Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties of a lancing device, with no mention of AI, ML, or data processing capabilities.

Therapeutic

No
The device is described as being for "hygienic collection of capillary blood for testing purposes" and obtaining a "capillary blood sample for testing purposes," indicating it is for diagnostic or monitoring purposes, not for treating a disease or condition.

Diagnostic

No

The device is a lancing device used for collecting blood samples. It does not perform any analysis or offer a diagnosis based on the collected blood.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "reusable blood lancet holder" and the performance studies detail mechanical testing and cleaning/disinfection validation, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The device's intended use is for the collection of capillary blood. It does not perform any diagnostic testing on the blood sample itself.
Device Description: It is described as a "reusable blood lancet holder" used "for obtaining a capillary blood sample for testing purposes." This reinforces its role in sample collection, not analysis.
Lack of Diagnostic Function: There is no mention of the device analyzing the blood, interacting with reagents, or providing any diagnostic results.
Performance Studies: The performance studies focus on the mechanical function, safety (sharp object injuries, bloodborne pathogens), and cleaning/disinfection of the lancing device itself. They do not involve evaluating the accuracy or performance of a diagnostic test.
Predicate Device: The predicate device (Accu-Chek Softclix Blood Lancing Device) is also a lancing device, which is a sample collection tool, not an IVD.

IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This lancing device's function is solely to obtain the sample, which is then used with a separate diagnostic device (like a blood glucose meter).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygjenic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Product codes

QRL

Device Description

The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Fingertip
Forearm

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended Use: Single patient in a home setting.
Not suitable for use by healthcare professionals with multiple patients in a healthcare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical bench testing was performed per the special controls in 21 CFR 878.4850(c). This included design verification & validation testing to ensure that the lancet blade can be manually changed with every use, that the structure and materials are consistent with the intended use and address the risk of sharp object injuries and blood borne pathogen transmission, and mechanical performance testing to demonstrate that the device will withstand the forces encountered during use.

Tests Performed and Results:
Mechanical performance verification for TRUEdraw lancing device:

Materials and mechanical characteristics - Pass
Operation of the lancing device - Pass
Product life and shock conditions - Pass
Cosmetic attributes - Pass

Mechanical performance verification for mini lancing device:

Materials and mechanical characteristics - Pass
Operation of the lancing device - Pass
Product life and shock conditions - Pass
Cosmetic attributes - Pass

Compatibility with commonly available general use lancets:

Critical dimensions (lancet body diameter, exposed needle length, body length) - Pass
Fit - Pass

Cleaning and disinfection validation - TRUEdraw lancing device and alternate site cap: 1,095 cleaning and disinfecting cycles using Super Sani-Cloth Wipes.
Pass. The TRUEdraw lancing device and alternate site cap may be cleaned and disinfected with Super Sani-Cloth Wipes once-daily for 3-years.

Cleaning and disinfection validation - mini lancing device and alternate site cap: 1,095 cleaning and disinfecting cycles using Super Sani-Cloth Wipes.
Pass. The mini lancing device and alternate site cap may be cleaned and disinfected with Super Sani-Cloth Wipes once-daily for 3-years.

Clinical testing is not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K214022

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

10/18/2022

Trividia Health Jacqueline Davis Global Regulatory Affairs Specialist IV 2400 N.W. 55th Court Fort Lauderdale, Florida 33309

Re: K221072

Trade/Device Name: TRUEdraw Lancing Device, Mini Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: September 20, 2022 Received: September 21, 2022

Dear Jacqueline Davis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K221072

Device Name

TRUEdraw Lancing Device; Mini Lancing Device

Indications for Use (Describe)

The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygjenic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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."

