(57 days)
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No
The summary describes a standard immunoassay system for measuring AMH levels 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 (IVD) assay used to measure Anti-Müllerian hormone (AMH) levels, which aids in the assessment of ovarian reserve. It is not used to treat a condition.
Yes
The device quantitatively determines anti-Müllerian hormone levels as "an aid in the assessment of ovarian reserve" and is "intended to distinguish between women presenting with AFC values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve)", which are diagnostic purposes. It is also explicitly stated that it is to be "used in conjunction with other clinical and laboratory findings".
No
The device description explicitly states that the system comprises the Access Anti-Mullerian Hormone Assay, Access Anti-Mullerian Hormone Calibrators, and the Access Immunoassay analyzers (Dxl 9000). These are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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 description mentions "human serum and lithium heparin plasma," which are biological specimens.
- Assay Type: It describes a "paramagnetic particle chemiluminescent immunoassay," which is a common type of in vitro diagnostic test.
- Performance Studies: The performance studies focus on analytical characteristics like method comparison, imprecision, linearity, and limits of detection/quantitation, which are typical evaluations for IVD devices.
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 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 (comma separated list FDA assigned to the subject device)
PQO
Device Description
The Access Anti-Mullerian Hormone Assay, Access Anti-Mullerian Hormone Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay System for the quantitative determination of Anti-Mullerian Hormone levels in human serum and lithium heparin plasma using the Dxl 9000 Access Immunoassay system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
fertility clinics.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: The results of the Access AMH assay on the Dxl 9000 are comparable to those of the Access AMH assay on Access 2. Further, the estimated bias at concentrations corresponding to reference limits defined on the predicate system suggest that such values have not changed appreciably on the Dxl 9000 system.
Imprecision: The within-laboratory (total) % CV ranged from 2.2% to 5.4%, for AMH concentrations > 0.16 ng/mL. Access AMH Advanced assay meets total error and bias acceptance criteria with maximum Total Error (TE) of 16%.
Linearity: The results of this study met the acceptance criterion and indicate that the Access AMH assay is linear on the Dxl 9000 Immunoassay System throughout the analytical measuring interval (0.08 - 24 ng/mL (0.57 - 171 pmol/L).
Limit of Blank (LoB): The LoB for AMH was determined to be 0.001 ng/mL on the Dxl 9000 Immunoassay System. The results of this study demonstrate that the AMH assay met the acceptance criterion of ≤ 0.01 ng/mL.
Limit of Detection (LoD): The LoD estimate for the AMH assay is 0.002 ng/mL on the Dxl 9000 Immunoassay System. The results of this study demonstrate that the AMH assay met the acceptance criterion of ≤ 0.02 ng/mL on the Dxl 9000 Access Immunoassay System.
Limit of Quantitation (LoQ): The results provided demonstrate the 20% CV LoQ estimate for the Access AMH assay is 0.003 ng/mL (0.02 pmol/L). The results provided demonstrate the LoQ at 20% within-laboratory (total) CV estimate of the Access AMH assay to be ≤ 0.08 ng/mL (0.57 pmol/L).
Reproducibility: The study shows that the Access AMH assay meets design input requirements for reproducibility on Dxl 9000 with an SD ≤ 0.042 ng/mL for values ≤ 0.16 ng/mL and CV ≤ 13.0% for values > 0.16 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope: 1.02 (95% CI: 1.00 - 1.03)
Intercept: 0.011 (95% CI: -0.013 - 0.067)
Correlation Coefficient R: 1.00
Within-laboratory (total) % CV: 2.2% to 5.4% for AMH concentrations > 0.16 ng/mL
Maximum Total Error (TE): 16%
LoB for AMH: 0.001 ng/mL (acceptance criterion ≤ 0.01 ng/mL)
LoD estimate for AMH: 0.002 ng/mL (acceptance criterion ≤ 0.02 ng/mL)
LoQ estimate for Access AMH assay (20% CV): 0.003 ng/mL (0.02 pmol/L)
LoQ at 20% within-laboratory (total) CV estimate: ≤ 0.08 ng/mL (0.57 pmol/L)
Reproducibility SD: ≤ 0.042 ng/mL for values ≤ 0.16 ng/mL
Reproducibility CV: ≤ 13.0% for values > 0.16 ng/mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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February 3, 2023
Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, MN 55318
Re: K223679
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: December 8, 2022 Received: December 8, 2022
Dear Kate Oelberg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula
Digitally signed by Paula
Caposino -S
Caposino -S
Date: 2023.02.03 17:08:40
-05'00'
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223679
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 therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Access AMH 510(k) Summary
510(k) Summary
510(k) Number K223679
Date Prepared: February 3, 2023
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
The assigned 510(k) number is K223679.
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612) 431-7315 Email: kmoelberg@beckman.com
Alternate Contact:
Madhuri Boppana Regulatory Affairs Analyst, Senior Email: mboppana@beckman.com
Device Name:
Common Name: Anti-Müllerian hormone test system Trade Name: Access AMH Classification Name: Anti-Müllerian hormone test system Classification Regulation: (21 CFR 862.1092)
Predicate Device: Device Name: Access AMH 510(k) Numbers: K170524
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Device Description
The Access Anti-Mullerian Hormone Assay, Access Anti-Mullerian Hormone Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay System for the quantitative determination of Anti-Mullerian Hormone levels in human serum and lithium heparin plasma using the Dxl 9000 Access Immunoassay system.
