K220633 · Ascensia Diabetes Care U.S., Inc. · QRL · Jun 3, 2022 · General, Plastic Surgery
Device Facts
Record ID
K220633
Device Name
MICROLET NEXT lancing device, MICROLET Lancet
Applicant
Ascensia Diabetes Care U.S., Inc.
Product Code
QRL · General, Plastic Surgery
Decision Date
Jun 3, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
Attributes
Pediatric
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.
Device Story
Manual lancing device used with disposable, sterile 28G stainless steel lancets; coated with medical-grade silicone. Device features adjustable endcap for fingertip sampling (5 depth settings) and clear endcap for alternative site testing (palm). User-operated at home; device is reusable (single-patient use). Mechanism involves spring-loaded puncture to obtain capillary blood droplet. Protective cap on lancet ensures sterility until use; used lancets are discarded. Device aids in blood glucose monitoring; provides patient benefit through controlled, comfortable blood sampling.
Clinical Evidence
Clinical study with 119 lay users (adults with Type 1 or Type 2 diabetes). 119/119 successfully obtained capillary blood from fingertips; 116/119 successfully obtained blood from palms. One non-device-related adverse event (hypoglycemia) reported. Study confirmed system is safe and effective for at-home use.
Technological Characteristics
Materials: Stainless steel needle (siliconized), plastic housing. Sterilization: Gamma radiation (SAL 10^-6). Dimensions: 102.5 x 19 x 20 mm. Sensing/Actuation: Mechanical spring-loaded puncture. Connectivity: None. Software: None.
Indications for Use
Indicated for collecting capillary blood from fingertip or palm for blood glucose or other testing. Fingertip sampling for persons age 2+ years; palm sampling (AST) for adults only. Single-patient use.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*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.
Predicate Devices
MICROLET® Lancet/MICROLET® NEXT lancing device (Class I, 510(k)-exempt)
Submission Summary (Full Text)
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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.
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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
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# 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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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
- 2. 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)
- 3. 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).
- 4. 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.
- 5. 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.
- 6. 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;<br>MICROLET® NEXT lancing device (510(k)-exempt), and proposed device<br>MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| No | Feature | Predicate Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences |
| 1 | Classification | Class I<br>Product Code: FMK<br>Regulation: 21 CFR 878.4850 | Class II<br>Product Code: QRL<br>Regulation: 21 CFR 878.4850 | Different |
| 2 | Subtype | Multiple Use Blood<br>Lancet For Single<br>Patient Use Only | Multiple Use Blood<br>Lancet For Single Patient<br>Use Only | Same |
| 3 | Type of Use | Over the Counter use | Over the Counter use | Same |
| 4 | Indications for Use | The MICROLET®<br>NEXT lancing device is<br>intended for collecting<br>capillary blood from<br>the fingertip or palm<br>for blood glucose<br>testing or other testing<br>utilizing small amounts<br>of blood. The Microlet<br>Next lancing device is<br>for single-patient use.<br>The Microlet Next<br>lancing device is used<br>with disposable, sterile<br>MICROLET® lancets.<br>The Microlet Next<br>lancing device with the<br>Microlet lancet are<br>intended for collecting<br>capillary blood persons<br>age two years and<br>older. | The MICROLET®NEXT<br>lancing device is intended<br>for collecting capillary<br>blood from the fingertip or<br>palm for blood glucose<br>testing or other testing<br>utilizing small amounts of<br>blood. The MICROLET<br>NEXT lancing device is<br>for single-patient use. The<br>MICROLET NEXT<br>lancing device is used<br>with disposable, sterile<br>MICROLET® lancets.<br>The MICROLET NEXT<br>lancing device with the<br>MICROLET lancet are<br>intended for collecting<br>fingertip capillary blood<br>from persons age two<br>years and older. The<br>alternative site testing<br>endcap is intended for | Different.<br>The<br>alternative<br>site testing<br>endcap is<br>intended for<br>collecting<br>capillary<br>blood from<br>the palm in<br>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<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences |
