| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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040
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Date of Entry 05/26/2025
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FR Recognition Number
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10-96
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| Standard | |
ANSI Z80.10-2014
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
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Scope/Abstract| This standard, together with ISO 15004-1:2009, Fundamental requirements and test methods - Part 1: General requirements applicable to all instruments - First edition, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP) for the detection, diagnosis, and management of ocular abnormalities. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
* Last paragraph of Clause B.5.3 "In the >23 mmHg group..."
* Clause B.5.5 "One or both eyes of each subject..." |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part because:
The last paragraph of subclause B.5.3 is in conflict with published literature (See supportive publication #2 listed below). Subclause B.5.3 allows repeated measurements in the same eye, which may then be treated as independent measurements. Results in the published literature show that repeated measurements on the same eye are correlated, not independent.
Subclause B.5.5 is in conflict with published literature (See supportive publication #2 listed below). Subclause B.5.5 allows both eyes of the same subject to be measured and treated as independent measurements. Results in the published literature show that the measurements between the left and right eyes of the same subject are correlated, not independent. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §886.1930 |
Tonometer, Ac-Powered
|
Class 2
|
HKX
|
| §886.1930 |
Tonometer, Manual
|
Class 2
|
HKY
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions, issued March 27, 2006.
2. Bhorade, et al. (2009). Variability of Intraocular Pressure Measurements in Observation Participants in the Ocular Hypertension Treatment Study. Ophthalmology. 116:717-724.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
