(35 days)
Not Found
Not Found
No
The description focuses on the mechanical and electronic components of a lancing device and does not mention any AI or ML capabilities.
No
The device is used to obtain a blood sample, not to treat a condition or disease.
No
Explanation: The device is used to obtain a blood sample, not to analyze or diagnose using the sample. It is a lancing device, which is a tool for sample collection, not diagnosis.
No
The device description explicitly states it is a "handheld, battery powered electronic lancing system" with "three major components, a reusable lancing control unit called the launcher, a disposable lancet disk with multiple sterile lancets, and disposable sterile isolation strips," indicating it is a hardware device with physical components.
Based on the provided information, the L1-Pro System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain a capillary blood sample. This is a step in the diagnostic process, but the device itself does not perform any diagnostic testing on the blood sample.
- Device Description: The description focuses on the mechanism for obtaining the sample (lancing system, lancet disk, isolation strips). It does not mention any components or processes related to analyzing the blood sample for diagnostic purposes.
- Lack of Diagnostic Information: The document does not mention any diagnostic parameters, measurements, or analysis performed by the device.
An IVD device is typically used to examine specimens (like blood) from the human body to provide information for diagnostic, monitoring, or screening purposes. The L1-Pro System's function is solely to collect the specimen, not to analyze it.
N/A
Intended Use / Indications for Use
The L1-Pro System is an automatic blood lancet device for multi-patient clinical use by a healthcare professional to obtain a capillary blood sample.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The L1-Pro System is a handheld, battery powered electronic lancing system used by a healthcare professional to obtain capillary blood samples in multi-patient clinical use. It consists of three major components, a reusable lancing control unit called the launcher, a disposable lancet disk with multiple sterile lancets, and disposable sterile isolation strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional / multi-patient clinical use
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)
Testing performed under the Design Control Process verified that the L I -Pro System performed according to specifications and is in compliance with all applicable performance standards.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Pelikan Technologies. The logo consists of the word "PELIKAN" followed by a diamond shape and the word "TECHNOLOGIES". Below the text is a black shape that resembles a bird's wing or a stylized wave.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The characters are 'K041665'. The characters are written in a dark ink on a white background. The handwriting is legible.
L 2 3 2004
510(k) Summary L1-Pro System Pelikan Technologies, Corp.
Prepared December 6, 2002
| Product Name: | L1-Pro System |
|---|---|
| Manufacturer: | Pelikan Technologies, Corp. |
| Generic Name | Blood lancet |
| Classification Name: | Manual surgical device for general use; blood lancet (Class I); |
| Classification code: | FMK; 21 CFR 878.4800 |
| Contact Person: | Jack S. Green, CQM |
| Quality Assurance Manager | |
| Pelikan Technologies, Corp. | |
| 1072 East Meadow Circle | |
| Palo Alto, California 94303 |
A. Legally Marketed Predicate Device
The LI-Pro System is substantially equivalent to the L1 System manufactured by Pelikan Technologies, Inc. and Autolet lite Clinisafe manufactured by Owen Mumford
B. Device Description
The L1-Pro System is a handheld, battery powered electronic lancing system used by a healthcare professional to obtain capillary blood samples in multi-patient clinical use. It consists of three major components, a reusable lancing control unit called the launcher, a disposable lancet disk with multiple sterile lancets, and disposable sterile isolation strips.
C. Intended Use
The LI-Pro System is an automatic blood lancet device for multi-patient clinical use by a healthcare professional to obtain a capillary blood sample.
D. Substantial Equivalence
The L1-Pro system is substantially equivalent to the intended use and technological characteristics of the predicate devices L1 and Autolet-lite Clinisafe.
E. Performance Data
Testing performed under the Design Control Process verified that the L I -Pro System performed according to specifications and is in compliance with all applicable performance standards.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Institute of Health & Human Services - USA. The seal is circular with the text "INSTITUTE OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JUL 2 3 2004
Mr. Jack S. Green, CQM Quality Assurance Manager Pelikan Technologies Corp. 1072 East Meadow Circle Palo Alto, California 94303
Re: K041665
Trade/Device Name: L1-Pro System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument Regulatory Class: I Product Code: FMK Dated: June 9, 2004 Received: June 21, 2004
Dear Mr. Green:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your coremined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreations) 75 ttg_enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, in eccordance with the provisions of the Federal Food, Drug, de vices marchave been roches in a trequire approval of a premarket approval application (PMA). and Cosmetter For (110) first the device, subject to the general controls provisions of the Act. The I ou may, dicrorore, marrov of the Act include requirements for annual registration, listing of general controls proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassinod (tional controls. Existing major regulations affecting your device can may or dayse to data analy and 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 r lease be actived haw read 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 or any I edotal bather and we well and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 80 7) accesses (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quinn of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Jack S. Green, CQM
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milhurn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for Pelikan Technologies. The logo consists of the word "PELIKAN" in bold, sans-serif font, followed by a small black circle and the word "TECHNOLOGIES" in a smaller, sans-serif font. Below the text is a black graphic that appears to be a stylized representation of a pelican.
Indications for Use
510(k) Number (if known): ____K041665
Device Name:____L1-PRO SYSTEM
Indications For Use:
The L1-Pro System is an automatic blood lancet device for multi-patient clinical use by a healthcare professional to obtain a capillary blood sample.
Prescription Use - X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milken
Division of General, Restorative, and Neurological Devices
510(k) Number K041665
L1Pro510(k)-Jun-10.doc
© Pelikan Technologies, Inc · COMPANY CONFIDENTIAL
Page 2 of 71