| | | | collecting capillary blood<br>from the palm in adults<br>only. | |
| 5 | Anatomi<br>cal<br>Location<br>in<br>the Body | Fingertip or ATS<br>(palm) | Fingertip or ATS (palm) | Same |
| 6 | Patient<br>Populati<br>on | persons age two years<br>and older. | persons age two years and<br>older. The alternative site<br>testing endcap is intended<br>for collecting capillary<br>blood from the palm in<br>adults only. | Different |
| 7 | Intended<br>User | Persons of different<br>ages diagnosed with<br>Diabetes;<br>can also be used by<br>caregivers or family<br>members who support<br>an individual with<br>Type1 and Type 2<br>diabetes. | Persons of different ages<br>diagnosed with Diabetes;<br>can also be used by<br>caregivers or family<br>members who support an<br>individual with Type1 and<br>Type 2 diabetes. | Same |
| 8 | Protectiv<br>e cover<br>of the<br>lancet | Protective cap is used<br>to<br>push the used lancet<br>into the center in order<br>to<br>avoid injuries. | Protective cap is used to<br>push the used lancet into<br>the center in order to<br>avoid injuries. | Same |
| 9 | Compati<br>bility of<br>Lancing | Compatible with<br>Microlet®<br>Next lancing device | Compatible with<br>Microlet®<br>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<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences |
| | device<br>with<br>Lancets | | | |
| 10 | Dimensions/Size | Lancets(Blade):<br>Size 28 G(Gauge)<br>length: 32.3 mm<br>width: 9.25 mm<br>depth: 6.45 mm<br>Lancing device(reusable base):<br>102.5 x 19 x 20 mm | Lancets(Blade):<br>Size 28 G(Gauge)<br>length: 32.3 mm<br>width: 9.25 mm<br>depth: 6.45 mm<br>Lancing device(reusable base): 102.5 x 19 x 20 mm | Same |
| 11 | Protrusion Length of needle(lancets) | 3.25 ±0.3 mm<br><br>Image: Diagram of protrusion length<br><br>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<br><br>Image: Diagram of protrusion length<br><br>Note- Protrusion Length of needle is the length of the exposed needle from the lancet body, after the protective cap is removed. | Same |
| 12 | Depth settings | 5 depth settings | 5 depth settings | Same |
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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.
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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.
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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;<br>MICROLET® NEXT lancing device (510(k)-exempt), and proposed device<br>MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|------|
| No | Feature | Predicate Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences | | | | | | | | | | | | | | | | | | | | | | | | |
| 13 | Penetration depth | Alternative site testing endcap:<br>3.33 mm.<br>Adjustable cap:<br><br>Setting Puncture Depth(mm) 1 1.25 2 1.65 3 2.00 4 2.38 5 2.75<br>The difference between each depth level is 0.4 mm or less. | | | | | | | | | | | | | Alternative site testing endcap:<br>3.33 mm.<br>Adjustable cap:<br><br>Setting Puncture Depth(mm) 1 1.25 2 1.65 3 2.00 4 2.38 5 2.75<br>The difference between each depth level is 0.4 mm or less. | | | | | | | | | | | | | Same |
| 14 | Duration of Body Contact | Transient, less than 1 minute | Transient, less than 1 minute | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| 15 | Use(Single patient) | Single use Sterile lancets | Single use Sterile lancets | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| 16 | Use(lancing devices) | Reusable. The lancing device is for use only on a single patient. | Reusable. The lancing device is for use only on a single patient | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| 17 | Sterilization method and SAL | Sterilized by Radiation SAL=10-6 | Sterilized by Radiation SAL=10-6 | Same | | | | | | | | | | | | | | | | | | | | | | | | |
