Predicate Devices

Not Found

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 and lancets. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.

Therapeutic

No
This device is a lancing device and lancet system intended for collecting capillary blood samples for diagnostic testing (blood glucose testing or other testing utilizing small amounts of blood), not for treating or rehabilitating a medical condition.

Diagnostic

No

Explanation: The device is a lancing device intended for collecting capillary blood samples. It is used to obtain the sample, not to diagnose. Diagnosis comes from testing the collected blood.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (lancing device, lancets made of steel and plastic) and mechanical actions (puncture, ejection, depth adjustment). There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, the MICROLET® NEXT lancing device and MICROLET® Lancets are not IVD (In Vitro Diagnostic) devices themselves.

Here's why:

IVD devices are used in vitro (outside the body) to examine specimens derived from the human body. They are used to provide information for diagnostic, monitoring, or screening purposes. Examples include blood glucose meters, pregnancy tests, or tests for infectious diseases.
The MICROLET® NEXT lancing device and lancets are used to collect the specimen (capillary blood). They are tools used on the body to obtain the sample that will then be used with an IVD device (like a blood glucose meter) for testing.

The text explicitly states the intended use is "for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood." This confirms their role as sample collection tools, not diagnostic devices.

Therefore, while they are essential for performing certain IVD tests, the lancing device and lancets themselves fall under a different regulatory classification (likely Class I medical devices for sample collection).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

Product codes (comma separated list FDA assigned to the subject device)

QRL

Device Description

Ascensia's blood lancets consists of two components. First component is a re-usable base which is referred as MICROLET® NEXT lancing device and the second component is a sterile single use blade which is referred as MICROLET® Lancet. The subject MICROLET® NEXT lancing device and MICROLET® Lancet falls under multiple Use Blood Lancet For Single Patient Use Only category. The subject MICROLET® NEXT Lancing Device is a pen-like instruments to be used with the compatible subject MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing. The MICROLET® NEXT Lancing Device is available with two endcaps: the Black/White cap for fingertip sampling and the Clear Alternative Site Testing (AST) for palm sampling. The Black/White cap has a dial control that allows the user to adjust the blade penetration depth for comfort when obtaining the blood droplet. The subject MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is intended to be used with compatible lancing devices. The lancets are sterile, single-use devices. They must be discarded after each use. The lancet comprises the following elements: a steel needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. They are available with 28G (0.36mm) diameter lancets. Together, they are intended for obtaining a capillary blood sample for blood glucose testing or other testing utilizing small amounts of blood. The lancet needle consists of stainless steel which is coated with medical grade silicone for smooth penetration of the skin. The lancet needle is siliconized. This is encased in a plastic cover. The proposed MICROLET® Lancets are offered in a variety of colors. Figure-2 shows different colored lancets (seven colors-Yellow. Orange, Red, Green, Blue, Purple and Pink). The needle tip is hidden by a protective cap, which has to be removed before usage and creates the sterile barrier. After usage the lancet can be placed back into the protective cap for disposal. thereby protecting users from unintended injuries. The proposed MICROLET® Lancet can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is Intended to be used with compatible lancing device. The lancet comprises the following elements: a steel needle, needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized by gamma radiation. The product can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® NEXT lancing device is used for obtaining capillary blood samples from the fingertip. Capillary samples can be obtained from the palm as well The lancing device is for use only on a single patient.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip or palm

Indicated Patient Age Range

persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

Intended User / Care Setting

Persons of different ages diagnosed with Diabetes; can also be used by caregivers or family members who support an individual with Type1 and Type 2 diabetes.

