Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, nonmechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.

VeriFine Safety lancet and VeriFine Mini-Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.

Both single-use Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet offers different gauge (needle diameter) options, to allow to choose the lancet which meets blood volume needs.

AI/ML Overview

The provided text is a 510(k) Summary for medical devices (blood lancets) and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It outlines a comparison of technical characteristics and performance testing that confirms the devices are comparable, not a study designed to establish quantitative performance against defined acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot, based on the input:

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

Acceptance Criteria (Implied by Comparison to Predicate/Standards)	Reported Device Performance (Summary of Bench Testing)
Same intended use as predicate	Same intended use as predicate
Same technological characteristics as predicate	Same technological characteristics as predicate
Compatible with lancing device (Promisemed Blood Lancet only)	Lancing device compatibility tested
Needle dimensions within specifications	Needle dimensions tested
Chemical properties within specifications	Chemical properties tested
Strong bond between lancet body and needle	Bond between lancet body and needle tested
Resistance to corrosion	Resistance to corrosion of needle tested
Locking function (VeriFine Safety/Mini-Safety Lancet only)	Locking function tested
Spring elasticity (VeriFine Safety/Mini-Safety Lancet only)	Spring elasticity tested
Percussive function (VeriFine Safety/Mini-Safety Lancet only)	Percussive function tested
Penetrate force (VeriFine Safety/Mini-Safety Lancet only)	Penetrate force tested
Biocompatible (ISO 10993 standards)	Biocompatibility (ISO 10993-1, 5, 10) established
Sterile (ISO 11137-1, ISO 11737-1, ISO 11737-2 standards)	Sterility (ISO 11137-1, ISO 11737-1, 11737-2) tested
5-year shelf-life (ASTM F1980-07(2011))	Shelf-life of 5 years validated
No new questions of safety/effectiveness compared to predicate	Bench testing verifies substantial equivalence

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

Sample Size for Test Set: Not specified. The document states "The bench testing performed verifies that the performance of the subject devices are substantially equivalent..." but does not provide specific sample sizes for these tests.
Data Provenance: Not specified.

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)

Not applicable. This is a medical device submission focused on physical and chemical performance, not diagnostic accuracy requiring expert interpretation or ground truth.

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

Not applicable. This is not a study requiring adjudication of interpretations.

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

Not applicable. This document pertains to blood lancets, which are physical medical devices, not AI-powered diagnostic tools.

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

Not applicable. This document pertains to blood lancets, not algorithms.

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

Not applicable in the context of diagnostic performance. For device characteristics, the "ground truth" would be established by physical/chemical measurement standards (e.g., ISO, ASTM standards for dimensions, sterility, biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

Not applicable. This is not an AI/algorithm-based device.

Summary

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

June 9, 2022

Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 1 7th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong Hong Kong

Re: K221368

Trade/Device Name: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK, QRK Dated: April 29, 2022 Received: May 12, 2022

Dear Wei Hsu:

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/cfpm/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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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 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 (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,

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) K221368

Device Name Promisemed Blood Lancet VeriFine Safety Lancet VeriFine Mini-Safety Lancet

Indications for Use (Describe) It 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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510(k) Summary

Date Prepared 1

May 9, 2022

Submitter's Information 2

Submission Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.

Contact: Zearou Yang

Telephone No.: +86 571 88772985

Fax No.:+86 571 88772985

Email: zearou.yang@promisemed.ca

ന Trade Name, Common Name, Classification

Trade/Product Name:

Promisemed Blood Lancet

VeriFine Safety Lancet

VeriFine Mini-Safety Lancet

Common Name: Blood Lancet

Classification name:

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Regulation Number: 21 CFR 878.4850

Device Class: Class II

Product Code: FMK, QRK

ব ldentification of Predicate Device(s)

K192666: Promisemed Blood Lancet

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VeriFine Safety Lancet

VeriFine Mini-Safety Lancet

5 Description of the Device

Intended Use 6

It is intended for capillary blood sampling.

7 Similarities and Differences of the Proposed Devices to the Predicate Devices

Promisemed Blood Lancet and VeriFine Safety Lancet/ VeriFine Mini-Safety Lancet are substantially equivalent to the predicate devices, K192666, in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same. The differences between the subject device and predicate device do not affect the intended use or raise new questions of safety and effectiveness.

A detailed comparison to the predicate is provided in Table 1 and Table 2.

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	Subject Device	Predicate Device(K192666)
Manufacturer	Promisemed HangzhouMeditech Co., Ltd	Promisemed HangzhouMeditech Co., Ltd	SignificantDifferences
Trade Name	Promisemed® BloodLancet	Promisemed® BloodLancet
Device Class	Class II	Class I (Exempt)	Different1
Product Code	QRK	FMK	Different1
Regulation number	878.8450	878.4800	Different1
Regulation Name	Single Use Only BloodLancet Without AnIntegral Sharps InjuryPrevention Feature	Lancet, Blood	Different1
IntendedUse/Indications forUse	It is intended forcapillary blood sampling.	It is intended for capillaryblood sampling.	Same
Biocompatibility	Biocompatibilityestablished	Biocompatibilityestablished	Same
Structure	Stainless steel needleencapsulated with aplastic body and cap,the cap is twisted off toexpose the needle foruse.	Stainless steel needleencapsulated with aplastic body and cap, thecap is twisted off toexpose the needle foruse.	Same
Material	Needle: Stainless steelBody and Cap:polyethylene	Needle: Stainless steelBody and Cap:polyethylene	Same
Single use	Yes	Yes	Same
Sterilization	Gamma	Gamma	Same
Labeling	Labeling requirementlisted in blood lancetreclassification finalorder (86 FR 66180) suchas hand washinginstruction and warningstatement aresupplemented.	No include hand washinginstruction and warningstatement listed in bloodlancet reclassificationfinal order (86 FR 66180).	DifferentThe differencedoes not affecttheeffectivenessand safety ofthe device.

