(240 days)
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.
0
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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 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 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.
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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
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FORM FDA 3881 (8/14) | Page 1 of 1 | PSC 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 | ||
---|---|---|
Item | Predicate Device | Candidate Device |
Intended Use | For 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. | ||
Measurement | Quantitative | Same |
Assay Range | 2.0–1000 mIU/mL (IU/L) | 2.6–1000 mIU/mL (IU/L) |
Assay Principle | Sandwich immunoassay | Same |
Technology | Direct chemiluminescent | Same |
Sample Type | Serum | Same |
Sample Volume | 50 µL | 25 µL |
Reagent | ||
Volume | 100 µL of Lite Reagent and 450 µL | |
of Solid Phase | 50 µL of Lite Reagent and 225 µL | |
of Solid Phase | ||
Incubation | ||
Time | 7.5 minutes at 37°C. | 8 minutes at 37°C |
Standardization | Standardized against the World | |
Health Organization (WHO) 4th IS | ||
75/589 reference material. | ||
Assigned values for calibrators are | ||
traceable to this | ||
standardization. | Same | |
Calibration | 2-point | Same |
Calibrators | ADVIA Centaur Calibrator B | Atellica IM CAL B |
Number of | ||
Calibrator | ||
Levels | Two levels | Same |
Controls | Commercial Controls | Same |
Number of | ||
Control Levels | 2 | Same |
Detection | ||
Antibody | Goat polyclonal anti-hCG antibody | |
labeled with acridinium ester | Same | |
Capture | ||
Antibody | Mouse monoclonal anti-hCG | |
antibody | ||
covalently coupled to paramagnetic | Same | |
particles | ||
Expected | ||
Values | 2–4 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 4360–74,883 | The 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
7
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:
Specimen | Comparative Assay (x) | Regression Equation | Sample Interval | Nᵃ | rᵇ |
---|---|---|---|---|---|
Serum | ADVIA Centaur Total hCG | $y = 0.94x + 0.23 mIU/mL (IU/L)$ | 2.4-947.7 mIU/mL (IU/L) | 115 | 1.00 |
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.