K Number
K223480
Device Name
Medipoint Blood Lancets
Date Cleared
2023-01-13

(56 days)

Product Code
Regulation Number
878.4850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
Device Description
Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use. The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.
More Information

Not Found

No
The device description and performance studies indicate a simple mechanical device (stainless steel lancet) with no mention of software, algorithms, or data processing that would suggest AI/ML.

No
A therapeutic device is used to treat or cure a disease or condition. This device is used to obtain a blood sample for testing, which is a diagnostic purpose, not a therapeutic one.

No

This device is a blood lancet, used to obtain a blood sample. It is a tool for sample collection, not for analyzing or interpreting the sample to diagnose a condition.

No

The device description clearly states it is a physical lancet made of stainless steel, used for obtaining a blood sample. It is a hardware device.

Based on the provided information, the Medipoint Blood Lancets are not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
  • Medipoint Blood Lancets' Function: The primary function of the Medipoint Blood Lancets is to obtain a capillary blood sample. They are a tool for collecting the specimen, not for performing the diagnostic test on the specimen itself.
  • Intended Use: The intended use clearly states "to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood." This reinforces their role as a collection device.
  • Device Description: The description focuses on the physical characteristics and sterilization of the lancet, not on any analytical or diagnostic capabilities.

While the blood sample obtained by the lancet will be used for an IVD test, the lancet itself is a specimen collection device, not an IVD.

N/A

Intended Use / Indications for Use

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

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

QRK

Device Description

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use.

The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing performed for the Medipoint Blood Lancets includes testing performed to ensure that predetermined performance criteria and conformance to special controls (21 CFR 878.4850) were met.

Performance Testing
The Medipoint Blood Lancets are constructed from a single piece of stainless steel and have no moving parts, joints, or caps which require mechanical testing. Performance testing completed for the Medipoint Blood Lancets demonstrates that the device withstands the forces encountered during use without bending or damage.

Biocompatibility Testing
Biocompatibility testing was selected based on ISO 10993 and the nature of device contact. The following biocompatibility tests were performed with passing results:

  • Cytotoxicity
  • Sensitization
  • Irritation or Intracutaneous Reactivity .
  • . Acute Systemic Toxicity (Material-Mediated Pyrogenicity)

All biocompatibility testing passed and demonstrates an acceptable biocompatibility profile for the intended nature and duration of contact of this device.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Medipoint Blood Lancets (510(k)-Exempt prior to reclassification, K221433

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4850 Blood lancets.

(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

0

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January 13, 2023

Medipoint Holdings, LLC Rochelle Stern Managing Partner 72 East 2nd St. Mineola, New York 11501

Re: K223480

Trade/Device Name: Medipoint Blood Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: November 18, 2022 Received: November 18, 2022

Dear Rochelle Stern:

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/cfpmn/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.

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

1

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 (OS) 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 mediation-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,

Jessica Carr -S

for 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) K223480

Device Name Medipoint Blood Lancets

Indications for Use (Describe)

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

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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K223480 – 510(k) Summary

Date Prepared:

01/13/2023

Submitted By:

Medipoint Holdings, LLC 72 East 2nd Street Mineola, NY 11501

Contact:

Name:Rochelle Stern
Title:Managing Partner
Telephone:516-294-8822
Email:rochelle@medipoint.com

Device:

Trade Name:Medipoint Blood Lancets
Common Name:Blood Lancet
FDA Product Code:QRK
Classification Name:Single Use Only Blood Lancet Without An Integral Sharps Injury
Prevention Feature
510(k) Number:K223480

Predicate Devices:

The device is substantially equivalent to the following predicate devices:

Primary Predicate:Medipoint Blood Lancets (510(k)-Exempt prior to reclassification
Secondary Predicate:Facet Technologies LLC Facet 28G Universal Lancet (K221433)

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Device Description:

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use.

The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.

Indications for Use:

Th Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Technological Characteristics and Performance Data (Predicate Comparison):

The device has equivalent design, intended use, material performance, and biocompatibility compared to the predicate devices.

The device has equivalent non-clinical performance as the primary predicate device.

A comparison of technological characteristics and performance data to the predicate devices is provided in Table 1, below.

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Traditional 510(k): Medipoint Holdings, LLC 72 East 2nd Street Mineola, NY 11501 510(k) Number: K223480

