(37 days)
Not Found
No
The device description and performance studies focus on the physical collection and preservation of oral fluid, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is intended for collecting, containing, and preserving oral fluid specimens for laboratory analysis, not for treating a condition or disease.
No
The device is designed for the collection, containment, and preservation of oral fluid specimens for transport to a laboratory, not for direct diagnosis. The diagnostic testing happens in the laboratory with the collected sample.
No
The device description clearly outlines physical components like a collector pad holder/handle, collector pad, collection tube, and envelopes, indicating it is a hardware-based medical device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory." This collection and preservation of a biological specimen for subsequent laboratory analysis is a core function of an IVD.
- Device Description: The device description details components like a collector pad to obtain the specimen and a collection tube with preservative fluid. These are typical components of devices designed for collecting and preparing biological samples for in vitro testing.
- Performance Studies: The performance studies mention testing characteristics like "specimen collection time and volume collected" and assessing the stability of "oral fluid specimens" after environmental testing. These studies are focused on the performance of the device in the context of collecting and preserving a biological sample for analysis.
- Predicate Devices: The predicate devices listed (Saliva Collection Device, EpiScreen™ Oral Collection Device) are also devices used for collecting oral fluid specimens, which are commonly used in IVD testing.
While the document doesn't explicitly state that the analysis of the collected oral fluid is an IVD process, the device's sole purpose is to facilitate that analysis by collecting and preserving the specimen. Therefore, the device itself is considered an IVD accessory or component, as it is intended for use in vitro (outside the body) to prepare a biological sample for diagnostic testing.
N/A
Intended Use / Indications for Use
The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a person under the supervision of a trained health care professional to collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.
Product codes (comma separated list FDA assigned to the subject device)
PJD
Device Description
The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision of a trained health care professional to obtain an oral fluid specimen and have the specimen contained for transport to a laboratory. The device consists of the following:
- A collector pad holder/handle with a collector pad, contained in a sealed "peel-apart" plastic envelope. . The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a predetermined amount of oral fluid has been collected.
- An Oral Fluid Collection Tube with a screw-on lid, containing preservative fluid. ..
- A clear plastic sealed envelope that contains all three of the above items. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral fluid specimens are collected which implies collection from the oral cavity/mouth.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription device, intended for use by a person under the supervision of a trained health care professional
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)
To assess the suitability of the Oral-Eze Oral Fluid Collection System, both the Oral-Eze device and the Saliva · Sampler predicate device were tested for a number of characteristics, such as specimen collection time and volume collected. The test results demonstrated that the Oral-Eze device is substantially equivalent to the Saliva-Sampler predicate device.
To obtain assurance that the oral fluid specimens would remain stable even after undergoing the extreme temperatures that can be experienced by any object sent by common carrier or by the U.S. Mail, Oral-Eze collection tubes with collector pads containing oral fluid specimens were subjected to environmental testing. The test results were considered to be within acceptable accuracy limits.
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.
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
JAN 13 1999
OSBORN LABORATORIES
A ChoicePoint™ Company
610(k) SUMMARY
Osborn Laboratories Oral-Eze™ Oral Fluid Collection System
December 4, 1998
Submitter Information:
Osborn Laboratories 19401 West 117" Street Olathe, Kansas 66062
Submitter's Name: Phone:
Gilbert P. Bourk III (913) 390-7146
Device Name:
Osborn Laboratories Oral-Eze Oral Fluid Collection System
Oral fluid collection kit Common Name:
Blood specimen collection device Classification Name:
Predicate Device Equivalence:
Substantial equivalence is claimed to the Saliva Collection Device (primary predicate device), cleared for commercial distribution per K942435, and to the EpiScreen™ Oral Collection Device (secondary predicate device), cleared for commercial distribution per K973395 and K970357.
Device Description:
The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision of a trained health care professional to obtain an oral fluid specimen and have the specimen contained for transport to a laboratory. The device consists of the following:
- A collector pad holder/handle with a collector pad, contained in a sealed "peel-apart" plastic envelope. . The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a predetermined amount of oral fluid has been collected.
- An Oral Fluid Collection Tube with a screw-on lid, containing preservative fluid. ..
- A clear plastic sealed envelope that contains all three of the above items. .
1
Intended Use:
The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a person under the supervision of a trained health care professional to collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.
Comparison of Technological Characteristics:
Essentially, the Oral-Eze and Saliva-Sampler devices use the same basic technology, i.e., collecting an oral fluid specimen on a fibrous pad and preserving it in a buffer solution contained in a collection tube. One major difference is that with the Oral-Eze device the collector pad is placed in the buccal cavity, whereas with the Saliva-Sampler the collector pad is placed sublingually. Another major difference is that only the collector pad of the Oral-Eze device is contained in the collection tube, whereas both the handle and collector pad of the Saliva-Sampler predicate device are contained in collection tube. In addition, even though the Oral-Eze device is not sterile and the handle and collector pad of the Saliva Sampler predicate device are sterile, the handle and collector pad of the secondary predicate device, the EpiScreen Oral Specimen Collection Device, are not sterile.
Summary of Performance Testing:
To assess the suitability of the Oral-Eze Oral Fluid Collection System, both the Oral-Eze device and the Saliva · Sampler predicate device were tested for a number of characteristics, such as specimen collection time and volume collected. The test results demonstrated that the Oral-Eze device is substantially equivalent to the Saliva-Sampler predicate device.
To obtain assurance that the oral fluid specimens would remain stable even after undergoing the extreme temperatures that can be experienced by any object sent by common carrier or by the U.S. Mail, Oral-Eze collection tubes with collector pads containing oral fluid specimens were subjected to environmental testing. The test results were considered to be within acceptable accuracy limits.
Conclusions:
Based on the above, we have concluded that the Oral Fluid Collection System is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Osborn Laboratories Mr. Gilbert P. Bourk, III Vice President and General Counsel 19401 WEST 117th ST. OLATHE, KANSAS 66062
FEB 0 6 2015
Re: K984361
Trade/Device Name: Osborn Laboratories Oral-Eze™ Oral Fluid Collection System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: II Product Code: PJD Dated: December 4, 1998 Received: December 7, 1998
Dear Mr. Bourk:
This letter corrects our previous Substantially Equivalent (SE) letter of January 13, 1999.
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
3
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/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 Four may obtain other generalism 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,
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
4
of Page
510(k) Number (if known): K984361
Device Name:_
Indications For Use:
Device Name:
Oral-Eze Oral Fluid Collection System
Indications for Use:
The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a The Oral Fidid Collection of a trained health care professional to collection of person under the supervision of a trained from our present with the collection and specificals, contain the collection area to the laboratory.
Sean Cooper
Division of Clinical Laboratory Devices 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)