(90 days)
No
The summary describes a standard in vitro diagnostic immunoassay kit and analyzer for measuring ferritin levels. There is no mention of AI, ML, image processing, or any data analysis techniques that would typically involve AI/ML. The performance studies focus on analytical validation metrics common for such assays.
No.
This device is an in vitro diagnostic assay used to quantitatively determine ferritin levels, aiding in the diagnosis of iron deficiency anemia and iron overload. It does not directly treat or prevent a disease and is therefore not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use" and "This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload."
No
The device description explicitly states that the device is an "Assay kit" and lists physical components like "Lite Reagent" and "Solid Phase Reagent," which are chemical and biological materials, not software. The performance studies also focus on the analytical performance of these reagents.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma..."
This statement directly identifies the device as being intended for use outside of the body to diagnose conditions, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and lithium heparin) using the Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.
Product codes (comma separated list FDA assigned to the subject device)
DBF
Device Description
The Atellica Ferritin Assay kit includes the following components: Lite Reagent: 5.0 mL/reagent pack. Contains Goat polyclonal anti-ferritin antibody (~0.64 µg/mL) labeled with acridinium ester in HEPES buffer; protein stabilizers; sodium azide (1650 ng/mL concentration of ferritin). Samples were tested in triplicates. The linearity data supports analytical measuring range of the Atellica Ferritin Assay of 0.9 - 1650 ng/mL. Values below the LoO are reported as
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
SIEMENS HEALTHCARE DIAGNOSTICS INC. KIRA GORDON, PHD SR. REGULATORY AFFAIRS SPECIALIST 511 BENEDICT AVE. TARRYTOWN NY 10591
Re: K171642
Trade/Device Name: Atellica IM Ferritin Assay Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: II Product Code: DBF Dated: May 31, 2017 Received: June 2, 2017
Dear Dr. Gordon:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kelly Oliner -S
For. Lea Carrington, M.S., MBA, MT Director Division of Immunology and Hematology 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) K171642
Device Name Atellica IM Ferritin Assay
Indications for Use (Describe)
The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and lithium heparin) using the Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.
| 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) |
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510(k) Summary of Safety and Effectiveness for the Atellica IM Ferritin Assay
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.
-
- 510(k) Number:
2. Applicant:
| Contact: | Kira Gordon, PhD
Sr. Regulatory Affairs Specialist |
|----------|--------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc
511 Benedict Ave,
Tarrytown, NY 10591 |
| Phone: | (914) 524-2996 |
| FAX: | (914) 524-3579 |
| Email: | kira.gordon@siemens-healthineers.com |
- August 24, 2017 3. Date:
4. Proprietary and Established Names: Atellica™ IM Ferritin (Fer) Assay
-
- Measureand
Ferritin
- Measureand
6. Regulatory Information:
Atellica™ Ferritin Assay Classification Names: Ferritin immunological test system. Regulation Number: 866.5340 Classification: Class II Product Code: DBF Atellica IM Ferritin Assay Trade name: Immunology Classification Panel:
7. Predicate Devices:
Device Name: ADVIA Centaur Ferritin Assay 510(k) Number: K992157 Manufacturer: Siemens Healthcare Diagnostics, Inc.
8. Intended Use:
See Indications for Use (Section 6)
9. Indications for Use:
The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and lithium heparin) using the
4
Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.
Special Conditions for Use Statement(s): For prescription use only
10. Device Description:
The Atellica Ferritin Assay kit includes the following components: Lite Reagent: 5.0 mL/reagent pack. Contains Goat polyclonal anti-ferritin antibody (~0.64 µg/mL) labeled with acridinium ester in HEPES buffer; protein stabilizers; sodium azide (in vitro diagnostic use
in the quantitative determination
of ferritin in human serum and
plasma (EDTA and lithium
heparin) using the Atellica™ IM
Analyzer.
This assay can be used as an aid in
the diagnosis of iron deficiency
anemia and iron overload. | For in vitro diagnostic use in the
quantitative determination of
ferritin in serum or plasma using
the ADVIA Centaur®, ADVIA
Centaur XP, and ADVIA Centaur
XPT systems to aid in the diagnosis
of iron deficiency anemia and iron
overload. |
| Instrument | Atellica IM | ADVIA Centaur |
| Measurement | Quantitative | Same |
| Technology | Chemiluminescence | Same |
| Assay Protocol | 2-site sandwich immunoassay | Same |
| Reagents | Lite Reagent - goat polyclonal
anti-ferritin antibody labeled with
acridinium ester.