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)

Performance Testing:

Vibration Testing: Pass. No external damage or deterioration noted.
Ejector Arm remove force: Pass. Results within acceptance range.
Endcap Assembly removal and install torque verification: Pass. Mean values within acceptable criteria.
Lancet Ejection force: Pass. Results within acceptance range.
Lancet insertion force: Pass. Results within acceptance range.
Priming force verification: Pass. Results within acceptance range.
Puncture Depth Setting verification: Pass. Results within acceptance range.
Trigger button actuation force: Pass. Results within acceptance range.
Device Size verification: Pass. Results within acceptance range.
Lancet Anti Rotation torque: Pass. Results within acceptance range.
Puncture setting torque: Pass. Results within acceptance range.
Solution Compatibility reliability testing: Pass. Results within acceptance range.
Reliability Testing Mechanical vibration free fall drop: Pass. Devices meet visual, functional and performance acceptance criteria.
High speed Camera Analysis: Pass. All device data results within acceptance criteria.
Corrosion Resistance testing: Pass. No corrosion noticed.
Dry heat storage test: Pass. No damage to functionality.
Mechanical vibration test: Pass. All device data results within acceptance criteria.
Thermal Shock: Pass. All device data results within acceptance criteria.
AST needle tip flush verification test: Pass. All devices met the min 1.3 mm needle tip distance.
Reliability Retail Carton Free Fall Drop Report: Pass. All devices met acceptance criteria.
Bulk Device shipping test: Pass. No damages observed to contents.
Shipping Simulation testing: Pass. All device packaging passed.
Human factor: Pass. Human factors validation testing demonstrated the device can be used by people with diabetes without serious use errors or problems under expected use conditions. Summative evaluation concluded the system is safe and effective for at-home use by people with diabetes.

Clinical Testing:

Study Type: Clinical evaluation with lay persons.
Sample Size: 119 lay persons (adults) enrolled, 119 completed.
Key Results:
- 119 adult subjects were able to obtain sufficient capillary blood volume from fingertips using the adjustable cap.
- 116 adult subjects were able to obtain sufficient capillary blood volume from the palm using the AST (Alternative site testing) endcap.
Performance was analyzed using the percentage of numeric vs non-numeric meter readings obtained. All primary and secondary objectives of the clinical study were met.
Adverse Events: One non-serious, mild, anticipated, non-device related adverse event of hypoglycemia reported and resolved.

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

Not Found. Clinical study focused on ability to obtain sufficient blood volume and usability for lay persons.

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.

MICROLET® Lancet/MICROLET® NEXT lancing device (Class I, 510(k)-exempt blood lancets and lancing device legally offered for sale on or before November 22, 2021).

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

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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 3, 2022

Ascensia Diabetes Care U.S., Inc. Sangram Yadav Regulatory Affairs Manager 5 Wood Hollow Road Parsippany, New Jersey 07054

Re: K220633

Trade/Device Name: MICROLET NEXT Lancing Device, MICROLET Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: May 6, 2022 Received: May 9, 2022

Dear Sangram Yadav:

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/cfpm/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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 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 medical devices and radiation-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,

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

510(k) Number (if known) K220633

Device Name The MICROLET® lancet and MICROLET® NEXT lancing device

Indications for Use (Describe)

The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

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)

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3

Image /page/3/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle next to a blue teardrop shape. Above the logo is the text "K220633".

510(k) Summary for MICROLET® NEXT lancing device and MICROLET® Lancet

Initial date prepared: March 02, 2022 Revised date: May 25, 2022

According to the requirements of 21 CFR 807.92, the following information is being submitted in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

1. Submitter: Ascensia Diabetes Care U.S., Inc 5 Wood Hollow Rd Parsippany, NJ 07054
  Contact: Sangram Yadav Regulatory Affairs Manager 5 Wood Hollow Rd Parsippany, NJ 07054 Phone: 201-936-8856 E-mail: sangram.yadav@ascensia.com

Alternate Contact: Brian Truchan Head, Pre-Market Regulatory Affairs 5 Wood Hollow Rd Parsippany, NJ 07054 Phone: +19142668530 E-mail: brian.truchan@ascensia.com

