ACCESS TOTAL BHCG (5TH IS)

K130020 · Beckman Coulter, Inc. · DHA · Oct 1, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130020
• Device Name: ACCESS TOTAL BHCG (5TH IS)
• Applicant: Beckman Coulter, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Oct 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

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. The assay is intended for use as an aid in the early detection of pregnancy. The Access Total βhCG (5th IS) calibrators are intended to calibrate the Access Total βhCG (5th IS) assay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems.

Device Story

The Access Total βhCG (5th IS) assay is an automated, paramagnetic particle, chemiluminescent immunoassay used on Access Immunoassay Systems to measure total βhCG (intact hCG and free β-subunit) in human serum and plasma. The device functions as a sandwich immunoassay; it captures hCG molecules from patient samples using specific antibodies. The system produces a quantitative result, which clinicians use as an aid in the early detection of pregnancy. The assay is intended for use in clinical laboratory settings by trained personnel. By providing accurate, standardized quantitative measurements of βhCG, the device assists healthcare providers in confirming pregnancy status, facilitating timely clinical management.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (total CV 3.1–21.7% across ranges). Linearity confirmed 0.6–1350 mIU/mL. LoB/LoD ≤ 0.5 mIU/mL; LoQ 0.6 mIU/mL. Method comparison (N=224) vs. predicate showed correlation (r=0.99). No cross-reactivity with FSH, LH, TSH, or hCG α-subunit. No high-dose hook effect up to 1,000,000 mIU/mL. Reference intervals established for non-pregnant females (18–40y, >40y, post-menopausal).

Technological Characteristics

Paramagnetic particle, chemiluminescent sandwich immunoassay. Reagents: rabbit anti-βhCG alkaline phosphatase conjugate, goat anti-mouse IgG, mouse monoclonal anti-βhCG. Substrate: Lumi-Phos 530. Measuring range: 0.6–1350 mIU/mL. Standardized to WHO 5th IS (07/364). Automated on UniCel DxI 800. Calibrators: 6 levels (0, 6, 35, 195, 620, 1350 mIU/mL) in BSA matrix.

Indications for Use

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

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

• Siemens ADVIA Centaur Total hCG Assay (k925277)

Submission Summary (Full Text)

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510(k) Summary Prepared September 30, 2013

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: Geraldine Baglien [phone] [phone] (fax)

Alternate Contact: Jeffrey Koll [phone] [phone] (fax)

### Device Name

| Trade Name: | Access Total βhCG (5th IS) Assay and Access Total<br>βhCG (5th IS) Calibrators on the Access®<br>Immunoassay Systems |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name: | Human chorionic gonadotropin |
| Classification Name: | Human chorionic gonadotropin (HCG) test system<br>(21 CFR 862.1155)<br>Secondary Calibrator (21CFR 862.1150) |

### Predicate Device

ADVIA Centaur Total hCG Assay (k925277) Manufactured by Siemens Healthcare Diagnostics, Inc.

OCT 0 1 2013

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### Device Description

The Access Total βhCG (5" IS) assay (standardized to WHO 5" International Standard), Access Total BhCG (5th IS) calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of total βhCG in human serum and plasma.

### Intended Use

The Access Total (ShCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro 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.

The Access Total βhCG (5th IS) Calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.

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## Comparison of Technological Characteristics

| Parameter | Access Total BhCG (50" IS) | Predicate ADVIA Centaur Total |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Assay and Access Total BhCG | hCG |
| | (5th IS) Calibrators | |
| Intended use | The Access Total BhCG (5th IS)<br>assay is a paramagnetic particle,<br>chemiluminescent immunoassay<br>for the quantitative determination<br>of total BhCG levels in human<br>serum and plasma using the<br>Access Immunoassay Systems.<br>This assay is intended for use as<br>an aid in the early detection of<br>pregnancy.<br>The Access Total BhCG (5th IS)<br>Calibrators are intended to<br>calibrate the Access Total BhCG<br>(5" IS) assay for the quantitative<br>determination of total BhCG levels<br>in human serum and plasma using<br>the Access Immunoassay<br>Systems | For in vitro diagnostic use in the<br>quantitative determination of<br>human chorionic gonadotropin<br>(hCG) in serum using the ADVIA<br>Centaur and ADVIA Centaur XP<br>systems. The results obtained from<br>hCG specimens are used as an aid<br>in the assessment of pregnancy<br>status. The assay detects the<br>intact hCG molecule and free beta-<br>subunit of the hCG molecule |
| Analyte Measured | Total BhCG (intact hCG and free<br>beta-subunit) | Intact hCG and free beta-subunit<br>hCG |
| Standardization | WHO 50 International Reference<br>Preparation, Chorionic<br>Gonadotropin, NIBSC Coded<br>07/364 | WHO 4th International Reference<br>Preparation, Chorionic<br>Gonadotropin, NIBSC Coded<br>75/589 |
| Technology | Sandwich immunoassay | Sandwich immunoassay |
| Format | Chemiluminescent | Chemiluminescent |
| Method | Automated | Automated |
| Calibration | Utilizes a stored calibration curve | Utilizes a stored calibration curve |
| Calibrator Levels | 6 levels<br>(0 mlU/mL, and approximately 6,<br>35, 195, 620 and 1350 mlU/mL) | 2 levels<br>(Low at approximately 7 mIU/mL<br>and High at approximately 300<br>mlU/mL) |
| Calibrator Matrix | Bovine serum albumin | Equine serum |
| Calibration Curve<br>Stability | 28 days | 28 days |
| Sample Type | Serum or plasma | Serum |
| Measuring Range | 0.6 - 1350 mIU/mL (IU/L) | 2.0 - 1000 mIU/mL (IU/L) |

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### Summary of Studies

Method Comparison: A comparison of 224 serum samples with hCG concentrations ranging from approximately 3.2 to 1095.9 mIU/mL were run on both the Access Total BhCG (5th IS) immunoassay and the predicate Siemens ADVIA Centaur Total hCG immunoassay. The results were compared using Passing-Bablok regression and Pearson correlation with the predicate on the x-axis. The observed linear fit had a slope = 1.04 with 95% confidence interval of 1.02 to 1.06, an intercept = 2.87 mIU/mL and a r = 0.99.

