(106 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
No
The device is intended for the hygienic collection of capillary blood for testing purposes, which is a diagnostic procedure, not a therapeutic one.
No
The device, a "Lancing System" (comprised of a "Sterile Lancet for Single Use" and a "Lancing Device"), is intended for the hygienic collection of capillary blood for testing purposes and to puncture the skin to obtain a drop of blood for diagnostic purposes. However, the device itself is a blood collection instrument and does not perform the diagnostic function.
No
The device description clearly outlines physical components like lancets made of stainless steel and plastic, and a lancing device with a needle base, spring, and casing. There is no mention of software as a component of the device.
Based on the provided information, the Lancing System (consisting of the Sterile Lancet for Single Use and the Lancing Device) is not an In Vitro Diagnostic (IVD) device itself.
Here's why:
- Definition of IVD: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental impairment, injury or disability, or to determine the safety and compatibility with potential recipients.
- Function of the Lancing System: The Lancing System's primary function is to collect a sample of capillary blood. It is a tool used to obtain the specimen, not to perform the diagnostic test on the specimen.
- Intended Use: The intended use clearly states it is for the "hygienic collection of capillary blood for testing purposes". This reinforces its role as a sample collection device.
- Device Description: The descriptions focus on the mechanical aspects of puncturing the skin and collecting the blood sample. There is no mention of analyzing the blood or providing diagnostic information.
- Predicate Device: The predicate device, "Accu-Chek Softclix Blood Lancing System," is also a lancing system, which are generally classified as Class II medical devices for sample collection, not IVDs.
In summary, the Lancing System is a medical device used to facilitate the collection of a biological sample (blood) that will then be used in an IVD test. It is a crucial component in the diagnostic process, but it is not the diagnostic device itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QRL, QRK
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 device 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. They can be used by patients and lay persons. They 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Indicated Patient Age Range
All ages
Intended User / Care Setting
"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" can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.
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)
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.
Biocompatibility testing was performed to verify the equivalence of the materials that are used. The following Biocompatibility properties are tested for the subject device:
- 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.
No clinical study is included in this submission.
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
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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
1
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
2
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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3
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, Lancing
Device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Sharps
Injury Prevention Feature |
| Device Classification: | Class 2 |
| Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4850 |
| Product Code: | QRL |
| Subsequent Product Code: | QRK |
4
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.
5
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. 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. | |||
| Regulation | |||
| Number | 21 CFR § 878.4850 | 21 CFR § 878.4850 | SE |
| Product Code | QRL/QRK | QRL/QRK | SE |
| Regulation | |||
| Name: | Lancing Device: | ||
| Multiple Use Blood Lancet For Single | |||
| Patient Use Only |
Single Use Lancet:
Single Use Only Blood Lancet
Without An Integral Sharps Injury
Prevention Feature | Lancing Device:
Multiple Use Blood Lancet For
Single Patient Use Only
Single Use Lancet:
Single Use Only Blood Lancet
Without An Integral Sharps Injury
Prevention Feature | SE |
| Basic Design | Lancing Device:
Housing, protective cap, spring,
button
Single Use Lancet:
Stainless steel needle encapsulated
with a plastic body and cap, the cap is
twisted off to expose the needle for
use. | Disposable needle:
Stainless steel needle encapsulated
with a plastic body and cap, the cap
is twisted off to expose the needle
for use. | SE |
| Patient Contact
Materials | Stainless steel, and plastics | Stainless steel and plastics | SE |
| Use Environment | Lancing Device:
This system is for use only on a single
patient in a home setting.
The Lancing Device is not suitable for
use by healthcare professionals
Lancet:
This system is for use only on a single
patient in a professional or home
setting. | Lancing Device:
This system is for use only on a
single patient in a home setting.
The Lancing Device is not suitable
for use by healthcare professionals
Lancet:
This system is for use only on a
single patient in a professional or
home setting. | SE |
| Depth
Adjustment | 5 levels | 11 level | Similar |
| Single/Multiple
Use | Lancing Device: multiple use | Lancing Device: multiple use | SE |
| | use | | |
| Mechanism | Spring firing
Manual disposal of lancet | Spring firing
Manual disposal of needle | SE |
| Sharp Prevention
Features | Yes | Yes | SE |
| Shelf Life | 5 years | 5 years | SE |
| Sterile | Lancing Device: Not sterilized
Sterile Lancet for Single Use: SAL
10-6 | Lancing Device: Not sterilized
Sterile Lancet for Single Use: SAL
10-6 | SE |
| Prescription/OTC | Prescription/OTC | OTC | SE |
| Intended Patient
Populations | All ages | All ages | SE |
6
7
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.
8
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.