1. Device name: MICROLET® Lancet and MICROLET® NEXT lancing device Classification name: Multiple Use Blood Lancet For Single Patient Use Only FDA CDRH review panel: General & Plastic Surgery Product Code: QRL Device Class: Class II Premarket review: Surgical and Infection Control Devices (OHT4) General Surgery Devices (DHT4A)
1. Predicate device: MICROLET® Lancet/MICROLET® NEXT lancing device (Class I, 510(k)-exempt blood lancets and lancing device legally offered for sale on or before November 22, 2021).
1. Device description:

Ascensia's blood lancets consists of two components. First component is a re-usable base which is referred as MICROLET® NEXT lancing device and the second component is a sterile single use blade which is referred as MICROLET® Lancet. The subject

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Image /page/4/Picture/0 description: The image shows the Ascensia Diabetes Care logo. The logo features a stylized letter 'A' in purple, with a blue teardrop shape to the right. Below the symbol, the word 'ASCENSIA' is written in purple, and below that, 'Diabetes Care' is written in a smaller font. The text 'K220633' is at the top of the image.

MICROLET® NEXT lancing device and MICROLET® Lancet falls under multiple Use Blood Lancet For Single Patient Use Only category. The subject MICROLET® NEXT Lancing Device is a pen-like instruments to be used with the compatible subject MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing. The MICROLET® NEXT Lancing Device is available with two endcaps: the Black/White cap for fingertip sampling and the Clear Alternative Site Testing (AST) for palm sampling. The Black/White cap has a dial control that allows the user to adjust the blade penetration depth for comfort when obtaining the blood droplet. The subject MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is intended to be used with compatible lancing devices. The lancets are sterile, single-use devices. They must be discarded after each use. The lancet comprises the following elements: a steel needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. They are available with 28G (0.36mm) diameter lancets. Together, they are intended for obtaining a capillary blood sample for blood glucose testing or other testing utilizing small amounts of blood. The lancet needle consists of stainless steel which is coated with medical grade silicone for smooth penetration of the skin. The lancet needle is siliconized. This is encased in a plastic cover. The proposed MICROLET® Lancets are offered in a variety of colors. Figure-2 shows different colored lancets (seven colors-Yellow. Orange, Red, Green, Blue, Purple and Pink). The needle tip is hidden by a protective cap, which has to be removed before usage and creates the sterile barrier. After usage the lancet can be placed back into the protective cap for disposal. thereby protecting users from unintended injuries. The proposed MICROLET® Lancet can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is Intended to be used with compatible lancing device. The lancet comprises the following elements: a steel needle, needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. The product can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® NEXT lancing device is used for obtaining capillary blood samples from the fingertip. Capillary samples can be obtained from the palm as well The lancing device is for use only on a single patient.

1. Indications for Use: The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.
1. Substantial Equivalence:

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Image /page/5/Picture/0 description: The image shows the text 'K220633' in a clear, sans-serif font. The text is presented in a single line, with each character distinctly visible. The number is likely an identification or serial number.

Image /page/5/Picture/1 description: The image shows the Ascensia Diabetes Care logo. The logo features a stylized letter "A" in purple, next to a light blue water droplet. Below the graphic is the text "ASCENSIA" in purple, with the words "Diabetes Care" in a smaller font size underneath.

Technological similarities and differences are as follows:

| Table 1.1 Comparison between predicate MICROLET® Lancet;
MICROLET® NEXT lancing device (510(k)-exempt), and proposed device

MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified)
No	Feature	Predicate Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class I, 510(k)-
exempt)	Proposed Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class II)	Similarities/
Differences
1	Classification	Class I
Product Code: FMK
Regulation: 21 CFR 878.4850	Class II
Product Code: QRL
Regulation: 21 CFR 878.4850	Different
2	Subtype	Multiple Use Blood
Lancet For Single
Patient Use Only	Multiple Use Blood
Lancet For Single Patient
Use Only	Same
3	Type of Use	Over the Counter use	Over the Counter use	Same
4	Indications for Use	The MICROLET®
NEXT lancing device is
intended for collecting
capillary blood from
the fingertip or palm
for blood glucose
testing or other testing
utilizing small amounts
of blood. The Microlet
Next lancing device is
for single-patient use.
The Microlet Next
lancing device is used
with disposable, sterile
MICROLET® lancets.
The Microlet Next
lancing device with the
Microlet lancet are
intended for collecting
capillary blood persons
age two years and
older.	The MICROLET®NEXT
lancing device is intended
for collecting capillary
blood from the fingertip or
palm for blood glucose
testing or other testing
utilizing small amounts of
blood. The MICROLET
NEXT lancing device is
for single-patient use. The
MICROLET NEXT
lancing device is used
with disposable, sterile
MICROLET® lancets.
The MICROLET NEXT
lancing device with the
MICROLET lancet are
intended for collecting
fingertip capillary blood
from persons age two
years and older. The
alternative site testing
endcap is intended for	Different.
The
alternative
site testing
endcap is
intended for
collecting
capillary
blood from
the palm in
adults only.
Table 1.1 Comparison between predicate MICROLET® Lancet;
MICROLET® NEXT lancing device (510(k)-exempt), and proposed device
			MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified)
No	Feature	Predicate Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class I, 510(k)-
exempt)	Proposed Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class II)	Similarities/
Differences
			collecting capillary blood
from the palm in adults
only.
5	Anatomi
cal
Location
in
the Body	Fingertip or ATS
(palm)	Fingertip or ATS (palm)	Same
6	Patient
Populati
on	persons age two years
and older.	persons age two years and
older. The alternative site
testing endcap is intended
for collecting capillary
blood from the palm in
adults only.	Different
7	Intended
User	Persons of different
ages diagnosed with
Diabetes;
can also be used by
caregivers or family
members who support
an individual with
Type1 and Type 2
diabetes.	Persons of different ages
diagnosed with Diabetes;
can also be used by
caregivers or family
members who support an
individual with Type1 and
Type 2 diabetes.	Same
8	Protectiv
e cover
of the
lancet	Protective cap is used
to
push the used lancet
into the center in order
to
avoid injuries.	Protective cap is used to
push the used lancet into
the center in order to
avoid injuries.	Same
9	Compati
bility of
Lancing	Compatible with
Microlet®
Next lancing device	Compatible with
Microlet®
Next lancing device	Same
Table 1.1 Comparison between predicate MICROLET® Lancet;
MICROLET® NEXT lancing device (510(k)-exempt), and proposed device
MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified)
No	Feature	Predicate Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class I, 510(k)-
exempt)	Proposed Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class II)	Similarities/
Differences
	device
with
Lancets
10	Dimensions/Size	Lancets(Blade):
Size 28 G(Gauge)
length: 32.3 mm
width: 9.25 mm
depth: 6.45 mm
Lancing device(reusable base):
102.5 x 19 x 20 mm	Lancets(Blade):
Size 28 G(Gauge)
length: 32.3 mm
width: 9.25 mm
depth: 6.45 mm
Lancing device(reusable base): 102.5 x 19 x 20 mm	Same
11	Protrusion Length of needle(lancets)	3.25 ±0.3 mm

Image: Diagram of protrusion length

Note- Protrusion Length of needle is the length of the exposed needle from the lancet body, after the protective cap is removed. | 3.25 ±0.3 mm

Image: Diagram of protrusion length

6

Image /page/6/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized purple triangle next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, with the words "Diabetes Care" written in a smaller font below it. The text "K220633" is at the top of the image.

7

Image /page/7/Picture/0 description: The image shows the text 'K220633' in a simple, sans-serif font. The text is presented in a clear and legible manner. The characters are evenly spaced and well-defined against the plain background. The text appears to be a code or identifier.

Image /page/7/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo consists of a purple triangle and a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, and below that, the words "Diabetes Care" are written in a smaller font.

8

Image /page/8/Picture/0 description: The image shows the text 'K220633' in a clear, sans-serif font. The text is presented in a single line, with each character distinctly visible. The number '2' is repeated multiple times within the string of text.

