(264 days)
Not Found
No
The document describes a standard immunoassay system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic immunoassay used to assess ovarian reserve, not to treat or cure a disease or condition.
Yes
The device quantitatively determines anti-Müllerian hormone (AMH) levels as an aid in assessing ovarian reserve, helping to distinguish between different levels of ovarian reserve, and is intended to be used in conjunction with other clinical and laboratory findings. These actions are characteristic of a diagnostic device.
No
The device description explicitly states that the system comprises the Access AMH assay, calibrators, QC, along with the Access 2 Immunoassay System analyzer. This indicates the system includes hardware components (the analyzer) in addition to the assay components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Access AMH assay is for the "quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma". This involves testing biological samples in vitro (outside the body).
- Device Description: The "Device Description" further clarifies that the system uses "human serum and plasma" for the determination of AMH levels.
- Input Imaging Modality: The "Not Applicable (In vitro diagnostic immunoassay)" entry confirms that it's not an imaging device but an in vitro test.
- Anatomical Site: The "Not Applicable (In vitro diagnostic immunoassay using serum and plasma)" entry reinforces that it's not applied to a specific anatomical site on the body but uses biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting fertility therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.
Product codes
PQO
Device Description
The Access AMH assay, Access AMH Calibrators, Access AMH QC, along with the Access 2 Immunoassay System analyzer comprise the Access Immunoassay System for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Between >= 21 and 0.16 ng/mL, and 0.16 ng/mL for samples = 21 and 15 AFC group the AMH cutoff is 1.77 ng/mL. The corresponding sensitivity and specificity were 88.9% and 59.1%, respectively.
For patients with an AMH concentration that was > 1.77 ng/mL, 52% were in the > 15 AFC group and 48% were in the
§ 862.1092 Anti-mullerian hormone test system.
(a)
Identification. An anti-mullerian hormone test system is an in vitro diagnostic device intended to measure anti-mullerian hormone in human serum and plasma. An anti-mullerian hormone test system is intended to be used for assessing ovarian reserve in women.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) An adequate traceability plan to minimize the risk of drift in anti-mullerian hormone test system results over time.
(ii) Detailed documentation of a prospective clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(A) Results must demonstrate adequate clinical performance relative to a well-accepted comparator.
(B) Clinical sample results must demonstrate consistency of device output throughout the device measuring range that is appropriate for the intended use population.
(C) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the proposed indications for use(s), and results of all statistical analyses.
(iii) Reference intervals generated by testing an adequate number of samples from apparently healthy normal individuals in the intended use population.
(2) The labeling required under § 809.10(b) of this chapter must include a warning statement that the device is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy, and that the device should be used in conjunction with the antral follicle count.
0
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November 13, 2017
Beckman Coulter, Inc. Debbie Kidder Senior Staff, Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K170524
Trade/Device Name: Access AMH Regulation Number: 21 CFR 862.1092 Regulation Name: Anti-Mullerian hormone test system Regulatory Class: Class II Product Code: PQO Dated: October 5, 2017 Received: October 6, 2017
Dear Debbie Kidder:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Silver Spring, MD 20993 www.fda.gov_
2
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Courtney)H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K170524
Device Name Access AMH
Indications for Use (Describe)
The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting fertility therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K170524
Date Prepared: November 9, 2017
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
- Primary Contact: Debbie Kidder (612)475-6022 (952) 368-7610 (fax)
| Alternate Contact: | Angela Kilian |
|---|---|
| (952) 368-1330 | |
| (952) 368-7610 (fax) |
Device Name
Proprietary / Trade Name: Access AMH Anti-Müllerian hormone test system Common Name: Classification Name: Anti-Müllerian hormone test system Product Code PQO (21 CFR 862.1092)
Predicate Device
Roche Elecsys® AMH System (DEN150057) Manufactured by Roche Diagnostics GmbH
Beckman Coulter Inc. Access AMH Assay Traditional 510(k) Page 1 of 11
5
System Description
The Access AMH assay, Access AMH Calibrators, Access AMH QC, along with the Access 2 Immunoassay System analyzer comprise the Access Immunoassay System for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and plasma.
Intended Use
The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting fertility therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.
6
Table 1: Comparison of Technological Characteristics to the AMH Assay Predicate
| Parameter | Access AMH Assay | Predicate
Roche Elecsys® AMH |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Access AMH assay is a paramagnetic particle
chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women with AFC (antral follicle count) values >15 (high ovarian reserve) and women with AFC values ≤15 (normal or diminished ovarian reserve). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting any fertility therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program. | The Elecsys AMH system is intended for use for the in vitro quantitative determination of anti-Müllerian hormone (AMH) in human serum and lithium heparin plasma. The determination of AMH is used for the assessment of ovarian reserve in women presenting to fertility clinics. The Elecsys AMH system is intended for use on Cobas e 411 analyzer This system is intended to distinguish between women with AFC (antral follicle count) values >15 (high ovarian reserve) and women with AFC values ≤15 (normal or diminished ovarian reserve). This system is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy. The Elecsys AMH system is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program. |
| Analyte
Measured | anti-Müllerian hormone (AMH) | anti-Müllerian hormone (AMH) |
| Sample Type | Serum or plasma | Serum or plasma |
| Technology | Sandwich immunoassay | Sandwich immunoassay |
| Format | Chemiluminescent | Electrochemiluminescence |
| Method | Automated | Automated |
| Measuring
Range | 0.08 – 24 ng/mL
(0.57– 171 pmol/L) | 0.01 – 23 ng/mL
(0.071 – 164.2 pmol/L) |
| Reagent
Stability | Unopened at 2° to 10°C until stated expiration date. | Unopened at 2° to 8°C up to stated expiration date. |
Beckman Coulter Inc. Access AMH Assay Traditional 510(k) Page 3 of 11
7
Limit of Blank (LoB): Access AMH was designed to have a Limit of Blank of ≤ 0.01 ng/mL (0.07 pmol/L). In one study, LoB testing determined the LoB for Access AMH to be 0.0040 ng/mL (0.029 pmol/L).
Limit of Detection (LoD): The Access AMH assay was designed to have a Limit of Detection (LOD) of ≤ 0.02 ng/mL (0.14 pmol/L). In one study, LoD testing determined the LoD for Access AMH to be 0.0098 ng/mL (0.07 pmol/L).
Imprecision: The AMH assay exhibits total imprecision of less than or equal to 10% CV for concentrations greater than or equal to 0.16 ng/mL, and total standard deviation (SD) ≤0.032 ng/mL at concentrations 0.16 Linearity: ng/mL, and ≤ 0.04 ng/mL for samples ≤ 0.16 ng/mL. One study analyzed using a polynominal regression method demonstrated a maximum deviation from linearity of 4.8% for samples > 0.16 ng/mL for samples ≤0.16 ng/mL.
| | | Reagent Lot
470103
Calibrator Lot P2
Access 2 #504310 | | Reagent Lot
470116
Calibrator Lot P3
Access 2 #504310 | | Reagent Lot
470103
Calibrator Lot P2
Access 2 #506902 | | Reagent Lot
470116
Calibrator Lot P2
Access 2 #506902 | | Reagent Lot
470098
Calibrator Lot P1
Access 2 #501022 | | Reagent Lot
470098
Calibrator Lot P2
Access 2 #509403 | |
|----------|-------------------------------|----------------------------------------------------------------|-------------------------------|----------------------------------------------------------------|-------------------------------|----------------------------------------------------------------|-------------------------------|----------------------------------------------------------------|-------------------------------|----------------------------------------------------------------|-------------------------------|----------------------------------------------------------------|--|
| Sample | Expected
Result
(ng/mL) | Observed
Result
(ng/mL) | Expected
Result
(ng/mL) | Observed
Result
(ng/mL) | Expected
Result
(ng/mL) | Observed
Result
(ng/mL) | Expected
Result
(ng/mL) | Observed
Result
(ng/mL) | Expected
Result
(ng/mL) | Observed
Result
(ng/mL) | Expected
