(30 days)
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay for hCG detection, focusing on reagents, performance characteristics (slope, intercept, correlation, bias), and predicate device comparison. There is no mention of AI, ML, image processing, or any computational methods beyond standard statistical analysis for performance evaluation.
No.
The device is an in vitro diagnostic assay used for the quantitative determination of human chorionic gonadotropin (hCG) to aid in the early detection of pregnancy. It does not provide therapy or treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the assay is "for in vitro diagnostic use."
No
The device description clearly outlines physical reagents (Lite Reagent, Solid Phase, DIL ReadyPack, DIL) which are hardware components, not software. The device is an in vitro diagnostic assay, not a software-only device.
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 quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma". This is the primary indicator of an IVD.
- Device Description: The description details reagents and components used to perform a test on biological samples (serum or plasma) outside of the body.
- Intended User/Care Setting: It specifies "in vitro diagnostic use", reinforcing its classification as an IVD.
- Performance Studies: The document describes performance studies conducted on biological specimens (serum and plasma) to evaluate the device's accuracy and reliability for diagnostic purposes.
- Predicate Device: The mention of a predicate device (K172322; Atellica® IM Total hCG (ThCG)) which is also an IVD further supports this classification.
All these elements align with the definition and characteristics of an In Vitro Diagnostic 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DHA
Device Description
The Atellica® IM Total hCG (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
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 (
§ 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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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
Regulatory Clinical Affairs Specialist |
|----------|-----------------------------------------------------------|
| Phone: | (914) 524-2458 |
| Fax: | (914) 524-3579 |
| E-mail: | mey.vasquez@siemens-healthineers.com |
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 |
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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
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
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 (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. | 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 |
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| | | gonadotropin
measurements are
intended for use as an aid
in the early detection of
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
lithium heparin) | | |
| Sample Volume | 25 µL | Same | | |
| Reagent
Volume | 45 µL of Lite Reagent and 203 µL of Solid
Phase | Same | | |
| Incubation
Time | 8 minutes at 37°C | Same | | |
| 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 | Atellica IM CAL B | Same | | |
| 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 particles | Same | | |
| 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. | Same | | |
| | Sample Category | N° | 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 |
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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 | |
| (IU/L) | 1.00 | ||||
| Lithium heparin plasma | 134 | 3.8-959.2 mIU/mL (IU/L) | 1.05 | 0.2 mIU/mL | |
| (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.
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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
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.
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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.