K Number
K172322
Device Name
Atellica IM Total hCG (ThCG)
Date Cleared
2018-03-29

(240 days)

Product Code
Regulation Number
862.1155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 using the Atellica IM Analyzer. The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.
Device Description
The Atellica IM Total hCG (ThCG) assay is an in vitro diagnostic assay for the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The assay utilizes a sandwich immunoassay principle with direct chemiluminescent technology. The reagents include a Lite Reagent containing goat polyclonal anti-hCG antibody labeled with acridinium ester and a Solid Phase containing mouse monoclonal anti-hCG antibody covalently coupled to paramagnetic particles. Ancillary reagents like Atellica IM ThCG DIL are also part of the system.
More Information

Not Found

No
The summary describes a standard in vitro diagnostic immunoassay using chemiluminescent technology. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance evaluation.

No
This device is an in vitro diagnostic assay used to quantify human chorionic gonadotropin (hCG) in human serum, which aids in the early detection of pregnancy. It does not directly treat, prevent, or mitigate a disease or condition; rather, it provides diagnostic information.

Yes

The "Intended Use / Indications for Use" section explicitly states that the assay is "for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy." This directly indicates its diagnostic purpose.

No

The device is an in vitro diagnostic assay that includes physical reagents (Lite Reagent, Solid Phase, Ancillary reagents) and is used with a specific hardware analyzer (Atellica IM Analyzer). It is not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The document explicitly states "for in vitro diagnostic use" in the very first sentence of the Intended Use section. It also describes the assay's purpose as the quantitative determination of hCG in human serum, which is a classic IVD application.
  • Device Description: The description details the components and principles of an in vitro assay (reagents, antibodies, paramagnetic particles, chemiluminescent technology).
  • Intended User/Care Setting: The document mentions "In vitro diagnostic use," implying use in a clinical laboratory setting by trained personnel, which is typical for IVDs.
  • Performance Studies: The performance studies described (Detection Capability, Precision, Method Comparison, Interference, Expected Values) are standard types of studies conducted to validate the analytical performance of an IVD.
  • Predicate Device(s): The mention of a predicate device (ADVIA Centaur® Total hCG assay) with a K number (K925277) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, often through the 510(k) pathway which requires comparison to a legally marketed predicate device.

N/A

Intended Use / 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 using the Atellica IM Analyzer. The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.

Product codes (comma separated list FDA assigned to the subject device)

JHI

Device Description

The Atellica IM ThCG Assay reagents come in the following configurations:
1 ReadyPack primary reagent pack containing Atellica IM ThCG Lite Reagent and Solid Phase Atellica IM ThCG master curve and test definition (90 Tests)
5 ReadyPack primary reagent packs containing Atellica IM ThCG Lite Reagent and Solid Phase Atellica IM ThCG master curve and test definition (450 Tests)

The ReadyPack consists of the following:
Atellica IM ThCG ReadyPack® primary reagent pack Lite Reagent
5.0 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
22.5 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 (

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.

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March 29, 2018

Siemens Healthcare Diagnostics Inc. Anoop Joy Regulatory Clinical Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591

Re: K172322

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: JHI Dated: February 20, 2018 Received: February 21, 2018

Dear Anoop Joy:

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

1

803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 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, Kellie B. Kelm -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

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known)K172322
Device NameAtellica 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 using the Atellica IM Analyzer. The Atellica IM ThCG 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)

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:

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)Page 1 of 1PSC Publishing Services (301) 443-6740 EF
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510(k) Summary of Safety and Effectiveness

Atellica IM Total hCG (ThCG)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K172322

. APPLICANT

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

Contact:Anoop Joy
Regulatory Clinical Affairs Specialist
Phone:(914) 524-2273
Fax:(914) 524-3579
E-mail:anoop.joy@siemens-healthineers.com

Date Prepared: March 28, 2018

Regulatory Information II.

Assay

Name of Device: Atellica IM Total hCG (ThCG) Classification: Class II Regulation Section: 21 CFR § 862.1155 Product Code: JHI Panel: Clinical Chemistry

PREDICATE DEVICE .

Assay

Name of Device: ADVIA Centaur® Total hCG assay 510 (k): K925277

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The Atellica IM ThCG Assay reagents come in the following configurations:

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

The ReadyPack consists of the following:

Atellica IM ThCG ReadyPack® primary reagent pack Lite Reagent

5.0 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

22.5 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 (

The Atellica IM Total ß-hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human gonadotropin (hCG) in human serum using the Atellica IM Analyzer.

The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.

INTENDED USE VI.

Same as Indications for Use

5

COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII PREDICATE DEVICE

The following table provides a comparison between the predicate and candidate device.

