(59 days)
Not Found
No
The device description and performance studies focus solely on the mechanical function and safety of a blood lancet for capillary blood sampling. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is used for capillary blood sampling to measure blood glucose levels, not for treating a disease or condition. While it aids in managing diabetes, it is a diagnostic tool, not a therapeutic one.
No
This device is a blood lancet used for capillary blood sampling. It is a tool for collecting a sample, but it does not analyze or interpret the sample to provide a diagnosis itself. The collected blood is then typically used with another device (like a glucometer) for diagnostic purposes.
No
The device description explicitly details physical components such as surgical steel, plastic housing, needles, caps, handles, buttons, springs, and a lancing device, indicating it is a hardware medical device.
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 sampling." This describes the method of obtaining a sample, not the analysis of the sample.
- Device Description: The device is a lancet designed to puncture the skin to collect blood. It does not perform any diagnostic test or analysis on the blood itself.
- Lack of Diagnostic Function: The description focuses on the physical act of blood collection and safety features. There is no mention of any component that interacts with the blood to provide a diagnostic result (e.g., a test strip, reagent, or sensor).
- Role in Blood Glucose Measurement: While the description mentions it can be used to measure blood glucose levels in diabetic patients, the lancet's role is solely to obtain the blood sample for a separate blood glucose meter (which is an IVD).
In summary, the device is a tool for collecting a biological sample (blood), which can then be used in an IVD for diagnostic purposes. The lancet itself does not perform the diagnostic test.
N/A
Intended Use / Indications for Use
It is intended for capillary blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
FMK, ORK
Device Description
The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through irradiation. The product has a shelf life of 3 years.
The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling.
The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for capillary blood sampling)
Indicated Patient Age Range
All ages
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus have successfully completed comprehensive bench testing, demonstrating full compliance with safety and effectiveness requirements. The testing protocol adhered to the FDA Guidance for Industry and FDA Staff on Medical Devices with Sharps Injury Prevention Features (dated August 30, 2024) and the special controls outlined in 21 CFR 878.4850 for blood lancets. Performance evaluation results confirmed that both devices successfully met all specified regulatory requirements and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 13, 2025
HLB Co., Ltd. Healthcare % Kyung-Hwan Kim Representative Consultant. RA/OA SMB Korea Co. 7. Boramae-ro 5ga-gil, Dongjak-gu 606-ho, 607-ho Seoul. 07071 Korea, South
Re: K243533
Trade/Device Name: Sterilized Eol Auto Lancet: Sterilized Eol Lancet Plus Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK, ORK Dated: November 15, 2024 Received: November 15, 2024
Dear Kyung-Hwan Kim:
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.
1
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).
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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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,
Digitally signed by Long H. Chen
Long H. Chen -S -s
Date: 2025.01.13 07:31:09 -05'00'
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
Indications for Use (Describe)
It is intended for capillary blood sampling.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
Image /page/4/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the letters "SMB" in a bold, sans-serif font, with the word "Korea" next to it in a lighter font. Underneath the main text, in a smaller font, it says "A Member of the Consulting Expert Group."
510(k) Summary
[Complying with 21 CFR 807.92]
SUBMITTER INFORMATION l.
| Company Name: | HLB Co., LTD. Healthcare |
|---|---|
| Address: | 10-5, Myeonghaksandanseo-ro, Yeondong-myeon, Sejong |
| si, Republic of Korea | |
| Phone: | +82-44-862-9134 |
| Contact Person: | Ms. Seung-won Baek, QMR |
| Cellular Phone: | +82-10-2247-5579 |
| Email: | info@smbkorea.com |
| 510(k) Owner: | SMB Korea Co. |
| 510(k) Preparer: | Mr. Kyung-hwan, Kim, Representative Consultant RA/QA |
II. DATE PREPARED
November 15, 2024
III. DEVICE IDENTIFICATION
| Trade or Proprietary Name: | Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus |
|---|---|
| Common or Usual Name: | Blood Lancet |
| Classification Name: | Single Use Only Blood Lancet With An Integral Sharps Injury |
| Prevention Feature, | |
| Single Use Only Blood Lancet Without An Integral Sharps | |
| Injury Prevention Feature | |
| Regulatory Class: | II |
| Product Code: | FMK, QRK |
| Regulation Number: | 21 CFR 878.4850 |
IV. PREDICATE DEVICE
| Trade or Proprietary Name: | VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Promisemed Blood Lancet |
|----------------------------|--------------------------------------------------------------------------------|
| 510(k) Number: | K221368 |
| Manufacturer: | Promisemed Hangzhou Meditech Co., Ltd. |
V. DEVICE DESCRIPTION
The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through
5
Image /page/5/Picture/1 description: The image shows the logo for SMB Korea. The logo consists of the text "SMB Korea" in a gray, sans-serif font. A curved line extends from under the "S" in SMB to under the "K" in Korea. Below the text "SMB Korea" is the text "A Member of the Consulting Expert Group" in a smaller, sans-serif font.
irradiation. The product has a shelf life of 3 years.
