EPISCREEN ORAL SPECIMEN COLLECTION DEVICE

K973395 · Epitope, Inc. · PJD · Feb 13, 1998 · Clinical Chemistry

Device Facts

• Record ID: K973395
• Device Name: EPISCREEN ORAL SPECIMEN COLLECTION DEVICE
• Applicant: Epitope, Inc.
• Product Code: PJD · Clinical Chemistry
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

Device Story

EpiScreen is an oral specimen collection device consisting of an absorbent cotton fiber pad on a nylon stick and a preservative solution in a plastic vial. The pad is impregnated with salts and gelatin to create a hypertonic environment, which stimulates the flow of gingival fluid when placed between the lower gum and cheek. After collection, the pad is placed into the vial containing preservative solution, which inhibits microbial growth on the specimen. The vial is sealed and transported to a laboratory for processing. The device is used to facilitate the collection of oral fluid for diagnostic testing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Device consists of a treated absorbent cotton fiber pad affixed to a nylon stick and a plastic specimen vial containing a preservative solution. The pad is impregnated with salts and gelatin to induce osmotic flow of gingival fluid. The device is a non-electronic, manual collection tool.

Indications for Use

Indicated for the collection, preservation, and transport of oral fluid specimens for laboratory testing.

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.

Predicate Devices

• EpiScreen Oral Specimen Collection Device (K970357)

Submission Summary (Full Text)

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K973395

3643278

FEB 1 3 1998

# EpiScreen™ Oral Specimen Collection Device 510(k) Summary

[as required by 21 CFR 807.92(c)]

submitted by Epitope, Inc.

8505 SW Creekside Place Beaverton, OR 97008 phone: [phone] fax: [phone]

> contact: Caroline Sayre Regulatory Affairs

August 19, 1997

EpiScreen 510(k) Summary Epitope, Inc.

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#### 510(k) Summary

### Trade Name: EpiScreen™ Common Name: Oral Specimen Collection Device

#### Device Description

The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common (Specifical vial). The Generativertonic environment which produces an osmotic sails and gelain, ereating a my perival mucosae. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow the gingival macoba (between was sorptive cotton fibers of the pad. Following the of Indecourt the Collection Pad is removed from the mouth and placed into a conection period, the Concession a preservative solution which serves to inhibit the Specifical The The Tim connect on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

#### Intended Use

EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

#### Classification

This 510(k) contains a modification to the package insert of the EpiScreen Oral This Jro(k) contains a mountains.
Specimen Collection Device (510(k) #970357). This product has been deemed a Class II device under the following classification:

- Blood Specimen Collection Device (Class II, 21 CFR §862.1675, Clinical . Chemistry and Clinical Toxicology Devices, Product Code 75JKA)
## Comparison of Technological Characteristics

EpiScreen is intended to collect oral fluid specimens, contain those specimens, and Epiccreen is intended to concer cliection and during transport from the collection preserve the specifical anter concesses been a modification only to the EpiScreen area to the laboratory. Since itself, Epitope considers this device to be substantially equivalent to the originally cleared EpiScreen device.

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# Comparison Table: Current EpiScreen vs. Modified EpiScreen

| Feature | Current EpiScreen | Modified EpiScreen |
|-----------------------|----------------------------------------------|----------------------------------------------|
| Indication | Collection/transport of oral fluid specimens | Collection/transport of oral fluid specimens |
| Collection Apparatus | ✓ | ✓ |
| Transport Container | ✓ | ✓ |
| Preservative Solution | ✓ | ✓ |

The EpiScreen device described in this 510(k) is identical to the currently cleared device and therefore does not raise new questions of safety and efficacy.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Epitope, Inc. Caroline R. Sayre, RAC Regulatory Affairs Supervisor 8505 SW CREEKSIDE PLACE BEAVERTON, OREGON 97008

FEB 0 6 2015

Re: K973395

Trade/Device Name: EpiScreen™ Oral Specimen Collection Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: II Product Code: PJD Dated: August 19, 1997 Received: August 21, 1997

Dear Ms. Sayre:

This letter corrects our previous Substantially Equivalent (SE) letter of February 13, 1998.

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 - Ms. Sayre

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 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.

Sincerely yours,

Keitt Jumo

tor i 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

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| 510(k) Number (if known): | |
|---------------------------|-------------------------------------------------------------------------------------------------|
| Device Name: | EpiScreen™ Oral Specimen Collection Device |
| Indications for Use: | |
| | EpiScreen is intended for use in the collection, preservation, and transport of oral specimens. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K973395 |
|---------------|---------|
|---------------|---------|

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

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דישובים חיי חייחחיים

Indications for Use
EpiScreen 510(k)