(55 days)
No
The device description and performance studies focus on the physical characteristics and usability of a disposable lancet for blood collection, with no mention of AI or ML technologies.
No
The device is used for capillary blood collection, which is a diagnostic procedure, not a therapeutic one. It facilitates the testing of blood glucose levels for diabetes management, but it does not treat the condition itself.
No
The device is a lancet used for capillary blood collection, which is a tool for obtaining a sample. It does not perform any diagnostic analysis or interpretation of the collected blood.
No
The device description clearly states it is a physical lancet with a needle, plastic components, and is sterilized by radiation. It is a hardware device for blood collection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for capillary blood collection." This describes a tool for obtaining a sample, not a device that performs a diagnostic test on that sample.
- Device Description: The description focuses on the physical components and function of the lancet (needle, plastic, cap, sterilization). It does not mention any components or processes related to analyzing or diagnosing a condition from the blood sample.
- Lack of Diagnostic Function: The device's sole purpose is to create a small puncture to allow blood to be collected. It does not interact with the blood in a way that provides diagnostic information.
- Clinical Study Focus: The clinical study described focuses on the usability of the lancet for obtaining a blood sample, not on the accuracy or performance of a diagnostic test. The mention of obtaining a numerical result on a BGMS (Blood Glucose Monitoring System) highlights that the diagnostic function resides in a separate device (the BGMS), not the lancet itself.
An IVD device is specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This lancet is a tool for collecting the specimen, not for performing the diagnostic test on it.
N/A
Intended Use / Indications for Use
The disposable MICROLET®NEXT Lancet is used for capillary blood collection.
Product codes
QRK
Device Description
The disposable MICROLET®NEXT Lancet is used for capillary blood collection. The device comprises of a stainless needle encapsulated with a plastic and protective cap; the protective cap is twisted off to expose the needle for use. The device is sterilized by radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile. Please refer to below attachments for detailed device description. pictures and packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip and palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay persons with diabetes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A total of 131 lay persons with diabetes, who had never used the proposed MCROLET™NEXT Lancet previously, were enrolled into the study at a sindle clinical site, and 120 completed the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test data to verify the performance of the proposed MICROLET®NEXT Lancets including: bio-compatibility, usability, Shelf life, clinical study, and the results of these testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence. Performance testing is included in this premarket notification to verify that any differences in technological characteristics of the proposed MICROLET®NEXT Lancets and the predicate 510(k)cleared Sterilance Disposable Blood lancets do not raise new questions of safety and effectiveness. It is concluded in this discussion supports substantial equivalence for the proposed the proposed MCROLET®NEXT Lancets and the predicate 510(k)cleared Sterilance Disposable Blood lancets.
A total of 131 lay persons with diabetes, who had never used the proposed MCROLET™NEXT Lancet previously, were enrolled into the study at a sindle clinical site, and 120 completed the study. Subjects demonstrated that they could use the proposed MCROLET®NEXT Lancet to obtain adequate blood volume from fingertip and palm lancing to obtain a numerical result on the BGMS(Blood Glucose Monitoring System), after reading the IFU to learn the basic operation of the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
August 15, 2024
Ascensia Diabetes Care US Inc Sangram Yadav Regulatory Affairs Manager, US 5 Wood Hollow Rd. Parsippany, New Jersey 07054
Re: K241810
Trade/Device Name: MICROLET®NEXT Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORK Dated: June 20, 2024 Received: June 21, 2024
Dear Sangram Yadav:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long H. Chen-S Digitally signed by Long H.Chen-S
Date: 2024.08.15 13:25:38 -0400
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
MICROLET®NEXT Lancet
Indications for Use (Describe)
The disposable MICROLET®NEXT Lancet is used for capillary blood collection.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
| K241810 | |
|---|---|
| 510(k) Summary | Prepared on: 2024-06-21 |
Contact Details 21 CFR 807.92(a)(1)
| Applicant Name | ASCENSIA DIABETES CARE US INC |
|---|---|
| Applicant Address | 5 WOOD HOLLOW RD Parsippany NJ 07054 United States |
| Applicant Contact Telephone | 2019368856 |
| Applicant Contact | Mr. SANGRAM YADAV |
| Applicant Contact Email | sangram.yadav@ascensia.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | MICROLET®NEXT Lancet |
|---|---|
| Common Name | Blood lancets |
| Classification Name | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Regulation Number | 878.4850 |
| Product Code(s) | QRK |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221507 | STERILANCE DISPOSABLE BLOOD LANCET | QRK |
Device Description Summary 21 CFR 807.92(a)(4)
The disposable MICROLET®NEXT Lancet is used for capillary blood collection. The device comprises of a stainless needle encapsulated with a plastic and protective cap; the protective cap is twisted off to expose the needle for use. The device is sterilized by radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile. Please refer to below attachments for detailed device description. pictures and packaging.
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
The disposable MICROLET®NEXT Lancet is used for capillary blood collection.
Indications for Use Comparison 21 CFR 807.92(a)(5)
The proposed MICROLET®NEXT Lancet has same indication for use as the predicate Sterilance Disposable Blood Lancet(Class II, K221507, Product code: QRK).
Technological Comparison 21 CFR 807.92(a)(6)
The proposed MICROLET®NEXT Lancet has the same fundamental technological characteristics as the predicate Sterilance Lancing Device (Class II, Product Code: QRL 510(k) K221970)., except for the following differences.
The primary difference is that proposed MICROLET®NEXT lancet is sold in one size (i.e.28 G limited to one size) and seven colors(Yellow, Orange, Red, Green, Blue, Purple and Pink) ; while predicate Sterilance Blood Lancets (Class II, K221507, Product code: QRK) are sold in additional sizes (28 G; other sizes such as 21G, 23G, 26G, 30G, 32G, 33G) and slightly different colors(Yellow, light blue, Pink, Dark blue,
4
Purple, Ivory yellow and Green). Additionally MCROLET®NEXT lancet has tighter dimensional specification within the range of predicate dimensions for exposed needle length.
Differences such additional sizes and slightly different colors (Yellow, light blue, Purple, lvory vellow and Green) between the proposed MCROLET NEXT Lancets and the predicate Sterilance Disposable Blood lancets (Class II, K221507, Product code: QRK) are supported by bio compatibility, Sterilization, performance tests, usability testing and clinical study.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Test data to verify the performance of the proposed MICROLET®NEXT Lancets including: bio-compatibility, usability, Shelf life, clinical study, and the results of these testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence. Performance testing is included in this premarket notification to verify that any differences in technological characteristics of the proposed MICROLET®NEXT Lancets and the predicate 510(k)cleared Sterilance Disposable Blood lancets do not raise new questions of safety and effectiveness. It is concluded in this discussion supports substantial equivalence for the proposed the proposed MCROLET®NEXT Lancets and the predicate 510(k)cleared Sterilance Disposable Blood lancets.
Summary of Clinical Testing:
A total of 131 lay persons with diabetes, who had never used the proposed MCROLET™NEXT Lancet previously, were enrolled into the study at a sindle clinical site, and 120 completed the study. Subjects demonstrated that they could use the proposed MCROLET®NEXT Lancet to obtain adequate blood volume from fingertip and palm lancing to obtain a numerical result on the BGMS(Blood Glucose Monitoring System), after reading the IFU to learn the basic operation of the system.
lt is concluded that the information provided in this discussion supports substantial equivalence for the proposed MICROLET®NEXT Lancets and the predicate 510(k)cleared Sterilance Disposable Blood lancets.