Image /page/8/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized "A" shape in purple next to a blue teardrop shape. Below the shapes, the text "ASCENSIA" is written in a bold font, with "Diabetes Care" written in a smaller font underneath.

| Table 1.1 Comparison between predicate MICROLET® Lancet;
MICROLET® NEXT lancing device (510(k)-exempt), and proposed device

MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified)
No	Feature	Predicate Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class I, 510(k)-
exempt)	Proposed Device
MICROLET® Lancet
MICROLET® NEXT
lancing device
(Class II)	Similarities/
Differences
13	Penetration depth	Alternative site testing endcap:
3.33 mm.
Adjustable cap:

Setting Puncture Depth(mm) 1 1.25 2 1.65 3 2.00 4 2.38 5 2.75
The difference between each depth level is 0.4 mm or less. | | | | | | | | | | | | | Alternative site testing endcap:
3.33 mm.
Adjustable cap:

9

Image /page/9/Picture/1 description: The image is a logo for Ascensia Diabetes Care. The logo features a purple triangle next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, with the words "Diabetes Care" written in a smaller font below it.

Table 1.1 Comparison between predicate MICROLET® Lancet;
MICROLET® NEXT lancing device (510(k)-exempt), and proposed device
MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified)
No	Feature	Predicate Device
MICROLET® Lancet MICROLET® NEXT lancing device
(Class I, 510(k)-exempt)	Proposed Device
MICROLET® Lancet MICROLET® NEXT lancing device
(Class II)	Similarities/
Differences
18	Shelf life	Lancets- 5 years	Lancets- 5 years	Same
19	Use life	Lancing device 3 years	Lancing device 2 years	Different
20	disinfecti
on
frequency	Once a week	After each use	Different

1. Summary of Non-Clinical Performance Data
  Biocompatibility: Cytotoxicity,Inctracutaneous, Systemic Toxicity, Hemolysis, Sensitization and Pyrogen testing was performed on all patient contacting materials lancet and lancing device in accordance with FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process (summarized in below table). All patient contact components demonstrated biocompatibility.

| Table 1.2 Biocompatibility testing standards and results for the proposed

MICROLET® Lancet and MICROLET® lancing device
No	Test	Standard	Results
1	Cytotoxicity
Study - ISO
Elution Method	ISO 10993-5:2009
Biological evaluation of medical
devices — Part 5: Tests for in vitro
cytotoxicity	Non-cytotoxic
2	ISO Guinea Pig
Maximization
Sensitization
Test	ISO 10993-10:2010
Biological evaluation of medical
devices — Part 10: Tests for irritation
and skin sensitization	Non-sensitizer

10

Image /page/10/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below these shapes, the word "ASCENSIA" is written in a bold, sans-serif font, with the words "Diabetes Care" written in a smaller font below it.

| Table 1.2 Biocompatibility testing standards and results for the proposed

MICROLET® Lancet and MICROLET® lancing device
No	Test	Standard	Results
3	ISO
Intracutaneous
Study in Rabbits	ISO 10993-10:2010
Biological evaluation of medical
devices - Part 10: Tests for irritation
and skin sensitization	Non-irritant
4	Material
Mediated
Pyrogenicity in
Rabbits	ISO 10993-11:2017
Biological evaluation of medical
devices - Part 11: Tests for systemic
toxicity	Non-pyrogenic
5	ISO Acute
Systemic
Toxicity	ISO 10993-11:2017
Biological evaluation of medical
devices - Part 11: Tests for systemic
toxicity	Non-toxic
6	ASTM
Hemolysis Study	ISO 10993-4:2017
Biological evaluation of medical
devices - Part 4: Selection of tests for
interactions with blood	Non-hemolytic
Biocompatibility testing for MICROLET® lancing device
7	Cytotoxicity
Study - ISO
Elution Method	ISO 10993-5:2009
Biological evaluation of medical
devices - Part 5: Tests for in vitro
cytotoxicity	Non-cytotoxic
8	ISO Guinea Pig
Maximization
Sensitization
Test	ISO 10993-10:2010
Biological evaluation of medical
devices - Part 10: Tests for irritation
and skin sensitization	Non-sensitizer
9	ISO
Intracutaneous
Study in Rabbits	ISO 10993-10:2010
Biological evaluation of medical
devices - Part 10: Tests for irritation
and skin sensitization	Non-irritant

