MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.

Device Description

MedtFine Blood Lancet is a small medical device used for capillary blood sampling. It is similar to a small scalpel with a double-edged needle used to make punctures, such as a fingerstick, to obtain small blood specimens. The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color. The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called "MedtFine Blood Lancet." It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown 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 acceptance criteria are primarily derived from various ISO standards. The reported device performance is presented in comparison to these standards and the predicate devices.

Acceptance Criteria Standard/Test	Device Performance (MedtFine Blood Lancet)
Physical Performance Tests
ISO 9626:2016 (Stainless Steel Needle Tubing) - Visual inspection	Smooth, clean, free from contamination, no color fading, sharp edge, free from burrs, hooks, blunt, straight, no slanting. Meets visual checking requirements of ISO 9626, ISO 7864, and internal requirements.
ISO 9626:2016 (Needle outer dimension)	33G: 0.20 mm, 30G: 0.32 mm, 28G: 0.36 mm. Meets needle outer dimension requirements of ISO 9626.
ISO 7864-2016 (Sterile Hypodermic Needles) - Chemical Characters (Acidity/Alkalinity)	33G: 0.31, 30G: 0.29, 28G: 0.34. Meets requirements of ISO 7864.
ISO 7864-2016 (Needle bond force)	33G: 12.15 N, 30G: 15.87 N, 28G: 15.39 N. Meets requirements of ISO 7864.
ISO 9626:2016 (Corrosion resistance)	No corrosion in NaCl solution for 7 hours. Meets corrosion resistance requirements of ISO 9626.
ISO 7864-2016 (Penetrate force/puncture force)	33G: 0.388 N, 30G: 0.543 N, 28G: 0.545 N. Meets requirements of ISO 7864. (Noted as lower than predicate, leading to less pain).
ISO 11608-1:2014 & ISO 11608-2 (Needle-based injection systems)	Tested in conformance. (Specific performance metrics not detailed, but referenced for compliance).
Lancing device compatibility	As a universal device, compatible with various commercially marketed lancing devices verified in usability testing.
Sterility Tests
ISO 11737-1:2018 (Determination of microorganisms on products)	Tested in conformance. (Specific results not detailed, but referenced for compliance).
ISO 11737-2:2019 (Tests of sterility)	Tested in conformance. (Specific results not detailed, but referenced for compliance).
ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2006 (Radiation sterilization)	Sterilized by gamma radiation, SAL = 10^-6. Tested in conformance.
ISO 11607-1:2019, ISO 11607-2:2019 (Packaging for terminally sterilized medical devices)	Tested in conformance. (Specific results not detailed, but referenced for compliance).
ASTM F1980 (Accelerated Aging of Sterile Barrier Systems)	Tested in conformance. (Specific results not detailed, but referenced for compliance).
ASTM F1929:2015 (Detecting Seal Leaks in Porous Medical Packaging)	Tested in conformance. (Specific results not detailed, but referenced for compliance).
ASTM D4169-16 (Performance Testing of Shipping Containers)	Tested in conformance. (Specific results not detailed, but referenced for compliance).
USP <71> (Sterility Test)	Tested in conformance.
Biocompatibility Tests
ISO 10993-1:2018 (Biological evaluation of medical devices)	No hemolysis, no cytotoxicity, no irritation and no skin sensitization, no acute systemic toxicity, no pyrogens. Tested in conformance.
ISO 10993-4:2017 (Interactions with blood)	No hemolysis. Tested in conformance.
ISO 10993-5:2009 (In vitro cytotoxicity)	No cytotoxicity. Tested in conformance.
ISO 10993-10:2010 (Irritation and Skin Sensitization)	No irritation and no skin sensitization. Tested in conformance.
ISO 10993-11:2017 (Systemic toxicity)	No acute systemic toxicity. Tested in conformance.
USP <85> (Bacterial Endotoxins Test)	No pyrogens. Tested in conformance.
USP <788> (Particulate matter in injection)	Tested in conformance. (Specific results not detailed, but referenced for compliance).
USP <161> (Bacterial endotoxin and pyrogen tests)	Tested in conformance.
Population Evaluation	Results support the intended wider population (child older than 2 years, adolescent, adult).