Table 1: Comparison to Predicate Devices

| Product

CharacteristicSubject DevicePrimary PredicateSecondary PredicateSubstantial Equivalence
ApplicantMedipoint Holdings, LLCMedipoint Holdings, LLCFacet Technologies LLCN/A
Product/Trade
NameMedipoint Blood LancetsMedipoint Blood LancetsFacet 28G Universal
LancetN/A
Common NameBlood LancetBlood LancetBlood LancetSame Common Name
Device
Classification
NameSingle Use Only Blood
Lancet Without An Integral
Sharps Injury Prevention
FeatureManual surgical
instrument for general useSingle Use Only Blood
Lancet Without An Integral
Sharps Injury Prevention
FeatureDifferent device classification name
compared to primary predicate due to
reclassification order. However, the
device is identical. Same
classification name as secondary
predicate.
510(k) NumberK223480N/A, 510(k)-exemptK221433N/A
Classification
Regulation21 CFR 878.485021 CFR 878.480021 CFR 878.4850Different classification regulation
compared to primary predicate due to
reclassification order. However, the
device is identical. Same
classification regulation as secondary
predicate.
Product CodeQRKFMKQRKDifferent product code compared to
primary predicate due to
reclassification order. However, the
device is identical. Same product
code as secondary predicate.
Intended UseMedipoint Blood Lancets
are indicated to obtain a
capillary blood sample
from the fingertip forMedipoint Blood Lancets
are intended for use to
puncture the skin to obtainThe Facet 28G Universal
Lancet is intended to
perform a skin puncture of
a finger or alternate siteThe subject device is intended for the
same use as the primary predicate
device and similar intended use
Product
CharacteristicSubject DevicePrimary PredicateSecondary PredicateSubstantial Equivalence
testing utilizing small
amounts of blood.

Medipoint Blood Lancets
are single-use only. | a drop of blood for
diagnostic purposes.

Medipoint Blood Lancets
are single-use only. | (palm of the hand, upper
arm, or forearm) for
collection of a droplet of
capillary blood for
subsequent diagnostic
testing. The Lancet may
be used in combination
with a reusable lancet
base (lancing device) that
accepts a universal-type
lancet to perform a lancing
event. The Facet
28G Universal Lancet is
for single use only on an
individual patient. | compared to the secondary predicate
device. |
| Indications for
Use | Medipoint Blood Lancets
are indicated to obtain a
capillary blood sample
from the fingertip for
testing utilizing small
amounts of blood. | Medipoint Blood Lancets
are indicated for fingertip
blood sampling for
diagnostic purposes. | The Facet 28G Universal
Lancet is a sterile,
disposable single use
device used to obtain a
droplet of capillary blood
for
subsequent diagnostic
testing from the finger or
an alternative site, such as
the palm, upper arm, or
forearm. The Lancet is
to be properly disposed of
after a single use on an
| There are minor differences in the
indications for use statement between
the subject device the predicate
devices but the indications for use are
substantially equivalent. |
| Sterility | Sterile (Moist Heat) | Sterile (Moist Heat) | Sterile (Gamma
Irradiation) | Identical sterilization process and
parameters compared to the primary
predicate. While the sterilization |
| Product
Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Substantial Equivalence |
| | | | | method is difference from the
secondary predicate, both are
provided sterile. |
| Type of Use | Over-The-Counter | Over-The-Counter | Over-The-Counter | Identical. |
| Device
Dimensions | 1 5/8" Long, 15/64" Wide,
0.007" Thick (0.025 –
0.032" Thick with knurls) | 1 5/8" Long, 15/64" Wide,
0.007" Thick (0.025 –
0.032" Thick with knurls) | Needle: 3.1±0.45 mm
Body: length not disclosed
in 510(k) summary | Device dimensions are identical to the
primary predicate. |
| Maximum
Penetration
Depth | 7/64 inch (2.78 mm) ±
1/64 inch (0.40 mm) | 7/64 inch (2.78 mm) ±
1/64 inch (0.40 mm) | 3.1±0.45 mm | Similar, the Medipoint Blood Lancet
maximum penetration is less than the
secondary predicate. |
| Materials of
Construction | 430 Stainless Steel | 430 Stainless Steel | 304 Stainless Steel needle
with low density
polyethylene body | Materials of construction are identical
to the primary predicate. The subject
device material and needle portion of
the secondary predicate are both
constructed of stainless steel. |
| Tip
Configuration | Bevel | Bevel | Bevel | Substantially equivalent, all devices
have a beveled point. |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Substantially equivalent, the subject
device has undergone
biocompatibility testing in accordance
with ISO 10993-1 based on the
intended nature and duration of
contact. |

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7

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Non-Clinical Testing:

Non-clinical testing performed for the Medipoint Blood Lancets includes testing performed to ensure that predetermined performance criteria and conformance to special controls (21 CFR 878.4850) were met.

Performance Testing

The Medipoint Blood Lancets are constructed from a single piece of stainless steel and have no moving parts, joints, or caps which require mechanical testing. Performance testing completed for the Medipoint Blood Lancets demonstrates that the device withstands the forces encountered during use without bending or damage.

Biocompatibility Testing

Biocompatibility testing was selected based on ISO 10993 and the nature of device contact. The following biocompatibility tests were performed with passing results:

  • Cytotoxicity ●
  • Sensitization
  • Irritation or Intracutaneous Reactivity .
  • . Acute Systemic Toxicity (Material-Mediated Pyrogenicity)

All biocompatibility testing passed and demonstrates an acceptable biocompatibility profile for the intended nature and duration of contact of this device.

Conclusions:

The subject device and the predicate devices underwent evaluation for equivalence in the intended use of each device, biocompatibility, performance, environment of use, and the principles of operation. This evaluation demonstrates that the subject device is substantially equivalent to the predicate devices.