(90 days)
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.
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.
The RedDrop ONE (One) device, a single-use blood lancing device, underwent clinical testing to demonstrate its performance and meet acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Total Success Rate | Over 95.0% |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the test set is not explicitly stated as a number of participants. However, the summary mentions that "Subjects produced their blood samples following the instructions for use."
The data provenance is prospective, as indicated by the "actual-use study" and subjects actively producing blood samples. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The study focuses on the device's ability to produce blood samples rather than a diagnostic interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (producing blood samples), adjudication by experts for ground truth is unlikely in the same way it would be for an AI diagnostic device. The "success" was likely objectively measured based on whether a blood sample was successfully produced.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study involving human readers and AI assistance was not conducted. This device is a lancing device for obtaining blood samples, not an AI diagnostic algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The RedDrop ONE is a physical medical device, not an algorithm. Its performance inherently involves a "human-in-the-loop" to operate it.
7. Type of Ground Truth Used
The ground truth used was the ability of the device to "produce blood samples from the upper arm of human subjects according to the device labeling." This implies an objective measurement of whether a sufficient micro-liter capillary whole blood sample was successfully obtained after using the device as instructed.
8. Sample Size for the Training Set
Not applicable. This device is a physical lancing device and does not involve AI algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for this physical medical device.
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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
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-
- 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
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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
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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)
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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. #206Fort Collins, CO 80526Phone: 970-443-8118Contact: Kris Buchanan, CEO |
|---|---|
| Date of Summary: | December 20, 2023 |
| Device Trade Name: | RedDrop ONE Lancet |
| Common or UsualName: | Blood LancetSingle Use Only Blood Lancet With An Integral Sharps InjuryPrevention 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 lancingdevice with an integral sharps injury prevention featureintended for producing microliter capillary whole bloodsamples. The device is adhered to the skin in the selectedposition on the upper arm. The device is actuated by slidingthe actuator causing an energized spring to release anddeploy the lancet array. The lancet array is deployed to amaximum depth of 2 mm to access capillaries. The lancetarray is then automatically retracted to a safe position thatprevents sharps injury and re-activation. Sliding the actuatoralso releases two spring loaded pistons that create a gentlevacuum to the skin to facilitate the emergence of capillaryblood from the sample site. |
| Intended Use/Indications for Use: | The RedDrop ONE Lancet is a single-use blood lancingdevice intended for producing microliter capillary whole bloodsamples. It does not collect or transport such samples. |
| Indications for UseComparison: | The indications for use of the candidate device are the sameas the indications for use of the predicate device. |
| TechnologicalComparison: | Penetration of capillary blood vessels and application ofvacuum to draw out whole blood samples is the underlyingprinciple of both the subject and predicate devices. At a highlevel, the subject and predicate device are both based on thesame technological elements:A spring-loaded array of sharp needles to penetrateskin to reach capillary vessels. A retraction mechanism to withdraw the needle arrayfrom the skin to a location where it can no longer beaccessed. A lock-out feature to permanently prevent the needlesfrom 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 theincision site. The following technological differences exist between thesubject and predicate devices: The subject device stores some spring energy in thedevice that the predicate device requires the user tosupply. The predicate device requires an actuation force that isdirected toward the body. A lighter actuation force ofthe subject device is applied parallel to the body. |
| Non-ClinicalPerformance Testing: | Non-Clinical performance testing was conducted to confirmthe device met its design specifications, intended use andsubstantial equivalence. Additional comparison testing to thepredicate device was conducted to further support substantialequivalence. Testing also included: |
| Package Integrity Testing including bubble leak per ASTMF2096 and Seal Strength per ASTM F88. | |
| Accelerated aging per ASTM F1980. | |
| Bacterial Endotoxins testing per ANSI/AAMI ST72. | |
| Clinical Testing,Summary andConclusions | The usability of the RedDrop ONE device with the instructionsfor use was evaluated in an actual-use study and is discussedin the clinical testing section of this submission. The device, inconjunction with the instructions for use, was found to be safe |
| and effective for the intended use, and all residual risks weredeemed acceptable for this type of device. An assessment ofclinical performance data for the RedDrop ONE devicesuccessfully demonstrated its ability to produce bloodsamples from the upper arm of human subjects according tothe device labeling. Subjects produced their blood samplesfollowing the instructions for use. The devices had a totalsuccess rate of over 95.0% and demonstrated that theyperformed as intended. | |
| In addition, clinical and useability studies were conductedhead-to-head with the predicate device to further confirmsubstantial equivalence. |
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§ 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.