(176 days)
970357
Not Found
No
The description focuses on the physical components and function of a specimen collection device, with no mention of AI or ML technologies.
No
The device is described as a collection and preservation system for oral fluid specimens, not as something that treats or diagnoses a condition. Its function is to collect specimens for later laboratory testing.
No
The device description indicates that EpiScreen is intended to collect, contain, and preserve oral fluid specimens for transport to a laboratory for processing and testing. It does not perform any analysis or interpretation of the specimens itself, which are functions of a diagnostic device. The 'Intended Use' specifically states its role in specimen handling, not diagnosis.
No
The device description clearly outlines physical components (cotton fiber pad, nylon stick, plastic container, plastic cap) and their functions in collecting and preserving a specimen, indicating it is a hardware device with no mention of software as the primary or sole component.
Based on the provided information, the EpiScreen device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for collecting, containing, and preserving oral fluid specimens for transport to a laboratory for processing and testing. This strongly suggests that the collected specimen will be used for diagnostic purposes in vitro (outside the body).
- Device Description: The description mentions a "preservative solution" to "inhibit" something on the collection pad, and that the vial is transported to a laboratory for "processing and testing." This further supports the idea that the collected sample is intended for laboratory analysis.
While the document doesn't explicitly state what the "testing" is for (e.g., detecting a specific disease marker), the entire process described aligns with the definition of an IVD, which is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
The fact that it's a specimen collection and preservation device intended for laboratory testing is the key indicator that it falls under the IVD category.
N/A
Intended Use / 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.
EpiScreen is intended for use in the collection, preservation, and transport of oral specimens.
Product codes (comma separated list FDA assigned to the subject device)
75JKA, PJD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral fluid specimens, gingival mucosa (between the lower gum and cheek)
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.
510(k) #970357
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
Image /page/0/Picture/0 description: The image shows the logo for Epitope. The logo is a black square with a white circle inside. The circle has a horizontal line through the middle, and the top and bottom halves of the circle are filled with a textured pattern. Below the logo, the word "EPITOPE" is printed in a bold, sans-serif font.
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: 503-641-6115 fax: 503-643-2781
contact: Caroline Sayre Regulatory Affairs
August 19, 1997
EpiScreen 510(k) Summary Epitope, Inc.
1
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.
2
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.
3
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
4
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 (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/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 (800) 638-2041 or (301) 796-7100 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
5
| 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
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
ー
ງນວນເອງຍຸງ
דישובים חיי חייחחיים
Indications for Use
EpiScreen 510(k)