(19 days)
Not Found
No
The 510(k) summary describes a simple luer kit for blood collection and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance studies typically associated with AI/ML devices.
No.
The device is described as a Luer Kit for blood collection, which is used for diagnostic purposes (collecting blood samples for tests), not for treating a disease or condition.
No.
The device is described as equipment for the collection of blood samples, not for analyzing or diagnosing conditions based on those samples.
No
The device description clearly indicates a "Luer Kit," which is a physical component used in blood collection systems. This is a hardware device, not software.
Based on the provided information, the ITL SampLok® Luer Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a part of vacuum blood collection equipment for the collection of blood samples". This describes a device used to collect a sample, not to test or analyze it.
- Device Description: The description reinforces this, stating it's a "Luer Kit for use with blood collection systems for collecting blood samples".
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing the blood sample itself (e.g., reagents, testing platforms, measurement of analytes).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. The ITL SampLok® Luer Kit is a tool for obtaining the sample, which is a necessary step before an IVD device would be used.
N/A
Intended Use / Indications for Use
The ITL SampLok® Luer Kit is intended to be used as part of a vacuum blood collection equipment for the collection of blood samples for various types of blood tests.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI
Device Description
Luer Kit for use with blood collection systems for collecting blood samples from Y connectors.
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
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)
Not Found
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.
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
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
JUL - 2 2002
XIII. Special 510k Summary
Contact Person: Bill Mobbs, Managing Director
Date of Summary Preparation: June 5, 2002
Trade Name: ITL SampLok® Luer Kit
Common Name: Needle holder and luer adaptor for blood sample collection for testing
Classification Name: Tubes, vials, systems, serum separators, blood collection
Establishment Registration Number: 9033436
Class: II
Product Code: JKA
Legally Marketed Substantially Equivalent Devices: SampLok® Needle Holder (K000777) and Nipro Luer Adaptor (K992729)
Description of Device: Luer Kit for use with blood collection systems for collecting blood samples from Y connectors.
Intended Use: The ITL SampLok® Luer Kit is intended to be used as part of a vacuum blood collection equipment for the collection of blood samples for various types of blood tests.
Comparison of Technical Characteristics: The ITL SampLok® Luer Kit consists of preattached SampLok® Needle Holder and Nipro Luer Adaptor, individually packaged and sterilized using ETO. The individual components are identical to previously cleared devices. The difference is that the previously cleared devices were packaged separately. The ITL SampLok® Luer Kit packages these two accessories together.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Mr. William Mobbs Director ITL Corporation 41-45 Tennant St, Fyshwick, Canberra, ACT 2609 AUSTRALIA
Re: K021941
Trade/Device Name: ITL SampLok® Luer Kit Regulation Number: 872.1675 and 880.5570 Regulation Name: Blood Specimen Collection Device and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: JKA and FMI Dated: June 6, 2002 Received: June 13, 2002
Dear Mr. Mobbs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
2
Page 2 - Mr. Mobbs
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_KOA194/
Device Name: _________________________________________________________________________________________________________________________________________________________________
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Indications for Use XII.
The ITL SampLok® Luer Kit is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests..
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Paltus Cicente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 02 510(k) Number .
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)