(66 days)
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No
The summary describes a blood collection kit, which is a physical device for collecting samples, and there is no mention of any software, algorithms, or data processing that would involve AI or ML.
No
The device is described as a blood collection kit for DNA, which is used for diagnostic purposes (collecting samples) rather than treating a medical condition.
No
The device is a blood collection kit for DNA, which is used to collect samples but does not perform any diagnostic analysis itself.
No
The device description explicitly states it includes physical components like blood collection tubes, vials, and vacuum sample tubes, which are hardware.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "blood collection kit for D.N.A." and is "intended for medical purposes to collection tubes." Collecting biological samples like blood for DNA analysis is a fundamental step in many in vitro diagnostic procedures.
- Device Description: The description reinforces the intended use by listing components like "blood collection tubes, vials, systems, or vacuum sample tubes," which are standard components used for collecting samples for laboratory testing.
While the description doesn't explicitly state that the collected DNA will be tested for diagnostic purposes, the act of collecting a biological sample specifically for DNA analysis, intended for medical purposes, strongly aligns with the definition of an IVD. IVDs encompass devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
The lack of information about image processing, AI/ML, performance studies, etc., is expected for a simple sample collection kit and doesn't negate its potential IVD classification. The core function of collecting a sample for subsequent in vitro analysis is the key indicator.
N/A
Intended Use / Indications for Use
A blood collection kit for D.N.A is a device intended for medical purposes to collection tribes A blood conection an for D.N. Is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.
Product codes
PJE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Izon Business Product, Inc. Mr. Jack Wertz President 520 West Nyack Road West Nyack, NY 10994
FEB 0 6 2015
Re: K010328
Trade/Device Name: DNA Blood Collection Kits Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: PJE Dated: January 30, 2001 Received: February 2, 2001
Dear Mr. Wertz:
This letter corrects our substantially equivalent letter of April 9, 2001.
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. Usting 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
1
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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kail Soms
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
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| 510(k) Number (if known): | K010328 |
|---|---|
| Device Name: | DNA Blood Collection Kit |
Indications For Use:
INDICATIONS FOR USE 510 (k) for Izon Business Products, Inc. DNA Blood Collection Kit
of (
Page
A blood collection kit for D.NA is a device intended for medical purposes to collection tribes A blood conection an for D.N. Is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.
(PLEASE DO NOT WRITE FELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Jean Cooper |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K010328 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |