# K984361: Oral-Eze Oral Fluid Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Osborn Laboratories, Inc.
- Decided: Jan 13, 1999 after 37 days
- Product code: PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970357 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942435: Saliva Sampler, Saliva Diagnostic Systems, Inc. (1995). Our OCR of the scanned summary read K842435, FDA’s number for Model T 101 Clinical Transmitter (Biometric Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Saliva-Sampler® Saliva Collection Device”.
- K973395: Episcreen Oral Specimen Collection Device, Epitope, Inc. (1998) Summary page 1.
- K970357: Episcreen, Epitope, Inc. (1997) Summary page 1.

## Most influential descendants
- K991800: Hemochek Urine Collection Kit (1999), 0 descendants of its own

## Recalls of this device
- Oct 7, 2011 · Not classified · Z-1101-2012: Low buffer fill volumes on Oral-Eze, an oral fluid collection system.

## 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.

Source page: https://510kreport.com/device/K984361
Methodology: https://510kreport.com/methodology