The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling.
The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.
VI. INDICATION FOR USE STATEMENT
It is intended for capillary blood sampling.
VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON
The comparison chart below supports the determination of substantial equivalence between the Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus, and the primary predicate (K221368) regarding intended use, technological characteristics, and principles of operation.
| | SUBJECT Device | PRIMARY PREDICATE
Device (K221368) | Significant Difference |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HLB Co., LTD. Healthcare | Promisemed Hangzhou
Meditech Co., Ltd. | – |
| Trade Name | Sterilized Eol Auto Lancet | VeriFine Safety Lancet
VeriFine Mini-Safety
Lancet | – |
| Regulation Description | Single Use Only Blood
Lancet With An Integral
Sharps Injury Prevention
Feature | Single Use Only Blood
Lancet With An Integral
Sharps Injury Prevention
Feature | – |
| Regulation Number | 21 CFR 878.4850 | 21 CFR 878.4850 | No difference. |
| Product Code | FMK | FMK | No difference. |
| Class | II | II | No difference. |
| Patient Population | All ages | All ages | No difference. |
| Prescription or OTC | OTC | OTC | No difference. |
| Intended Use/
Indications for Use | It is intended for capillary
blood sampling. | It is intended for capillary
blood sampling. | No difference. |
| Direction for use | 1. Remove the lancet's
protective cap by
unscrewing it.
-
Draw blood from a
site that has been
sterilized with | 1. Rotate the twisting
cap less than half a
round. -
Pull out the twisting
cap. -
Place the device on | Similarly:
There is no significant
difference between
subject device and
predicate device. They
describe the same |
| | SUBJECT Device | PRIMARY PREDICATE
Device (K221368) | Significant Difference |
| | alcohol swabs. 3.
Press the lancet's
push button to
draw blood from
the desired site. | the puncture site
and push to start. -
Discard lancet into a
sharp container. -
Press lightly on the
finger toward the
puncture site to
obtain adequate
blood sample. | process without notable
distinctions. |
| Number of Uses | Single use | Single use | No difference. |
| Design and Structure | Image: Lancet | Image: VeriFine Safety Lancet | Difference:
The subject device has
minor shape changes
compared to predicate
device, but these are
within the acceptable
range and do not
introduce a significantly
different design.
Performance tests
address these
differences, ensuring no
impact on design
principles, usage,
effectiveness, or safety. |
| Material | Needle: Stainless steel
Spring: Galvanized steel
housing, hub and Safety:
HDPE
Trigger: PP
Lancet body, cap: PP | Needle: Stainless steel
Spring: Galvanized steel
wire
Shield, hub and Safety:
ABS
Trigger: POM
Lancet body, cap: PE | No difference. |
| Gauge | 26G, 28G, 30G | 18G, 21G, 23G, 25G, 26G | Similarly: |
| | SUBJECT Device | PRIMARY PREDICATE
Device (K221368) | Significant Difference |
| | | 28G, 30G | The subject device's
gauge is within the
predicate device's range. |
| Needle Length (mm) | 1.5 | 1.2, 1.4, 1.6, 1.8, 2.0, 2.2,
2.4, 2.6, 2.8 | Similarly:
The subject device's
gauge is within the
predicate device's range. |
| Sterilization Method | Electron beam | Gamma | No difference. |
| Shelf-Life | 3 years | 5 years | No difference. |
| Biocompatibility | Biocompatible according
to ISO 10993-1 | Biocompatible according
to ISO 10993-1 | No difference. |
Device Comparison Chart: Similarities and Differences – Sterilized Eol Auto Lancet
6
HLB Co., LTD. Healthcare - K243533 Traditional 510(k) Premarket Submission Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus
Image /page/6/Picture/1 description: The image shows the logo for SMB Korea, which is part of the Consulting Expert Group. The logo features the text "SMB Korea" in a gray, sans-serif font, with a stylized swoosh graphic above the letters "MB". Below the main text, in a smaller font, is the tagline "A Member of the Consulting Expert Group."
