(104 days)
The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature.
The Disposable Safety Lancets consists 7 parts, include a lancet cap, body, slide, lancet, tip cover, spring and bottom. The models of the Disposable Safety Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. Used Gamma sterilization, and are products for single use.
The provided document describes a 510(k) premarket notification for "Disposable Safety Lancets" by Suzhou Kyuan Medical Apparatus Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of AI performance. Therefore, many of the requested details related to an AI-driven device's acceptance criteria and study proving its performance (e.g., MRMC studies, training set details, expert ground truth) are not applicable to this submission.
However, the document does contain information about performance testing for the mechanical and biological aspects of the lancet. I will extract the relevant information for the acceptance criteria and performance of the device itself (the lancet), not a hypothetical AI component, as well as indicating where information is not present or not applicable based on the nature of the submission.
Acceptance Criteria and Device Performance (Non-AI Device)
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Testing Item | Acceptance Criteria (Specification) | Reported Device Performance (Result) |
|---|---|---|---|
| 01 | Appearance | Disposable Safety Lancets the surface should be smooth without edge, no dirt and damage, deformation and other poor appearance. | Pass |
| 02 | Launch Length | The length of the needles in the Disposable Safety Lancet is different in different genders and ages. The launch length of the needle is determined according to the length of the purchase, and the general emission length is 1.2mm-2.8mm. | Pass |
| 03 | Sharpness | Penetration force ≤1.00N. | Pass |
| 04 | Feature (Safety) | The tip of the needle can shrink quickly after firing, and the tip of the needle is not exposed. | Pass |
| 05 | Feature (Single Use) | Disposable Safety Lancets Only one launch, not another. | Pass |
| 06 | Initial Bioburden | Initial bioburden of the device shall be less than 100CFU/g | Pass |
| 07 | Sterile | The sterile blood lancet shall be sterile | Pass |
Biocompatibility Testing:
| Item | Test Method | Acceptance Criteria (Implicit: No adverse reaction) | Reported Device Performance (Result) |
|---|---|---|---|
| Cytotoxic test | ISO 10993-5:2009 | No Cytotoxicity | No Cytotoxicity |
| Skin sensitization test | ISO 10993-10:2010 | No Skin sensitization | No Skin sensitization |
| Intracutaneous test | ISO 10993-10:2010 | No irritation | No irritation |
| Acute systemic toxicity test | ISO 10993-11:2017 | No Acute Systemic Toxicity | No Acute Systemic Toxicity |
| Hemolysis test | ISO 10993-4:2017 | No Hemolysis | No Hemolysis |
| Pyrogen Test | USP <151> | Non-pyrogenic | Non-pyrogen |
Sterilization and Shelf Life Testing:
- Irradiation sterilization validation: Per ISO 11173-1 and ISO 11173-3 (Pass, implied by conclusion of substantial equivalence).
- Pyrogen testing: Per USP <151> (Pass, as listed in biocompatibility).
- Simulated shipping: Per ASTM D4169 (Pass, implied by conclusion of substantial equivalence).
- Shelf life: 5 years determined based on stability study which includes ageing test (Pass, implied by conclusion of substantial equivalence).
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each of the performance or biocompatibility tests. It broadly states "The following performance data were provided in support of the substantial equivalence determination." This is common for 510(k) summaries where detailed protocols and raw data are part of the full submission but not typically presented in this summary format.
Data Provenance: Not explicitly stated beyond "non-clinical testing." It's generally assumed these tests were conducted at the manufacturer's or contracted labs (often in China, given the manufacturer's location in Suzhou, P.R.China) as part of their quality system requirements. These are laboratory tests of device properties, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a submission for a physical medical device (lancet), not an AI device that requires expert-established ground truth for image or data interpretation. The "ground truth" for the lancet specifications is based on physical measurements, mechanical properties testing, and standardized biological/chemical tests performed in a lab setting, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human interpretation or subjective assessment that would require an adjudication method for this type of device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on pre-defined engineering specifications, material properties, and standardized biological safety endpoints (e.g., a penetration force <= 1.00N, sterility, no cytotoxicity). These are objective measurements and test results, not subjective expert consensus or clinical outcomes data in a broad sense.
8. The sample size for the training set
This is not applicable. This is not an AI device and does not involve a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI device and does not involve a training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters 'FDA' in white. To the right of the blue square is the text 'U.S. FOOD & DRUG ADMINISTRATION' in blue.
