FDA UDI In Commercial Distribution 🇺🇸 United States

Sensonics' Microencapsulated Smell Tests

DI: G051ODMT0 · Model: ODMT · Sensonics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sensonics' Microencapsulated Smell Tests
Primary DI
G051ODMT0
Version / Model
ODMT
Company Name
Sensonics, Inc.
Labeler DUNS
107213563
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-29
Public Version
1
Public Version Date
2025-02-06
Public Version Status
New
Public Device Record Key
1ffb1769-9ed5-4dbd-be45-144f1954949b

Device Description

The OMT provides a subjective assessment of odor discrimination in general and short-term odor memory in particular. This instrument is a 12-item, single-target, four-alternative, forced- choice test with nominal 10-, 30-, and 60-sec delay intervals. However, these delay intervals are not sacrosanct and can be modified by the test user according to his or her interests or needs. The OMT is based on the match-to-sample paradigm. A unique feature of the OMT is the ease of presentation of the stimuli, since the test administrator must simply scratch open a set of micro- encapsulated odors with a pencil for the subject to sample at the appropriate time points. The micro- encapsulated odorants used in this test – banana, peppermint, rose, and peanut -- were chosen to be isointensive so that only the qualitative stimulus dimension is salient. In this test, a target odorant is released by scratching the odorized label, which is then presented to the subject for sampling. After a given delay interval, four microencapsulated odorants (three of which are foils) are similarly released and presented at ~ five second intervals. The subject’s task is to report which odor in the odor response set is the same as the target stimulus. During the delay interval, each subject is required to count aloud backwards by threes from 280 to minimize verbal rehearsal. The odorants used in the test are counter-balanced such that all odorants occur an equal number of times at each delay interval. The order of the delay intervals is the same for each subject and is as follows for the 12 respective items: 10, 30, 30, 60, 10, 60, 60, 30, 60, 30, 10, & 10 sec. The target odors (TO) and the response set choices (RC) for each of these 12 items are as follows (correct response in italics): (1) TO: PEA; RC: EA, PNUT, PEA, MINT; (2) TO: MIN RC: PEA, MINT, EA, PNUT; (3) TO: PNUT; RC: EA, PEA, MINT, PNUT; (4) TO: EA; RC: EA, PNUT, PEA, MINT; (5) TO: MINT; RC: MINT, EA, PEA, PNUT; (6) TO: PEA; RC: EA, PE

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NRK Kit, Test, Olfactory

GMDN Terms

Code Name
65154 Olfactory test stick

Identifiers

Type ID
Primary G051ODMT0

Customer Contacts

Phone
856-547-7702