Accu-Chek Safe-T-Pro Plus Lancing Device by Roche Diabetes Care, Inc.

The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel. The Accu-Chek Safe-T-Pro Plus lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Plus lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only. It has a 23 Gauge needle with 3 depth levels by twisting cap: 1.3 mm, 1.8 mm, 2.3 mm. It is spring-driven and loading/priming is not required. Press release button to activate lancet mechanism.

AI/ML Overview

The provided text is a 510(k) premarket notification for the "Accu-Chek Safe-T-Pro Plus Lancing Device". It focuses on establishing substantial equivalence to predicate and reference devices rather than presenting specific acceptance criteria and a detailed study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML devices.

However, based on the information provided, I can extract the non-clinical testing performed and infer the acceptance criteria and details about the study.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) for comparison within a table, as one would expect for an AI/ML device. Instead, it describes "nonclinical bench testing" and "design verification and validation testing" to ensure risk management and mechanical function. The "reported device performance" is broadly stated as "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

However, we can infer acceptance criteria related to safety and functionality from the types of testing mentioned and the characteristics of the device.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Mechanical Design & Functionality:
Proper function of lancing mechanism (needle extension/retraction)	Verified through "design verification and validation testing" ensuring "mechanical functions are suitable for use over the lifetime of the device."
Optimal penetration depth for capillary blood sampling	Confirmed through "design verification and validation testing" ensuring "mechanical functions are suitable for use over the lifetime of the device." (Specifically, 1.3 mm, 1.8 mm, 2.3 mm depths are specified in device characteristics)
Sharps Injury Prevention:
Lancet retraction and concealment before and after use	Confirmed: Lancet is "retracted and concealed before and after use." Implicitly verified through testing for "sharps injury prevention features."
Device rendered inoperative after single use	Confirmed: "Once the lancet is used, it is rendered inoperative." Implicitly verified through testing for "sharps injury prevention features."
Passive safety mechanism activation	Confirmed: "passive safety mechanism that automatically activates after the device is used, requiring no action on the part of the user." Implicitly verified through testing.
Sterility:
Device sterility (Gamma irradiation)	Confirmed: Device is "sterile" and "sterilized by Gamma irradiation."
Risk Management:
All identified risks addressed and mitigated appropriately	Confirmed: "risk analysis confirmed that all identified risks were addressed and mitigated appropriately."
Acceptable residual risks	Confirmed: "All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings."
No special performance or safety concerns	Confirmed: "There were no special performance or safety concerns identified."
Overall Performance:
Performance "as well or better than legally marketed predicate and reference devices"	The device "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical bench testing. It does not provide details on a "test set" in the context of clinical data for performance metrics. For the "nonclinical bench testing," the sample size of devices tested is not specified. The data provenance is also not specified, but it would typically be internal testing conducted by the manufacturer. Since it's bench testing, concepts of retrospective or prospective data usually don't apply in the same way as clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes a physical medical device (lancing device) and its mechanical and safety performance, not an AI/ML algorithm that requires expert-established ground truth for a test set. There is no mention of experts or ground truth in this context.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies involving interpretation of data, often by multiple readers, which is not the case here.

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 section is not applicable. The device is a "lancing device," a physical tool for blood sampling. It does not involve AI or software for diagnostic interpretation, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely outside the scope of this device.

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

This section is not applicable as the device is a lancing device and does not involve any algorithm or software with standalone performance.

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

This section is not applicable. For a lancing device, the "ground truth" for its performance would be its physical properties, sterility, mechanical reliability, and safety features, which are evaluated through engineering tests and quality control, not clinical "ground truth" like pathology or outcomes data in the sense of diagnostic accuracy.

8. The sample size for the training set

This section is not applicable. The device is not an AI/ML product and does not have a "training set."