7
HLB Co., LTD. Healthcare - K243533 Traditional 510(k) Premarket Submission Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus
Image /page/7/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" stacked on top of the word "Korea". A curved line extends from the bottom of the "S" to the top of the "B". Below the word "Korea" is the text "A Member of the Consulting Expert Group" in a smaller font size.
Device Comparison Chart: Similarities and Differences – Sterilized Eol Lancet Plus
| | SUBJECT Device | PRIMARY PREDICATE
Device (K221368) | Significant Difference |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HLB Co., LTD. Healthcare | Promisemed Hangzhou
Meditech Co., Ltd. | – |
| Trade Name | Sterilized Eol Lancet Plus | Promisemed® Blood
Lancet | – |
| Regulation Description | Single Use Only Blood
Lancet Without An
Integral Sharps Injury
Prevention Feature | Single Use Only Blood
Lancet Without An
Integral Sharps Injury
Prevention Feature | – |
| Regulation Number | 21 CFR 878.4850 | 21 CFR 878.4850 | No difference. |
| Product Code | QRK | QRK | No difference. |
| Class | II | II | No difference. |
| Patient Population | All ages | All ages | No difference. |
| Prescription/OTC | OTC | OTC | No difference. |
| Intended use/
Indications for Use | It is intended for capillary
blood sampling. | It is intended for capillary
blood sampling. | No difference. |
| Number of Uses | Base (lancing device):
Not applicable
Lancet: single use | Base (lancing device): Not
applicable
Lancet: single use | No difference |
| Design and Component | Image: blue lancet | Image: blue lancet | Difference:
The subject device has
minor shape changes
compared to predicate
device, but these are
within the acceptable
range and do not
introduce a significantly
different design.
Performance tests
address these
differences, ensuring no |
| | Stainless steel needle
encapsulated in a plastic
body and cap, the cap is
twisted off to expose the
needle for use. | Stainless steel needle
encapsulated in a plastic
body and cap, the cap is
twisted off to expose the
needle for use. | |
8
Image /page/8/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from the left side of the "S" in SMB, arching over the letters and ending near the "K" in Korea.
| | SUBJECT Device | PRIMARY PREDICATE
Device (K221368) | Significant Difference |
|----------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------|
| | | | impact on design
principles, usage,
effectiveness, or safety. |
| Material | Needle: Stainless steel
Handle, Protective cap:
PE | Needle: Stainless steel
Handle, Protective cap:
PE | No difference. |
| Gauge | 26G, 28G, 30G | 28G, 30G, 32G, 33G | Similarly:
The subject device's
gauge is within the
predicate device's range. |
| Needle Length (mm) | 3.0 | 3.0 | No difference. |
| Sterilization Method | Electron beam | Gamma | No difference. |
| Shelf-Life | 3 years | 5 years | No difference. |
| Biocompatibility | Biocompatible according
to ISO 10993-1 | Biocompatible according
to ISO 10993-1 | No difference. |
NON-CLINICAL PERFORMANCE DATA VIII.
The following tests were conducted:
Sterilization and Shelf-Life
The sterility of the subject devices is ensured through a sterilization method validated according to ISO 11137-1:2006/AMD 2:2018, ISO 11137-2:2013/AMD 1:2022, and ISO 11137-3:2017.
The shelf life of the device is three years from the date of manufacture, as per ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices.
Biocompatibility Testing
Biocompatibility classification follows the FDA Guidance based on ISO 10993-1:2019, which outlines the biological evaluation and testing of medical devices within a risk management framework.
The devices in question are classified as Externally Communicating Medical Devices intended for circulating blood with limited exposure (≤24 hours).
These devices have successfully completed all testing required by ISO 10993-1:2019 and the associated FDA guidance document.
Performance testing
The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus have successfully completed comprehensive bench testing, demonstrating full compliance with safety and effectiveness requirements. The testing protocol adhered to the FDA Guidance for
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Industry and FDA Staff on Medical Devices with Sharps Injury Prevention Features (dated August 30, 2024) and the special controls outlined in 21 CFR 878.4850 for blood lancets. Performance evaluation results confirmed that both devices successfully met all specified regulatory requirements and safety standards.
IX. CLINICAL TESTS
Clinical performance testing was not deemed necessary as the non-clinical testing was sufficient to demonstrate substantial equivalence.
X. CONCLUSIONS
Based on the comparison of intended use, technological characteristics, and performance testing results, the Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are substantially equivalent to the predicate device. The non-clinical test results demonstrate that the devices are as safe and effective as the predicate device. The differences in technological characteristics do not raise any new issues of safety or effectiveness. Therefore, these devices are suitable for their intended use in capillary blood sampling.