10/3/2022
Suzhou Kyuan Medical Apparatus Co., Ltd. Shi Ye Manager Beigiao Town, Suzhou City, P.R.China Suzhou, Jiangsu China
Re: K221778
Trade/Device Name: Disposable Safety Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: June 10, 2022 Received: June 21, 2022
Dear Shi Ye:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220387.
Device Name
Disposable Safety Lancets
Indications for Use (Describe)
Disposable Safety Lancets
The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K221778 510(k) summary
l Submitter
Device submitter: Suzhou Kyuan Medical Apparatus Co., Ltd. Beiqiao Town, Suzhou City, P.R.China
Contact person: Shi Ye General Manager Phone: +86-512 65995113 Fax: +86-512 65495768 Email: shi.ye@medi-kyuan.com
Date: 08/30/2022
II Device
510K Number: K221778 Trade Name of Device: Disposable Safety Lancets Common Name: Blood Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Single Use Only Blood Lancet with an Integral Sharps Injury Prevention Feature Regulatory Class: II Product code: FMK Review Panel: General & Plastic Surgery
III Predicate Devices
| Trade name: | SurgiLance® Safety Lancets |
|---|---|
| Common name: | Blood Lancets |
| Classification: | l-Lancet with Sharps Prevention Feature, 21CFR 878.4800 |
| Product Code: | FMK |
| Premarket Notification: | K101145 |
| Manufacturer: | MediPurpose Pte, Ltd. |
IV Device description
The Disposable Safety Lancets consists 7 parts, include a lancet cap, body, slide, lancet, tip cover, spring and bottom. The models of the Disposable Safety Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature. The lancet is hit by pressure, and once the device strikes, the lancet needle
{4}------------------------------------------------
can puncture the skin. Used Gamma sterilization, and are products for single use.
V Indications for use
Disposable Safety Lancets
The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature.
VI Comparison of technological characteristics with the predicate devices
The Disposable Safety Lancets have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Disposable Safety Lancets and predicate devices do not alter suitability of the proposed device for its intended use.
| Devicefeature | Subject Device | Predicate Device K101145 | Comment | ||
|---|---|---|---|---|---|
| Indicationsfor use | The Disposable SafetyLancets is intended tobe used in a hospital orat home to obtaincapillary blood samplesfrom the fingertip fortests using smallamounts of blood. Thedevice contains a sharpinjury protection feature. | The SurgiLance® SafetyLancet is a puncture deviceto obtain micro bloodsamples. The SurgiLance®Safety Lancet has a sharpsprevention feature toprotect the user from aneedlestick injury. | SimilarComment 1 | ||
| Productcode | FMK | FMK | Equivalent | ||
| Safetyprotectionfeatures | Yes | Yes | Equivalent | ||
| Reusedurability | Single use | Single use | Equivalent | ||
| Sterilization | Irradiation | Not available | DifferentComment 2 | ||
| Model | 18G; 21G; 23G; 26G;28G; 30G; 32G; 33G | SLN 170: 28G; | Different | ||
| Devicefeature | Subject Device | Predicate Device K101145 | Comment | ||
| SLN 100: 21G;SLN 200: 21G;SLN 240: 21G;SLN 300: 21G;SLB 200: 18G;SLB 250: 18G;(Information gathered fromMediPurpose Pte, Ltd.official website) | Comment 3 | ||||
| PenetrationDepth | 18G | 1.8mm | SLN 170- 28G 1.7mm | ||
| 21G | 1.8mm and2.2mm | SLN 100- 21G 1.0mm | |||
| 23G | 1.8mm and2.2mm | SLN 200- 21G 1.8mm | |||
| 26G | 1.8mm | SLN 240- 21G 2.2mm | |||
| 28G | 1.8mm | SLN 300- 21G 2.8mm | |||
| 30G | 1.8mm and1.5mm | SLB 200- 18G 1.8mm | |||
| 32G | 1.5 mm | SLB 250- 18G 2.3mm(Information gathered fromMediPurpose Pte, Ltd.official website) | |||
| 33G | 1.5 mm | ||||
| NeedleLength | 18G | 18.3mm±1.0mm | SLN 170- 28G 17.7mm | ||
| 21G | 18.3mm±1.0mm18.7mm±1.0mm | SLN 100- 21G 17.3mm | |||
| 23G | 18.3mm±1.0mm18.7mm±1.0mm | SLN 200- 21G 17.7mm | |||
| 26G | 18.3mm±1.0mm | SLN 240- 21G 18.1mm | |||
| 28G | 18.3mm±1.0mm | SLN 300- 21G 18.6mm | |||
| SLB 200- 18G 17.7mm | |||||
| SLB 250- 18G 18.2mm | |||||
| Devicefeature | Subject Device | Predicate Device K101145 | Comment | ||
| 30G 18.3mm±1.0mm18.1mm±1.0mm | |||||
| 32G 18.1mm±1.0mm | |||||
| 33G 18.1mm±1.0mm | |||||
| Materials ofparts incontact withhumanbody | Lancet needle: 304 stainless steel;Body and cap: ABS or PP; | Lancet needle: medical grade stainless steel;Housing and cap: plastics | SimilarComment 4 |
{5}------------------------------------------------
{6}------------------------------------------------
Discussion:
Comment 1
Minor rewording of the Intended Use statement has been made for the purpose of streamlining the information provided to the user. The subject device and the predicate device have the same intended use, to puncture the skin to obtain drops of blood for diagnostic purposes. The same basic technology characteristics for a lancet with sharps injury prevention of Disposable Safety Lancets as compared with the predicate device. The general purpose of the device and its function remain unchanged. The minor rewording of the Intended Use statement does not raise different questions of safety and effectiveness.
