(106 days)
"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"
The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
"Sterile Lancet for Single Use" is a single use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.
"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"
"Sterile Lancet for Single Use" is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals in hospital settings or patients at home.
"Sterile Lancet for Single Use" is a disposable blood lancet intended for a single use that is comprised of a cap, a single use blade attached to a solid, non-reusable base, and it is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The needle is protected with a cap before use. The steel needle is made of stainless steel SUS304. The needle cap and needle base are made of polyethylene plastic, and are injection molded. The Sterile Lancet for Single Use is sterilized by gamma irradiation.
"Sterile Lancet for Single Use" can be used alone in either home or healthcare settings, or be used together with "Lancing Device" in home settings.
Based on different design and shape, there are three different types of "Sterile Lancet for Single Use", and also can accommodate different needle gauges.
"Lancing Device" is a multiple use, sterile, medical devices designed to be used in collecting the blood sample. The products can be used by patients and lay persons. Thev are not intended for healthcare workers because the device can not be used among different patients.
Lancing Device is a multiple use capillary blood lancet intended for use on a single patient. Before each use, a single use lancet is attached to the reusable case, and when launched, is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
After use, the single use blade ("Sterile Lancet for Single Use") is disposed of, and the lancing device is cleaned and disinfected, ready for the next use.
The lancing device has five adjustable gears (marked 1 to 5) that allow for different puncture depth.
Lancing Device is made of a needle base, spring, a launching part, return spring, launch button, a casing, and a cap. The needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components.
The provided document is a 510(k) summary for a medical device (lancing system) seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and performance data.
However, the request asks for details related to a study proving the device meets acceptance criteria specific to AI/Machine Learning models, including expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets.
The provided document does not contain any information about an AI/Machine Learning model. The device described is a physical lancing system for blood collection. Therefore, the requested information regarding AI/ML specific acceptance criteria and study designs (like MRMC, human-in-the-loop, or training/test set ground truth for AI) is not applicable to this submission.
The document discusses non-clinical performance testing (physical, chemical, mechanical properties, packaging integrity, sterilization validation) and biocompatibility testing, which are standard for physical medical devices. It explicitly states: "No clinical study is included in this submission." This further confirms the absence of any data related to AI/ML performance evaluation as specified in your prompt.
Therefore, I cannot populate the table or answer the specific questions about AI/ML model acceptance criteria and study design based on the provided text.
However, I can extract the information that is relevant to the device's acceptance testing as described in the document:
Acceptance Criteria and Device Performance (as per the provided 510(k) Summary for a Lancing System):
Since this is a physical medical device (lancing system) and not an AI/ML model, the "acceptance criteria" and "device performance" relate to physical, chemical, and mechanical properties, not AI metrics like sensitivity, specificity, or AUC. The document states "All tests were verified to meet acceptance criteria" without listing the specific numeric criteria or results for each test.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Tests Performed | Acceptance Criteria (Not explicitly quantified in the document) | Reported Device Performance (as stated in the document) |
|---|---|---|---|
| Physical Properties | Appearance, Dimension | (Assumed to be within specified ranges) | "All tests were verified to meet acceptance criteria." |
| Chemical Properties | pH, Metal, Sterility, Corrosion Resistance | (Assumed to be within acceptable limits for safety and function) | "All tests were verified to meet acceptance criteria." |
| Mechanical Properties | Launch Performance, Puncture Force, Puncture Depth, Drop Test, Twist Force, Detach Force, Structure Firmness | (Assumed to be within design specifications for intended function) | "All tests were verified to meet acceptance criteria." |
| Safety Features | Injury preventing features | (Assumed to meet relevant safety standards) | "All tests were verified to meet acceptance criteria." |
| Contamination Control | Bacterial endotoxin | (Assumed to be within limits, e.g., < 0.25 EU/mL) | "All tests were verified to meet acceptance criteria." |
| Packaging Integrity | (Assumed to maintain sterility and device integrity) | "All tests were verified to meet acceptance criteria." | |
| Stability | Stability evaluation | (Assumed to maintain performance over shelf life) | "All tests were verified to meet acceptance criteria." |
| Durability/Life Cycle | Use life study | (Assumed to meet specified number of uses) | "All tests were verified to meet acceptance criteria." |
| Sterilization | Sterilization validation (SAL 10^-6) | (Assumed to meet sterility assurance level) | "All tests were verified to meet acceptance criteria." |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Non-cytotoxic | "The results show that 'Lancet System' does not cause biocompatibility concerns." |
| Irritation Oral Mucosa Irritation (ISO 10993-10) | Non-irritant | "The results show that 'Lancet System' does not cause biocompatibility concerns." | |
| Sensitization (ISO 10993-10) | Non-sensitizing | "The results show that 'Lancet System' does not cause biocompatibility concerns." | |
| Acute Toxicity (ISO 10993-11) | Non-acutely toxic | "The results show that 'Lancet System' does not cause biocompatibility concerns." | |
| Pyrogenicity (ISO 10993-3) | Non-pyrogenic | "The results show that 'Lancet System' does not cause biocompatibility concerns." |
Regarding the AI/ML specific questions (2-9), the document explicitly states information that makes them not applicable: "No clinical study is included in this submission." and the device is not an AI/ML product.
However, to address the prompt for completeness based on the absence of AI/ML, I will state "Not Applicable" for these points.
2. Sample sized used for the test set and the data provenance: Not Applicable (No AI/ML model, tests are bench testing on physical units)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (No AI/ML model; ground truth for physical device testing is based on engineering specifications and laboratory measurements)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable (No AI/ML model; testing is primarily objective bench 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: Not Applicable (No AI/ML model)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable (No AI/ML model)
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the physical device, ground truth for performance is established by engineering specifications, relevant ISO standards, and established laboratory measurement techniques.
8. The sample size for the training set: Not Applicable (No AI/ML model)
9. How the ground truth for the training set was established: Not Applicable (No AI/ML model)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2022
Shandong Lianfa Medical Plastic Products Co. Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K222472
Trade/Device Name: Lancing System, Sterile Lancet for Single Use, Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: October 12, 2022 Received: October 14, 2022
Dear Charles Shen:
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
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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 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,
Jessica Carr -S
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222472
Device Name
Lancing System, Sterile Lancet for Single Use, Lancing Device
Indications for Use (Describe)
"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"
The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
"Sterile Lancet for Single Use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K222472
510(k) Summary:
This summary of 510k safety and effectiveness informationis being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 1
Shandong Lianfa Medical Plastic Products Co. Ltd. No. 1 Shuangshan Sanjian Road Zhangqiu, Jinan, Shandong Province, China, Zipcode 250200 Tel: (086) 531-61328777 Submitter's FDA Registration Number: 3003723176
Contact Person 2
Dr. Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
3 Date of Summary: November 22, 2022
4 Device Name:
| Trade Name: | Lancing System, Sterile Lancet for Single Use, LancingDevice |
|---|---|
| Common Name: | Lancing Device, Blood Lancet |
| Classification Name: | Multiple Use Blood Lancet For Single Patient Use Only/Single Use Only Blood Lancet without An Integral SharpsInjury Prevention Feature |
| Device Classification: | Class 2 |
| Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4850 |
| Product Code: | QRL |
| Subsequent Product Code: | QRK |
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5 Predicate Device Information:
K214022, "Accu-Chek Softclix Blood Lancing System", manufactured by "Roche Diabetes Care, Inc."
6 Device Description:
"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"
"Sterile Lancet for Single Use" is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals in hospital settings or patients at home.
"Sterile Lancet for Single Use" is a disposable blood lancet intended for a single use that is comprised of a cap, a single use blade attached to a solid, non-reusable base, and it is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The needle is protected with a cap before use. The steel needle is made of stainless steel SUS304. The needle cap and needle base are made of polyethylene plastic, and are injection molded. The Sterile Lancet for Single Use is sterilized by gamma irradiation.
"Sterile Lancet for Single Use" can be used alone in either home or healthcare settings, or be used together with "Lancing Device" in home settings.
Based on different design and shape, there are three different types of "Sterile Lancet for Single Use", and also can accommodate different needle gauges.
"Lancing Device" is a multiple use, sterile, medical devices designed to be used in collecting the blood sample. The products can be used by patients and lay persons. Thev are not intended for healthcare workers because the device can not be used among different patients.
Lancing Device is a multiple use capillary blood lancet intended for use on a single patient. Before each use, a single use lancet is attached to the reusable case, and when launched, is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
After use, the single use blade ("Sterile Lancet for Single Use") is disposed of, and the lancing device is cleaned and disinfected, ready for the next use.
The lancing device has five adjustable gears (marked 1 to 5) that allow for different puncture depth.
Lancing Device is made of a needle base, spring, a launching part, return spring, launch button, a casing, and a cap. The needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components.
