(56 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is used to obtain blood samples, which is a diagnostic purpose, not a therapeutic one. It facilitates the collection of data for diagnosis rather than treating a condition.
No
This device is used to obtain capillary blood samples (lancing device), which is a step performed to collect samples for diagnostic testing, but the device itself does not perform any diagnostic analysis or provide diagnostic information.
No
The device description explicitly states it is a "Lancing device" and describes physical components and performance testing related to mechanical function (penetration depth, bounce, puncture, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain capillary blood samples." This is a device used to collect a sample, not to test or analyze the sample itself.
- Device Description: The description focuses on the mechanical function of the device (lancing, penetration depth, single patient use). It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, test strips, analytical methods, or any other elements typically associated with in vitro diagnostic devices.
- Performance Studies: The performance studies described (biocompatibility, bench testing) focus on the physical and mechanical performance of the lancing device, not on the accuracy or reliability of a diagnostic test.
An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or screening purposes. This lancing device is simply a tool for obtaining the specimen.
N/A
Intended Use / Indications for Use
Lancing device is used with disposable blood lancet to obtain capillary blood samples.
Product codes G
QRL
Device Description
Lancing device is used with disposable blood lancet to obtain capillary blood samples. It has multiple penetration depth levels, normally 6 or 9. Lancing device is for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip Palm (AST end cap) Forearm (AST end cap)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Intracutaneous reactivity
Non-clinical data
The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: - Appearance and Printing appearance
- Basic Dimensions
- Compatible performance
- Bounce performance
- Puncture performance
- Adjustable performance
- Lancet unloading performance
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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August 30, 2022
SteriLance Medical(Suzhou) Inc. Susan Sun Quality Manager No.168 PuTuoShan Road Suzhou, Jiangsu 215153 China
Re: K221970
Trade/Device Name: Lancing device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: June 22, 2022 Received: July 5, 2022
Dear Susan Sun:
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 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
1
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,
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) K221970
Device Name Lancing device
Indications for Use (Describe)
Lancing device is used with disposable blood lancet to obtain capillary blood samples.
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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3
5 510(k) Summary
Section 5_510(k) Summary 5- 1 / 5
4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2022/6/20
1. Submission sponsor
Name: SteriLance Medical (Suzhou) Inc. Address: No.168 PuTuoShan Road, New District, 215153 Suzhou, Jiangsu, P. R. China Contact person: Susan Sun Title: Quality Manager E-mail: registration@sterilance.com Tel: 86-0512-65799308 Ext 9294
2. Subject Device Information
| Trade/Device Name | Lancing device |
|---|---|
| Model | LDE; LDE AST; LDE4; LDE4 AST; NanoSense; OneStep |
| Common Name | Lancing device |
| Regulatory Class | Class II |
| Classification | 21CFR 878.4850 / Multiple use blood lancet for single patient use |
| only / QRL | |
| Submission type | Traditional 510(K) |
3. Predicate Device
ACON Laboratories, Inc., On call® Lancing device under K113332.
4. Device Description
Lancing device is used with disposable blood lancet to obtain capillary blood samples. It has multiple penetration depth levels, normally 6 or 9. Lancing device is for single patient use only.
న. Intended use & Indication for use
Lancing device is used with disposable blood lancet to obtain capillary blood samples.
6. Comparison to the Predicate Device
| Comparison item | Subject Device:Lancing device | Predicate Device: On call® Lancing device (K113332) | Comparison |
|---|---|---|---|
| Product code | QRL | NBW | Different¹ |
| Regulation code | 21CFR 878.4850 | 21CFR 862.1345 | Different¹ |
| Classification | Class II | Class II | Same |
| Type of use | OTC | OTC | Same |
5
| Intended use
& indications
for use | Lancing device is used with the disposable blood lancet to obtain capillary
blood samples. | | | | | The On Call® Lancing
Device is used with On
Call® disposable sterile
lancets to draw capillary
blood from the fingertip,
palm (at the base of the
thumb) or forearm, for
blood glucose testing or
other testing utilizing small
amounts of blood. The On
Call® Lancing Device is
intended to be used by a
single patient and should
not be shared. | Similar |
|------------------------------------------|-------------------------------------------------------------------------------------------------|-----------|-----------|-----------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Reuse
durability | Multi use for single patient | | | | | Multi use for single patient | Same |
| Self life | 5years | | | | | 5years | Same |
| Depth
adjustment | Model | LDE | LDE4 | NanoSense | OneStep | 6 gear
Puncture depth Requirement
(Unit:mm) | Different2 |
| | 1-gear | 0.60±0.30 | 0.50±0.30 | 0.80±0.30 | 0.60±0.30 | Gear 1 0.60mm±0.30mm | |
| | 1.5-gear | / | 0.70±0.30 | 0.95±0.30 | 0.75±0.30 | Gear 2 0.90mm±0.30mm | |
| | 2-gear | 0.90±0.30 | 0.90±0.30 | 1.10±0.30 | 0.90±0.30 | Gear 3 1.20mm±0.30mm | |
| | 2.5-gear | / | 1.10±0.30 | 1.25±0.30 | 1.05±0.30 | Gear 4 1.50mm±0.30mm | |
| | 3-gear | 1.20±0.30 | 1.30±0.30 | 1.40±0.30 | 1.20±0.30 | Gear 5 1.80mm±0.30mm | |
| | 3.5-gear | / | 1.50±0.30 | 1.55±0.30 | 1.35±0.30 | Gear 6 2.10mm±0.30mm | |
| | 4-gear | 1.50±0.30 | 1.70±0.30 | 1.70±0.30 | 1.50±0.30 | | |
| | 4.5-gear | / | 1.90±0.30 | 1.85±0.30 | 1.65±0.30 | | |
| | 5-gear | 1.80±0.30 | 2.10±0.30 | 2.00±0.30 | 1.80±0.30 | | |
| | 6-gear | 2.10±0.30 | / | / | / | | |
| | The puncture depth of LDE AST and LDE4 AST is more than 1.1mm
which is Non adjustable depth. | | | | | | |
| Mechanical
loading | Spring-driven | | | | | Spring-driven | Same |
| Puncture
sites | Fingertip
Palm (AST end cap)
Forearm (AST end cap) | | | | | Fingertip
Palm
Forearm | Same |
| Materials of
parts in | Priming barrel: ABS
Ejector: POM | | | | | Plastic composition: ABS
Clear cap: Transparent | Different3 |
Section 5_510(k) Summary
5- 3 / 5
5- 3 / 5
6
| contact with
human body | Lancet holder: ABS
Trigger button: ABS
Adjusting head inner core: ABS
Out cover: ABS
End Cap: ABS
AST end cap: PS | ABS | |
| ---------------------------- | ---------------------------------------------------------------------------------------------------------------------------------- | ----- | -- |
|---|
Different': The classification and Regulation number are different because FDA issued the final order about Reclassification of Blood Lancets on 11/22/2021.
Similar: The intended use is same. The subject device is draw capillary blood from the fingertip, and use AST end cap can draw capillary blood from palm or forearm. The difference does not raise any safety and effectiveness questions.
Different: The puncture depth adjustment difference does not raise any safety and effectiveness questions. The puncture depth was verified in the performance test report.
Different : The raw materials of proposed devices may be different from the predicate devices.
However, all the materials are known biocompatible materials that have been used in lancing device or other similar medical devices.
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization ●
- Intracutaneous reactivity ●
Non-clinical data
The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Appearance and Printing appearance
- Basic Dimensions
- Compatible performance
- Bounce performance
- Puncture performance
- Adjustable performance
- Lancet unloading performance
Section 5 510(k) Summary 5- 4 / 5
7
8. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.