Access Total ßhCG (5th IS)

K221990 · Beckman Coulter, Inc. · DHA · Dec 27, 2022 · Clinical Chemistry

Device Facts

• Record ID: K221990
• Device Name: Access Total ßhCG (5th IS)
• Applicant: Beckman Coulter, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Dec 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Access Total βhCG (5 th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

Device Story

Paramagnetic particle, chemiluminescent immunoassay; measures total βhCG in human serum/plasma. Operates on Dxl 9000 Access Immunoassay Analyzer. Two-step sandwich method; automated processing. Used in clinical laboratory settings by trained personnel. Output is quantitative βhCG concentration; aids clinicians in early pregnancy detection. Benefits include standardized, automated, and reproducible pregnancy testing.

Clinical Evidence

Bench testing only. Studies included method comparison (R² ≥ 0.90, slope 1.00 ± 0.10), imprecision (within-lab total CV 2.5%–4.7% for >3.9 mIU/mL), linearity, reproducibility (CV < 13.0% for >3.9 mIU/mL), LoB (0.1 mIU/mL), LoD (0.2 mIU/mL), and LoQ (0.6 mIU/mL).

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay; two-step sandwich method. Automated system. Standardized to WHO 5th International Standard (NIBSC 07/364). Measuring range 0.6 to 1350 mIU/mL. Uses Lumi-Phos PRO substrate. Compatible with Dxl 9000 Access Immunoassay Analyzer.

Indications for Use

Indicated for the quantitative determination of total βhCG levels in human serum and plasma as an aid in the early detection of pregnancy.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• Access Total βhCG (5th IS) Assay (K130020)

Submission Summary (Full Text)

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December 27, 2022

Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318

Re: K221990

Trade/Device Name: Access Total βhCG (5th IS) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) Test System Regulatory Class: Class II Product Code: DHA Dated: July 5, 2022 Received: July 6, 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

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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) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Acting 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) k221990

Device Name ACCESS TOTAL BHCG (5th IS)

#### Indications for Use (Describe)

The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

| 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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Access Total βhCG (5th IS) 510(k) Summary

### 510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1).

The assigned 510(k) number is k221990.

#### Submitted By:

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

#### Contact Person:

Kate Oelberg 1000 Lake Hazeltine Drive Chaska, MN 55318 Phone: [phone] Email: [e-mail]

#### Alternate Contact:

Kuljeet Kaur Office Phone: [phone] Email: [e-mail]

#### Date Prepared:

July 5, 2022

#### Device Name:

Common Name: Total βhCG (5th IS) Assay Trade Name: Access Total BhCG (5th IS) Classification Name: Human chorionic gonadotropin (HCG) test system Classification Regulation: [21 CFR 862.1155] Product Code: DHA

#### Predicate Device:

The Access Total βhCG (5th IS) Assay/Calibrators claim substantial equivalence to previously cleared Access Total βhCG (5th IS) Assay FDA 510(k) Number K130020 cleared on 10/1/2013.

#### Device Description:

The Access Total βhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

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## Intended Use:

The Access Total βhCG (5 th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

## Comparison of Technological Characteristics to the Predicate (Assay)

| System<br>Attribute/Characteristic | Access Total ββhCG (5th IS)<br>on Dxl 9000 Access<br>Immunoassay Analyzer<br>k221990 | Predicate Access Total<br>ββhCG (5th IS) on Dxl 800<br>Access Immunoassay<br>System k130020 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for Use | The Access Total βhCG (5th<br>IS) assay is a paramagnetic<br>particle, chemiluminescent<br>immunoassay for the<br>quantitative determination of<br>human Total βhCG (5th IS)<br>levels in human serum and<br>plasma. This assay is intended<br>for use as an aid in the early<br>detection of pregnancy. | Same |
| Analyte Measured | Total βhCG | Same |
| Standardization | WHO 5th International<br>Standard for Chorionic<br>Gonadotropin (NIBSC Code<br>07/364) | Same |
| Technology | Two-step sandwich | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration<br>curve | Same |
| Sample Type | Serum or lithium heparin<br>plasma | Same |
| Measuring Range | 0.6 to approximately 1350<br>mIU/mL | Same |
| Stability | Stable at 2 to 10°C for 28 days<br>after initial use | Same |
| Reagent Pack<br>formulation and<br>packaging | Access Reagent Pack<br>formulation and packaging. | Same |
| Instrument | Dxl 9000 Access<br>Immunoassay Analyzer | UniCel Dxl 800 Access<br>Immunoassay System |
| Substrate | Lumi-Phos PRO substrate | Access Substrate |
| Reagent Configurations | Two Configurations:<br>1) 100 determinations, 2) | One Configuration:<br>100 determinations, 2 packs, |
| System<br>Attribute/Characteristic | Access Total ββhCG (5th IS)<br>on Dxl 9000 Access<br>Immunoassay Analyzer<br>k221990 | Predicate Access Total ββhCG (5th IS) on Dxl 800<br>Access Immunoassay<br>System k130020 |
| | packs, 50 tests/pack (for<br>predicate and candidate<br>instrument)<br>2) 200 determinations, 2<br>packs, 100 tests/pack (for<br>candidate instrument only) | 50 tests/pack |

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## Summary of Studies:

Method Comparison: The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10 and supports the equivalence of the Access Total ßhCG assay on Dxl 9000 to the predicate device, the Access Total BhCG assay on Access 2 Instrument. The bias estimate data supports the reference intervals defined on the Access 2 system have not changed appreciably on the Dxl 9000 system.

Imprecison: The within-laboratory (total) % CV ranged from 2.5% to 4.7%, for hCG concentrations > 3.9 mlU/mL. The within-laboratory (total) SD ranged from 0.04 to 0.06 for hCG concentrations ≤ 3.9 mlU/mL ..

Linearity: This study shows that the acceptance criteria was met for non-linearity within ± 0.39 mlU/mL for values ≤ 3.9 mlU/mL and ± 10.0% for values > 3.9 mlU/mL.

Reproducibility: This study shows that the Access Total ßhCG (5th IS) assav meets design input requirements for reproducibility on the Dxl 9000 with an SD ≤ 0.51 for values ≤ 3.9 mlU/mL and CV < 13.0% for values > 3.9 mlU/mL.

LoB/LoD: The data demonstrated the LoB estimate of the Total βhCG (5th IS) assay is 0.1 mlU/mL and the LoD is 0.2 mIU/mL.

LoQ: LoQ was determined as the lowest concentration which met the design requirements of 20% CV and recovery of ± 0.1 mIU/mL for three reagent lots when compared to the WHO 5™ International Standard for Chorionic Gonadotropin (NIBSC Code 07/364). This study determined the LoQ for Access Total βhCG (5th IS) to be 0.6 mIU/mL (IU/L).

## Substantial Equivalence Comparison Conclusion

The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Total βhCG (5th IS) assay on DxI 9000 Access Immunoassav Analyzer.