Note- MICROLET® NEXT lancing device, including adjustable (ABS) and Alternate Site Testing (AST) (Polycarbonate) caps; subject to this premarket notification is identical to the previously legally US-marketed (510k exempt) device in formulation, processing, sterilization, and geometry, and no other chemicals have been added.

8. Performance Testing

The following Performance testing were conducted to demonstrate the basic performance of MICROLET® Lancet and lancing device and confirmed that the MICROLET® Lancet and lancing device performs as intended.

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Image /page/11/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo consists of a stylized letter "A" in purple, next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, with the words "Diabetes Care" written in a smaller font below it.

| Table 1.3 Performance testing for the proposed MICROLET® Lancet and

MICROLET® NEXT lancing device
No	Test	Results
1	Vibration Testing	Pass
There was no external damage or deterioration noted to any of the devices tested.
2	Ejector Arm remove force	Pass
The Ejector arm force results for all devices were within the acceptance range.
3	Endcap Assembly removal and install
torque verification	Pass
Both the install and removal torque mean values were well within acceptable criteria.
4	Lancet Ejection force	Pass
All device results were within the acceptance range.
5	Lancet insertion force	Pass
All device results were within the acceptance range.
6	Priming force
verification	Pass
All device results were within the acceptance range.
7	Puncture Depth
Setting verification	Pass
All device results were within the acceptance range.
8	Trigger button
actuation force	Pass
All device results were within the acceptance range.
9	Device Size
verification	Pass
All device results were within the acceptance range.
10	Lancet Anti Rotation torque	Pass
All device results were within the acceptance range.
11	Puncture setting
torque	Pass
All device results were within the acceptance range.
12	Solution
Compatibility reliability testing	Pass
All device results were within the acceptance range.
13	Reliability Testing
Mechanical vibration
free fall drop	Pass
All devices meet the visual , functional and
performance acceptance criteria relevant to test
requirements.
14	High speed Camera
Analysis	Pass
All device data results were within acceptance criteria.
15	Corrosion Resistance
testing	Pass
After the test no corrosion was noticed on any of the
product parts.
16	Dry heat storage test-	Pass
Table 1.3 Performance testing for the proposed MICROLET® Lancet and
MICROLET® NEXT lancing device
No	Test	Results
17	Dry heat Storage test	After the test no damage to the functionality of the
device was noticed.
Pass
After the test no damage to the functionality of the
device was noticed.
18	Mechanical vibration test	Pass
All device data results were within acceptance criteria.
19	Thermal Shock	Pass
All device data results were within acceptance criteria
20	AST needle tip flush
verification test	Pass
All devices met the min 1.3 mm needle tip distance.
21	Reliability Retail
Carton Free Fall
Drop Report	Pass
All devices met tested in the retail carton kit meet the
acceptance criteria.
22	Bulk Device shipping
test	Pass
No damages were observed to the content after the
test.
23	Shipping Simulation
testing	Pass
All device packaging passed the shipping simulations
testing.
24	Human factor	Pass
The MICROLET® Lancet and MICROLET® NEXT
lancing device human factors validation testing was
conducted to demonstrate the device can be used by
people with diabetes without serious use errors or
problems under the expected use conditions. The
summative evaluation concluded the system is safe
and effective for at-home use by people with diabetes.

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Image /page/12/Picture/0 description: The image shows the text 'K220633' in a clear, sans-serif font. The text is presented in a straightforward manner, with each character distinctly visible. The numbers and letters are evenly spaced, contributing to the overall readability of the text.