Result
(ng/mL) | Observed
Result
(ng/mL) | |
| Sample 1 | 0.00 | 0.00 | 0.00 | 0.0025 | 0.00 | 0.00 | 0.01 | 0.005 | 0.004 | 0.004 | 0.004 | 0.004 | |
| Sample 2 | 3.22 | 3.14 | 3.26 | 3.17 | 2.88 | 3.08 | 2.87 | 3.1 | 3.02 | 2.91 | 3.04 | 2.93 | |
| Sample 3 | 6.44 | 6.18 | 6.51 | 6.10 | 5.76 | 5.82 | 5.73 | 5.86 | 6.04 | 5.97 | 6.08 | 5.93 | |
| Sample 4 | 9.66 | 9.17 | 9.76 | 9.02 | 8.64 | 8.99 | 8.59 | 9.15 | 9.06 | 8.74 | 9.12 | 8.80 | |
| Sample 5 | 12.88 | 12.57 | 13.02 | 12.29 | 11.52 | 11.86 | 11.45 | 11.87 | 12.08 | 11.54 | 12.17 | 11.92 | |
| Sample 6 | 16.10 | 15.28 | 16.27 | 15.29 | 14.10 | 14.23 | 14.32 | 14.36 | 15.10 | 14.74 | 15.21 | 14.79 | |
| Sample 7 | 19.32 | 18.45 | 19.52 | 18.79 | 17.28 | 17.39 | 17.18 | 17.67 | 18.12 | 17.94 | 18.26 | 19.30 | |
| Sample 8 | 22.54 | 21.71 | 22.77 | 22.14 | 20.16 | 20.81 | 20.04 | 20.61 | 21.14 | 21.36 | 21.29 | 21.22 | |
| Sample 9 | 25.75 | 25.76 | 26.03 | 26.03 | 23.04 | 23.30 | 22.90 | 22.90 | 24.16 | 23.80 | 24.33 | 24.46 | |
Linearity – Expected and Observed Concentrations
Beckman Coulter Inc. Access AMH Assay Traditional 510(k) Page 6 of 11
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Analytical Specificity:
Serum samples with AMH concentrations of approximately 2 and 10 ng/mL (14.3 and 71 pmol/L) were spiked with concentrations of the substances below and run on a single Access 2 Immunoassay System. Total Protein (human serum albumin) was tested in serum samples with AMH concentrations of approximately 2 and 7 ng/mL (14.3 and 50 pmol/L). Values were calculated as described in CLSI EP7-A2. Interference was determined by testing controls (no interfering substance added) and matched test samples (with interfering substance added). There was no significant interference (exceeding 10% shift in dose) observed when the following substances were tested at the indicated concentrations.
| Substance | Highest Concentration Added |
|---|---|
| Acetaminophen | 20 mg/dL |
| Acetylsalicylic acid | 65 mg/dL |
| Ampicillin sodium salt | 1000 mg/L |
| Ascorbic acid | 170 µmol/L |
| Bilirubin (Conjugated) | 43 mg/dL |
| Bilirubin (Unconjugated) | 40 mg/dL |
| Biotin | 179 ng/mL |
| Cefoxitin sodium salt | 2500mg/L |
| Cyclosporin A | 5 mg/L |
| Doxycycline hyclate | 50 mg/L |
| Folic acid | 0.4 mg/L |
| Gamma Globulin | 60 mg/L |
| Hemoglobin | 1 g/dL |
| Heparin (low molecular weight) | 3000 U/L |
| lbuprofen | 50 mg/dL |
| lgA | 1.8 g/dL |
| lgG | 2.5 g/dL |
| IgM | 0.5 g/dL |
| Intralipids | 37 mmol/L |
| Levodopa | 20 mg/L |
11
| Levothyroxine sodium hydrate | 0.2 mg/L |
|---|---|
| Metformin | 2000 mg/L |
| Methyldopa | 20 mg/L |
| Metronidazole | 200 mg/L |
| N-Acetyl-L-cysteine | 150 mg/L |
| Phenylbutazone | 400 mg/L |
| Rheumatoid Factor | 1000 IU/mL |
| Rifampicin | 60 mg/L |
| Theophylline | 100 mg/L |
| Triptoréline (Gonapeptyl) | 0.1 mg/L |
| Total protein (human serum albumin) | 12 g/dL |
| Uric Acid | 1.4 mmol/L |
Cross-reactivity:
Serum samples with AMH concentrations of approximately 2 and 10 ng/mL (14.3 and 71 pmol/L) spiked with concentrations of the substances below and run on a single Access 2 Immunoassay System. Activin A was tested in serum samples with AMH concentrations of approximately 1 and 5 ng/mL (7.1 and 36 pmol/L). Values were calculated per CLSI EP7-A2. There was no significant cross reactivity (exceeding 5% cross reactivity) observed when the following substances were tested at the indicated concentrations:
| Cross-reactant Substance | Highest Concentration Added |
|---|---|
| Inhibin A | 100 ng/mL |
| Activin A | 16.32 $ μ $ g/L |
| hLH | 100 mlU/mL |
| hFSH | 115 mlU/mL |
| TGF β-1 | 65 ng/mL |
Matrix Comparison: A comparison of fifty-seven (57) matched sets of serum (gel and no gel) and plasma (lithium-heparin) samples with AMH concentrations spanning as much of the assay range as practicably possible. All sample type combinations pass the specification of slope equal to 1.00 ± 0.10.
