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.

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. .

AI/ML Overview

The provided text describes the "Osborn Laboratories Oral-Eze™ Oral Fluid Collection System." Since this is a collection device and not a diagnostic or AI-powered system, the typical acceptance criteria and study designs (like MRMC studies) for such devices are not applicable in the same way they would be for an AI algorithm interpreting medical images.

Instead, the performance evaluation focuses on direct comparison to predicate devices and ensuring the practical utility and stability of the collected specimens.

Here's an analysis based on the provided text, adapted for a medical device that collects biological samples:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Metric	Predicate Device A (Saliva Collection Device, K942435) Performance (Implied)	Predicate Device B (EpiScreen™ Oral Collection Device, K973395 and K970357) Performance (Implied)	Oral-Eze™ Oral Fluid Collection System Performance
Substantial Equivalence	Overall functional equivalence for oral fluid collection and preservation.	Established as safe and effective.	Established as safe and effective.	Claimed to be substantially equivalent to both predicates.
Specimen Collection Time	Not explicitly stated, but implies similar or acceptable collection time.	Performance not quantified.	Performance not quantified.	Tested to be comparable to Saliva-Sampler.
Volume Collected	Not explicitly stated, but implies similar or acceptable volume.	Performance not quantified.	Performance not quantified.	Tested to be comparable to Saliva-Sampler.
Specimen Stability (Environmental)	Ability of collected oral fluid specimens to remain stable under extreme temperatures (e.g., during transport).	Not explicitly stated/tested; relevant for Oral-Eze.	Not explicitly stated/tested; relevant for Oral-Eze.	Test results within acceptable accuracy limits for specimens subjected to environmental testing.
Indications for Use (Prescription)	Intended for use by person under supervision of trained health care professional to collect, contain, and preserve oral fluid specimens for transport to laboratory.	Yes	Yes	Yes (Matches)
Non-Sterility	Device is not sterile.	Saliva-Sampler: Sterile.	EpiScreen: Not sterile.	Device is not sterile. (Comparable to EpiScreen on this characteristic).
Specimen Storage/Transport	Ability to contain and preserve specimens effectively during transport.	Yes	Yes	Yes
Indicator for Sufficient Collection	Visual indicator for predetermined amount of oral fluid collected.	Not mentioned.	Not mentioned.	Blue color appears in indicator port when predetermined amount is collected. (Unique feature to Oral-Eze compared to mentioned predicates).

Note: The text explicitly states "The test results demonstrated that the Oral-Eze device is substantially equivalent to the Saliva-Sampler predicate device" for characteristics like collection time and volume. For environmental stability, it states "The test results were considered to be within acceptable accuracy limits." The specific quantitative thresholds for these metrics are not provided in the summary.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The text only mentions "To assess the suitability... both the Oral-Eze device and the Saliva · Sampler predicate device were tested for a number of characteristics." For environmental testing, it notes "Oral-Eze collection tubes with collector pads containing oral fluid specimens were subjected to environmental testing."
Data Provenance: Not explicitly stated. The testing seems to be internal to Osborn Laboratories. Given it's a pre-market submission, it would typically be conducted under controlled laboratory conditions, possibly drawing from a pool of healthy volunteers for initial collection tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This level of detail is not provided. For a device like this, "ground truth" would likely involve objective measurements (e.g., volume collected, chemical analysis of preservative efficacy, stability of drugs/analytes in collected samples, if relevant, although not detailed here). The "suitability" and "acceptable accuracy limits" would be determined by laboratory professionals or engineers with expertise in medical device testing and quality control.

4. Adjudication Method for the Test Set:

Not applicable or provided. This is typically for subjective assessments (e.g., image interpretation). Performance for this device would rely on objective measurement against pre-defined engineering or performance specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a fluid collection system, not an AI diagnostic or assistance tool, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used:

For the performance testing mentioned:

Comparison to Predicate Performance: The "ground truth" for collection time and volume was likely the observed performance of the predicate device (Saliva-Sampler).
Defined Acceptable Limits: For environmental stability, the "ground truth" would be pre-defined "acceptable accuracy limits" for the integrity and chemical stability of the oral fluid specimens after exposure to extreme temperatures. This would usually be based on established laboratory standards or regulatory guidance for specimen transport.

8. The Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set.

Summary

{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:

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:

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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.