Image /page/12/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" formed by a purple triangle on the left and a blue teardrop shape on the right. Below the symbol, the word "ASCENSIA" is written in a bold, sans-serif font, with the words "Diabetes Care" in a smaller font underneath.

8. Clinical Testing:

A total of 119 lay persons who had never used the proposed MICROLET® Lancet and MICROLET® NEXT lancing device previously were enrolled into the study at the Mishawaka site, and 119 completed the study.

119 adult subjects were able to obtain sufficient capillary blood volume from ● fingertips to conduct blood glucose testing, by using the adjustable cap.
. 116 adult subjects were able to obtain sufficient capillary blood volume from the palm to conduct blood glucose testing, by using the AST(Alternative site testing endcap.

13

Image /page/13/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter 'A' formed by a purple triangle and a blue teardrop shape. Below the symbol, the word 'ASCENSIA' is written in bold, followed by 'Diabetes Care' in a smaller font.

The demographics and diabetes history information for all subjects enrolled in the study (n=119) included the following:

22% (26) reported they had type 1 diabetes; 76% (90) had type 2 diabetes and 3% ● (3) had diabetes but did not know their diabetes type
The average (mean) age was 55.1 years (with a range of 23 to 84 years). ●
. 80.7% (96) of subjects were less than age 65 years

Below is the demographic information for subjects:

Gender: Female 61(51.3%); Male 58(48.7%)

Ethnicity: Hispanic/Latino 3(2.5%); Non-Hispanic 110(92.4%); not reported 6(5.0%)

Race: Asian 1(0.8%), African American 14(11.8%), Caucasian 99(83.2%), American Indian/Alaskan Native 3(2.5%), Wish to not report 3(2.5%).

Following was the inclusion/exclusion criteria for the clinical study:

Inclusion Criteria:

Males and females, 18 years of age and older ●
People with type 1 or type 2 diabetes
People who regularly perform self-tests (at least once/day) with their own lancing device
Able to speak, read and understand English (subjects must demonstrate ability to read a paragraph from the first page of the Informed Consent document to qualify for the study)
. Willing to complete all study procedures

Exclusion Criteria:

Those with missing tips of the fingers indicated numerically or are physically unable to lance the palm areas and all 6 of the fingers
Hemophilia or any other bleeding disorder ●
Pregnancy
Physical, visual or neurological impairments that would make the person unable to perform, testing. Subjects who have used the proposed lancing device in a previous clinical evaluation

Adverse Events: One (1) adverse event of hypoglycemia was reported. This was a nonserious, mild, anticipated, non-device related Adverse Event (AE). The event was resolved prior to the subject leaving the clinical site.

Conclusion- The acceptability of capillary blood volume obtained using the adjustable fingerstick and alternative site testing endcap by lay users with diabetes, was determined by study staff testing the blood on a Contour next family of blood glucose meters. Performance was analyzed using the percentage of numeric vs non-numeric meter readings obtained. All primary and secondary objectives of the clinical study were met.

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Image /page/14/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle next to a blue teardrop shape. Above the logo is the alphanumeric code K220633.

1. Conclusion Regarding Substantial Equivalence
  The proposed MICROLET® NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The Microlet Next lancing device is for single-patient use. The Microlet Next lancing device is used with disposable, sterile MICROLET® lancets. The Microlet Next lancing device with the Microlet lancet are intended for collecting capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

The proposed MICROLET® Lancet/ MICROLET® NEXT lancing device has the similar intended use, incorporate the same fundamental technology as the predicate MICROLET® Lancet/ MICROLET® NEXT lancing device which were previously 510 (k) exempt. The differences between 510(k)-exempt MICROLET® Lancet/ MICROLET® NEXT lancing device (legally offered for sale on or before November 22, 2021) and up classified MICROLET® Lancet lancing device do not raise any new questions of safety, or effectiveness. Test data to verify the performance of the up classified MICROLET® Lancet/lancing device has been provided including: biocompatibility, Sterility, clinical and non-clinical performance testing and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.