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.

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.

AI/ML Overview

The provided text describes a lancing device and its comparison to a predicate device, focusing on substantial equivalence for regulatory purposes. It reports on laboratory testing for disinfection efficacy but does NOT contain specific acceptance criteria or a study proving the device meets those criteria in terms of clinical performance or accuracy for drawing blood samples.

Therefore, most of the requested information cannot be extracted directly from the provided document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria for device performance (e.g., depth of puncture, amount of blood drawn, pain level). It primarily focuses on the physical specifications of the device and its virucidal efficacy.

Acceptance Criteria	Reported Device Performance
Puncture Depth Setting	6 steps (for On Call® Lancing Device)
Lancet no touch ejection function	Yes (for On Call® Lancing Device)
Virucidal Efficacy (Duck Hepatitis B as surrogate for Human Hepatitis B)	All components demonstrated complete inactivation using proposed disinfection protocol.
Intended Use	Meets intended use description.
Physical Specifications:
- Lancing Device Length	103mm
- Diameter (1)	16mm
- Diameter (2)	15.6mm
- Plastic composition	ABS (Acrylonitrile-Butadiene-Styrene)
- Clear Cap composition	Transparent ABS

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Virucidal Efficacy Validation Testing: The document states this testing was performed in a "Laboratory." It does not specify the sample size (e.g., number of lancing devices tested), country of origin, or if it was retrospective or prospective. It only mentions "all components listed above from the Lancing Device."
Clinical Tests: The document states: "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." This means clinical tests for the lancing device itself were not performed for this submission; rather, it refers to a separate submission for the companion glucose monitoring system (K111371) for broader clinical context, not specifically for the lancing device's blood drawing performance. Therefore, no sample size or data provenance details for clinical performance of the lancing device are available in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving expert assessment or ground truth establishment for clinical performance of the lancing device. The virucidal efficacy testing would have been conducted by laboratory personnel according to established protocols, but no expert "ground truth" establishment in the sense of clinical interpretation is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study requiring adjudication is described for the lancing device's performance.

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

Not applicable. This device is a mechanical lancing device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical lancing device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Virucidal Efficacy Validation Testing: The "ground truth" for this test would be the successful inactivation of the specified virus (duck Hepatitis B as a surrogate for human Hepatitis B) as confirmed by laboratory assays.
Clinical Performance: No ground truth for clinical performance (e.g., successful blood draw, adequate blood volume, pain assessment) is directly addressed for the lancing device in this document, as it refers to a separate submission for the glucose monitoring system.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it's a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. This device does not involve a training set.

Summary

{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	862.1345Class II	NBW	Blood Lancet	Lancets

Description:

{1}------------------------------------------------

Intended Use:

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

{3}------------------------------------------------

"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.

{4}------------------------------------------------

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

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

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.