(100 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biological compatibility of a simple mechanical lancet, with no mention of AI/ML terms or functionalities.
No
The device is used for capillary blood collection, which is a diagnostic procedure, not a therapeutic one.
No
This device is used for capillary blood collection, which is a method of obtaining a sample, not performing a diagnosis. The device description and performance studies focus on the physical characteristics and safety of the lancet, not on its ability to detect or identify a medical condition.
No
The device description explicitly states it is a physical device comprising a stainless needle encapsulated with a plastic body and cap, and the performance studies focus on physical characteristics and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for capillary blood collection." This describes a device used to obtain a biological sample, not to test or analyze it.
- Device Description: The description focuses on the physical components and function of collecting blood. There is no mention of reagents, test strips, or any components designed to perform a diagnostic test on the collected blood.
- Lack of Diagnostic Function: An IVD device is specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This lancet's function ends with the collection of the blood sample.
While the blood collected by the lancet can be used for IVD testing, the lancet itself is a tool for sample collection, not a diagnostic device.
N/A
Intended Use / Indications for Use
Disposable Blood Lancet is used for capillary blood collection.
Product codes
QRK, QRL
Device Description
Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood collection. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use. The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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 bench testing performed verifies that the performance of the proposed device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests are as follow:
- Appearance and Cleanliness and Needle tip appearance
- Needle dimension, Exposed length of product
- Cap site, Needle tip sharpness and Binding Strength
- Double needles. Empty needle and Reverse needle
- Compatibility test between Disposable blood lancet and Lancing Device
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process". The tests include the following tests: In Vitro Cytotoxicity (ISO 10993-5: 2009, No Cytotoxicity), Skin Sensitization (ISO 10993-10: 2010, No Skin sensitization), Intracutaneous reactivity (ISO 10993-10: 2010, No irritation), Acute Systemic Toxicity (ISO 10993-11: 2017, No Acute Systemic Toxicity), Material-Mediated Pyrogenicity (ISO 10993-11: 2017, Absence of pyrogen). No clinical tests were performed.
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
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 31, 2022
SteriLance Medical (Suzhou) Inc. Ms. Susan Sun Manager No.168 PuTuoShan Road, New District Suzhou, Jiangsu 215153 China
Re: K221507
Trade/Device Name: Disposable Blood Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK,QRL Dated: July 28, 2022 Received: August 4, 2022
Dear Ms. 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) K221507
Device Name Disposable Blood Lancet
Indications for Use (Describe) Disposable Blood Lancet is used for capillary blood collection.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Date of Summary prepare: August 31, 2022
1. Submission Sponsor
| Applicant Name | SteriLance Medical (Suzhou) Inc. |
|---|---|
| Address | No.168 PuTuoShan Road, New District, 215153 Suzhou, |
| Jiangsu, P.R.China | |
| Contact person | Susan Sun |
| Phone | +86-512-65799308 |
2. Submission correspondent
| Name | SteriLance Medical (Suzhou) Inc. |
|---|---|
| Address | No.168 PuTuoShan Road, New District, 215153 |
| Suzhou, Jiangsu, P.R.China | |
| Post Code | 215153 |
| Phone No. | +86-512-65799308 |
| Contact Person | Susan Sun |
| registration2@sterilance.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Blood Lancet |
| Model: | Soft |
| Classification name: | Lancet, Blood |
| Review Panel: | General & Plastic Surgery |
| Product Code: | QRK, QKL |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4850 |
4. Legally Marketed Predicate Device
| Trade Name | Promisemed Blood Lancet |
|---|---|
| Regulation number | 21 CFR 878.4800 |
| Regulation class | I |
| Regulation name | Manual Surgical Instrument for General Use |
| 510(k) Number | K192666 |
| Product Code | FMK |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd. |
4
5. Device Description
Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood collection. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use.
The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.
6. Intended Use/ Indications for Use
Disposable Blood Lancet is used for capillary blood collection.
| Comparison
item | Subject Device:
Disposable Blood Lancet
(K221507) | Predicate Device:
Promisemed Blood Lancet
(K192666) | Comments |
|----------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------|-------------|
| Product Code | QRK, QKL | FMK | Different 1 |
| Regulation
Number | 21 CFR § 878.4850 | 21 CFR § 878.4800 | Different1 |
| Classification | Class II | Class I | Different 1 |
| Type of use | OTC | OTC | Same |
| Intended
use &
Indication
s for Use | Disposable Blood Lancet is
used for capillary blood
collection. | It is intended for capillary
blood sampling. | Same |
| Applicable
user | Adult and pediatric | Adult and pediatric | Same |
| Reuse
durability | Single use | Single use | Same |
| Sterilization
method and
SAL | Sterilized by Radiation
SAL=10-6 | Sterilized by Radiation
SAL=10-6 | Same |
| Shelf life | 5 Years | 3 Years | Different 2 |
| Component | Needle, Needle body,
and
Protective cap | Needle, Needle body, and
Cap | Same |
7. Technological characteristics comparison
5
| Comparison
item | Subject Device:
Disposable Blood Lancet
(K221507) | Predicate Device:
Promisemed Blood Lancet
(K192666) | Comments |
|---------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|----------|
| Specification
(needle
diameter) | 21G, 23G, 26G, 28G, 30G,
32G, 33G | Contain a variety of gauge
(unknown the detail) | Similar |
| Materials | Needle: stainless steel
Needle body and cap:
Polyethylene | Needle: stainless steel
Needle body and cap:
Polyethylene | Same |
Different 1 : On November 22, 2021, FDA reclassified blood lancet, therefore, the product code, regulation number and classification are different.
Different 2 : The shelf life of the subject device is different from the predicate device. The shelf life
of the subject device has been verified in accordance with ASTM F1980, demonstrating that the performance of the device and the integrity of the sterile barrier remain stable over the claimed 5year shelf life. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
Similar: In ISO 9626, the needle size is designated by nominal diameter, corresponding gauge size. Gauge size ranges from 10G-34G. The difference in gauge size does not affect intended use. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
8. Summary of non-clinical testing
*Performance Testing
The bench testing performed verifies that the performance of the proposed device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests are as follow:
- Appearance and Cleanliness and Needle tip appearance
- . Needle dimension, Exposed length of product
- Cap site, Needle tip sharpness and Binding Strength ●
- Double needles. Empty needle and Reverse needle
- Compatibility test between Disposable blood lancet and Lancing Device ●
*Biocompatibility
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk
6
| Item | Test method | Test result |
|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | No Cytotoxicity |
| Skin Sensitization | ISO 10993-10: 2010 | No Skin sensitization |
| Intracutaneous reactivity | ISO 10993-10: 2010 | No irritation |
| Acute Systemic Toxicity | ISO 10993-11: 2017 | No Acute Systemic Toxicity |
| Material-Mediated | ||
| Pyrogenicity | ISO 10993-11: 2017 | Absence of pyrogen |
Management Process". The tests include the following tests:
9. Brief discussion of clinical tests
No clinical tests were performed.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Disposable Blood Lancets are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K192666.