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

The document does not explicitly state the specific sample sizes used for each individual non-clinical test conducted for the MedtFine Blood Lancet. It generally states that "all proposed device types' performance testing is run" for the different gauge sizes.

The data provenance is from non-clinical testing conducted by the manufacturer, Shanghai Carelife International Trading Co. Ltd. (China). The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate compliance.

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

This detailed information is not provided in the document. The non-clinical testing appears to be primarily laboratory-based measurements and evaluations against established ISO standards and internal requirements, rather than relying on expert consensus for "ground truth" in the way a clinical study might for image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this 510(k) submission. The non-clinical tests described are objective measurements against predefined standards, which do not typically involve human adjudication or consensus methods like those used in clinical studies for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing is available for this device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as this describes a physical medical device (blood lancet), not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by:

International Standards: Primarily ISO standards (e.g., ISO 9626, ISO 7864, ISO 10993, ISO 11137, ISO 11607, ISO 11737).
National Standards/Pharmacopoeias: ASTM standards (e.g., ASTM F1980, ASTM F1929, ASTM D4169) and USP (United States Pharmacopeia) tests (e.g., USP <71>, USP <85>, USP <788>, USP <161>).
Internal Requirements: For visual checking, additional internal requirements "derived from the visual checking sections of ISO 9626 and ISO 78664" were used.

These standards define the acceptable range or qualitative outcome for each test (e.g., "no corrosion," "meets requirements," specific numerical limits).

8. The Sample Size for the Training Set

This question is not applicable. This is a submission for a physical medical device. The concepts of "training set" and "validation set" are relevant to machine learning/AI models, which are not involved here. The manufacturer performed a series of tests on the device itself to demonstrate its inherent properties and safety.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8.

Summary

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September 21, 2022

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

Shanghai Carelife International Trading Co. Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, Shanghai 201114 China

Re: K221383

Trade/Device Name: MedtFine Blood Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: August 18, 2022 Received: August 23, 2022

Dear Evan Hu:

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

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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 (OS) 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,

Colin Chen Acting 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) K221383

Device Name MedtFine Blood Lancet

Indications for Use (Describe)

MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K221383 510(K) SUMMARY

1. Preparation date: 9/16/2022

2. Submitter

Manufacturer: Shanghai Carelife International Trading Co. Ltd. Address: 1707 Yinqiao Bldg.,58 Jinxin Rd.201206 Shanghai, PEOPLE'S REPUBLIC OF CHINA person: Xiaoying, Quality Contact zxy@shanghaicarelife.com Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net

3. Device

Trading name: MedtFine Blood Lancet Common name: Sterile Blood Lancet Classification Name: Single Use Only Blood Lancet Without an Integral Sharps Injury Prevention Feature Classification: Class II Product code: QRK

4. Predicate device

Primary predicate device: Promisemed Blood Lancet - K192666 Reference device: Accu-Chek Softclix Blood Lancing System - K214022

5. Device description

The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color.

The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.

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Table 1. Device models

Gauge Size	Designated metric size	Color
28G	0.36	Green-Blue
30G	0.30	Grey-Blue
33G	0.20	Transparent

1. Indications for use/Intended use
  MedtFine Blood Lancet is intended for use together with a lancing device for puncture of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
1. Comparison of technological characters between proposed and predicate devices