{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<br>MICROLET® Lancet MICROLET® NEXT lancing device<br>(Class I, 510(k)-exempt) | Proposed Device<br>MICROLET® Lancet MICROLET® NEXT lancing device<br>(Class II) | Similarities/<br>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<br>on<br>frequency | Once a week | After each use | Different |
- 7. 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<br>MICROLET® Lancet and MICROLET® lancing device | | | |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------|
| No | Test | Standard | Results |
| 1 | Cytotoxicity<br>Study - ISO<br>Elution Method | ISO 10993-5:2009<br>Biological evaluation of medical<br>devices — Part 5: Tests for in vitro<br>cytotoxicity | Non-cytotoxic |
| 2 | ISO Guinea Pig<br>Maximization<br>Sensitization<br>Test | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices — Part 10: Tests for irritation<br>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<br>MICROLET® Lancet and MICROLET® lancing device | | | |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------|
| No | Test | Standard | Results |
| 3 | ISO<br>Intracutaneous<br>Study in Rabbits | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>and skin sensitization | Non-irritant |
| 4 | Material<br>Mediated<br>Pyrogenicity in<br>Rabbits | ISO 10993-11:2017<br>Biological evaluation of medical<br>devices - Part 11: Tests for systemic<br>toxicity | Non-pyrogenic |
| 5 | ISO Acute<br>Systemic<br>Toxicity | ISO 10993-11:2017<br>Biological evaluation of medical<br>devices - Part 11: Tests for systemic<br>toxicity | Non-toxic |
| 6 | ASTM<br>Hemolysis Study | ISO 10993-4:2017<br>Biological evaluation of medical<br>devices - Part 4: Selection of tests for<br>interactions with blood | Non-hemolytic |
| Biocompatibility testing for MICROLET® lancing device | | | |
| 7 | Cytotoxicity<br>Study - ISO<br>Elution Method | ISO 10993-5:2009<br>Biological evaluation of medical<br>devices - Part 5: Tests for in vitro<br>cytotoxicity | Non-cytotoxic |
| 8 | ISO Guinea Pig<br>Maximization<br>Sensitization<br>Test | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>and skin sensitization | Non-sensitizer |
| 9 | ISO<br>Intracutaneous<br>Study in Rabbits | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>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.
{11}------------------------------------------------
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<br>MICROLET® NEXT lancing device | | |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No | Test | Results |
| 1 | Vibration Testing | Pass<br>There was no external damage or deterioration noted to any of the devices tested. |
| 2 | Ejector Arm remove force | Pass<br>The Ejector arm force results for all devices were within the acceptance range. |
| 3 | Endcap Assembly removal and install<br>torque verification | Pass<br>Both the install and removal torque mean values were well within acceptable criteria. |
| 4 | Lancet Ejection force | Pass<br>All device results were within the acceptance range. |
| 5 | Lancet insertion force | Pass<br>All device results were within the acceptance range. |
| 6 | Priming force<br>verification | Pass<br>All device results were within the acceptance range. |
| 7 | Puncture Depth<br>Setting verification | Pass<br>All device results were within the acceptance range. |
| 8 | Trigger button<br>actuation force | Pass<br>All device results were within the acceptance range. |
| 9 | Device Size<br>verification | Pass<br>All device results were within the acceptance range. |
| 10 | Lancet Anti Rotation torque | Pass<br>All device results were within the acceptance range. |
| 11 | Puncture setting<br>torque | Pass<br>All device results were within the acceptance range. |
| 12 | Solution<br>Compatibility reliability testing | Pass<br>All device results were within the acceptance range. |
| 13 | Reliability Testing<br>Mechanical vibration<br>free fall drop | Pass<br>All devices meet the visual , functional and<br>performance acceptance criteria relevant to test<br>requirements. |
| 14 | High speed Camera<br>Analysis | Pass<br>All device data results were within acceptance criteria. |
| 15 | Corrosion Resistance<br>testing | Pass<br>After the test no corrosion was noticed on any of the<br>product parts. |
| 16 | Dry heat storage test- | Pass |
| Table 1.3 Performance testing for the proposed MICROLET® Lancet and<br>MICROLET® NEXT lancing device | |…
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
