RightLance Blood Lancing System by Beijing Ruicheng Medical Supplies Co., Ltd.

The RightLance 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.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is 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.

Device Description

The proposed device, RightLance 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.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is 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.

The RightLance Blood Lancing System is made up of Lancing Device and Disposable Lancet.

The Model of Lancing Device: RC-AD-III; RC-AD-IIIT; RC-AD-VIU; RC-AD-VIX; RC-AD-VIXT; RC-AD-VII; RC-AD-XI; RC-AD-XII; RC-AD-XIV; Sinodraw; RC-LD-16; RC-LD-17; RC-LD-18; RC-LD-19

The Model of Disposable Lancet: I Size: 21G, 23G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the RightLance Blood Lancing System. The document focuses on establishing substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System, rather than providing a detailed study that proves the device meets specific acceptance criteria as one might find for an AI/ML powered device.

Therefore, many of the requested elements for AI/ML device studies (like effect size for MRMC studies, training set details, or complex ground truth establishment) are not applicable to this type of submission.

Here's an analysis based on the provided text, focusing on what is relevant for a non-AI medical device submission:

Acceptance Criteria and Device Performance

There isn't a table of quantitative performance acceptance criteria in the typical sense of measuring algorithm accuracy (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the comparison to the predicate device and compliance with recognized international standards and internal design specifications. The device is accepted if it performs "as well as or better than" the predicate device and meets its own design specifications.

The comparison table provided (page 4) details the technological characteristics, highlighting similarities and differences with the predicate.

Table of Acceptance Criteria (Implied by Predicate Comparison and Standards) and Reported Device Performance

Acceptance Criterion (Implied)	Reported Device Performance (Summary of Non-Clinical Testing)
Indications for Use (IFU)	The RightLance Blood Lancing System has the same IFU as the predicate device (Accu-Chek Softclix Blood Lancing System) for hygienic collection of capillary blood from fingertip and alternative sites, single-patient home use, and not for healthcare professionals with multiple patients.
Technological Characteristics (Design, Mechanism, Operation, Energy, Features, Form, Fit, Function)	"The RightLance Blood Lancing System and predicate device share the same technological characteristics including their design, mechanical mechanism, principle of operation, energy source and usage, features, form, fit, and function." (Page 5) Detailed comparison provided in table on page 4 (Needle size, depth adjustment, mechanical loading, load/firing, anatomical sites, sharps injury prevention).
Biocompatibility	Complies with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization), ISO 10993-11 (systemic toxicity), ISO 10993-4 (interactions with blood).
Sterilization	Complies with ISO 11137-2 for establishing sterilization dose (gamma irradiation).
Pyrogenicity	Complies with USP34<151> Rabbit Pyrogen Test.
Performance (Functional Safety & Efficacy based on physical attributes)	Bench tests conducted for: Basic Size, Puncture Depth, Lancing Device Cap Removal, Lancing Device Firing Force, Drop, Drawing Force, The tightness of lancing device. These tests "demonstrated that the proposed device complies with its design specification." (Page 7) Specific quantitative results are not provided in this summary.
Shelf Life (Aging)	Validation performed.

Study Details (as applicable)

Sample size used for the test set and the data provenance:
- No "test set" in the context of an AI/ML algorithm evaluation.
- For the non-clinical bench testing, the sample sizes are not specified in the provided summary.
- Data provenance: Not applicable for this type of device where laboratory bench testing is the primary evidence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment by experts for this type of mechanical lancing device. The performance is assessed against engineering specifications and international standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process is described or relevant for this device.
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:
- No. This is not an AI/ML powered device, so MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual mechanical device, not an algorithm. The non-clinical tests assess the device's physical and functional performance directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" would be defined by engineering specifications, international standards (e.g., ISO, USP), and the performance characteristics of the predicate device. For example, a "puncture depth" test would have an expected range based on design, and the device's output would be measured against that.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
How the ground truth for the training set was established:
- Not applicable. No training set.

Summary

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September 7, 2022

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font, also in blue.