Solid Phase Reagent - mouse
monoclonal anti-ferritin antibody
covalently coupled to
paramagnetic particles. | Same |
| Sample type | Serum, Heparinized Plasma,
EDTA Plasma | Same |
| Assay Range | 0.9-1650 ng/mL | 0.5-1650 ng/mL |
| Calibrators | 2-point calibration | Same |
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13. Standard/Guidance Document Reference
The following recognized standard and guidance documents were used:
- Format for Traditional and Abbreviated 510(k)s Guidance for Industry and FDA Staff -
- -In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
- Guidance for Industry and FDA Staff Assayed and Unassaved Quality Control Material -
- EP05-A3 (7-251) Evaluation of Precision Performance of Quantitative Measurement -Methods: Approved Guideline
- -EP06-A (7-193) Evaluation of the Linearity Of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
- EP07-A2 (7-127) Interference Testing in Clinical Chemistry; Approved Guideline; Approved -Guideline
- -EP09-A3 (7-245) Measurement Procedure Comparison And Bias Estimation Using Patient Samples: Approved Guideline
- -EP17-A2 (7-233) Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline
- EP25-A (7-235) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline -
- -EP28-A3c (7-224) Defining, Establishing, And Verifying Reference Intervals In The Clinical Laboratory; Approved Guideline
14. Performance Characteristics
Substantial equivalence was demonstrated by testing performance characteristics, listed below, including method comparison, precision, interfering and cross-reactive substances.
1. Analytical Performance
a. Precision
Precision estimates were computed according to CLSI document EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline. Within run (repeatibility) and total imprecision were evaluated by testing 6 serum based samples. calibrators and controls. The elevated levels were spiked with ferritin (liver source) to achieve appropriate concentrations. The samples were assayed in duplicate over the course of 20 days, two runs per day, for a total of 40 runs and 80 replicates.
| Repeatability | Within-Lab | |||||
|---|---|---|---|---|---|---|
| Mean | SD | SD | ||||
| Sample | Reps | (ng/mL) | (ng/mL) | CV (%) | (ng/mL) | CV (%) |
| Serum A | 80 | 4.2 | 0.15 | 3.5 | 0.31 | 7.2 |
| Serum B | 80 | 8.2 | 0.14 | 1.8 | 0.44 | 5.4 |
| Serum C | 80 | 41.9 | 0.57 | 1.4 | 1.78 | 4.2 |
| Serum D | 80 | 65.4 | 0.82 | 1.3 | 2.89 | 4.4 |
| Serum E | 80 | 118.3 | 1.44 | 1.2 | 4.79 | 4.0 |
| Serum F | 80 | 487.1 | 8.00 | 1.6 | 20.39 | 4.2 |
| Serum G | 80 | 779.9 | 20.69 | 2.7 | 44.48 | 5.7 |
| Serum H | 80 | 1453.6 | 49.51 | 3.4 | 91.40 | 6.3 |
| Control 1 | 80 | 51.8 | 0.84 | 1.6 | 2.49 | 4.8 |
| Control 2 | 80 | 132.7 | 1.61 | 1.2 | 6.01 | 4.5 |
| Control 3 | 80 | 374.0 | 4.97 | 1.3 | 20.69 | 5.5 |
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b. Linearity/assav reportable range:
Linearity studies were conducted according to CLSI EP06-A: Evaluation of the Linearity of Ouantitative Measurement Procedures. Eleven samples with ferritin concentrations distributed throughout the assay range were prepared using high and low human serum pools (low 1650 ng/mL concentration of ferritin). Samples were tested in triplicates.
| | Observed
ng/mL (Y) | Expected
ng/mL | Predicted
ng/mL
(Ŷ) | Predicted %
Difference
(Y-Ŷ)/Ŷ100 | |
|---|-----------------------|-------------------|---------------------------|------------------------------------------|--|
| A | 0.20 | 0.2 | -0.71 | n/a | |
| B | 6.05 | 7.06 | 5.57 | 8.65% | |
| C | 11.28 | 13.93 | 11.84 | -4.69% | |
| D | 22.22 | 27.65 | 24.39 | -8.88% | |
| E | 46.04 | 55.11 | 49.49 | -6.96% | |
| F | 98.38 | 110.03 | 99.68 | -1.30% | |
| G | 200.39 | 219.86 | 200.07 | 0.16% | |
| H | 401.92 | 439.53 | 400.84 | 0.27% | |
| I | 810.18 | 878.86 | 802.39 | 0.97% | |
| J | 1267.43 | 1318.2 | 1203.94 | 5.27% | |
| K | 1757.53 | 1757.53 | 1605.50 | 9.47% | |
| | Weighted linear fit: | Y=0.914X-0.888 | | | |
The linearity data supports analytical measuring range of the Atellica Ferritin Assay of 0.9 - 1650 ng/mL. Values below the LoO are reported as