Comment 2
The sterilization method of predicate device is not available. However, the subject device was ensured sterility by sterilization validation. Therefore, the differences on sterilization do not raise new questions about safety and effectiveness.
Comment 3
The needle length is similar as the predicate device, while it is the penetration depth and diameter of needle rather than needle length that affect the amount of blood collected. However, the different of models and penetration depth are just in dimension. Different needle diameters and depths of lancet was allowed to choose to meet blood volume needs and the difference were addressed by performance tests. Different needle specification will be selected by physician per patient's condition. This difference does
{7}------------------------------------------------
not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
Comment 4
The subject device utilizes some of the same materials, specifically the use of medical grade stainless steel for the lancet needles but may use different types plastics for the bodies, caps. All the materials are known biocompatible materials that have been used in lancets or other similar medical devices, and the materials of subject device were demonstrated by the biocompatibility tests done. The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
VII Summary of non-clinical testing
The following performance data were provided in support of the substantial equivalence determination.
| No | Testingitem | Specification | Result |
|---|---|---|---|
| 01 | Appearance | Disposable Safety Lancets the surface should besmooth without edge, no dirt and damage,deformation and other poor appearance. | Pass |
| 02 | LaunchLength | The length of the needles in the Disposable SafetyLancet is different in different genders and ages.The launch length of the needle is determinedaccording to the length of the purchase, and thegeneral emission length is 1.2mm-2.8mm. | Pass |
| 03 | Sharpness | $Penetration force ≤1.00N.$ | Pass |
| 04 | Feature | The tip of the needle can shrink quickly after firing,and the tip of the needle is not exposed. | Pass |
| 05 | Disposable Safety Lancets Only one launch, notanother. | Pass | |
| 06 | Initialbioburden | $Initial bioburden of the device shall be less than100CFU/g$ | Pass |
| 07 | Sterile | The sterile blood lancet shall be sterile | Pass |
Biocompatibility testing
{8}------------------------------------------------
Biocompatibility of the Disposable Safety Lancets were evaluated in accordance with ISO 10993-1:2018 for the body contact category. The following tests were performed, as recommended:
| Item | Test method | Test results |
|---|---|---|
| Cytotoxic test | ISO 10993-5:2009 | No Cytotoxicity |
| Skin sensitization test | ISO 10993-10:2010 | No Skin sensitization |
| Intracutaneous test | ISO 10993-10:2010 | No irritation |
| Acute systemic toxicity test | ISO 10993-11:2017 | No Acute Systemic Toxicity |
| Hemolysis test | ISO 10993-4:2017 | No Hemolysis |
| Pyrogen Test | USP <151> | Non- pyrogen |
Sterilization and shelf life testing
-
Irradiation sterilization validation per ISO 11173-1 and ISO 11173-3.
-
Pyrogen testing per USP <151>
- A Simulated shipping per ASTM D4169
- A The 5 years shelf life of the device is determined based on stability study which includes ageing test.
VIII Conclusion
The Disposable Safety Lancets are substantially equivalent to its predicate device (SurgiLance® Safety Lancets). The differences between the predicate and subject device do not raise any new or different questions of safety or effectiveness. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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.