Anti-Müllerian Hormone Test System
The Anti-Mullerian Hormone Test System is an in vitro diagnostic device intended to measure anti-Mullerian hormone (AMH) in human serum and plasma as an aid for assessing ovarian reserve in women, which can inform decisions related to fertility treatment. It is classified as FDA Class 2 under 21 CFR 862.1092 in the Clinical Chemistry specialty, requiring 510(k) premarket notification. The device provides a quantitative measure used in reproductive endocrinology. Product code PQO; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQO
- Device Class
- FDA class 2
- Regulation Number
- 862.1092
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Jun 02, 2023 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K223679 | Access AMH | Feb 03, 2023 | Substantially Equivalent | Beckman Coulter, Inc. |
| K203757 | Elecsys AMH | Jun 10, 2022 | Substantially Equivalent | Roche Diagnostics |
| K170524 | Access AMH | Nov 13, 2017 | Substantially Equivalent | Beckman Coulter, Inc. |
| DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Dec 19, 2016 | Unknown | Roche Diagnostics |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.