(156 days)
No
The device description and performance studies indicate a purely mechanical lancing device with no mention of AI or ML capabilities.
No.
A therapeutic device is used to treat or cure a disease or condition, while this device is used to collect blood samples for diagnostic testing (blood glucose monitoring), not for treatment.
No
A lancing device is used to collect blood, which is then used for testing. It does not perform any diagnostic function itself. Diagnostic functions are typically performed by devices that analyze the blood sample, such as blood glucose meters.
No
The device description clearly states it is a "mechanical device" and describes its function in holding and firing a lancet, indicating it is a hardware device.
Based on the provided information, the On Call® Lancing Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to draw capillary blood. It is a tool for obtaining a sample, not for performing a diagnostic test on that sample.
- Device Description: It is described as a "mechanical device holding and firing the lancet for collecting capillary whole blood." This reinforces its function as a sample collection tool.
- Lack of Diagnostic Function: The device itself does not analyze the blood or provide any diagnostic information. It is used in conjunction with a blood glucose monitoring system (which is an IVD) for testing.
- Predicate Device: The predicate device is also a lancing device, which are typically classified as Class I devices and not IVDs.
- Clinical Tests: The discussion of clinical tests focuses on virucidal efficacy (disinfection), not on diagnostic performance metrics like sensitivity or specificity.
In summary, the On Call® Lancing Device is a sample collection device, which is a component used in the process of performing an in vitro diagnostic test, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The On Call® Lancing Device is used with On Call® disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. The On Call® Lancing Device is intended to be used by a single patient and should not be shared.
Product codes (comma separated list FDA assigned to the subject device)
NBW, FMK
Device Description
The On Call "Lancing Device is a mechanical device holding and firing the lancet for collecting capillary whole blood sampled from the fingertip, palm, and forearm in conjunction with On Call® Chosen Blood Glucose Monitoring System for testing glucose in blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm (at the base of the thumb) or forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single patient
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)
Laboratory Testing Virucidal Efficacy Validation Testing: Under the conditions of cleaning and disinfection protocol using proposed disinfectant wipe. all components listed above from the Lancing Device had demonstrate complete inactivation of duck Hepatitis B in surrogate to human Hepatitis B. It is demonstrated that the proposed disinfection protocol with the disinfectant is effective against Hepatitis B virus through viral challenge of the material used to manufacture the housing of the 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.
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
510(k) SUMMARY
APR 1 8 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The Assigned 510(k) number is
Submitter's Identification:
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121 Tel.: 858-875-8057 Fax: 858-875-8099
Date Prepared: 4/11/2012
Contact Person:
Aaron Friday RA/CA Associate
Proprietary Name of the Device:
On Call" Lancing Device
Common Name:
Lancing Device, blood lancet
Classification Name:
Class II 862.1345 Glucose test system
Predicate Device:
On Call® Plus Lancing Device under On Call® Plus Blood Glucose Monitoring System. ACON Laboratories Inc., 10125 Mesa Rim Road, San Diego, CA 92121, USA 510(k) Number: K090057
Device Name:
On Call Lancing Device
| Proprietary Name | Classification | Product Code | Description | Common Name |
|---|---|---|---|---|
| On Call® Lancing Device | 862.1345 | |||
| Class II | NBW | Blood Lancet | Lancets |
Description:
The On Call "Lancing Device is a mechanical device holding and firing the lancet for collecting capillary whole blood sampled from the fingertip, palm, and forearm in conjunction with On Call® Chosen Blood Glucose Monitoring System for testing glucose in blood.
1
Intended Use:
The On Call® Lancing Device is used with On Call® disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. The On Call® Lancing Device is intended to be used by a single patient and should not be shared.
2019
Technological Characteristics:
Specification of Lancing Device:
| Features | Specification |
|---|---|
| Lancing Device Length | 103mm |
| Diameter(1) | 16mm |
| Diameter(2) | 15.6mm |
| Plastic composition | ABS (Acrylonitrile-Butadiene-Styrene) |
| Clear Cap composition | Transparent ABS |
Image /page/1/Figure/5 description: The image shows a technical drawing of a device, possibly a tool or instrument. The drawing includes dimensions labeled with numbers, such as '111' and '72', indicating specific measurements of the object's parts. The device appears to have a cylindrical body with some features on the surface. The drawing is a technical illustration, likely used for engineering or manufacturing purposes.