Intended Use
The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Mullerian 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.
| Parameter | Access AMH Assay on Access
2 Immunoassay System
Predicate - K170524 | Access AMH Assay on Dxl 9000
Access Immunoassay Analyzer |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 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 | Same |
| Parameter | Access AMH Assay on Access
2 Immunoassay System
Predicate – K170524 | Access AMH Assay on Dxl 9000
Access Immunoassay Analyzer |
| | 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. | |
| Analyte
Measured | Anti-Müllerian hormone (AMH)
levels in human serum and
lithium heparin plasma | Same |
| Technology | Two-site immunoenzymatic
(sandwich) assay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration
curve | Same |
| Sample Type | Serum or plasma | Same |
| Reagent Pack
formulation and
packaging | Access Reagent Pack
formulation and packaging. | Same |
| Measuring
Range | 0.08-24 ng/mL (0.57-171
pmol/L). | Same |
| Reagent
Stability | Unopened at 2° to 10°C until
stated expiration date | Same |
| Substrate | Access Substrate | Lumi-Phos PRO Substrate |
| Instrument | Access 2 Immunoassay system | Dxl 9000 Access Immunoassay
Analyzer |
Comparison of Technological Characteristics to the Predicate
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Summary of Studies
Method Comparison: The results of the Access AMH assay on the Dxl 9000 are comparable to those of the Access AMH assay on Access 2. Further, the estimated bias at concentrations corresponding to reference limits defined on the predicate system suggest that such values have not changed appreciably on the Dxl 9000 system.
| N | Concentration
Range* (ng/mL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R |
|-----|---------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 126 | 0.11 - 22 | 1.02 | 1.00 - 1.03 | 0.011 | -0.013 -
0.067 | 1.00 |
*Range is Access 2 values
Imprecision: The within-laboratory (total) % CV ranged from 2.2% to 5.4%, for AMH concentrations > 0.16 ng/mL. Access AMH Advanced assay meets total error and bias acceptance criteria with maximum Total Error (TE) of 16%.
| | ng/mL | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-
Laboratory | |
|----------|-------|------|-------------------------------|-----|-------------|-----|-------------|-----|-----------------------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 88 | 0.29 | 0.010 | 3.6 | 0.006 | 2.0 | 0.006 | 2.0 | 0.013 | 4.6 |
| Sample 2 | 88 | 0.80 | 0.030 | 3.7 | 0.000 | 0.0 | 0.000 | 0.0 | 0.030 | 3.7 |
| Sample 3 | 88 | 1.0 | 0.03 | 3.0 | 0.02 | 2.1 | 0.03 | 3.0 | 0.05 | 4.8 |
| Sample 4 | 88 | 2.4 | 0.11 | 4.5 | 0.00 | 0.0 | 0.05 | 2.0 | 0.12 | 5.0 |
| Sample 5 | 88 | 5.1 | 0.18 | 3.4 | 0.03 | 0.7 | 0.09 | 1.7 | 0.20 | 3.9 |
| Sample 6 | 88 | 6.9 | 0.19 | 2.8 | 0.00 | 0.0 | 0.16 | 2.3 | 0.25 | 3.6 |
| Sample 7 | 88 | 13 | 0.4 | 3.1 | 0.3 | 1.9 | 0.3 | 2.6 | 0.6 | 4.5 |
| Sample 8 | 88 | 16 | 0.7 | 4.4 | 0.0 | 0.0 | 0.5 | 3.1 | 0.8 | 5.4 |
| Sample 9 | 88 | 19 | 0.5 | 2.6 | 0.3 | 1.8 | 0.3 | 1.4 | 0.6 | 3.4 |
Linearity: The results of this study met the acceptance criterion and indicate that the Access AMH assay is linear on the Dxl 9000 Immunoassay System throughout the analytical measuring interval (0.08 - 24 ng/mL (0.57 - 171 pmol/L).
7
Limit of Blank (LoB): The LoB for AMH was determined to be 0.001 ng/mL on the Dxl 9000 Immunoassay System. The results of this study demonstrate that the AMH assay met the acceptance criterion of ≤ 0.01 ng/mL.
Limit of Detection (LoD): The LoD estimate for the AMH assay is 0.002 ng/mL on the Dxl 9000 Immunoassay System. The results of this study demonstrate that the AMH assay met the acceptance criterion of ≤ 0.02 ng/mL on the Dxl 9000 Access Immunoassay System.
Limit of Quantitation (LoQ): The results provided demonstrate the 20% CV LoQ estimate for the Access AMH assay is 0.003 ng/mL (0.02 pmol/L). The results provided demonstrate the LoQ at 20% within-laboratory (total) CV estimate of the Access AMH assay to be ≤ 0.08 ng/mL (0.57 pmol/L).
Reproducibility: The study shows that the Access AMH assay meets design input requirements for reproducibility on Dxl 9000 with an SD ≤ 0.042 ng/mL for values ≤ 0.16 ng/mL and CV ≤ 13.0% for values > 0.16 ng/mL.
Conclusion: The information provided in this submission demonstrates that the proposed new device is substantially equivalent to the predicate device.