Anti-Mullerian Hormone Test System

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I3CGlobal FDA 510k, IVDR

FDA 510K for Anti-Mullerian Hormone Test System

The Anti-Mullerian Hormone (AMH) Test System is an in vitro diagnostic device used to measure AMH levels in human serum and plasma. AMH is a key marker for assessing ovarian reserve, helping healthcare providers evaluate a woman’s fertility potential, especially in fertility clinics.

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FDA 510K for Anti-Mullerian Hormone Test System Device Code and Regulation Number

Intended Use of Anti-Mullerian Hormone Test System

These in vitro diagnostic devices are designed to measure AMH levels in human serum and plasma, aiding in the assessment of ovarian reserve in women

S.

No.

 Product Code Device Regulation Description Regulation Number Device Class
1 PQO Anti-Mullerian Hormone (AMH) Test System Anti-Mullerian Hormone Test System 21 CFR 862.1092 2

Anti-Mullerian Hormone Test System (AMH)

Intended Use

This device is an in vitro diagnostic test used to measure Anti-Mullerian Hormone (AMH) levels in human serum and lithium heparin plasma. AMH levels are used to assess ovarian reserve in women visiting fertility clinics.

Device Description

An Anti-Mullerian Hormone Test System is an in vitro diagnostic device intended to measure Anti-Mullerian Hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women. It is used as a prescription device.

It is a diagnostic test that uses a sandwich test principle with two monoclonal AMH-specific antibodies: one biotinylated and the other labelled with a ruthenium complex. It is designed for the quantitative measurement of Anti-Mullerian Hormone (AMH) levels in human serum and lithium heparin plasma.  The assay operates on the cobas e immunoassay analyzer, providing quantitative results that assist in assessing ovarian reserve.

Performance Testing (Analytical) for Anti-Mullerian Hormone Test System

  • Precision (Reproducibility and Repeatability)
  • Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantification (LoQ)
  • Interference study
  • Linearity
  • Specificity
  • Stability study
  • Cross reactivity
  • Matrix comparison
  • Method comparison

Clinical Testing

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