Atellica IM Total hCG (ThCG)

K192790 · Siemens Healthcare Diagnostics, Inc. · DHA · Oct 30, 2019 · Clinical Chemistry

Device Facts

• Record ID: K192790
• Device Name: Atellica IM Total hCG (ThCG)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Oct 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Atellica® IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma (EDTA or lithium heparin) using the Atellica® IM Analyzer. Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

Device Story

The Atellica® IM Total hCG (ThCG) assay is an in vitro diagnostic test used on the Atellica® IM Analyzer to quantitatively measure human chorionic gonadotropin (hCG) in human serum or plasma. The device utilizes a sandwich immunoassay principle with direct chemiluminescent technology. It employs a goat polyclonal anti-hCG antibody labeled with acridinium ester and a mouse monoclonal anti-hCG antibody coupled to paramagnetic particles. The analyzer processes samples to produce a quantitative result, which clinicians use as an aid in the early detection of pregnancy. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Specimen equivalency was evaluated by comparing serum to EDTA and lithium heparin plasma samples using Deming linear regression (N=116 for EDTA, N=134 for lithium heparin). Results showed high correlation (r=1.00) with slopes of 1.02 and 1.05, respectively. Interference testing per CLSI EP07-ed3 confirmed minimal bias (<2%) for both anticoagulants at tested concentrations.

Technological Characteristics

Sandwich immunoassay; direct chemiluminescent technology. Reagents: Goat polyclonal anti-hCG antibody labeled with acridinium ester; mouse monoclonal anti-hCG antibody on paramagnetic particles. Standardized against WHO 4th IS 75/589. Assay range: 2.6–1000 mIU/mL. Incubation: 8 minutes at 37°C. Sample volume: 25 µL. Automated system (Atellica IM Analyzer).

Indications for Use

Indicated for the quantitative determination of hCG in human serum or plasma (EDTA or lithium heparin) 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

October 30, 2019

Siemens Healthcare Diagnostics Inc. Mey Lyn Vasquez Regulatory Clinical Affairs Specialist 511 Benedict Ave. Tarrytown, NY 10591

Re: K192790

Trade/Device Name: Atellica® IM Total hCG (ThCG) Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA Dated: September 27, 2019 Received: September 30, 2019

Dear Mey Lyn Vasquez:

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

{1}------------------------------------------------

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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For: Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) k192790

Device Name Atellica® IM Total hCG (ThCG)

#### Indications for Use (Describe)

The Atellica® IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma (EDTA or lithium heparin) using the Atellica® IM Analyzer.

Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: none;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

# 510(k) Summary of Safety and Effectiveness

Introduction: According to the requirements of SMDA 1990 and 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.

The assigned 510(k) Number: ____k192790_______________________________________________________________________________________________________________________________________

#### 1. APPLICANT

Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA

| Contact: | Mey Lyn Vasquez<br>Regulatory Clinical Affairs Specialist |
|----------|-----------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

Date Prepared: October 30, 2019

#### Regulatory Information 2.

#### Assay

| Trade Name | Atellica® IM Total hCG (ThCG) |
|------------------------|------------------------------------------------|
| Device | System, Test, Human Chorionic Gonadotropin |
| Regulation Description | Human chorionic gonadotropin (HCG) test system |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry |
| Product Code | DHA |
| Regulation Number | 21 CFR 862.1155 |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" are several orange dots arranged in a circular pattern.

#### 3. PREDICATE DEVICE

### Assay

Name of Device: Atellica® IM Total hCG (ThCG) 510 (k): k172322

#### DEVICE DESCRIPTION 4.

The Atellica® IM Total hCG (ThCG) Assay reagents come in the following configurations:

| Contents | Number<br>of Tests |
|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| 1 ReadyPack primary reagent pack containing Atellica IM ThCG<br>Lite Reagent and Solid Phase<br>Atellica IM ThCG master curve and test definition | 90 |
| 5 ReadyPack primary reagent packs containing Atellica IM ThCG<br>Lite Reagent and Solid Phase<br>Atellica IM ThCG master curve and test definition | 450 |

The ReadyPack consists of the following:

### Atellica IM ThCG ReadyPack primary reagent pack Lite Reagent

4.5 mL/reagent pack Goat polyclonal anti-hCG antibody (~0.1 µg/mL) labeled with acridinium ester in buffered saline; sodium azide (0.1%); preservatives

### Solid Phase

20.3 mL/reagent pack Mouse monoclonal anti-hCG antibody (~0.02 mg/mL) covalently coupled to paramagnetic particles in buffered saline; sodium azide (0.1%); preservatives.

### Atellica IM ThCG DIL ReadyPack ancillary reagent pack

25.0 mL/pack Buffered heat-treated equine serum; EDTA; sodium azide (< 0.1%); preservatives

### Atellica IM ThCG DIL

50.0 mL/vial Buffered heat-treated equine serum; EDTA; sodium azide (< 0.1%); preservatives

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a cluster of orange dots.

#### 5. INDICATIONS FOR USE

The Atellica® IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma (EDTA or lithium heparin) using the Atellica® IM Analyzer.

Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

#### 6. INTENDED USE

Same as Indications for Use

#### 7. Purpose of the Submission

The purpose of this submission is for the addition of plasma (EDTA and lithium heparin) sample claim for the Atellica® IM Total hCG (ThCG) assay.

#### COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE 8. PREDICATE DEVICE

The following table demonstrates substantial equivalence between the Atellica® IM Total hCG (ThCG) assay (Candidate Device) that has modified Instructions for Use (Package Inserts) with the addition of the plasma (EDTA and lithium) sample claim and the currently marketed Atellica® IM Total hCG (ThCG) assay (Predicate Device) that was cleared under 510(k) k172322.

| Assay | | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate Device | Candidate Device |
| | Atellica® IM Total hCG (ThCG) | Atellica® IM Total hCG (ThCG) |
| Intended Use | The Atellica® IM Total hCG (ThCG) assay is for <i>in vitro</i> diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica® IM Analyzer.<br>The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy. | The Atellica® IM Total hCG (ThCG) assay is for <i>in vitro</i> diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma (EDTA or lithium heparin) using the Atellica® IM Analyzer.<br>Human chorionic |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

| | | gonadotropin<br>measurements are<br>intended for use as an aid<br>in the early detection of<br>pregnancy. | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------|------------------------------------------------------------|
| Measurement | Quantitative | Same | | |
| Assay Range | 2.6–1000 mIU/mL (IU/L) | Same | | |
| Assay Principle | Sandwich immunoassay | Same | | |
| Technology | Direct chemiluminescent | Same | | |
| Sample Type | Serum | serum or plasma (EDTA or<br>lithium heparin) | | |
| Sample Volume | 25 µL | Same | | |
| Reagent<br>Volume | 45 µL of Lite Reagent and 203 µL of Solid<br>Phase | Same | | |
| Incubation<br>Time | 8 minutes at 37°C | Same | | |
| Standardization | Standardized against the World Health<br>Organization (WHO) 4th IS 75/589 reference<br>material. Assigned values for calibrators are<br>traceable to this<br>standardization. | Same | | |
| Calibration | 2-point | Same | | |
| Calibrators | Atellica IM CAL B | Same | | |
| Number of<br>Calibrator<br>Levels | Two levels | Same | | |
| Controls | Commercial Controls | Same | | |
| Number of<br>Control Levels | 2 | Same | | |
| Detection<br>Antibody | Goat polyclonal anti-hCG antibody labeled<br>with acridinium ester | Same | | |
| Capture<br>Antibody | Mouse monoclonal anti-hCG antibody<br>covalently coupled to paramagnetic particles | Same | | |
| Expected<br>Values | Data were obtained on 366 serum samples<br>from 192 apparently healthy non-pregnant<br>females and 174 apparently healthy<br>postmenopausal females. The expected<br>value range of non-pregnant females was<br>1.5–4.2 mIU/mL (IU/L) and the<br>postmenopausal female population<br>was 1.8–10.1 mIU/mL (IU/L), as shown in<br>the table below. | Same | | |
| | Sample Category | N° | Median<br>mIU/mL (IU/L) | Reference Interval<br>mIU/mL (IU/L)<br>2.5-97.5 Percentile |
| | Non-Pregnant Females<br>(Age: 17-54) | 192 | 2.0 | 1.5-4.2 |
| | Postmenopausal Females<br>Age: ≥ 41 | 174 | 3.9 | 1.8-10.1 |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots arranged in a circular pattern.

#### PERFORMANCE CHARACTERISTICS DATA 9.

### Detection Capability

Cleared under premarket submission k172322

### Precision

Cleared under premarket submission k172322

### Method Comparison

Cleared under premarket submission k172322

## Specimen Equivalence

Specimen equivalency was determined using the Deming linear regression model in accordance with CLSI Document EP09-A3. The following results were obtained:

| Tube (y) vs. Serum (x) | Na | Sample Interval | Slope | Intercept | rb |
|-------------------------|-----|-------------------------|-------|-----------------------|------|
| Dipotassium EDTA plasma | 116 | 3.8-959.2 mIU/mL (IU/L) | 1.02 | -1.4 mIU/mL<br>(IU/L) | 1.00 |
| Lithium heparin plasma | 134 | 3.8-959.2 mIU/mL (IU/L) | 1.05 | 0.2 mIU/mL<br>(IU/L) | 1.00 |

a Number of samples tested.

b Correlation coefficient.

The assay is designed to have a slope of 0.90–1.10 for alternate tube types versus serum. Agreement of the specimen types may vary depending on the study design and sample population used. Assay results obtained at individual laboratories may vary from the data presented.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a cluster of orange dots.

# Interferences

l

Interference testing was performed in accordance with CLSI Document EP07-ed3.12 The following results were obtained:

| Substance | Substance Test Concentration | Analyte Concentration<br>mIU/mL (IU/L) | Bias (%) |
|------------------|------------------------------|----------------------------------------|----------|
| Dipotassium EDTA | 9.0 mg/mL | 21.1 | 1.5 |
| | | 626.4 | 0.7 |
| Heparin | 75 U/mL | 25.4 | 1.8 |
| | | 668.9 | 0.7 |

Assay results obtained at individual laboratories may vary from the data presented.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.

## Expected Values

Cleared under premarket submission k172322

#### X. CONCLUSION

Comparative testing of the Atellica IM ThCG Assay is substantially equivalent in principle and performance to the Predicate Device – Atellica IM Total hCG (ThCG) assay cleared under 510(k) k172322.