Assay
ItemPredicate DeviceCandidate Device
Intended UseFor in vitro diagnostic use in the
quantitative determination of
human chorionic gonadotropin
(hCG) in serum. The results
obtained from hCG specimens are
used as an aid in the assessment
of pregnancy status. This assay
detects the intact hCG molecule
and free beta-subunits of the hCG
molecule.The Atellica IM Total β-hCG
(ThCG) assay is for in vitro
diagnostic use in the quantitative
determination of human
gonadotropin (hCG) in human
serum using the Atellica IM
Analyzer.
The Atellica IM ThCG assay is
intended for use as an aid in the
early detection of pregnancy.
MeasurementQuantitativeSame
Assay Range2.0–1000 mIU/mL (IU/L)2.6–1000 mIU/mL (IU/L)
Assay PrincipleSandwich immunoassaySame
TechnologyDirect chemiluminescentSame
Sample TypeSerumSame
Sample Volume50 µL25 µL
Reagent
Volume100 µL of Lite Reagent and 450 µL
of Solid Phase50 µL of Lite Reagent and 225 µL
of Solid Phase
Incubation
Time7.5 minutes at 37°C.8 minutes at 37°C
StandardizationStandardized against the World
Health Organization (WHO) 4th IS
75/589 reference material.
Assigned values for calibrators are
traceable to this
standardization.Same
Calibration2-pointSame
CalibratorsADVIA Centaur Calibrator BAtellica IM CAL B
Number of
Calibrator
LevelsTwo levelsSame
ControlsCommercial ControlsSame
Number of
Control Levels2Same
Detection
AntibodyGoat polyclonal anti-hCG antibody
labeled with acridinium esterSame
Capture
AntibodyMouse monoclonal anti-hCG
antibody
covalently coupled to paramagneticSame
particles
Expected
Values2–4 weeks 39.1–8388 (mIU/mL)
(IU/L)
5–6 weeks 861–88,769
6–8 weeks 8636–218,085
8–10 weeks 18,700–244,467
10–12 weeks 23,143–181,899
13–27 weeks 6303–97,171
28–40 weeks 4360–74,883The 2.5 and 97.5 percentiles of the
concentration values were
considered the expected value
range of the Atellica IM ThCG
assay. The expected value range of
non-pregnant females was 1.5—4.2
mIU/mL (IU/L) and the
postmenopausal female population
was 1.8–10.1 mIU/mL (IU/L)

Table 1: Substantial Equivalence Comparison

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PERFORMANCE CHARACTERISTICS DATA VIII.

Detection Capability

Detection capability was determined in accordance with CLSI Document EP17-A2.

The LoB corresponds to the highest measurement result that is likely to be observed for a blank sample. The LoB of the Atellica IM ThCG assay is 1.5 mIU/mL (IU/L).

The LoD corresponds to the lowest concentration of hCG that can be detected with a probability of 95%. The LoD for the Atellica IM ThCG assay is 1.7 mlU/mL (IU/L), and was determined using 601 determinations, with 300 blank and 301 low-level replicates, and an LoB of 1.5 mIU/mL (IU/L).

The LoQ corresponds to the lowest amount of hCG in a sample at which the percent total error is 30%. The LoQ of the Atellica IM ThCG assay is 2.6 mIU/mL (IU/L), and was determined using multiple samples prepared from the World Health Organization (WHO) human chorionic gonadotropin reference material (NIBSC code: 99/688) in the interval 1.9–6.7 mIU/mL (IU/L). All samples were assayed in replicates of 5 in each of 2 runs per day using 2 reagent lots, over a period of 5 days

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Precision

Precision was determined in accordance with CLSI Document EP05-A3. Samples were assayed in duplicate in 2 runs per day for 20 days using two reagent lots on each of two Atellica IM analyzers. The following results were obtained:

| Sample | Na | Mean
mIU/mL
(IU/L) | Repeatability | | Between Run | | Between Day | | Within-Lab | |
|-----------|-----|--------------------------|-------------------------|------|------------------------|------|-------------------------|------|-------------------------|------|
| | | | SDb
mIU/mL
(IU/L) | %CVc | SD
mIU/mL
(IU/L) | %CVc | SDb
mIU/mL
(IU/L) | %CVc | SDb
mIU/mL
(IU/L) | %CVc |
| Serum 1 | 320 | 2.4 | 0.2 | 8.8 | 0.1 | 3.3 | 0.1 | 4.7 | 0.3 | 10.5 |
| Serum 2 | 320 | 12.6 | 0.4 | 2.8 | 0.2 | 1.6 | 0.1 | 1.0 | 0.4 | 3.4 |
| Serum 3 | 320 | 782.0 | 14.0 | 1.8 | 6.9 | 0.9 | 6.7 | 0.9 | 17.0 | 2.2 |
| Control 1 | 320 | 6.8 | 0.3 | 4.5 | 0.0 | 0.3 | 0.2 | 3.0 | 0.4 | 5.5 |
| Control 2 | 320 | 23.4 | 0.6 | 2.6 | 0.4 | 1.7 | 0.4 | 1.6 | 0.8 | 3.5 |
| Control 3 | 320 | 202.1 | 3.6 | 1.8 | 2.4 | 1.2 | 3.4 | 1.7 | 5.5 | 2.7 |

Number of samples tested. a

മ Standard deviation.