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

This section is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 13, 2023

Roche Diabetes Care, Inc. Kacia Mills Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250-0457

Re: K232488

Trade/Device Name: Accu-Chek Safe-T-Pro Plus Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 17, 2023 Received: August 17, 2023

Dear Kacia Mills:

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

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

For comprehensive regulatory information about 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, Digitally signed by Mark Mark Trumbore -S Date: 2023.11.13 14:48:49 Trumbore -S -05'00 Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232488

Device Name Accu-Chek Safe-T-Pro Plus Lancing Device

Indications for Use (Describe)

The Accu-Chek Safe-T-Pro Plus lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

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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Contact Details [21 CFR 807.92(a)(1)] Applicant Name: Roche Diabetes Care, Inc. Applicant Address: 9115 Hague Road Indianapolis, IN 46250-0457; United States of America Applicant Contact Telephone: +1 317-709-4223 Applicant Contact: Mrs. Kacia Mills Applicant Contact Email: kasey.mills@roche.com

Device Name [21 CFR 807.92(a)(2)]

Device Trade Name: Accu-Chek Safe-T-Pro Plus Lancing Device Common Name: Blood Lancets Classification Names: Single use only blood lancet with an integral sharps injury prevention feature Regulation Number: 878.4850, Class II Product Code: FMK

Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]

Predicate #1: K220849 Predicate Trade Name: Accu-Chek Safe-T-Pro Plus Lancing Device Product Code: FMK

Legally Marketed Reference Devices [21 CFR 807.92(a)(3)]

Reference #1: K222090 Predicate Trade Name: Safety Lancet Product Code: FMK Reference #2: K221433 Predicate Trade Name: Facet 28G Universal Lancet Product Codes: QRK, QRL

Device Description Summary [21 CFR 807.92(a)(4)]

Intended Use/Indications for Use [21 CFR 807.92(a)(5)]

The Accu-Chek Safe-T-Pro Plus lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

