(129 days)
The ImPress is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
The LetsGetChecked ImPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressed against the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.
The provided FDA 510(k) summary for the LetsGetChecked ImPress blood lancing device (K242680) outlines several non-clinical performance studies conducted to demonstrate substantial equivalence to its predicate device (TAP Lancet, K223201). However, it does not include a table of acceptance criteria and reported device performance for the usability study, nor does it provide detailed information regarding the study design elements typically found for a study proving acceptance criteria.
The information provided primarily focuses on the device's technical characteristics and the types of non-clinical tests performed. It mentions usability testing but lacks specific performance metrics or acceptance criteria for that test.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given document. While it states that "Usability Testing was performed to verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device," it does not specify the quantitative or qualitative acceptance criteria for these aspects or the actual performance results against those criteria.
2. Sample size used for the test set and the data provenance
For the Usability Testing: The document does not specify the sample size used for this test. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided for the usability testing or any other test. "Ground truth" in the context of usability would typically refer to expert evaluation of user performance or validated criteria for "good" usability.
4. Adjudication method for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, often with AI assistance. This device is a blood lancing device, not an imaging diagnostic tool. Therefore, an MRMC study was not performed, and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is also more relevant for AI/ML-driven diagnostic or assistive devices. As the LetsGetChecked ImPress is a mechanical blood lancing device, it does not involve algorithms or AI. Therefore, a standalone algorithm-only performance study was not performed, and this question is not applicable.
7. The type of ground truth used
For the usability testing, the "ground truth" would likely be defined by a set of pre-established usability goals and criteria, as the device is mechanical and its function is to produce blood samples. The document states the usability testing aimed to "verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device." This implies a combination of:
- Performance-based criteria: Successful production of blood samples.
- Qualitative user feedback: Ease of use and user satisfaction.
- Compliance with instructions: Verification of user comprehension.
However, the specific methods for establishing these "truths" (e.g., expert observation, direct measurement, user questionnaires with pre-defined success rates) are not detailed.
8. The sample size for the training set
This question is applicable to devices involving machine learning or AI. As the ImPress is a mechanical device, there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
As there is no training set (see point 8), this question is not applicable.
Summary of what is available and what is missing:
The document lists several non-clinical studies conducted (Shelf-life, Transport, Biocompatibility, Usability, Accidental Drop) and states their purpose (confirm specifications, intended use, substantial equivalence). For the Usability Testing, it broadly describes the goals (user comprehension, ability to produce samples, ease of use, satisfaction). However, it lacks the specific quantitative or qualitative acceptance criteria and the detailed results of these tests, which would directly "prove" the device meets acceptance criteria. Furthermore, details regarding sample sizes, ground truth establishment, expert involvement, and adjudication methods for the usability study are not provided in this specific FDA letter and summary.
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January 13, 2025
PrivaPath Diagnostics Ltd (dba LetsGetChecked) Karen Walsh Director of Manufacturing Quality and Regulatory Unit 1. Northern Cross Business Park North Road, Dublin 11 Dublin, D11XT26 Ireland
Re: K242680
Trade/Device Name: LetsGetChecked Impress Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: September 6, 2024 Received: December 10, 2024
Dear Karen Walsh:
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
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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;
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- 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 ImPress 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.
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 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 (QS) 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.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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.
HEATHED Digitally signed by
HEATHER HEATHER AGLER -S Date: 2025.01.13 AGLER -S 17:06:24 -05'00'
for 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
Submission Number (if known)
Device Name
LetsGetChecked ImPress
Indications for Use (Describe)
The ImPress 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 K242680 | Prepared on: 2024-12-09 | |
|---|---|---|
| -- | ------------------------ | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | PrivaPath Diagnostics Ltd (dba LetsGetChecked) |
| Applicant Address | Unit 1, Northern Cross Business Park North Road, Dublin 11, D11XT26, Ireland Dublin D11XT26 Ireland |
| Applicant Contact Telephone | 003538724 4 2164 |
| Applicant Contact | Ms. Karen Walsh |
| Applicant Contact Email | kwalsh@letsgetchecked.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | LetsGetChecked Impress |
| Common Name | Blood Lancets |
| Classification Name | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Regulation Number | 878. 4850 |
| Product Code(s) | FMK |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K223201 | TAP Lancet | FMK |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The LetsGetChecked ImPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressed against the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
|---|---|
| ---------------------------------- | --------------------- |
The ImPress 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 | 21 CFR 807.92(a)(5) |
|---|---|
| -------------------------------- | --------------------- |
Indications for use are the same as the predicate.
| Technological Comparison | 21 CFR 807.92(a)(6) |
|---|---|
| -------------------------- | --------------------- |
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The indications for use of the candidate device has been found to the selected predicate device. Penetration of capillary blood vessels and application of vacuum to draw out wholes 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:
- Spring-loaded blade(s) to penetrate skin to reach capillary vessels. .
- A retraction mechanism to withdraw the blades(s) 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.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical performance studies were conducted to confirm the device met specifications intended use, and to demonstrate substantial equivalence. The following testing was conducted:
-
Shelf-life Testing per ASTM F1980
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Transport testing per D7386-16 and D4169-22
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Biocompatibility Testing per 10993-5 (Cytotoxicity)
Usability Testing was performed to verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device.
Accidental Drop Testing
The performance testing conducted as part of the 510k) submission provides robust evidence that the candidate device meets or exceeds the safety, effectiveness, and performance standards of the predicate device.
The nondinical testing conducted on the device demonstrate that it is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified as per section 21 CFR 807.92(a)(3). The testing results support the conclusion that the device meets all relevant safety and performance criteria, ensuring its suitability for its intended use.
§ 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.