  • Coefficient of variation. ು

Method Comparison

The Atellica IM ThCG assay is designed to have a correlation coefficient of ≥ 0.95 and a slope of 1.0 ±0.10 compared to the ADVIA Centaur Total hCG assay. Assay comparison was determined using the weighted Deming regression model in accordance with CLSI Document EP09-A3. The following results were obtained:

SpecimenComparative Assay (x)Regression EquationSample IntervalNᵃrᵇ
SerumADVIA Centaur Total hCG$y = 0.94x + 0.23 mIU/mL (IU/L)$2.4-947.7 mIU/mL (IU/L)1151.00

a Number of samples tested.

b Correlation coefficient.

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Interference testing was performed in accordance with CLSI Document EP07-A2 using the Atellica IM Analyzer.

The following substances were added to serum samples containing different concentrations of hCG. Bias is the difference in the results between the control sample (does not contain the interferent) and the test sample (contains the interferent) expressed in percent. Analyte results should not be corrected based on the bias.

| Substance | Substance Test Concentration | Analyte Concentration
mIU/mL (IU/L) | Bias (%) |
|----------------------|------------------------------|----------------------------------------|----------|
| Acetaminophen | 20 mg/dL | 5.7 | 0.9 |
| | 20 mg/dL | 495.3 | 2.9 |
| Acetylsalicylic acid | 65 mg/dL | 5.4 | 7.3 |
| | 65 mg/dL | 502.1 | -0.8 |
| Atropine | 20 mg/dL | 5.7 | -4.7 |
| | 20 mg/dL | 503.6 | -0.9 |
| Caffeine | 308 $ µmol/L $ | 5.6 | 5.4 |
| | 308 $ µmol/L $ | 511.9 | -1.8 |
| EDTA | 3.4 $ µmol/L $ | 5.5 | 5.9 |
| | 3.4 $ µmol/L $ | 508.9 | -2.2 |
| Ethanol | 100 mg/dL | 6.0 | -6.6 |
| | 100 mg/dL | 506.2 | 2.0 |
| Gentisic acid | 117 $ µmol/L $ | 6.2 | -5.8 |
| | 117 $ µmol/L $ | 507.1 | -2.7 |
| Heparin | 7200 IU/dL | 5.5 | -2.3 |
| | 7200 IU/dL | 491.3 | 1.1 |
| Human Serum Albumin | 6 g/dL | 6.0 | -0.3 |
| | 6 g/dL | 511.8 | 1.3 |
| Ibuprofen | 50 mg/dL | 5.5 | 6.5 |
| | 50 mg/dL | 490.1 | -2.7 |

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Hemolysis, Icterus, and Lipemia (HIL): The Atellica IM ThCG assay is designed to have ≤ 10% interference from hemoglobin, bilirubin, and lipemia. Interfering substances were tested at the levels indicated in the table below. Bias is the difference in the results between the control sample (does not contain the interferent) and the test sample (contains the interferent) expressed in percent.

| Substance | Substance Test Concentration | Analyte Concentration
mIU/mL (IU/L) | Bias (%) |
|-------------------------|------------------------------|----------------------------------------|----------|
| Hemoglobin | 1000 mg/dL (0.62 mmol/L) | 5.6 | 8.9 |
| | 1000 mg/dL (0.62 mmol/L) | 501.7 | -1.2 |
| Bilirubin, conjugated | 40 mg/dL (681 $\mu$ mol/L) | 6.1 | -0.3 |
| | 40 mg/dL (681 $\mu$ mol/L) | 530.3 | -1.8 |
| Bilirubin, unconjugated | 40 mg/dL (681 $\mu$ mol/L) | 6.0 | 0.3 |
| | 40 mg/dL (681 $\mu$ mol/L) | 520.8 | -1.8 |
| Lipemia (Intralipid®) | 3000 mg/dL (34 mmol/L) | 6.1 | 2.0 |
| | 3000 mg/dL (34 mmol/L) | 458.8 | 2.4 |

Expected Values

Data were obtained on 366 serum samples from 192 apparently healthy non-pregnant females and 174 apparently healthy postmenopausal females. The expected value range of non-pregnant females was 1.5—4.2 mIU/mL (IU/L) and the postmenopausal female population was 1.8–10.1 mIU/mL (IU/L), as shown in the table below.

| Sample Category | Na | Median
mIU/mL (IU/L) | Reference Interval
mIU/mL (IU/L)
2.5-97.5 Percentile |
|--------------------------------------|-----|-------------------------|------------------------------------------------------------|
| Non-Pregnant Females
(Age: 17-54) | 192 | 2.0 | 1.5-4.2 |
| Postmenopausal Females
Age: ≥ 41 | 174 | 3.9 | 1.8-10.1 |

a Number of samples.

CONCLUSION x

Comparative testing of the Atellica IM ThCG Assay is substantially equivalent in principle and performance to the Predicate Device - ADVIA Centaur® Total hCG assay cleared under 510(k) K925277.