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	Predicate Device - Accu-Chek Safe-T-Pro PlusLancing Device	Candidate Device - Accu-ChekSafe-T-Pro Plus Lancing Device	Reference Device 1 - SafetyLancet (K222090)	Reference Device 2 - Facet28G Universal Lancet(K221433)
Devicedescription	The Accu-Chek Safe-T-ProPlus lancing device is a needleused for capillary bloodsampling for use in diagnostictesting.The Accu-Chek Safe-T-ProPlus lancing device contains asharps injury preventionfeature where the lancet isretracted and concealed beforeand after use. Once the lancetis used, it is renderedinoperative. The device isdesigned for single use only.	The Accu-Chek Safe-T-Pro Pluslancing device is a needle used forcapillary blood sampling for use indiagnostic testing.The Accu-Chek Safe-T-Pro Pluslancing device contains a sharpsinjury prevention feature where thelancet is retracted and concealedbefore and after use. Once thelancet is used, it is renderedinoperative. The device is designedfor single use only.	Safety Lancet, could bedivided into Model XY, ModelXH, and Model XA accordingto the design features and keyfunctional elements. Thedevice is sterilized by Gammaray (Co-60 or e-beam) and forsingle use. The shelf life is 5years.	The Facet 28G UniversalLancet (Facet Lancet) is asterile, single use, bloodsampling device used to obtaina sample of capillary blood fordiagnostic purposes, primarilyfor blood glucose monitoringin diabetic patients.
Indicationsfor Use	The Accu-Chek Safe-T-ProPlus lancing device is a sterile,single-use, disposable lancingdevice intended to be used byhealthcare professionals. It isdesigned for capillary bloodsampling from the fingertip ofadults and children 1 year andolder or, if the patient is achild under 1 year, from theheel.	The Accu-Chek Safe-T-Pro Pluslancing device is intended toproduce a capillary blood samplefor testing utilizing small amountsof blood.	Safety Lancet is intended to beused to obtain capillary bloodsample to perform medicaltesting, including bloodglucose monitoring and fortests using small amounts ofblood.	The Facet 28G UniversalLancet is a sterile, disposablesingle use device used toobtain a droplet of capillaryblood for subsequentdiagnostic testing from thefinger or an alternative site,such as the palm, upper arm,or forearm. The Lancet is to beproperly disposed of after asingle use on an individualchild, adolescent, or adultpatient in home testing.
IntendedUsers	Healthcare professionals	Healthcare professionals andconsumers	Consumers	Consumers
	Predicate Device – Accu-Chek Safe-T-Pro PlusLancing Device	Candidate Device – Accu-Chek Safe-T-Pro Plus Lancing Device	Reference Device 1 – Safety Lancet (K222090)	Reference Device 2 – Facet 28G Universal Lancet (K221433)
Number of Uses	Single use only with integral sharps injury prevention feature	Same	Same	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature and Multiple Use Blood Lancet For Single Patient Use Only
Device images	Image: Accu-Chek Safe-T-Pro Plus Lancing Device	Image: Accu-Chek Safe-T-Pro Plus Lancing Device	Image: Safety Lancet (K222090) Models XY, XH, and XA	Not available
Lancet Sterility	Gamma irradiation	Same	Same	Same
	Predicate Device – Accu-Chek Safe-T-Pro PlusLancing Device	Candidate Device - Accu-ChekSafe-T-Pro Plus Lancing Device	Reference Device 1 – SafetyLancet (K222090)	Reference Device 2 - Facet28G Universal Lancet(K221433)
NeedleGauge andDepth levels	23 Gauge needle with 3 depthlevels by twisting cap:1.3 mm1.8 mm2.3 mm	Same	Model XYDimension/gauge:21G,23G,25G,26G,28G,30G (Needletype), 1.2mm (Bladetype) Penetration depth:1.4mm-2.8mm(Needletype), 1.6mm-2.0mm(Blade type) Model XH Dimension/gauge:18G,21G,23G,28G(Needle type), 1.5mm(Blade type) Penetration depth:1.2mm-2.8mm (Needletype), 1.6mm-2.0mm(Blade type) Model XA Dimension/gauge:21G,23G,28G (Needletype) Penetration depth:1.3mm/1.8mm/2.3mm,1.5mm/2.0mm/2.5mm(Needle type)	28 Gauge needle, multipledepth options depending onmultiple use blood lancetdevice used with single useonly blood lancet
Mechanicalloading	Spring-driven	Same	Same	Same for multiple use bloodlancet device in which thesingle use blood lancet is used
	Predicate Device – Accu-Chek Safe-T-Pro PlusLancing Device	Candidate Device - Accu-ChekSafe-T-Pro Plus Lancing Device	Reference Device 1 – SafetyLancet (K222090)	Reference Device 2 - Facet28G Universal Lancet(K221433)
Load andfiring	Loading / priming the deviceis not required.Press release button to activatelancet mechanism.	Same	Same	Loading is required.
Anatomicalsites	Fingertip (adults and children1 year and older)Heel (child under 1 year)	Same	Fingertip	Fingertip, palm, upper arm,forearm
Sharps injuryprevention	The Accu-Chek Safe-T-ProPlus lancing device is designedwith a sharps injury preventionfeature. It is a passive safetymechanism that automaticallyactivates after the device isused, requiring no action onthe part of the user. The lancetremains in the housing beforeand after use. After activation,the single-use device cannot beused again.	Same	Same	N/A

Similarities / Differences Between Candidate, Predicate, and Reference Devices

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Indications for Use Comparison [21 CFR 807.92(a)(5)]

The indications for use statement of the candidate device and of the predicate device are not identical. However, the intended use is the same, which is to obtain a blood sample testing. The package insert for the candidate device was updated to clearly separate indications for use and the intended test population.

Technological Comparison [21 CFR 807.92(a)(6)]

The technological characteristics of the candidate device are the same as the predicate.

Non-Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]

Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification and validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device. See more in attached Verification Summary.

Clinical Testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified. See Risk documents provided in Biocompatibility section.

The Accu-Chek Safe-T-Pro Plus Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices.

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.