3

K221072 - TRUEdraw Lancing Device; Mini Lancing Device 510(k) Summary

Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Trividia Health
Applicant Address	2400 N.W. 55th Court
Ft. Lauderdale, FL 33309 United States
Applicant Contact Telephone	(800) 342-7226
Applicant Contact	Ms. Jacqueline Davis
Applicant Contact Email	jdavis@trividiahealth.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	TRUEdraw Lancing Device; Mini Lancing Device
Common Name	Lancing device
Classification Name	Multiple Use Blood Lancet For Single Patient Use Only
Regulation Number	878.4850(c)
Product Code	QRL
Legally Marketed Predicate Device	21 CFR 807.92(a)(3)
Predicate #	K214022
Predicate Trade Name	Accu-Chek Softclix Blood Lancing Device
Product Code	ORL

Device Description Summary

The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.

Intended Use/Indications for Use

The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Indications for Use Comparison 21 CFR 807.92(a)(5)

The indications for use of the subject devices are the same as the predicate with the exception that the subject devices are indicated for the forearm as an alternative site and the alternative sites for the predicate devices include the palm, upper arm, and forearm.

Technological Comparison 21 CFR 807.92(a)(6)

The subject devices have the same technological characteristics as the predicate device in terms of design and general type of materials used, principle of operation, usage, features, and function.

4

	Subject Devices	Predicate Device
	TRUEdraw Lancing Device;
Mini Lancing Device	Accu-Chek Softclix Lancing Device
(cleared as part of the Accu-Chek
Softclix Blood
Lancing System under K214022)
Description	The TRUEdraw/ Mini Lancing
Device is a reusable lancet base
that uses compatible single-use,
sterile lancets to obtain a drop of
blood from a fingertip or
alternative site (forearm) using the
clear end cap.	The Accu-Chek Softclix Lancing
Device uses compatible Accu-Chek
Softclix Lancets to obtain a drop of
blood from a fingertip or
alternative sites using the Accu-Chek
Softclix Alternative Site Testing
(AST) Cap.
Intended Use/ Indications
for Use	For use with a disposable sterile
lancet for the hygienic collection
of capillary blood for testing
purposes from the side of a
fingertip and from the forearm.

For use only on a single patient
in a home setting.

Not suitable for use by
healthcare professionals with
multiple patients in a healthcare
setting. | 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.

For use only on a single patient in a
home setting.

5

Alternative site cap	Yes
	Yes

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Nonclinical bench testing was performed per the special controls in 21 CFR 878.4850(c). This included design verification & validation testing to ensure that the lancet blade can be manually changed with every use, that the structure and materials are consistent with the intended use and address the risk of sharp object injuries and blood borne pathogen transmission, and mechanical performance testing to demonstrate that the device will withstand the forces encountered during use.

Description	Tests Performed	Results
Mechanical performance
verification for TRUEdraw
lancing device	- Materials and mechanical
characteristics

Operation of the lancing device
Product life and shock conditions
Cosmetic attributes | - Pass
Pass
Pass
Pass
Pass |
| Mechanical performance
verification for mini lancing
device | - Materials and mechanical
characteristics
Operation of the lancing device
Product life and shock conditions
Cosmetic attributes | - Pass
Pass
Pass
Pass
Pass |
| Compatibility with commonly
available general use lancets | - Critical dimensions (lancet body
diameter, exposed needle length,
body length)
Fit | - Pass
Pass |
| Cleaning and disinfection
validation - TRUEdraw lancing
device and alternate site cap | 1,095 cleaning and disinfecting cycles using
Super Sani-Cloth Wipes. | Pass. The TRUEdraw lancing
device and alternate site cap
may be cleaned and disinfected
with Super Sani-Cloth Wipes
once-daily for 3-years. |
| Cleaning and disinfection
validation - mini lancing
device and alternate site cap | 1,095 cleaning and disinfecting cycles using
Super Sani-Cloth Wipes. | Pass. The mini lancing device
and alternate site cap may be
cleaned and disinfected with
Super Sani-Cloth Wipes once-
daily for 3-years. |

Clinical testing is not applicable.

Conclusion

The results of nonclinical testing demonstrate that the subject devices are as safe, as effective, and perform as well as or better than the predicate device identified above.