The lancet is intended for capillary blood sampling. The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T) The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)
Device Story
Device consists of sterile, single-use lancets and reusable lancing devices; used to obtain capillary blood samples for diagnostic testing. Lancet comprises stainless steel needle encapsulated in plastic body/cap. Lancing device uses spring-loaded mechanism (carbon steel spring) to fire lancet into skin; features adjustable penetration depth. Used in home or clinical settings by patients or healthcare professionals. Device provides sharp injury prevention via needle retraction. Benefits include safe, controlled blood sampling for point-of-care testing.
Clinical Evidence
No clinical data. Bench testing only. Simulated clinical use study performed on 640 samples per ISO 23908 and FDA sharps injury prevention guidance. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity) per ISO 10993-1.
Technological Characteristics
Materials: Stainless steel (needle), ABS, POM, PC, PS, PE, EVA (body/cap). Energy: Mechanical (carbon steel spring). Sterilization: Radiation (SAL 10^-6) for lancets. Connectivity: None. Form factor: Handheld lancing device with replaceable lancets.
Indications for Use
Indicated for capillary blood sampling from fingertip, palm, or forearm for testing using small blood volumes. Intended for single-patient use only.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 15, 2024
Tianjin Huahong Technology Co., Ltd. Ningning Wang Registered Engineer A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin, 300308 China
Re: K243306
Trade/Device Name: Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VIII, IX); Lancing device (HH-X-T. HH-XV-T. HH-XVI-T. HH-XVI-T. HH-XVIII-T. HH-XIX. HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL, ORK Dated: October 17, 2024 Received: October 21, 2024
Dear Ningning Wang:
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/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
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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).
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-devices/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 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
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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,
Digitally signed by Long H. Chen
Long H. Chen -S-5
Date: 2024.11.15 10:06:41 -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
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#### Indications for Use
Submission Number (if known)
K243306
| Device Name | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX);<br>Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-<br>T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-<br>T, HH-XXVII-T) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use (Describe) | |
| Lancet: | The lancet is intended for capillary blood sampling. |
| Lancing device: | The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII- T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)<br>The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T) |
| 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)
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# 510(k) summary
#### l Submitter
Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China
Establishment Registration Number: 3009498536
Contact person: Ms. Ningning Wang Registered Engineer Tel.: +86-13021381776 E-mail: ningning.wang@hh-technology.com
Preparation date: October 17, 2024
#### II Proposed Device
| Trade Name of Device: | Lancet, Lancing device |
|-----------------------|-------------------------------------------------------|
| Common name: | Multiple Use Blood Lancet For Single Patient Use Only |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product code: | QRL and QRK |
| Review Panel | General & Plastic Surgery |
#### III Predicate Devices
| 510(k) Number: | K220475 |
|-----------------|--------------------------------------|
| Trade name: | Lancet, Lancing device |
| Classification: | Class II |
| Product Code: | QRL, QRK |
| Manufacturer: | Tianjin Huahong Technology Co., Ltd. |
#### IV Device description
#### Lancet
The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip.
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The Lancet is composed three components: needle, main body and protective cap. Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
## Lancing Device
Along with a lancet, the lancing device is used to obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel.
The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first.
For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first.
The Lancing Device is provided non-sterile.
#### V Indication for use
Lancet
The lancet is intended for capillary blood sampling.
## Lancing Device
The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a sinqle patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T) The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T).
VI Comparison of technological characteristics with the predicate devices The comparison and discussion between the Proposed device and the predicate devices are listed in below table 1&2:
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| Item | Predicate device<br>(K220475) | Proposed device | Comments on<br>Similarities/Differ<br>ences | Safety/Effectiveness<br>Statement |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Lancet | No Change | N/A | No new concerns.<br>The product name remains<br>unchanged |
| Product Code | QRL and QRK | No Change | N/A | No new concerns.<br>The product code remains<br>the same, reflecting no<br>change in device<br>functionality. |
| Regulation No. | 21 CFR § 878.4850 | No Change | N/A | No new concerns.<br>The regulation number<br>remains consistent. |
| Class | II | No Change | N/A | No new concerns.<br>The device remains in Class<br>II, indicating no change in<br>risk level. |
| Prescription/over-<br>the-counter use | Over-The-Counter Use | No Change | N/A | No new concerns.<br>The over-the-counter use<br>remains consistent. |
| Indication for use | The lancet is intended for<br>capillary blood sampling. | No Change | N/A | No new concerns.<br>The Indication for use<br>remains consistent. |
| Applicable user | Healthcare professional or lay<br>person | No Change | N/A | No new concerns.<br>The applicable user remains<br>consistent. |
| Reuse durability | Single use | No Change | N/A | No new concerns.<br>The single use remains<br>consistent. |
| Sterilization method<br>and SAL | Sterilized by Radiation<br>SAL=10-6 | No Change | N/A | No new concerns.<br>The sterilization method and<br>SAL remains consistent. |
| Manufacturing<br>aspects | For the Lancet, stainless steel<br>needle is fed into an injection<br>molding machine to over-mold<br>plastic material (polyethylene<br>(PE) and Ethylene Vinyl Acetate<br>(EVA) and calcium powder)<br>forming a body and cap,<br>encapsulating the stainless steel<br>needles. | No Change | N/A | No new concerns.<br>The manufacturing aspects<br>remains consistent. |
| Design and<br>Functionality<br>aspects | The Lancet comprises a<br>stainless steel needle<br>encapsulated with a plastic body<br>and cap, the cap is twisted off to<br>expose the needle for use | No Change | N/A | No new concerns.<br>The design and functionality<br>aspects remains consistent. |
| Needle length range | 3.2±0.3mm(Model: IA、IB、<br>IC、ID、IE、IK、IL、IM、<br>IIA、IIB、III、VI)<br>2.1±0.3mm (Model: V) | 3.2±0.3mm (Model:<br>IA、IB、IC、ID、IE、IK、<br>IL、IM、IIA、IIB、III、<br>VI、VII)<br>2.1±0.3mm (Model: V)<br>2.2±0.3mm (Model:<br>VIII, IX ) | New three models<br>of VII, VIII and IX<br>were added. | No new concerns.<br>Model VII can only be used<br>in conjunction with our<br>company's HH-XXV-T<br>lancing device. After the<br>performance test and the<br>matching test, the product<br>can be guaranteed to be<br>safe and effective. Model VIII<br>can only be used in<br>conjunction with our<br>company's HH-XXIX-T<br>lancing device. After the<br>performance test and the<br>matching test, the product<br>can be guaranteed to be<br>safe and effective. Model IX<br>can only be used in<br>conjunction with our<br>company's HH-XXX-T<br>lancing device. After the |
| | | | | performance test and the<br>matching test, the product<br>can be guaranteed to be<br>safe and effective. Model IX<br>is a little smaller than model<br>VIII. |
| | 1.50±0.02mm (16G) | 1.50±0.02mm (16G) | | |
| | 1.20±0.01mm (18G) | 1.40±0.02mm (17G) | | |
| | 1.07±0.01mm (19G) | 1.20±0.01mm (18G) | | |
| | 0.91±0.01mm (20G) | 1.07±0.01mm (19G) | | |
| | 0.82±0.01mm (21G) | 0.91±0.01mm (20G) | | |
| | 0.72±0.01mm (22G) | 0.82±0.01mm (21G) | | |
| | 0.64±0.01mm (23G) | 0.72±0.01mm (22G) | New three size of | No new concerns. |
| Gauge range | 0.57±0.01mm (24G) | 0.64±0.01mm (23G) | 17G, 35G and 37G<br>were added. | The added sizes are within<br>the original approved sizes. |
| | 0.51±0.01mm (25G) | 0.57±0.01mm (24G) | | |
| | 0.46±0.01mm (26G) | 0.51±0.01mm (25G) | | |
| | 0.41±0.01mm (27G) | 0.46±0.01mm (26G) | | |
| | 0.36±0.01mm (28G) | 0.41±0.01mm (27G) | | |
| | 0.34±0.01mm (29G) | 0.36±0.01mm (28G) | | |
| | 0.31±0.01mm (30G) | 0.34±0.01mm (29G) | | |
| | 0.26±0.01mm (31G) | 0.31±0.01mm (30G) | | |
| | | | | |
| | 0.24±0.01mm (32G) | 0.26±0.01mm (31G) | | |
| | 0.21±0.01mm (33G) | 0.24±0.01mm (32G) | | |
| | 0.19±0.01mm (34G) | 0.21±0.01mm (33G) | | |
| | 0.17±0.01mm (36G) | 0.19±0.01mm (34G) | | |
| | 0.15±0.01mm (38G) | 0.18±0.01mm (35G) | | |
| | | 0.17±0.01mm (36G) | | |
| | | 0.16±0.01mm (37G) | | |
| | | 0.15±0.01mm (38G) | | |
| Shelf-life | 5 years | No Change | N/A | No new concerns.<br>The shelf-life aspects<br>remains consistent. |
| Materials of parts in<br>contact with human<br>body | The Lancet has a needle that is<br>made of stainless steel and a<br>body and a cap that are made of<br>polyethylene and Ethylene Vinyl<br>Acetate (EVA) and calcium<br>powder. | The Lancet has a needle<br>that is made of stainless<br>steel and a body and a<br>cap that are made of<br>polyethylene and Ethylene<br>Vinyl Acetate (EVA) and<br>calcium powder. | Material of body<br>and a cap is added<br>the PE which is<br>only contact intact<br>skin. | No new concerns.<br>The raw materials added this<br>time are the same as in<br>K220475, all are PE, only the<br>grades are different, and the<br>human body surface is in<br>contact with the complete<br>skin, reviewed geometric<br>changes per CDRH's<br>Biocompatibility Guidance,<br>That these materials pose a |
| | | | | very low biocompatibility risk,<br>and we have done the<br>appropriate biological tests<br>for this purpose, and the test<br>results show that it meets the<br>requirements. |
| Biocompatibility | Conforms to the requirements of<br>ISO 10993 series standards. | No Change | N/A | No new concerns.<br>The biocompatibility remains<br>consistent. |
| Performance<br>requirements | Remain no change | No Change | N/A | No new concerns.<br>Performance requirements<br>remain unchanged, ensuring<br>consistent functionality. |
| Label/Labeling | Complied with 21 CFR part 801 | No Change | N/A | No new concerns.<br>The labeling remains<br>consistent. |
Table 1 General Comparison of Lancet
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| Table 2 General Comparison of Lancing device | | | | |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate device<br>(K220475) | Proposed device | Comments on<br>Similarities/Differ<br>ences | Safety/Effectiveness<br>Statement |
| Product name | Lancing device | No Change | N/A | No new concerns.<br>The product name remains<br>unchanged |
| Product Code | QRL | No Change | N/A | No new concerns.<br>The product code remains<br>the same, reflecting no<br>change in device<br>functionality. |
| Regulation No. | 21 CFR § 878.4850 | No Change | N/A | No new concerns.<br>The regulation number<br>remains consistent. |
| Class | II | No Change | N/A | No new conc…
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