Beijing Ruicheng Medical Supplies Co., Ltd. % Mr. Ray Wang General Manager No.13 Yanqi Ave, Yanqi Economic Development Zone, Huairou District, Beijing China, 101400

Re: K222034

Trade/Device Name: RightLance Blood Lancing System Regulation Number: 21 CFR 878.4850 Regulation Name: general & plastic surgery Regulatory Class: Class II Product Code: QRL, QRK Dated: July 7, 2022 Received: July 11, 2022

Dear Mr. Wang:

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

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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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K222034

Device Name RightLance Blood Lancing System

Indications for Use (Describe)

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is 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.

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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1. Date of Preparation: 09/07/2022
1. Contact Details [21 CFR 807.92(a)(1)]

Applicant (Sponsor) Name: Beijing Ruicheng Medical Supplies Co., Ltd. Applicant (Sponsor) Address: No.13 Yanqi Ave, Yanqi Economic Development Zone, Huairou District, Beijing China, 101400

Applicant Contact #1: Mr. Ray Wang Tel: +86-18910677558 Email: information@believe-med.com

Applicant Contact #2: Ms. Yuechao Li Tel: +86-18910106615 Email: lily@ruichengmedical.com

Proposed Device Name [21 CFR 807.92(a)(2)] 3. Device Trade Name: RightLance Blood Lancing System. Common Name: Blood Lancet. Classification Name: Blood Lancet. Regulation Name: 878.4850, Class II Product Code: QRL, QRK
1. Legally Marketed Predicate Device [21 CFR 807.92(a)(3)] 510(k) Number: K214022 Product Name: Accu-Chek Softclix Blood Lancing System Manufacturer: Roche Diabetes Care, Inc.
1. Device Description [21 CFR 807.92(a)(4)]

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is 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.

The RightLance Blood Lancing System is made up of Lancing Device and Disposable Lancet.

The Model of Lancing Device: RC-AD-III; RC-AD-IIIT; RC-AD-VIU; RC-AD-VIX; RC-AD-VIXT; RC-AD-VII; RC-AD-XI; RC-AD-XII; RC-AD-XIV; Sinodraw; RC-LD-16; RC-LD-17; RC-LD-18; RC-LD-19

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The Model of Disposable Lancet: I Size: 21G, 23G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G

Indication for Use Statement [21 CFR 807.92(a)(5)] 6.
The RightLance 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.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is 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

1. Indication for Use Comparison [21 CFR 807.92(a)(5)]
  The indications for use of the RightLance Blood Lancing System are the same as the predicate device, the Accu-Chek Softclix Blood Lancing System.