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7 Indications for Use:
"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"
The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
"Sterile Lancet for Single Use" is a single use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.
8 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between the subject Lancing System and the predicate device K214022, Accu-Chek Softclix Blood Lancing System.
Table 1: Comparison of Intended Use, Design, Material, and Processing: Lancing System
| Description | Subject Device | Predicate Device (K214022) | SE Determination |
|---|---|---|---|
| Indication for Use | "Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.The lancing device is for use only on a | System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | Similar |
| single patient in a home setting. Thislancing device is not suitable for use byhealthcare professionals with multiplepatients in a healthcare setting. | |||
| "Sterile Lancet for Single Use" is a singleuse device indicated for capillary bloodsampling. It can be used in conjunctionwith "Lancing Device" in home settings,or be used standalone in both home andhospital settings. | |||
| RegulationNumber | 21 CFR § 878.4850 | 21 CFR § 878.4850 | SE |
| Product Code | QRL/QRK | QRL/QRK | SE |
| RegulationName: | Lancing Device:Multiple Use Blood Lancet For SinglePatient Use OnlySingle Use Lancet:Single Use Only Blood LancetWithout An Integral Sharps InjuryPrevention Feature | Lancing Device:Multiple Use Blood Lancet ForSingle Patient Use OnlySingle Use Lancet:Single Use Only Blood LancetWithout An Integral Sharps InjuryPrevention Feature | SE |
| Basic Design | Lancing Device:Housing, protective cap, spring,buttonSingle Use Lancet:Stainless steel needle encapsulatedwith a plastic body and cap, the cap istwisted off to expose the needle foruse. | Disposable needle:Stainless steel needle encapsulatedwith a plastic body and cap, the capis twisted off to expose the needlefor use. | SE |
| Patient ContactMaterials | Stainless steel, and plastics | Stainless steel and plastics | SE |
| Use Environment | Lancing Device:This system is for use only on a singlepatient in a home setting.The Lancing Device is not suitable foruse by healthcare professionalsLancet:This system is for use only on a singlepatient in a professional or homesetting. | Lancing Device:This system is for use only on asingle patient in a home setting.The Lancing Device is not suitablefor use by healthcare professionalsLancet:This system is for use only on asingle patient in a professional orhome setting. | SE |
| DepthAdjustment | 5 levels | 11 level | Similar |
| Single/MultipleUse | Lancing Device: multiple use | Lancing Device: multiple use | SE |
| use | |||
| Mechanism | Spring firingManual disposal of lancet | Spring firingManual disposal of needle | SE |
| Sharp PreventionFeatures | Yes | Yes | SE |
| Shelf Life | 5 years | 5 years | SE |
| Sterile | Lancing Device: Not sterilizedSterile Lancet for Single Use: SAL10-6 | Lancing Device: Not sterilizedSterile Lancet for Single Use: SAL10-6 | SE |
| Prescription/OTC | Prescription/OTC | OTC | SE |
| Intended PatientPopulations | All ages | All ages | SE |
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The subject Lancing System is essentially identical to the predicate device in terms of indications for use, design, material, and processing. The minor differences do not affect the safety and performance of the device
9 Summary of Device Non-Clinical Performance Testing:
Bench testing was performed per internal procedures to ensure that the "Lancing System" met its specifications. The following tests were performed:
- Physical properties (appearance, dimension) ●
- Chemical properties (pH, metal, sterility, corrosion resistance)
- Mechanical properties (launch performance, puncture force, puncture depth, drop ● test, twist force, detach force, structure firmness)
- Injury preventing features ●
- Bacterial endotoxin
- Packaging integrity ●
- Stability evaluation .
- Use life study ●
- Sterilization validation
All tests were verified to meet acceptance criteria.
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10 Biocompatibility Testing
Biocompatibility testing was performed to verify the equivalence of the materials that are used. The following Biocompatibility properties are tested for the subject device
| Description | Test Standard |
|---|---|
| Cytotoxicity | ISO 10993-5 |
| Irritation Oral Mucosa Irritation | ISO 10993-10 |
| Sensitization | ISO 10993-10 |
| Acute Toxicity | ISO 10993-11 |
| Pyrogenicity | ISO 10993-3 |
The results show that "Lancet System" does not cause biocompatibility concerns.
11 Clinical Testing
No clinical study is included in this submission
12. Conclusion
The proposed device of "Lancing System" which consists of "Sterile Lancet for Single Use" and "Lancing Device" has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate 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.