Imprecision: Serum and plasma samples within run imprecision ranged from 1.8 to 4.8 %CV, between run imprecision ranged from 0.9 to 6.0 %CV, and total imprecision ranged from 2.6 to 6.6 %CV at levels between 3.9 and 1350 mlU/mL. The assay exhibits total imprecision of less than 10% CV for concentrations greater than 3.9 mIU/mL and < 0.39 SD at concentrations < 3.9 mlU/mL.

High-dose Hook Effect: The Access Total BhCG (5" IS) assay demonstrated no highdose hook to 1,000,000 mIU/mL in a serum sample.

Linearity: The Access Total BhCG (5" IS) assay has demonstrated to be linear across the range of the assay (0.6 to 1350 mlU/mL) in serum samples.

Dilution Recovery: The Access Total βhCG (5th IS) assay has been demonstrated to dilute recover across the range of the assay (0.6 to 1350 mIU/mL) in serum and plasma samples. Samples containing hCG concentrations from approximately 1150 mIU/mL to 270,000 mlU/mL can be diluted 200-fold and average recovery 100 ± 15%.

Limit of Blank (LoB): The highest measurement result observed with no analyte present in a serum sample is ≤ 0.5 mIU/mL (n=156).

Limit of Detection (LoD): The lowest concentration of analyte in a serum sample that can be detected with a stated probability (95%) is ≤ 0.5 mIU/mL.

Limit of Quantitation (LoQ): The lowest concentration of analyte in serum and plasma samples that can be quantitatively determined is ≤ 0.6 mIU/mL.

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Analytical Specificity: There is no significant interference from total protein, bilirubin, hemoglobin, or triglycerides in serum samples. Additionally, substances similar in structure to hCG when added to a patient serum sample with an approximate hCG concentration of 2.9 mlU/mL showed no significant cross-reactivity.

Isoform Recognition: In serum samples, the Access Total BhCG 5th IS assay recognizes intact hCG, the ß subunit of hCG, nicked intact hCG and nicked ßhCG isoforms. The free a-Dsubunit and B-core fragment vield no detectable response.

Expected Values: Total BhCG concentrations were measured in human serum samples collected from apparently healthy non-pregnant females, which included premenopausal and post-menopausal women, using the Access Total ßhCG (5" IS) assay. Concentrations of total ßhCG measured in 100% of samples were determined to be ≤ 11.6 mIU/mL (IU/L).

Matrix Comparison: A comparison of forty-two (42) matched sets of serum (gel and no gel) and plasma (lithium-heparin) samples with hCG concentrations ranging from approximately 0.5 to 1350 mlU/mL were compared using Passing-Bablok regression with serum (no gel) on the x-axis. The observed linear fit for serum vs. serum (gel) had an estimated slope = 0.99 with a confidence interval (CI) of 0.98 to 1.01, and an estimated intercept = -0.05 mlU/mL with a Cl of -0.15 to 0.10 mlU/mL. The observed linear fit for serum vs. plasma had an estimated slope = 1.05 with a Cl of 1.02 to 1.07, and an estimated intercept = -0.08 mlU/mL with a Cl of -0.28 to 0.05 mlU/mL.

### Conclusion:

The Access Total BhCG (5" IS) Assay and Access Total BhCG (5th IS) Calibrators, for use on the Access Immunoassay Systems, are substantially equivalent to the predicate device, Siemens ADVIA Total hCG assay (k925277) for the measurement of hCG and are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOods-Gh(19 Silver Spring, MI) 20993-1602

October 1. 2013

Beckman Coulter, Inc. c/o Geraldine L. Baglien 1000 Lake Hazeltine Drive CHASKA MN 55318-1084

Re: K130020 Trade/Device Name: Access Total BhCG (5th IS) Assay Access Total BhCG (5th IS) Calibrators Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: DHA, JIX Dated: September 17, 2013 Received: September 18, 2013

Dear Ms. Baglien:

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 conninered prior to May 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may. therefore. manner of the Act include requirements for annual registration, listing of general controls provisions or actice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additiciation. Thease note: ODTC: Set 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). If your device is classince (see above) meeting 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 that I DA has made a coloring administered by other Federal agencies. You must of any Federal Statures and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, morading, or medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements medical device-related adverse events) (2) regulation (21 CFR Part 820); and if applicable. the as set form in the quality systems (20) regaration (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2-Ms. Baglien

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Fou may of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Carol C. Benson -S for

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

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### Indications for Use

510(k) Number (if known): K130020

Device Name: Access Total BhCG (5th IS) Assay and Access Total BhCG (5th IS) Calibrators on the Access® Immunoassay Systems.

Indications for Use:

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

The Access Total BhCG (5th IS) calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -5 2013.10.01 09:47:48 -04'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_k130020