	Proposed Device K222034	Predicate Device K214022
Indications for use	The RightLance Blood LancingSystem is intended for the hygieniccollection of capillary blood for testingpurposes from the side of a fingertipand from alternative sites, such as thepalm, the upper arm, and the forearm.The sterile, single-use lancets are to beused with the reusable lancing devicethat is to be cleaned and disinfectedbetween each use, and then the lancetsare to be disposed of.This system is for use only on a singlepatient in a home setting.This system is not suitable for use byhealthcare professionals with multiplepatients in a healthcare setting	The Accu-Chek Softclix BloodLancing System is intended for thehygienic collection of capillary bloodfor testingpurposes from the side of a fingertipand from alternative sites, such as thepalm, the upper arm, and the forearm.The sterile, single-use lancets are tobe used with the reusable lancingdevice that is to be cleaned anddisinfectedbetween each use, and then thelancets are to be disposed of.This system is for use only on asingle patient in a home setting.This system is not suitable for use byhealthcare professionals withmultiple patients in a healthcaresetting
	Proposed Device K222034	Predicate Device K214022
Device description	The Lancing Device uses compatibleDisposable Lancet to obtain a drop ofblood from a fingertip or alternativesites	The Accu-Chek Softclix Lancing Deviceuses compatible Accu-Chek SoftclixLancets to obtain a drop of blood from afingertip or alternative sites using theAccu-Chek Softclix Alternative SiteTesting (AST) Cap.
Number ofUses	Base (lancing device): multiple useLancet: single use	Base (lancing device): multiple useLancet: single use
LancetSterility	Yes, gamma irradiation	Yes, gamma irradiation
Needle	0.80mm (21G); beveled cut with 3facets0.60mm (23G); beveled cut with 3facets0.50mm (25G); beveled cut with 3facets0.45mm (26G); beveled cut with 3facets0.40mm (27G); beveled cut with 3facets0.37mm (28G); beveled cut with 3facets0.32mm (30G); beveled cut with 3facets0.26mm (31G); beveled cut with 3facets0.23mm (32G); beveled cut with 3facets0.20mm (33G); beveled cut with 3facets	0.4mm (28G); beveled cut with 3 facets
Depthadjustment	RC-AD-III: 6 levels by adjustingcap(0.3mm-1.5mm)RC-AD-IIIT: 6 levels by adjustingcap(0.3mm-1.5mm)RC-AD-VIU: 6 levels by adjustingcap(0.7mm-2.2mm)RC-AD-VIX: 6 levels by adjustingcap(0.3mm-1.5mm)	11 levels by twisting cap(0.8mm-2.3mm)
	RC-AD-VIXT: 6 levels by adjustingcap(0.3mm-1.5mm)RC-AD-VII: 6 levels by adjustingcap(0.7mm-2.2mm)RC-AD-XI: 11 levels by adjustingcap(0.3mm-1.6mm)RC-AD-XII: 9 levels by adjustingcap(0.4mm-1.8mm)RC-AD-XIV: 9 levels by adjustingcap(0.4mm-1.8mm)Sinodraw: 10 levels by adjustingcap(0.4mm-1.6mm)RC-LD-16: 10 levels by adjustingcap(0.1mm-1.5mm)RC-LD-17: 5 levels by adjustingcap(0.1mm-1.5mm)RC-LD-18: 10 levels by adjustingcap(0.1mm-1.5mm)RC-LD-19: 10 levels by adjustingcap(0.1mm-1.5mm)
Mechanicalloading	Spring-driven	Spring-driven
Load andfiring	● Load by pressing priming buttonwhen lancet is inserted,● Fire by pressing the release button.	● Load by pressing priming button whenlancet is inserted,● Fire by pressing the release button.
Anatomicalsites	● Fingertip● Ball of the hand (palm)● Upper arm● Lower arm (forearm)	● Fingertip● Ball of the hand (palm)● Upper arm● Lower arm (forearm)
Sharpsinjuryprevention	Lancets are covered by a sterile barriercap until twisted off before use. Untilfiring, the lancet is contained within thelancing device housing. Immediatelyafter firing, the lancet is automaticallyretracted back into housing. An ejectorsleeve can then be pulled forward forcontactless disposal of the lancet	Lancets are covered by a sterile barrier capuntil twisted off before use. Until firing,the lancet is contained within the lancingdevice housing. Immediately after firing,the lancet is automatically retracted backinto housing. An ejector sleeve can then bepulled forward for contactless disposal ofthe lancet

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

The RightLance Blood Lancing System and predicate device share the same e technological characteristics including their design, mechanical mechanism, principle of operation, energy source Page 2 of 5

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and usage, features, form, fit, and function.

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9. Non-Clinical Testing Summary [21 CFR 807.92(b)]

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

The test results demonstrated that the proposed device complies with its design specification. The bench testing performed shown as following:

ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-4:2017, Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood

ISO 11137-2, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose - Method VD max.

USP34<151>, Rabbit Pyrogen Test

Performance Testing - Basic Size

Performance Testing - Puncture Depth

Performance Testing - Lancing Device Cap Removal

Performance Testing - Lancing Device Firing Force

Performance Testing - Drop

Performance Testing - Drawing Force

Performance Testing - The tightness of lancing device

Shelf Life (aging) Validation

1. Clinical Testing [21 CFR 807.92(b)] Clinical Testing is not applicable;
1. Conclusions [21 CFR 807.92(b)]

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed 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.