(265 days)
Not Found
No
The summary describes a standard immunoassay for measuring folate levels and does not mention any AI or ML components. The performance studies focus on analytical characteristics of the assay itself.
No
The device is an in vitro diagnostic assay used for the quantitative determination of folate, which aids in the diagnosis and treatment of anemias. It does not directly treat or prevent a disease; rather, it provides information for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Atellica™ Folate assay is for in vitro diagnostic use..." and "Folic acid measurements are used in the diagnosis and treatment of anemias."
No
The device description clearly lists physical components (reagents, calibrators, etc.) which are not software. The performance studies also focus on the analytical performance of an immunoassay, not software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Atellica™ Folate assay is for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer."
This statement directly identifies the device as being intended for diagnostic purposes performed outside of the body (in vitro).
N/A
Intended Use / Indications for Use
The Atellica™ Folate assay is for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.
Product codes (comma separated list FDA assigned to the subject device)
CGN
Device Description
The Atellica™ IM Folate Assay components include:
- Atellica™ IM Folate Primary Reagent ReadyPack:
- Atellica™ IM Folate Lite Reagent: Folate labeled with acridinium ester (~9.8 ng/mL) in buffer; bovine serum albumin; sodium azide (0.1%); preservatives.
- Atellica™ IM Folate Solid Phase Reagent: Purified avidin (~20 µg/mL) covalently coupled to paramagnetic particles in buffer; human serum albumin; preservatives.
- Atellica™ IM Folate Binding Protein: Purified folate binding protein (~1.0 µg/mL) covalently coupled to biotin in buffer; bovine serum albumin; preservatives.
- Atellica™ IM Folate Calibrator:
- Atellica™ IM Folate Low and High Calibrators: After reconstitution, low or high levels of N-5-methyltetrahydrofolic acid; buffer; human serum albumin; sodium azide ( 5.38 ng/mL.
- RBC folate (Normal): N=286, Median = 425 ng/mL, 95th Percentile Range = 280 - 791 ng/mL.
Detection Limits: Determined as described in CLSI protocol EP17-A2.
- Serum: LoB = 0.19 ng/mL, LoD = 0.38 ng/mL, LoQ = 0.56 ng/mL.
- RBC hemolysate: LoB = 0.00 ng/mL, LoD = 0.21 ng/mL, LoQ = 0.56 ng/mL.
Interference: Studies performed according to CLSI EP07-A2. No significant interference (
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.
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April 12, 2018
Siemens Healthcare Diagnostics Inc. Darius Daruwala Senior Specialist, Regulatory Affairs 511 Benedict Avenue Tarrytown, NY 10591
Re: K172201
Trade/Device Name: Atellica IM Folate Assay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: February 28, 2018 Received: March 1, 2018
Dear Darius Daruwala:
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
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
Indications for Use
510(k) Number (if known) K172201
Device Name Atellica™ IM Folate Assay
Indications for Use (Describe)
The Atellica™ Folate assay is for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.
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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3
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K172201
Date Prepared 1.
April 12, 2018
2. Applicant Information
| Contact: | Darius Daruwala
Regulatory Affairs Senior Specialist |
|----------|-----------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-524-2812 |
914-524-3579 Fax:
Email: darius.daruwala@siemens.com
Regulatory Information 3.
Table 1. Regulatory Information for Atellica™ IM Folate Assay
| Trade Name | Atellica™ IM Folate Assay |
|---|---|
| Model Numbers | 10995572 (1-pack); 10995573 (5-pack) |
| Common Name | Immunoassay, Folate |
| Classification Name | Folic Acid Test System |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry (75) |
| Product Code | CGN |
| Regulation Number | 862.1295 |
Predicate Device Information 4.
ADVIA Centaur Folate
Predicate Device Name: ADVIA Centaur Folate 510(k) Number: K010050
5. Intended Use / Indications for Use
Atellica™ IM Folate
The Atellica™ IM Folate assay is for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica™ IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.
4
Device Description 6.
Table 3. Summary of Ingredients of the Atellica™ IM Folate Assay Components
| Component | Volume | Ingredients |
|---|---|---|
| Atellica™ IM Folate Primary Reagent ReadyPack (included in assay kit) | ||
| Atellica™ IM Folate Lite Reagent | 10.0 mL/pack | Folate labeled with acridinium ester (~9.8 ng/mL) in buffer; bovine serum albumin; sodium azide (0.1%); preservatives |
| Atellica™ IM Folate Solid Phase Reagent | 20.0 mL/pack | Purified avidin (~20 µg/mL) covalently coupled to paramagnetic particles in buffer; human serum albumin; preservatives |
| Atellica™ IM Folate Binding Protein | 10.0 mL/pack | Purified folate binding protein (~1.0 µg/mL) covalently coupled to biotin in buffer; bovine serum albumin; preservatives |
| Atellica™ IM Folate Calibrator (included in assay kit) | ||
| Atellica™ IM Folate Low and High Calibrators | 3.0 mL/vial | After reconstitution, low or high levels of N-5-methyltetrahydrofolic acid; buffer; human serum albumin; sodium azide (Item |
| (Candidate Device) | ADVIA Centaur Folate Assay | |
| (Predicate Device) | ||
| (K010050) | ||
| ----------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |
| Intended Use | For in vitro diagnostic use in the | |
| quantitative determination of folate in | ||
| serum or red blood cells using the | ||
| Atellica™ IM analyzer. Folic acid | ||
| measurements are used in the | ||
| diagnosis and treatment of anemias. | For in vitro diagnostic use in the | |
| quantitative determination of folate | ||
| in serum or red blood cells using the | ||
| ADVIA Centaur system. | ||
| Instrument | Atellica IM | ADVIA Centaur |
| Measurement | Quantitative | Same |
| Methodology | Chemiluminescence | Same |
| Assay Protocol | Competitive immunoassay | Same |
| Traceability/ | ||
| Standardization | Internal standards. Values have been | |
| assigned to correlate to the Predicate | ||
| device. | Same | |
| Specimen Type | Human Serum, | |
| Red Blood Cells (RBC) | Same | |
| Lower Limit of | ||
| Measuring Range | LoQ | Analytical Sensitivity |
| Sample Volume | 100 µL | 150 µL |
| Reagents | Lite Reagent: Folate labeled with | |
| acridinium ester (~9.8 ng/mL) in Buffer; | ||
| bovine serum albumin; sodium azide | ||
| (0,1%) and preservatives. | ||
| Solid Phase Reagent: Buffered avidin | ||
| (~20 µg/mL) covalently coupled to | ||
| paramagnetic particles in buffer; | ||
| human serum albumin and | ||
| preservatives. | ||
| Folate Binding Protein: Purified folate | ||
| binding protein (~1.0 µg/mL) covalently | ||
| coupled to biotin in buffer; bovine | ||
| serum albumin and preservatives | Same | |
| Measuring Range | Serum: 0.56 – 24 ng/mL | 0.35 - 24 ng/mL |
| RBC: 0.98 – 17.51 ng/mL | 0.35 - 24 ng/mL | |
| Calibration | 2-point calibration | Same |
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Standard/Guidance Document References 9.
The following recognized standards from Clinical Laboratory Standards Institute (CLSI) were used as a basis of the study procedures described in this submission:
- Evaluation of Precision of Quantitative Measurement Procedures: Approved S Guideline - Third Edition (CLSI EP05-A3, 2014; Recognition Number 7-251)
- S Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (CLSI EP06-A, 2003; Recognition Number 7-193)
- S Interference Testing in Clinical Chemistry: Approved Guideline - Second Edition (CLSI EP07-A2, 2005; Recognition Number 7-127)
- S Measurement Procedure Comparison And Bias Estimation Using Patient Samples --Third Edition (CLSI EP9-A3, 2013; Recognition Number 7-245)
- S Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline -- Second Edition (CLSI EP17-A2, 2013; Recognition Number 7-233)
- S Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory: Approved Guideline - Third Edition (CLSI EP28-A3c - formerly C28-A3c, 2010; Recognition Number 7-224)
- S Medical devices – Application of risk management to medical devices (ANSI/AAMI/ISO 14971:2007/(R)2010; Recognition Number 5-70)
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10. Performance Characteristics
10.1 Precision
A 20-day precision study was performed according to CLSI EP5-A3. Four human serum and five whole blood samples and two levels of controls were tested.
| Repeatability | Within-Lab | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample | Na | (ng/mL) | (nmol/L) | SDb | |||||
| (ng/mL) | |||||||||
| (nmol/L) | |||||||||
| (%) | CVc | ||||||||
| (%) | SD | ||||||||
| (ng/mL) | |||||||||
| (nmol/L) | CV | ||||||||
| (%) | |||||||||
| Serum Control 1 | 80 | 2.82 | 6.39 | 0.09 | 0.20 | 3.3 | 0.17 | 0.39 | 6.1 |
| Serum Control 2 | 80 | 5.43 | 12.30 | 0.14 | 0.32 | 2.5 | 0.35 | 0.79 | 6.4 |
| Serum 1 | 80 | 1.42 | 3.22 | 0.05 | 0.11 | N/Ad | 0.08 | 0.18 | N/A |
| Serum 2 | 80 | 4.13 | 9.35 | 0.10 | 0.23 | 2.4 | 0.24 | 0.54 | 5.9 |
| Serum 3 | 80 | 6.19 | 14.02 | 0.18 | 0.41 | 2.9 | 0.36 | 0.82 | 5.9 |
| Serum 4 | 80 | 9.23 | 20.91 | 0.24 | 0.54 | 2.6 | 0.60 | 1.36 | 6.5 |
| Whole Blood Sample 1 | 80 | 94.89 | 214.93 | 4.56 | 10.33 | N/A | 6.55 | 14.84 | N/A |
| Whole Blood Sample 2 | 80 | 153.11 | 346.79 | 4.40 | 9.97 | 2.9 | 11.21 | 25.39 | 7.3 |
| Whole Blood Sample 3 | 80 | 362.58 | 821.24 | 9.82 | 22.24 | 2.7 | 19.99 | 45.28 | 5.5 |
| Whole Blood Sample 4 | 80 | 563.94 | 1277.32 | 19.34 | 43.81 | 3.4 | 35.18 | 79.68 | 6.2 |
| Whole Blood Sample 5 | 80 | 899.24 | 2036.78 | 45.66 | 103.42 | 5.1 | 62.92 | 142.51 | 7.0 |
| Whole Blood Control 1 | 80 | 77.24 | 174.95 | 2.68 | 6.07 | N/A | 5.48 | 12.41 | N/A |
| Whole Blood Control 2 | 80 | 257.52 | 583.28 | 6.51 | 14.75 | 2.5 | 16.84 | 38.14 | 6.5 |
a Number of samples tested
b Standard deviation
c Coefficient of variation
d Not applicable; there is no CV requirement at these concentrations
10.2 Linearity
Serum:
A linearity study was performed according to CLSI EP06-A using 9 samples spanning the assay range, which were prepared using high and low human serum pools. The mean was taken from each sample tested in triplicate. As presented below, the bias from the linear fit estimate was 5.38 |
| RBC folate | | | |
| Normal | 286 | 425 | 280 - 791 |
As with all in vitro diagnostic assays, each laboratory should determine its own reference interval for the diagnostic evaluation of patient results.
10.8 Detection Limits
The limit of blank (LoB), limit of detection (LoD), and the limit of quantitation (LoQ) were determined as described in CLSI protocol EP17-A2. The LoB is defined as the highest measurement result that is likely to be observed for a blank sample. The LoD is defined as the lowest concentration of Folate that can be detected with 95% probability. The LoQ is defined as the lowest concentration of Folate that can be detected at a total CV of 20%.
The Atellica IM Folate assay has an LoB of 0.19 ng/mL, an LoD of 0.38 ng/mL, and an LoQ of 0.56 ng/mL for serum and an LoB of 0.00 ng/mL, an LoD of 0.21 ng/mL, and an LoQ of 0.56 ng/mL for RBC hemolysate.
10.9 Interference
Interference studies were performed according to CLSI EP07-A2 to evaluate the performance of the Atellica IM Folate assay in the presence of endogenous and other interfering substances. Two human sample pools were tested. One sample pool had approximately 4.0 ng/mL Folate. The second sample pool had approximately 12.0 ng/mL Folate. These sample pools were spiked with potential interferents. There was no indication
10
510(k) Summary
of interference (