capillaryblood sample for glucosemonitoring or other test thatrequire one or two drops ofblood. A depth adjustable capallows the best depth of skin
Items	Proposed DeviceRIGHTEST Lancing Device GD500,GE Lancing Device and iGlucoseLancing Device	Primary Predicate DeviceOn Call Lancing Device	Secondary PredicateDeviceGenteel Lancing Device	SubstantialEquivalenceComparisonAssessment
	penetration for each individualuser.
Puncture device toobtain micro bloodsamples	Yes	Yes	Yes	Same
Clear cap for testingalternative site	Yes	Yes	Yes	Same
Lancet retractedafter use to preventsharp injure	Yes	Yes	Yes	Same
Mechanical loadingand firing function	Yes	Yes	Yes	Same
Ejecting the usedlancet Withouttouching the useddisposable lancet	Yes	Yes	Yes	Same
The depth ofpenetration	7 different depthsThe settings of penetration depths are0.5 mm, 0.7 mm, 0.9 mm 1.1 mm, 1.3mm, 1.5 mm and 1.7 mm.	6 different depths	six interchangeablecontact tips	Different
OTC/Rx	OTC	OTC	OTC	Same
Design	Image: RIGHTEST Lancing Device GD500, GE Lancing Device and iGlucose Lancing Device design	Image: On Call Lancing Device design	Image: Genteel Lancing Device design	Similardesign

SECTION 5-510(k) SUMMARY

Page 6 of 8 pages

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K221062

SECTION 5-510(k) SUMMARY

Page 7 of 8 pages

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L. SUMMARY OF PERFORMANCE DATA

The following performance data were provided to demonstrate the safety and efficacy:

ISO 10993-5 In vitro Cytotoxicity A.
ISO 10993-23 Skin Irritation B.
C. ISO 10993-10 Skin Sensitization (Maximization Test)
D. Functional tests were validated and completed.
E. The cleaning and disinfections on the materials of device were evaluated and tested.
M. SUBSTANTIAL EQUIVALENCE CONCLUSION

BIONIME CORPORATION concludes that the RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device is substantially equivalent to predicate devices in regard to indications for use, design, and technology, without raising any safety and efficacy risks or concerns.

SECTION 5-510(k) SUMMARY Page 8 of 8 pages

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.