12
| Sample type comparison | Slope | Sample Range
(ng/mL) | N |
|------------------------------------|-------|-------------------------|----|
| Lithium Heparin vs.Serum
No Gel | 1.03 | 0.20 to 13.75 | 57 |
| Lithium Heparin vs. Serum
Gel | 1.05 | 0.19 to 13.71 | 57 |
| Serum Gel vs. Serum No Gel | 0.99 | 0.20 to 13.75 | 57 |
Method Comparison: A comparison of 121 values across the range of the assay using the Access AMH assay on the Access 2 Immunoassay system and a commercially available immunoassay kit gave the following statistical data using Passing Bablok regression and Spearman correlation for the r calculation:
| N | Range of
Observations (ng/mL) | Intercept
(ng/mL) | Slope
(95% CI) | Correlation
Coefficient (r) |
|-----|----------------------------------|----------------------|--------------------|--------------------------------|
| 121 | 0.070 to 22.80 | 0.04 | 1.03 (1.01 – 1.06) | 0.99 |
Access AMH Clinical Study: A multicenter, clinical study of 164 women was used to correlate AMH values to the antral follicle count (AFC) in women presenting to fertility clinics for evaluation. The trial enrolled women at 13 geographically diverse sites in the US who were between ≥ 21 and 15 (33%). For the > 15 AFC group the AMH cutoff is 1.77 ng/mL. The corresponding sensitivity and specificity were 88.9% and 59.1%, respectively. For patients with an AMH concentration that was > 1.77 ng/mL, 52% were in the > 15 AFC group and 48% were in the ≤ 15 AFC group. The study results support the system can distinguish between women with AFC values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve).
Expected Reference Intervals: The serum and plasma samples were prospectively procured from apparently healthy, non-pregnant females at five (5) geographically diverse sites. Subjects were required to have regular menstrual cycles between 21 and 35 days, both ovaries present, and proven fertility. Populations studied are described by group in the table below.
| Serum AMH | |||
|---|---|---|---|
| Group (years) | Sample Size | Median ng/mL | |
| (pmol/L) | 95% Reference Interval | ||
| ng/mL (pmol/L) | |||
| 18-25 | 120 | 3.6 | |
| (25.70) | 1.02 - 14.63 | ||
| (7.28 - 104.46) | |||
| 26-30 | 131 | 3.82 | |
| (27.27) | 0.69 - 13.39 | ||
| (4.93 - 95.60) | |||
| 31-35 | 120 | 2.47 | |
| (17.64) | 0.36 - 10.07 | ||
| (2.57 - 71.90) | |||
| 36-40 | 123 | 1.71 | |
| (12.21) | 0.18 - 5.68 | ||
| (1.29 - 40.56) | |||
| 41-45 | 126 | 0.54 | |
| (3.86) | 0.01 - 2.99 | ||
| (0.07 - 21.35) |
14
| Plasma AMH | |||
|---|---|---|---|
| Group (years) | Sample Size | Median ng/mL | |
| (pmol/L) | 95% Reference Interval | ||
| ng/mL (pmol/L) | |||
| 18-25 | 120 | 3.75 | |
| (26.78) | 1.04 - 15.25 | ||
| (7.43 - 108.89) | |||
| 26-30 | 131 | 4.06 | |
| (28.99) | 0.74 - 13.81 | ||
| (5.28 - 98.60) | |||
| 31-35 | 120 | 2.56 | |
| (18.28) | 0.38 - 10.50 | ||
| (2.71 - 74.97) | |||
| 36-40 | 123 | 1.78 | |
| (12.71) | 0.19 - 6.06 | ||
| (1.36 - 43.27) | |||
| 41-45 | 126 | 0.56 | |
| (4.00) | 0.01 - 3.17 | ||
| (0.07 - 22.63) |
Conclusion:
The conclusions drawn from the nonclinical and clinical testing demonstrate that the Access AMH assay for use on the Access Immunoassay Systems, are as safe, as effective, and performs as well as the predicate.