聞 1 STERILANCE 施泰朵加拿(短款卸針型,六福) Drawing 1 LDE STERILANCE Lancing devices
On Call® Lancing Device
The On Call® Lancing Device is for collecting fresh capillary blood samples obtained from the fingertip, forearm, and palm. The lancing device is manufactured for ACON Laboratories by EN ISO 13485-certified third-party supplier: Sterilance Medical (Suzhou) Inc. (No. 68 Litanghe Rd., Xiangcheng, Suzhou, Jiangsu 215113, P.R.China).
Image /page/1/Figure/9 description: This image shows the different parts of a lancing device. The parts include the cocking barrel, ejection button, release button, lancet holder, sterile lancet, safety tab, puncture depth settings, lancing device cover, and clear cap. The clear cap is for testing on the forearm and palm.
2
Comparison to Predicate Device:
| Features | On Call® Lancing Device | On Call® Plus Lancing Device under On Call Plus Blood Glucose System (K090057) |
|---|---|---|
| Similarities | ||
| Intend for Use | The On Call® Lancing Device is used with On Call® disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. The On Call® Lancing Device is intended to be used by a single patient and should not be shared. | The On Call® Plus Lancing Device is used with compatible disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. |
| Puncture device to obtain micro blood samples | Yes | Yes |
| Lancet retracted after use to prevent sharp injure | Yes | Yes |
| Clear cap for testing on forearm and palm | Yes | Yes |
| Mechanical loading and firing function | Cocking barrel with releasing button | Same |
| Differences | ||
| Lancet no touch ejection function | Yes | No |
| Puncture Depth setting | 6 steps | 5 steps |
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Guidance documents:
The following guidance documents were followed:
- "FDA Public Health Notification: Use of Fingerstick Devices on More than One Person l Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication" (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
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- "CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses 2 Risk or Transmitting Bloodborne Pathogens" (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
- 3 US Environmental Protection Agency Office of Pesticide Programs. List D: EPA's Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus (January 9, 2009) http://www.epa.gov/oppad001/list d hepatitisbhiv.pdf
- Letter to Manufacturers of Blood Glucose Monitoring Systems Listed With the FDA 4 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics /ucm227935. htm
Laboratory Testing Virucidal Efficacy Validation Testing:
Under the conditions of cleaning and disinfection protocol using proposed disinfectant wipe. all components listed above from the Lancing Device had demonstrate complete inactivation of duck Hepatitis B in surrogate to human Hepatitis B. It is demonstrated that the proposed disinfection protocol with the disinfectant is effective against Hepatitis B virus through viral challenge of the material used to manufacture the housing of the lancing device.
The detailed Virucidal Efficacy Validation Testing protocol and report are presented in Attachment I.
Discussion of Clinical Tests Performed:
On Call® lancing device is a class I device exempt. On Call® Chosen Blood Glucose Monitoring system clinical tests report please refers to K111371.
Conclusion:
The laboratory testing for disinfection and the clinical study results of On Call® Lancing Device in conjunction with On Call® Chosen Blood Glucose Monitoring system (k11371) demonstrate that the On Call Lancing Device is substantially equivalent to the On Call® Plus Lancing Device in the On Call® Plus Blood Glucose Monitoring System (K090057) and it is safe, effective and easy-to-use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002
APR 1 8 2012
Acon Laboratories, Inc. % Mr. Aaron Friday Clinical & Regulatory Affairs Associate 10125 Mesa Rim Road San Diego, California 92121
Re: K113332
Trade/Device Name: On Call® Lancing Device Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: FMK, NBW Dated: March 2, 2012 Received: March 5, 2012
Dear Mr. Friday:
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
5
Page 2 - Mr. Aaron Friday
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Fa
. Melkerson
Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number: K113332
Device Name: On Call Lancing Device
The On Call® Lancing Device is used with On Call® disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. The On Call® Lancing Device is intended to be used by a single patient and should not be shared.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-off Office of Device Evaluation Evaluation and Safety 510(k) _ K113332
Nel R.D. Sulin for man
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K113332
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