(57 days)
No
The device description and performance studies focus on mechanical function and physical testing, with no mention of AI or ML.
No
The device is used to collect capillary blood for testing purposes, not to treat a disease or condition.
No
The device collects capillary blood for testing, but it does not perform the testing or analysis itself. It is a lancing device for sample collection.
No
The device description clearly details a physical lancing device made of ABS plastic, aluminum, and stainless steel, with mechanical components for puncturing the skin. It does not describe a software-only product.
Based on the provided information, the One Drop Lancing Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The One Drop Lancing Device's primary function is to collect the specimen (capillary blood) by puncturing the skin. It does not perform any analysis or testing on the blood itself.
- The device description clearly states its purpose is to "function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing." This describes a tool for sample collection, not a diagnostic test.
- The blood glucose testing itself, which would be performed on the collected blood, is the IVD component. The lancing device is a necessary accessory for obtaining the sample for that IVD test.
Therefore, the One Drop Lancing Device is a medical device used in conjunction with an IVD (the blood glucose test), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.
Product codes
QRL, QRK
Device Description
The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet
The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites.
The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed.
The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single patient use in a home setting.
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
Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied. This includes mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the device continued to meet the specified requirements. Physical testing included dimensional measurements, function reliability drop test, piercing depth test, and cock force test. Biocompatibility was evaluated through a battery of tests to meet ISO 10993-1 requirements.
Compatibility between the One Drop branded Lancets and the One Drop Lancing Device was tested previously under 510(k) K221383 under the device name MedtFine Blood Lancet, which is the same device as the One Drop branded Lancets.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
February 15, 2023
STAT Medical Devices % Mr. Kevin Walls, MBA Principal Consultant FDA Compliance Group 33 Golden Eagle Lane Littleton. Colorado 80127
Re: K223815
Trade/Device Name: ONE DROP Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: QRL,QRK Dated: December 20, 2022 Received: December 20, 2022
Dear Mr. Walls:
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
1
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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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)
Device Name
ONE DROP Lancing Device
Indications for Use (Describe)
The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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3
One Drop Lancing Device 510(k) Summary
Name and Address of Sponsor
STAT Medical Devices 2056 N.E. 153rd Street North Miami Beach, FL 33162 Hemel Mariano (Quality Manager) 305-945-0011 Ext. 312 hmariano@statdevices.com
Establishment Registration Number: 1058955
Document Date: 02/01/2023
Name and Address of Official Correspondent
FDA Compliance Group 33 Golden Eagle Lane Littleton, Colorado 80127 Contact: Mr. Kevin Walls, MBA Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
Device Information
Trade Name: One DropLancing Device Common Name: Blood Lancets & Lancing Devices Classification Name: Blood lancets Requlation Number: 878.4850, Class II Product Code: QRL, QRK
Device Description
The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet
The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites.
The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level
4
by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed.
The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.
Indications for Use
The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.
Legally Marketed Predicate Device
Predicate #: K214022
Predicate Trade Name: Accu-Chek Softclix Blood Lancing System
Product Code: QRL, QRK
Similarities and Differences between Candidate Device and Predicate Device:
| | Predicate Device - Accu-Chek Softclix
Blood Lancing System K214022 | Candidate Device – One Drop
Lancing Device |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | Accu-Chek Softclix Blood Lancing
Device uses Accu-Chek Softclix
Lancets to obtain a drop of blood from
a fingertip or alternate sites using the
Accu-Chek Softclix Alternate Site
Testing (AST) Cap. | One Drop Lancing Device uses the
One Drop branded Lancets to obtain
a drop of blood from a fingertip. |
| Intended
Use | Accu-Chek Softclix Blood Lancing
Device System is intended for the
hygienic collection of capillary blood for
testing purposed from the side of a
finger and from alternate site, such as
the palm, the upper arm, and the
forearm. | One Drop Lancing Device is intended
for the hygienic collection of capillary
blood for testing purposed from the
side of a finger. |
5
| Indications
for Use | The Accu-Chek Softclix Blood 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 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. | The One Drop Lancing Device is for use
with One Drop branded Lancets to
collect capillary blood for testing
purposes from the fingertip. The One
Drop Lancing Device is for single patient
use in a home setting. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of
Uses | Base (lancing device) – multiple use | Base (lancing device) – multiple use |
| | Lancet - single use | Lancet - single use |
| Device
Images | Lancing Device & AST Cap: | Lancing Device: |
| ONE DROP | ||
|---|---|---|
6
| | Image: Lancet and lancet cap | One Drop branded Lancet (K221383):
Image: One Drop branded Lancet |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lancet
Sterility | Yes, gamma irradiation | Yes, gamma irradiation |
| Needle | 0.4mm (28G); beveled cut with 3 facets | 0.21mm (33G); beveled cut with 3 facets |
| Depth
Adjustment | 11 levels by twisting cap | 5 depth settings by sliding lever |
| Mechanical
Loading | Spring-driven | Spring-driven |
| Load and
Firing | Load by pressing priming button when
lancet is inserted,
Fire by pressing release button | Load by advancing lancet into holding
section and pushing down,
Fire by pressing release button |
| Anatomical
Sites | Fingertip
Ball of hand (palm)
Upper arm
Lower arm | Fingertip |
| Sharps
Injury
Prevention | Lancets are covered by a sterile barrier
cap until twisted off before use. Until
firing, the lancet is contained within the
lancing device housing. Immediately
after firing, the lancet is automatically
retracted back into the housing. An
ejector sleeve can then be pulled
forward for contactless disposal of the
lancet. | Lancets are covered by a sterile barrier
cap until twisted or pulled off before
use. Until firing, the lancet is contained
within the lancing device housing.
Immediately after firing, the lancet is
automatically retracted back into the
housing. An ejector sleeve can then be
pulled forward for contactless disposal
of the lancet. |
7
Non-Clinical Testing Summary and Conclusions
Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied. This includes mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the device continued to meet the specified requirements. Physical testing included dimensional measurements, function reliability drop test, piercing depth test, and cock force test. Biocompatibility was evaluated through a battery of tests to meet ISO 10993-1 requirements.
Compatibility between the One Drop branded Lancets and the One Drop Lancing Device was tested previously under 510(k) K221383 under the device name MedtFine Blood Lancet, which is the same device as the One Drop branded Lancets.
Conclusion
The intended use, technology, non-clinical testing, and functionality of the One Drop Lancing Device demonstrate a substantially equivalent safety and effectiveness profile to the predicate device.