Characters	Proposed device(K221383- MedtFine Blood Lancet)	Primary predicatedevice(K192666-PromisemedBlood Lancet)	Reference device(K214022- Accu-ChekSoftclix Blood LancingSystem)	Remark	Type of use	over-the-counter	over-the-counter	over-the-counter	Same
Product code	QRK	FMK	QRL, QRK	#1	Configurationand materials	Needle sheath: PEHub: PPNeedle: SUS 304	Cap: PEBody: PENeedle: SUS	CapBodyNeedle	#6
Regulation No.	21 CFR 878.4850	21 CFR 878.4800	21 CFR 878.4850	#2	Needle Gauge	28G, 30G, 33G	21G, 26G, 28G, 30G	28G	#7
Classification	Class II	Class I	Class II	#3	Sterility	Sterilized by gammaradiationSAL = $10^{-6}$	Sterilized by gammaradiationSAL = $10^{-6}$	Sterilized by gammaradiationSAL = $10^{-6}$	Same
Intended use	MedtFine Blood Lancet isintended for use togetherwith a lancing device forpuncture of skin to obtaina drop of capillary bloodfrom fingertip or fromalternative sites.	It is intended forcapillary bloodsampling.	The Accu-Chek SoftclixBlood Lancing System isintended for the hygieniccollection of capillaryblood for testingpurposes from the side ofa fingertip and fromalternative sites, such asthe palm, the upper arm,and the forearm.	#4	Single-use	Single use on one patient,no more than one use	Single use on onepatient, no more thanone use	Single use on one patient,no more than one use	Same
Indications foruse			Accu-Chek SoftclixLancets:The sterile, single-uselancets are to be usedwith the reusable lancingdevice that is to becleaned and disinfectedbetween each use, andthen the lancets are to bedisposed of.	#5	Sharp injuryprotection	No sharp injury protectionfunction	No sharp injuryprotection function	Lancets are covered by asterile barrier cap untiltwisted off before use.Until firing, the lancet iscontained within thelancing device housing.Immediately after firing,the lancet isautomatically retractedback into housing. Anejector sleeve can thenbe pulled forward forcontactless disposal ofthe lancet	#8
Intendedpopulation	Child older than 2 yearsAdolescentAdult	Adult	Not known	#9
Visualinspection	(a) Smooth, clean,free from contamination(b) No color fading(c) Sharp edge, freefrom burrs, hook, andblunt.(d) Straight, noslantingMeet visual checkingrequirements of ISO 9626,ISO 7864, and internalrequirements	Meet visual checkingrequirements of ISO9626 and ISO 7864	Not known	#10
Needledimension-	33G: 3.47 mm30G: 3.52 mm	21G: 3mm26G: 3mm28G: 3mm	Not known	#11

Table 2. Characters comparison

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exposed needlelength	28G: 3.25 mm	30G: 3mm
Needledimension-OD	33G: 0.20 mm30G: 0.32 mm28G: 0.36 mmMeet needle outerdimension requirementsof ISO 9626	Meet needle outerdimensionrequirements of ISO9626	Not known	Same
ChemicalCharacters	Limits for acidity oralkalinity33G: 0.3130G: 0.2928G: 0.34Meet requirements of ISO7864	Meet requirements ofISO 7864	Not known	Same
Needle bondforce	33G: 12.15 N30G: 15.87 N28G: 15.39 NMeet requirements of ISO7864	Meet requirements ofISO 7864	Not known	Same
Resistance tocorrosion	No corrosion in NaClsolution for 7 hoursMeet corrosion resistancerequirements of ISO 9626	Meet corrosionresistancerequirements of ISO9626	Not known	Same
Lancing devicecompatibility	As a universal device, it iscompatible with variouscommercially marketedlancing devices verified inusability testing.	It claims to becompatible withlancing devices.	It claims to be compatiblewith the Accu-ChekSoftclix Blood LancingSystem	Same
Penetrateforce/punctureforce	33G: 0.388 N30G: 0.543 N28G: 0.545 NMeet requirements of ISO7864	30G: 0.656 N28G: 0.751 NMeet requirements ofISO 7864	Not Known	#12
Biocompatibility	No hemolysisNo cytotoxicityNo irritation and no skinsensitizationNo acute systemic toxicityNo pyrogens	No cytotoxicityNo irritation and noskin sensitization	Not Known	#13

#1, #2 and #3:

Single-use only blood lancet without an integral sharps injury prevention feature was once a Class I device exempted from 510(k) registration. However, the regulation was last amended, and the device is reclassified to Class II, effective on 12/03/2021. The device is given the

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product code QRK under regulation 21 CFR part878.4850. So, the differences are administrative differences, which cannot affect the device's safety and effectiveness.

The reference device is a combination device that consists of a lancet and a lancing device. In this case, only the lancet is used to be compared. So, there is no difference in product code, requlation number, and classification.

In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.

#4 and #5

There is no difference of intended use and indication for use between the proposed device and the primary predicate device. They are both intended to equip with a lancing device and then puncture the skin to obtain capillary blood.

However, the reference device is a combination system, and only the lancet is compared. For this view, there is also no difference.

