The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites. The shelf-life of the product is 5 years.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Sterile Lancets for Single Use). It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" with numerical targets in a formal table corresponding to performance. Instead, it refers to "Performance testing is conducted according to Inspection Specification" and states that "the test sample has undergone accelerated aging for 5.5 years" and "passed all tests." The performance attributes tested are listed.

Here's an interpretation of the performance attributes and the implied acceptance criteria from the text:

Acceptance Criterion (Implied)	Reported Device Performance
Appearance: Acceptable visual inspection	The device passed tests after accelerated aging. (Implied: Appearance remained acceptable.)
Dimension: Within specified tolerances	The device passed tests after accelerated aging. (Implied: Dimensions remained within specified tolerances.)
Firmness of needle and main body: Adequate mechanical integrity	The device passed tests after accelerated aging. (Implied: Firmness remained adequate.)
Puncture Performance: Satisfactory for capillary blood sampling	The device passed tests after accelerated aging. (Implied: Puncture performance remained satisfactory.)
Matching: Compatibility with lancing devices	The device passed tests after accelerated aging. (Implied: Compatibility remained.)
Launch Performance: Adequate for intended use	The device passed tests after accelerated aging. (Implied: Launch performance remained adequate.)
Bacterial endotoxin: Below specified limits	The device passed tests after accelerated aging. (Implied: Bacterial endotoxin levels were below limits.)
Sterilization (SAL=10-6): Achieved	Sterilized by Radiation SAL=10-6. The device passed tests after accelerated aging. (Implied: Sterility was maintained.)
Biocompatibility: Conforming to ISO 10993 standards	Conforms to the requirements of ISO 10993 series standards, specifically: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity.
Shelf-life: 5 years	After five years of accelerated aging, the product has passed all tests, so it can be guaranteed that the product can be used normally within five years.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the numerical sample size used for performance testing. It generally refers to "the test sample."
Data Provenance: The document indicates that the testing was conducted by Ningbo Caremed Medical Products Co., Ltd., based in China. The data would be retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the device is a medical lancet and the testing involves objective physical, chemical, and biological performance tests, not subjective interpretation by experts to establish a "ground truth" like in imaging or diagnostic AI. The "ground truth" for these tests would be the established scientific and engineering standards and methods.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods are typically used when subjective expert opinion is involved in ground truth establishment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those involving human interpretation (e.g., radiologists interpreting images). This device is a sterile lancet for single-use capillary blood sampling, a physical instrument, and does not involve human readers interpreting output that would be improved by AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This information is not applicable. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing of the lancet is based on:

Established scientific and engineering standards: For dimensions, firmness, puncture performance, matching, launch performance.
Specific ISO standards: For biocompatibility (ISO 10993 series) and sterilization (SAL of 10-6).
Bacterial endotoxin limits: Established regulatory or compendial limits.
Accelerated aging protocols: To simulate real-time shelf-life.

8. Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML algorithm 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 this device.

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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

October 28, 2024

Ningbo Caremed Medical Products Co., Ltd. % Kyra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai, China

Re: K242622

Trade/Device Name: Sterile Lancets for Single Use Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL Dated: August 27, 2024 Received: September 3, 2024

Dear Kyra Kang:

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 (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/cdrb/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.

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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).

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 QS regulation requires device manufacturers to review and approve changes to device design and production (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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 Long H. Chen
Long H. Chen -S-s
Date: 2024.10.28 15:36:30 -04'00'

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) K242622

Device Name Sterile Lancets for Single Use

Indications for Use (Describe) Lancet is intended 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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K242622

510(k) Summary

l. Submitter

Ningbo Caremed Medical Products Co., Ltd. No.79 Jiutang Road, Hangzhou Bay New Zone, Ningbo, China

Preparation date: October 24, 2024.

Contact person: Ms. Cen Wei Position: General Manager Tel.: +86-574-58582551 E-mail: Wei-cen@caremed-nb.com

Submission Correspondent

Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com

II. Proposed Device

Device Trade Name:	Sterile Lancets for Single Use
Common name:	Blood Lancets
Regulation Number:	21 CFR 878.4850
Regulatory Class:	Class II
Product code:	QRK
Review Panel:	General & Plastic Surgery

III. Predicate Devices

510(k) Number:	K220475
Trade name:	Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HHXVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HHXXIII-T, HH-XXIV-T)
Common name:	Blood Lancets
Classification:	Class II
Product Code:	QRL,QRK
Manufacturer	Tianjin Huahong Technology Co., Ltd.

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IV. Device description

The Sterile Lancets for Single Use is intended for capillary blood sampling.

The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites.

The shelf-life of the product is 5 years.

V. Indication for use

The Sterile Lancets for Single Use is intended for capillary blood sampling.

VI. Comparison of technological characteristics with the predicate devices

Characteristics	Proposed device	Predicate device(K220475)	Discussion
Manufacturer	Ningbo Caremed MedicalProducts Co., Ltd.	Tianjin Huahong TechnologyCo., Ltd.	/
Productname	Sterile Lancets for Single Use	Lancet	/
Productcode	QRK	QRL,QRK	Same
RegulationNo.	21 CFR § 878.4850	21 CFR § 878.4850	Same
Class	II	II	Same
Prescription/over-the-counter use	Over-The-Counter Use	Over-The-Counter Use	Same
Indicationforuse	The Sterile Lancets for SingleUse is intended for capillaryblood sampling.	It is intended for capillaryblood sampling	Same
Applicable	Healthcare professional or	Healthcare professional or	Same
user	lay person	lay person
Reusedurability	Single use	Single use	Same
SterilizationmethodandSAL	Sterilized by RadiationSAL=10-6	Sterilized by RadiationSAL=10-6	Same
Manufacturingaspects	For the Lancet, stainlesssteel needle is fed into aninjection molding machine toover-mold plastic material(polyethylene (PE) andColor master batch) forminga body and cap, encapsulatingthe stainlesssteel needles.	For the Lancet, stainlesssteel needle is fed into aninjection molding machine toover-mold plastic material(polyethylene (PE) andEthylene Vinyl Acetate (EVA)and calcium powder) forminga body and cap,encapsulating the stainlesssteel needles.	Same
DesignandFunctionalityaspects	The Lancet comprises astainless steel needleencapsulated with a plasticbody and cap, the cap istwisted off to expose theneedle for use.	The Lancet comprises astainless steel needleencapsulated with a plasticbody and cap, the cap istwisted off to expose theneedle for use.	Same
Needlelengthrange	$3.2\pm0.3$ mm	$3.2\pm0.3$ mm (Model: IA、IB、IC、ID、IE、IK、IL、IM、IIA、IIB、III、VI)$2.1\pm0.3$ mm (Model : V)	Same
Gaugerange	18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G,28G, 29G, 30G, 31G, 32G,33G, 34G	$1.50\pm0.02$ mm (16G)$1.20\pm0.01$ mm (18G)$1.07\pm0.01$ mm (19G)$0.91\pm0.01$ mm (20G)	Similar 1
		0.72±0.01mm (22G)0.64±0.01mm (23G)0.57±0.01mm (24G)0.51±0.01mm (25G)0.46±0.01mm (26G)0.41±0.01mm (27G)0.36±0.01mm (28G)0.34±0.01mm (29G)0.31±0.01mm (30G)0.26±0.01mm (31G)0.24±0.01mm (32G)0.21±0.01mm (33G)0.19±0.01mm (34G)
Shelf-life	5 years	5 years	Same
Materialsofparts incontactwithhumanbody	Needle: Stainless steelNeedle holder (Main body &Protective cap): PE&Colormaster batch	The Lancet has a needle thatis made of stainless steeland silicone oil. The bodyand cap are made ofpolyethylene (PE) andEthylene Vinyl Acetate (EVA)and calcium powder.	Similar 2
Biocompatibility	Conforms to therequirements of ISO 10993series standards.	Conforms to therequirements of ISO 10993series standards.	Same
Label/Labeling	Complied with 21 CFR part801	Complied with 21 CFR part801	Same

Table 5.2-1 General Comparison of Sterile Lancets for Single Use

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Similar 1- Gauge range

The gauge range of proposed device can be covered by predicate device, all performance has been tested, this difference will not raise any issues in safety and effectiveness

Similar 2 – Materials of parts in contact with human body

Biocompatibility of the Sterile Lancets for Single Use was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1", this difference will not raise any issues in safety and effectiveness.

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VII. Non-Clinical Testing

Performance Testing

Performance testing is conducted according to Inspection Specification, the test sample has undergone accelerated aging for 5.5 years.

Tested the following projects : Appearance, Dimension, Firmness of needle and main body, Puncture Performance, Matching, Launch Performance, Bacterial endotoxin, Sterilization

Biocompatibility testing

Biocompatibility of the Sterile Lancets for Single Use was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1" The following testing was conducted:

A Cytotoxicity ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Sensitization ISO 10993-10:2021 Biological evaluation of medical devices Part 10: A Tests for skin sensitization
Irritation ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Acute Systemic ISO 10993-23:2021 Biological evaluation of medical devices Part 23: > Tests for irritation
Pyrogenicity ISO 10993-11:2017 Biological evaluation of medical devices Part 11: A Tests for systemic toxicity

Sterility and Shelf -life

After five years of accelerated aging, the product has passed all tests, so it can be guaranteed that the product can be used normally within five years, and the shelf life can reach five years

VIII. Clinical Testing

No clinical study is included in this submission.

IX. Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated

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K242622

device. Accordingly, the proposed device is 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.