DEVICE: Sensonics' Microencapsulated Smell Tests (G051ODMT0)

Device Identifier (DI) Information

Sensonics' Microencapsulated Smell Tests
ODMT
In Commercial Distribution

Sensonics, Inc.
G051ODMT0
HIBCC

1
107213563 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
65154 Olfactory test stick
A non-powered, scented device intended to be used to assess a patient’s olfactory function (normosmia, hyposmia, or anosmia). It typically consists of a scented stick(s) intended to be sniffed by the patient, followed by patient description of smell perception. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NRK Kit, Test, Olfactory
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1ffb1769-9ed5-4dbd-be45-144f1954949b
February 06, 2025
1
January 29, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
856-547-7702
sales@sensonics.com
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