SALIVA SAMPLER

K942435 · Saliva Diagnostic Systems, Inc. · PJD · Aug 21, 1995 · Clinical Chemistry

Device Facts

• Record ID: K942435
• Device Name: SALIVA SAMPLER
• Applicant: Saliva Diagnostic Systems, Inc.
• Product Code: PJD · Clinical Chemistry
• Decision Date: Aug 21, 1995
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Device Story

The Saliva Sampler is a device used for the collection of saliva specimens. It functions as a specimen collection tool to facilitate the gathering of oral fluid for subsequent diagnostic testing. The device is intended for use in clinical or laboratory settings by healthcare professionals or trained personnel. By providing a standardized method for saliva collection, it assists in the diagnostic process, allowing for the analysis of saliva-based biomarkers or analytes. The device does not perform analysis itself but serves as the primary interface for obtaining the biological sample required for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a saliva specimen collection tool classified under 21 CFR 862.1675 (Blood specimen collection device). No specific materials, dimensions, or software characteristics are detailed in the provided documentation.

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue

Document Control Center – WO66-G609

Silver Spring, MD 20993-0002

Saliva Diagnostics Systems

Mr. Ron Lealos

President

11719 NE 95TH STREET

VANCOUVER, WA 98682

FEB 06 2015

Re: K942435

Trade/Device Name: Saliva Sampler

Regulation Number: 21 CFR 862.1675

Regulation Name: Blood specimen collection device

Regulatory Class: II

Product Code: PJD

Dated: January 3, 1995

Received: January 11, 1995

Dear Mr. Lealos:

This letter corrects our previous Substantially Equivalent (SE) letter of August 21, 1995.

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. 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

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Page 2 – Mr. Lealos

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/ReportaProblem/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.

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

Enclosure