Table 1: Device Comparison Chart for Promisemed Blood Lancet

Note 1: In response to blood lancet reclassification.

Table 2: Device Comparison Chart for VeriFine Safety Lancet/ VeriFine Mini-Safety Lancet

	Subject Device	Predicate Device(K192666)	SignificantDifferences
Manufacturer	Promisemed HangzhouMeditech Co., Ltd	Promisemed HangzhouMeditech Co., Ltd
Trade Name	VeriFine Safety LancetVeriFine Mini-SafetyLancet	VeriFine Safety LancetVeriFine Mini-SafetyLancet
Device Class	Class II	Class I (Exempt)	Different¹
Product Code	FMK	FMK	Same
Regulation number	878.8450	878.4800	Different¹
Regulation Name	Single Use Only BloodLancet With An IntegralSharps Injury PreventionFeature	Lancet, Blood	Different¹
IntendedUse/Indications forUse	It is intended forcapillary blood sampling.	It is intended forcapillary blood sampling.	Same
Direction for use	1. Rotate the twistingcap less than half around2. Pull out the twistingcap3. Place the device onthe puncture site andpush to start4. Discard lancet into asharp container5. Press lightly on thefinger toward thepuncture site to obtainadequate blood sample	1. Rotate the twistingcap less than half around2. Pull out the twistingcap3. Place the device onthe puncture site andpush to start4. Discard lancet into asharp container5. Press lightly on thefinger toward thepuncture site to obtainadequate blood sample	Same
Gauge	18G,21G,23G,25G,26G,28G,30G	18G,21G,23G,25G,26G,28G,30G	Same
Needle Length (mm)	1.2, 1.4, 1.6, 1.8, 2.0,2.2, 2.4, 2.6, 2.8	1.2, 1.4, 1.6, 1.8, 2.0,2.2, 2.4, 2.6, 2.8	Same
Biocompatibility	Biocompatibilityestablished	Biocompatibilityestablished	Same
Structure/Design	VeriFine Safety Lancetand VeriFine Mini-SafetyLancet are spring-loadedlancet.VeriFine Safety lancet/VeriFine Mini-SafetyLancet are activatedwhen you press thedevice against yourfinger.Once activated theneedle retracts into thebody of the device whichreduces the risk ofinjury as the result if anexposed needle. The	VeriFine Safety Lancetand VeriFine Mini-SafetyLancet are spring-loadedlancet.VeriFine Safety lancet/VeriFine Mini-SafetyLancet are activatedwhen you press thedevice against yourfinger.Once activated theneedle retracts into thebody of the device whichreduces the risk of injuryas the result if anexposed needle. The	Same
	needle into the skin andthe second withdrawsthe needle back into theshield.	needle into the skin andthe second withdrawsthe needle back into theshield.
Material	Needle: Stainless steel	Needle: Stainless steel	Same
	Spring: Galvanized steelwire	Spring: Galvanized steelwire
	Shield, hub and Safety:ABS	Shield, hub and Safety:ABS
	Trigger POM	Trigger POM
	Lancet body, cap: PE	Lancet body, cap: PE
Single use	Yes	Yes	Same
Sterilization	Gamma	Gamma	Same
Labeling	Labeling requirementlisted in blood lancet	No include hand washinginstruction and warning	Different
	reclassification finalorder (86 FR 66180) suchas hand washing	statement listed in bloodlancet reclassificationfinal order (86 FR	The differencedoes not affectthe
	instruction and warningstatement aresupplemented.	66180).	effectivenessand safety ofthe device.

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Note 1: In response to blood lancet reclassification.

8 Performance Testing Summary

The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

· Visual Inspection
Needle Dimensions
Chemical properties
Bond between lancet body and needle
Resistance to corrosion of the needle
· Lancing device compatibility test (Promisemed Blood Lancet only)
Locking function
Spring elasticity*
Percussive function*
Penetrate force*

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(* VeriFine Safety Lancet and VeriFine Mini-Safety Lancet only)

Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
Sterility and Shelf-Life
- -ISO 11137-1:2006, Sterilization of Health Care Products Radiation -Part 1: Requirements for Development, Validation and Routine control of a sterilization process for medical devices
- -ISO 11737-1:2006, Sterilization of Health Care Products -Microbiological Methods - Part 1: Determination of Population of Microorganisms on products
- -ISO 11737-2:2009, Sterilization of Medical Devices Microbiological Methods - Part 2: Tests of Sterility Performed in the Definition, validation and maintenance of a sterilization process
- Shelf life of 5 years is validated using ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Conclusion の

Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet has the same intended use and technological characteristics as the predicate. The labeling changes made to subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed 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.