In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.

#6:

The configurations are different. The proposed device has a removable needle sheath (or called a cap). The user could directly remove the needle sheath and load it to a lancing device. However, the primary and reference devices have an integrity structure, which means the cap, body, and needle are over-molded together from an injection machine. The user should twist the cap to expose the needle and the load to a lancing device. The differences are rising from the different manufacturing processes. So, the process validation and device performance testing are run to verify the device's effectiveness.

The materials used are different. Due to the integrity structure, the primary predicate and reference devices only use PE to make the cap and body. However, the proposed device uses PE to make the sheath (cap) and PP to make the hub (cap) due to two separated manufacturing processes and late assembly. So, biocompatibility testing is run to verify the device's safety.

The proposed device uses SUS 304 to make a needle; however, the predicate device does not reveal the exact stainless-steel grade. The difference between different SUS grades is their performance. So, performance testing is conducted to verify the device's effectiveness.

In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.

#7:

The proposed device has three types of gauge, more than the primary and reference device. The primary predicate device has four types, according to their official website, and the reference device only has one type. So, all proposed device types' performance testing is run to verify the device's effectiveness.

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In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.

#8:

Unlike the reference device, the proposed and predicate devices do not claim sharp injury protection features, meaning they don't contain the sharp injury prevention structure. It cannot affect safety and effectiveness.

#9: The intended population of the proposed device is wider than the primary predicate device. So, the manufacturer conducts population evaluation testing, and the results support the intended population, demonstrating substantial equivalence.

#10: The proposed device uses an additional internal requirement to conduct the device's visual checking to confirm no deficiencies in visual appearance. The internal requirements are derived from the visual checking sections of ISO 9626 and ISO 78664. The visual checking results meet all requirements, so there is no significant difference compared with the predicate device, demonstrating substantial equivalence.

#11: The needle length of the proposed device is slightly longer than the predicate device. Testings of performance and usability show no impact of a slightly longer needle on device properties because the exposed needle length is tuned by the lancing device, not the lancet itself, demonstrating the substantial equivalence.

#12: The proposed device's penetrate force (puncture force) is lower than the primary predicate device, meaning that the proposed device lancet is easier to puncture into the patient's skin, resulting in a less painful feeling for patients. Results show that the proposed device is comparable to the predicate device in the penetrate force, demonstrating substantial equivalence.

#13: The proposed device conducts six items of biocompatibility testing, but the predicate device only conducts three items. Results show that the proposed device is as safe as the proposed device, demonstrating substantial equivalence.

1. Non-clinical testing results
  The non-clinical tests of this proposed device are tested in conformance with the following standards.
(1) Physical performance testing
(a) ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
(b) ISO 7864-2016 Sterile hypodermic needles for single use requirements and test methods

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(c) ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods - Part 1: Needle-based injection systems
(d) ISO 11608-2 Needle-based injection system s for medical use — Requirements and test methods — Part 2: Double-ended pen needles
(2) Sterility
(a) ISO 11737-1:2018, Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products.
(b) ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
(c) ISO 11137-1:2006, Radiation sterilization of medical devices part 1: Requirements for the development, validation and routine control of the sterilization process of medical devices.
(d) ISO 11137-2:2013, Radiation sterilization of medical devices part 2: Determination of sterilization dose.
(e) ISO11137-3 : 2006 Radiation sterilization of medical devices part 3: Dosage guidelines.
(f) ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
(q) ISO 11607-2:2019, Packaqing for terminally sterilized medical devices--Part 2: Validation requirements for forming, sealing and assembly processes
(h) ASTM F1980: Standard for Accelerated Aging of Sterile Barrier Systems and Medical Devices
(i) ASTM F1929: 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
(j) ASTM D4169-16 Standard Practice For Performance Testing Of Shipping Containers And Systems
(k) USP <71> Sterility Test
(3) Biocompatibility testing
(a) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
(b) ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
(c) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
(d) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
(e) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
(f) USP <85> Bacterial Endotoxins Test
(q) USP <788>Particulate matter in injection

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(h) USP <161>Medical Devices-Bacterial endotoxin and pyrogen tests

9. Clinical testing

No clinical testing is available for this device.

10. Conclusion

The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.

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.