MULTIPLE (IZON DNA BLOOD COLLECTION KIT)

K010328 · Izon Business Products, Inc. · PJE · Apr 9, 2001 · Clinical Chemistry

Device Facts

• Record ID: K010328
• Device Name: MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
• Applicant: Izon Business Products, Inc.
• Product Code: PJE · Clinical Chemistry
• Decision Date: Apr 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

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.

Device Story

DNA Blood Collection Kit consists of collection tubes, vials, systems, or vacuum sample tubes used to collect blood specimens for DNA analysis. Device facilitates sample acquisition for subsequent laboratory processing. Used in clinical settings by healthcare professionals. Output is a collected blood sample in a container suitable for transport and analysis. Benefits include standardized collection of biological material for genetic testing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Blood collection kit comprising tubes, vials, or vacuum systems. Mechanical device for specimen containment. No electronic components, software, or active energy sources.

Indications for Use

Indicated for the collection of blood samples for DNA analysis. Intended for use as a blood specimen collection device.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

| 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) | <div style="text-align:center;">Jean Cooper</div> |
|-----------------------------------------|---------------------------------------------------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K010328 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |