(90 days)
Not Found
No
The device description and performance studies focus on mechanical action and vacuum for blood collection, with no mention of AI/ML terms or functionalities.
No
The device is described as a blood lancing device for collecting samples, not for treating a condition or disease.
No
Explanation: The device is a blood lancing device intended for producing blood samples, not for diagnosing medical conditions. It facilitates the collection of samples but does not perform analysis or provide diagnostic information itself.
No
The device description clearly outlines a physical, single-use blood lancing device with mechanical components (springs, pistons, lancet array) and a sharps injury prevention feature. It is a hardware device, not software.
Based on the provided information, the RedDrop ONE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to produce microliter capillary whole blood samples. It explicitly states it "does not collect or transport such samples." IVD devices are used to examine specimens (like blood) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanism for lancing the skin and facilitating blood emergence. It does not describe any components or processes for analyzing or testing the blood sample itself.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of test, analysis, or measurement on the blood sample. Its function is purely to obtain the sample.
The RedDrop ONE is a blood lancing device, which is a tool used to obtain a blood sample, which may then be used with an IVD device for testing.
N/A
Intended Use / Indications for Use
The RedDrop ONE is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The RedDrop ONE Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The device is adhered to the skin in the selected position on the upper arm. The device is actuated by sliding the actuator causing an energized spring to release and deploy the lancet array. The lancet array is deployed to a maximum depth of 2 mm to access capillaries. The lancet array is then automatically retracted to a safe position that prevents sharps injury and re-activation. Sliding the actuator also releases two spring loaded pistons that create a gentle vacuum to the skin to facilitate the emergence of capillary blood from the sample site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical performance testing was conducted to confirm the device met its design specifications, intended use and substantial equivalence. Additional comparison testing to the predicate device was conducted to further support substantial equivalence. Testing also included: Package Integrity Testing including bubble leak per ASTM F2096 and Seal Strength per ASTM F88. Accelerated aging per ASTM F1980. Bacterial Endotoxins testing per ANSI/AAMI ST72.
The usability of the RedDrop ONE device with the instructions for use was evaluated in an actual-use study and is discussed in the clinical testing section of this submission. The device, in conjunction with the instructions for use, was found to be safe and effective for the intended use, and all residual risks were deemed acceptable for this type of device. An assessment of clinical performance data for the RedDrop ONE device successfully demonstrated its ability to produce blood samples from the upper arm of human subjects according to the device labeling. Subjects produced their blood samples following the instructions for use. The devices had a total success rate of over 95.0% and demonstrated that they performed as intended.
In addition, clinical and useability studies were conducted head-to-head with the predicate device to further confirm substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The devices had a total success rate of over 95.0%.
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.
TAP Lancet (K223201)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2024
RedDrop Dx Kris Buchanan CEO 2401 Research Blvd. #206 Fort Collins. Colorado 80526
Re: K234081
Trade/Device Name: RedDrop ONE (One) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: December 22, 2023 Received: December 22, 2023
Dear Kris Buchanan:
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 (the 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 and the limitations described below. 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.
The OHT4: Office of Surgical and Infection Control Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling in addition to being placed prominently immediately after any images or references to a collection tube:
-
- This device is only for use with compatible collection tubes that are cleared for use with this device:
-
- This device is not intended for use as a blood collection kit; and
1
-
- This device is not intended for at-home collection or collection by lay-users.
Furthermore, the indication for use "The RedDrop ONE is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples." must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
- This device is not intended for at-home collection or collection by lay-users.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 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 (OS) 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.
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 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-regulatory
2
assistance/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,
Binita S. Ashar -S
Binita Ashar, M.D., M.B.A., F.A.C.S. Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
RedDrop ONE (One)
Indications for Use (Describe)
The RedDrop ONE is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary – RedDrop ONE
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
| Submitter: | RedDrop Dx, Inc.
2401 Research Blvd. #206
Fort Collins, CO 80526
Phone: 970-443-8118
Contact: Kris Buchanan, CEO |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | December 20, 2023 |
| Device Trade Name: | RedDrop ONE Lancet |
| Common or Usual
Name: | Blood Lancet
Single Use Only Blood Lancet With An Integral Sharps Injury
Prevention Feature |
| Regulation Number: | 21 CFR 878.4850 |
| Device Class: | ll |
| Product Code: | FMK |
| Panel: | General Surgery OHT4 |
| Predicate Device: | TAP Lancet (K223201) |
| Device Description: | The RedDrop ONE Lancet is a single-use blood lancing
device with an integral sharps injury prevention feature
intended for producing microliter capillary whole blood
samples. The device is adhered to the skin in the selected
position on the upper arm. The device is actuated by sliding
the actuator causing an energized spring to release and
deploy the lancet array. The lancet array is deployed to a
maximum depth of 2 mm to access capillaries. The lancet
array is then automatically retracted to a safe position that
prevents sharps injury and re-activation. Sliding the actuator
also releases two spring loaded pistons that create a gentle
vacuum to the skin to facilitate the emergence of capillary
blood from the sample site. |
| Intended Use/
Indications for Use: | The RedDrop ONE Lancet is a single-use blood lancing
device intended for producing microliter capillary whole blood
samples. It does not collect or transport such samples. |
| Indications for Use
Comparison: | The indications for use of the candidate device are the same
as the indications for use of the predicate device. |
| Technological
Comparison: | Penetration of capillary blood vessels and application of
vacuum to draw out whole blood samples is the underlying
principle of both the subject and predicate devices. At a high
level, the subject and predicate device are both based on the
same technological elements:
A spring-loaded array of sharp needles to penetrate
skin to reach capillary vessels. A retraction mechanism to withdraw the needle array
from the skin to a location where it can no longer be
accessed. A lock-out feature to permanently prevent the needles
from being re-deployed. A mechanical means of manual activation. A means of sealing the device to the skin. A means of using spring force to create vacuum at the
incision site. The following technological differences exist between the
subject and predicate devices: The subject device stores some spring energy in the
device that the predicate device requires the user to
supply. The predicate device requires an actuation force that is
directed toward the body. A lighter actuation force of
the subject device is applied parallel to the body. |
| Non-Clinical
Performance Testing: | Non-Clinical performance testing was conducted to confirm
the device met its design specifications, intended use and
substantial equivalence. Additional comparison testing to the
predicate device was conducted to further support substantial
equivalence. Testing also included: |
| | Package Integrity Testing including bubble leak per ASTM
F2096 and Seal Strength per ASTM F88. |
| | Accelerated aging per ASTM F1980. |
| | Bacterial Endotoxins testing per ANSI/AAMI ST72. |
| Clinical Testing,
Summary and
Conclusions | The usability of the RedDrop ONE device with the instructions
for use was evaluated in an actual-use study and is discussed
in the clinical testing section of this submission. The device, in
conjunction with the instructions for use, was found to be safe |
| and effective for the intended use, and all residual risks were
deemed acceptable for this type of device. An assessment of
clinical performance data for the RedDrop ONE device
successfully demonstrated its ability to produce blood
samples from the upper arm of human subjects according to
the device labeling. Subjects produced their blood samples
following the instructions for use. The devices had a total
success rate of over 95.0% and demonstrated that they
performed as intended. | |
| In addition, clinical and useability studies were conducted
head-to-head with the predicate device to further confirm
substantial equivalence. | |
5
6