(143 days)
Not Found
No
The device description and intended use clearly describe a mechanical lancing device. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on mechanical penetration capability.
No.
The device is a lancing device used to collect blood samples, not to treat a condition or disease.
No
The device is a lancing device used to draw blood, which is then used for testing (e.g., blood glucose testing). However, the device itself does not perform any diagnosis or analysis of the blood; it only collects the sample.
No
The device description explicitly states it is a "dual-spring mechanical blood lancet holder," which is a physical hardware device.
Based on the provided information, the Genteel lancing device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to draw capillary blood. It is a tool for sample collection.
- Device Description: It's described as a "mechanical blood lancet holder" for "collecting capillary whole blood."
- Lack of Diagnostic Function: The description focuses on the mechanism of blood collection, not on analyzing the blood or providing a diagnostic result. The blood collected is then used for other testing (like blood glucose testing), which would be performed by a separate IVD device (e.g., a glucose meter).
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Genteel lancing device is a necessary step before an IVD test, but it is not the test itself.
N/A
Intended Use / Indications for Use
The Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood.
The Genteel lancing device is for Single Patient Use Only.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The Genteel® Lancing Device (Genteel) is a dual-spring mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The Genteel lancing device is used with commercially available, sterile, standard square shaft blood lancets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip or alternate sites
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 Data: Performance testing includes a Penetration Capability protocol that demonstrates substantial equivalence.
Clinical Performance Data: Not applicable. Genteel does not require clinical testing for demonstrating substantial equivalence and safety/efficacy.
Conclusions from Performance Testing: The Genteel 510(k) documents and results of the non-clinical testing demonstrate that Genteel is substantially equivalent to the On Call Chosen Lancing Device and the Autolet Impression Lancing Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2016
Genteel, LLC % Mr. Mark DuVal, J.D., FRAPS DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1820 Minneapolis, Minnesota 55402
Re: K153670
Trade/Device Name: Genteel Lancing Device Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: FMK Dated: December 14, 2015 Received: December 31, 2015
Dear Mr. Mark DuVal:
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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153670
Device Name The Genteel Lancing Device
Indications for Use (Describe)
The Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood.
The Genteel lancing device is for Single Patient Use Only.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
-
- Date Prepared: 2016-05-10
-
- Submitted on behalf of:
Genteel, LLC 2904 Rawhide St West Linn, OR 97068 Phone: (844) 436-8335 (844-GENTEEL) Email: support@mygenteel.com
-
- Contact person:
Mark DuVal, J.D., FRAPS President & CEO, DuVal & Associates, P.A. 825 Nicollet Mall Suite 1820 Minneapolis, MN 55402 Phone: (612) 338-7170 Email: duval@duvalfdalaw.com
- Contact person:
-
- Trade Name: Genteel Common/Usual Name: Lancing device Product Code: FMK (Blood lancet) Classification Name: Manual surgical instrument for general use (21 CFR 878.4800. Product Code: FMK)
-
- Predicate device:
| 510(K) Number: | K113332 |
|---|---|
| Device Name: | On Call® Lancing Device |
| Applicant: | Acon Laboratories, Inc. |
| 510(K) Number: | N/A - 510(k) exempt |
| Device Name: | Autolet® Impression Lancing Device |
| (Manufactured by Owen Mumford Limited) | |
| Applicant: | N/A - 510(k) exempt |
-
- Device Description:
The Genteel® Lancing Device (Genteel) is a dual-spring mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The Genteel lancing device is used with commercially available, sterile, standard square shaft blood lancets.
- Device Description:
4
7. Intended Use:
Genteel is a blood lancet holder. Its indications for use statement is as follows:
The Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. The Genteel lancing device is for Single Patient Use Only.
-
- Summary of Technological Characteristics of Genteel compared to predicate devices:
The Genteel® Lancing Device (Genteel) is substantially equivalent to the chosen predicate devices, the On Call® Chosen Lancing Device (K113332) and the Autolet Impression Lancing Device (510(k) exempt). Genteel has the same intended use as the predicate devices, in that they are both for firing lancets for the collection of capillary blood samples. Genteel and the Autolet Impression predicate device are also intended for use for fingertip and alternate site testing. Genteel and the predicate devices are primarily made from different plastics which are both medical grade, and also have the same fundamental technological characteristics in that they use the same simple, well-known, dual-spring technology for firing square-shaft lancets. They also have varying puncture depth settings, via six interchangeable contact tips on Genteel and six and seven adiustable settings on adjustable dials on the predicate devices. There is a slight difference between Genteel and the predicate devices for aiding the drawing of blood after lancing. The predicate devices instruct users to massage the skin by the lancing site, whereas Genteel generates a soft vacuum to help draw blood to the surface after lancing. As demonstrated, Genteel is substantially equivalent to the predicate devices.
- Summary of Technological Characteristics of Genteel compared to predicate devices:
-
- Non-Clinical Performance Data:
Performance testing includes a Penetration Capability protocol that demonstrates substantial equivalence.
- Non-Clinical Performance Data:
-
- Clinical Performance Data:
Not applicable. Genteel does not require clinical testing for demonstrating substantial equivalence and safety/efficacy.
- Clinical Performance Data:
-
- Conclusions from Performance Testing:
The Genteel 510(k) documents and results of the non-clinical testing demonstrate that Genteel is substantially equivalent to the On Call Chosen Lancing Device and the Autolet Impression Lancing Device.
- Conclusions from Performance Testing: