(154 days)
Not Found
No
The description details a standard immunoassay method based on turbidity measurement and calibration curves, with no mention of AI or ML.
No
This device is for in vitro diagnostic use to measure ferritin levels, aiding in the diagnosis of conditions like hemochromatosis and iron deficiency anemia. It does not directly treat or prevent a disease, which is characteristic of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the ADVIA® 1650 Chemistry Ferritin (FRT) Reagent is "For in vitro diagnostic use in the quantitative determination of ferritin" and that "Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism." This clearly indicates its role in disease diagnosis.
No
The device description clearly outlines physical reagents and calibrators used in a chemistry system, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: Both the Ferritin Reagent and the Liquid Specific Protein Calibrators explicitly state "For in vitro diagnostic use".
- Purpose of the Device: The device is intended to quantitatively determine ferritin in human serum and plasma to aid in the diagnosis of diseases affecting iron metabolism. This is a classic example of an in vitro diagnostic test.
- Method of Operation: The device analyzes biological samples (serum and plasma) outside of the body to provide diagnostic information.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent:
For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 1650 Chemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The ADVIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (FRT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.
Product codes (comma separated list FDA assigned to the subject device)
DBF, JIX
Device Description
The Ferritin reagents are ready-to-use liquid reagents. They are supplied in two different package sizes: 200 tests/wedge, 4 wedges/kit and 800 tests/wedge, 4 wedges/kit. In the ADVIA Chemistry Ferritin assay, sample is diluted and reacted with a buffer containing latex particles coated with antibody specific for ferritin. The formation of the antibodyantigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 658 nm. By constructing a standard curve from the absorbance of standards, ferritin concentration of a sample can be determined.
ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid, buffer based product containing multiple analytes derived from human sources. The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required).
The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL.
Values for the new lots are assigned from a master lot that is referenced to the WHO 3rd International Standard IBSC 94/572
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Data
Method Comparison between the ADVIA 1650 Chemistry Ferritin assay and N Latex Ferritin assay gave the following correlation statistics, when tested with patient samples:
Slope: 1.00 (95% CI: 0.97 – 1.03)
Intercept: 0.00 (95% CI: -3.4-3.4)
n: 47
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary
AUG 1 7 2011
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.
| Submitter's Name: | Kira Gordon
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave,
Tarrytown, NY 10591 |
|--------------------------|------------------------------------------------------------------------------------------------|
| Date of Preparation: | March 07, 2011 |
| Name of Product: | ADVIA® Chemistry Ferritin (FRT) Reagent
ADVIA® Chemistry Liquid Specific Protein Calibrator |
| FDA Classification Name: | Ferritin immunological test system (Class II)
Calibrator (Class II) |
Predicate Device:
The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:
| New Product | Predicate Device | 510(k)
number | Device
Class | Regulation | Product
Code |
|-----------------------------------------------------------|-------------------------------------|------------------|-----------------|------------|-----------------|
| ADVIA® Chemistry
Ferritin (FRT)
Reagent | N Latex Ferritin
reagent | K993273 | Class II | 866.5340 | DBF |
| ADVIA® Chemistry
Liquid Specific
Protein Calibrator | Randox Liquid
Protein Calibrator | K061056 | Class II | 862.1150 | JIX |
Device Description:
The Ferritin reagents are ready-to-use liquid reagents. They are supplied in two different package sizes: 200 tests/wedge, 4 wedges/kit and 800 tests/wedge, 4 wedges/kit. In the ADVIA Chemistry Ferritin assay, sample is diluted and reacted with a buffer containing latex particles coated with antibody specific for ferritin. The formation of the antibodyantigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 658 nm. By constructing a standard curve from the absorbance of standards, ferritin concentration of a sample can be determined.
ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid, buffer based product containing multiple analytes derived from human sources. The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required).
1
The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL.
Values for the new lots are assigned from a master lot that is referenced to the WHO 3rd International Standard IBSC 94/572
Intended Use:
The ADVIA Chemistry Ferritin reagent is for in vitro diagnostic use in the quantitative measurements of ferritin in human serum and plasma on the ADVIA Chemistry systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O_2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Ferritin (FRT), Immunoglobulin A_2 (IGA 2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods
Comparison to Predicate Device:
Both the ADVIA Chemistry Ferritin reagent and the predicate N Latex Ferritin reagent employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the important similarities and differences of these methods is provided in the following table:
| Item | New Device:
ADVIA Chemistry Ferritin | Predicate Device:
N Latex Ferritin |
|----------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Ferritin | Ferritin |
| Intended Use | For in vitro diagnostic use in the
quantitative measurement of ferritin | For in vitro diagnostic use in the
quantitative determination of
ferritin |
| Measurement | quantitative | quantitative |
| Sample type | Serum , Heparinized Plasma, EDTA
plasma | Serum , Heparinized Plasma |
| Reference interval | Men: 20-250 ng/mL (20-250 µg/L)
Women: 10–120 ng/mL (10–120
µg/L) | Men (n = 216): 20 - 290 µg/L
Women, premenopausal (n = 193):
4.5 - 170 µg/L
Women, postmenopausal (n = 47):
24 - 260 µg/L |
| Format | Liquid | Liquid |
| Use of Calibrators | Yes | Yes |
| Analytical
measuring interval | 6 - (450-500) ng/mL | Up to 640 ng/mL |
2
| Method Principle | turbidometric | nephelometry |
|---|---|---|
| Reagents | Two: R1 and R2 | Three: Reagent, Supplementary A |
| and Supplementary B | ||
| Instrument to be | ||
| used | ADVIA 1650 Chemistry | BN System |
| Hook | Up to 40,000 ng/mL | Up to 10,000 ng/mL |
Both the ADVIA Chemistry Liquid Specific Protein Calibrator and the predicate Randox Liquid Protein Calibrator are used in calibrations of ferritin on Chemistry systems. A comparison of the important similarities and differences is provided in the following table:
| Item | New Device:
ADVIA Chemistry Liquid
Specific Protein Calibrator | Predicate Device:
Randox Liquid Protein
Calibrator |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for in vitro diagnostic use in the
calibration of ADVIA®
Chemistry system for the Alpha-
Acid-Glycoprotein (AAG), Alpha-
1-Antitrypsin (AAT), Anti-
streptolysin-O_2 (ASO_2),
Complement C3 (C3),
Complement C4 (C4), Ferritin
(FRT)*, Haptoglobin (HAPT),
Immunoglobulin A_2 (IGA_2),
Immunoglobulin G_2 (IGG_2),
Immunoglobulin M_2 (IGM_2),
Prealbumin (PREALB),
Rheumatoid Factor (RF),
Transferrin (TRF) methods
-
- subject of this submission | Liquid Protein Calibrators are an
in vitro diagnostic product used for
the calibration of ASO,
Complement C3, Complement C4,
CRP, Ferritin, Haptoglobin, IgA,
IgG, IgM, Prealbumin and
Transferrin assays on Clinical
Chemistry and Immunoassay
systems |
| Instrument | ADVIA® Chemistry Systems | Abbott Spectrum, Abbott Aeroset,
Abbott
Architect i2000, Architect i2000sr,
Ace analyser, Bayer Advia 1650,
Advia 2400,
Advia 1200, Dade Dimension
RXL, Dimension AR, Hitachi 704,
Hitachi 717,
Hitachi 911, Hitachi 917, Hitachi
912, Hitachi 747, Kone progress,
AU800,
AU600, AU400, AU2700,
AU5400, Selectra Vitalab,
Synchron CX4, Synchron |
| | | CX5, Synchron CX7, Synchron
LX20, ILAB300, ILAB900,
ILAB1800,
ILAB600, RX Daytona, RX Imola,
Cobas Mira, Cobas Mira S, Cobas
Mira Plus
systems. |
| Formulation /
analytes present | Alpha-acid-glycoprotein
Anti-streptolysin
Alpha-1-Antitrypsin
Ferritin
Immunoglobulin A
Immunoglobulin G
Immunoglobulin M
Immunoglobulin E
Complement C3
Complement C4
Haptoglobin
Microalbumin
Myoglobin
Prealbumin
Rheumatoid Factor
Transferrin
CRP | Same |
| Measured Analytes
(value assigned) | Alpha-acid-glycoprotein (AAG)
Anti-streptolysin-O (ASO)
Alpha-1-Antitrypsin (AAT)
Ferritin (FRT)
Immunoglobulin A_2 (IGA_2)
Immunoglobulin G_2 (IGG_2)
Immunoglobulin M_2 (IGM_2)
Complement C3 (C3)
Complement C4 (C4)
Haptoglobin (HAPT)
Prealbumin (PREALB)
Rheumatoid Factor (RF)
Transferrin (TRF) | ASO
Complement C3
Complement C4
CRP
Ferritin
Haptoglobin
IgA
IgG
IgM
Prealbumin
Transferrin |
| Form | Liquid | Same |
| Traceability for
ferritin analyte | WHO 3rd International Standard
IBSC 94/572 | Same |
| Matrix | Buffered base | Same |
| Analyte source | Derived from human source | Same |
| Number of levels | Six (the lowest level is a zero-
level) | Same |
| Fill Volume | 1.0 mL each vial | Same |
- subject of this submission | Liquid Protein Calibrators are an
3
.
4
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Married Concession of Concession, Carolina Comerce of | And and a free and the first and the first and the comments of the are and the comments of the are and the comments of the are the comments of the are the comments of the are |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ( | C
AHAH |
| | MAN
Vial
01100 | 19870 |
| stability | - 310 V | ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ |
| | And And Any Commend Control Controllery
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | And Anticle Anticle Antique of Children States
| Acres Marken Brond and Achard - Statist A & A BREA A & ANDRE A & |
|---|
Comments on Substantial Equivalence:
Method Comparison between the ADVIA 1650 Chemistry Ferritin assay and N Latex Ferritin assay gave the following correlation statistics, when tested with patient samples:
Method Comparison Data ADVIA 1650 Chemistry Ferritin vs. Predicate Method
| New Device | Predicate
Device | Slope | Intercept | n |
|-------------------------------------|---------------------|-------------------------------|----------------------------|----|
| ADVIA 1650
Chemistry
Ferritin | N Latex
Ferritin | 1.00
(95% CI: 0.97 – 1.03) | 0.00
(95% CI: -3.4-3.4) | 47 |
Conclusion:
The ADVIA Chemistry Ferritin assay with the associated ADVIA Chemistry Liquid Specific Protein Calibrator is substantially equivalent in principle and performance to the N Latex Ferritin assay.
Kira Gordon Regulatory Affairs & Compliance June 24, 2011
5
Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Dr. Kira Gordon Senior Regulatory Affairs Specialist 511 Benedici Avenue Tarrytown, NY 10591
AUG 1 7 2011
Re: K110736
| K110736 | |
|---|---|
| Trade/Device Name: | ADVIA ® Chemistry Ferritin Reagent |
| ADVIA® Chemistry Liquid Specific Protein Calibrator | |
| Regulation Number: | 21 CFR §866.5340 |
| 21 CFR §862.1150 | |
| Regulation Name: | Ferritin immunological test system |
| Calibrator | |
| Regulatory Class: | Class II |
| Product Code: | DBF, JIX |
| Dated: | July 18, 2011 |
| Received: | July 19, 2011 |
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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
6
Page 2 – Dr. Kira Gordon
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Qeena Philip
Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K110736
ADVIA® Chemistry Ferritin Reagent Device Name: ADVIA® Chemistry Liquid Specific Protein Calibrator
Indications For Use:
The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent:
For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 1650 Chemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The ADVIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (FRT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Side-Off
Division Side - Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K 110 510K
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