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.

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

AI/ML Overview

The document describes the Siemens Healthcare Diagnostics Inc. ADVIA® Chemistry Ferritin (FRT) Reagent and ADVIA® Chemistry Liquid Specific Protein Calibrator. The study presented focuses on the Ferritin Reagent and its comparison to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly based on the correlation between the new device and the predicate device. The primary performance metric reported is a method comparison study.

Acceptance Criteria	Reported Device Performance (ADVIA 1650 Chemistry Ferritin vs. N Latex Ferritin)
Close correlation to predicate device	Slope: 1.00 (95% CI: 0.97 – 1.03)
	Intercept: 0.00 (95% CI: -3.4 – 3.4)

The reported performance, with a slope of 1.00 and an intercept of 0.00 (both with narrow confidence intervals that include these ideal values), indicates a very strong correlation and agreement with the predicate device, thereby meeting the implicit acceptance criteria for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 47 patient samples
Data Provenance: Not explicitly stated whether the samples were retrospective or prospective, nor their country of origin. The term "patient samples" is general.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The ground truth in this context is established by the measurements from the predicate device (N Latex Ferritin assay), which is an established, legally marketed device. There is no mention of experts establishing a separate ground truth for these samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The study is a quantitative measurement comparison between two devices, not a diagnostic interpretation or classification that would typically involve an adjudication process by experts. Performance is determined by statistical correlation, not expert consensus on individual case interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. This device is an in vitro diagnostic reagent and calibrator for automated chemistry systems, not an imaging or interpretive AI device that involves human readers/interpreters. Therefore, an MRMC study or AI assistance comparison is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone study was done. The method comparison data presented is for the ADVIA 1650 Chemistry Ferritin assay (the new device) operating as an algorithm/system, without human interpretation influencing the measurement results directly. The output is a quantitative ferritin concentration.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison study was effectively established by the predicate device's measurements (N Latex Ferritin assay). The new device's performance is being assessed against the established performance of the predicate device, assuming the predicate device provides accurate measurements within its validated range.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes a comparison study for a fully developed reagent and calibrator, not a software algorithm that typically undergoes a training phase with a distinct training set. The development of the assay itself would involve internal validation and optimization, but details of such a "training set" are not part of this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is largely not applicable in the context of a reagent-based IVD requiring predicate comparison. For the development and internal validation of such a system, ground truth would typically be established through highly accurate reference methods, certified reference materials, or correlation with established laboratory methods to ensure accuracy and precision. However, details of this process for the new device's internal development are not part of the publicly available 510(k) summary.

Summary

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K110736

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 GordonSiemens Healthcare Diagnostics Inc.511 Benedict Ave,Tarrytown, NY 10591
Date of Preparation:	March 07, 2011
Name of Product:	ADVIA® Chemistry Ferritin (FRT) ReagentADVIA® 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	DeviceClass	Regulation	ProductCode
ADVIA® ChemistryFerritin (FRT)Reagent	N Latex Ferritinreagent	K993273	Class II	866.5340	DBF
ADVIA® ChemistryLiquid SpecificProtein Calibrator	Randox LiquidProtein Calibrator	K061056	Class II	862.1150	JIX

Device Description:

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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 thequantitative measurement of ferritin	For in vitro diagnostic use in thequantitative determination offerritin
Measurement	quantitative	quantitative
Sample type	Serum , Heparinized Plasma, EDTAplasma	Serum , Heparinized Plasma
Reference interval	Men: 20-250 ng/mL (20-250 µg/L)Women: 10–120 ng/mL (10–120µg/L)	Men (n = 216): 20 - 290 µg/LWomen, premenopausal (n = 193):4.5 - 170 µg/LWomen, postmenopausal (n = 47):24 - 260 µg/L
Format	Liquid	Liquid
Use of Calibrators	Yes	Yes
Analyticalmeasuring interval	6 - (450-500) ng/mL	Up to 640 ng/mL

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Method Principle	turbidometric	nephelometry
Reagents	Two: R1 and R2	Three: Reagent, Supplementary Aand Supplementary B
Instrument to beused	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 LiquidSpecific Protein Calibrator	Predicate Device:Randox Liquid ProteinCalibrator
Intended Use	for in vitro diagnostic use in thecalibration 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 anin vitro diagnostic product used forthe calibration of ASO,Complement C3, Complement C4,CRP, Ferritin, Haptoglobin, IgA,IgG, IgM, Prealbumin andTransferrin assays on ClinicalChemistry and Immunoassaysystems
Instrument	ADVIA® Chemistry Systems	Abbott Spectrum, Abbott Aeroset,AbbottArchitect i2000, Architect i2000sr,Ace analyser, Bayer Advia 1650,Advia 2400,Advia 1200, Dade DimensionRXL, Dimension AR, Hitachi 704,Hitachi 717,Hitachi 911, Hitachi 917, Hitachi912, Hitachi 747, Kone progress,AU800,AU600, AU400, AU2700,AU5400, Selectra Vitalab,Synchron CX4, Synchron
		CX5, Synchron CX7, SynchronLX20, ILAB300, ILAB900,ILAB1800,ILAB600, RX Daytona, RX Imola,Cobas Mira, Cobas Mira S, CobasMira Plussystems.
Formulation /analytes present	Alpha-acid-glycoproteinAnti-streptolysinAlpha-1-AntitrypsinFerritinImmunoglobulin AImmunoglobulin GImmunoglobulin MImmunoglobulin EComplement C3Complement C4HaptoglobinMicroalbuminMyoglobinPrealbuminRheumatoid FactorTransferrinCRP	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)	ASOComplement C3Complement C4CRPFerritinHaptoglobinIgAIgGIgMPrealbuminTransferrin
Form	Liquid	Same
Traceability forferritin analyte	WHO 3rd International StandardIBSC 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

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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	PredicateDevice	Slope	Intercept	n
ADVIA 1650ChemistryFerritin	N LatexFerritin	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

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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

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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

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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.

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)

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Office of In Vitro Diagnostic Device Evaluation and Safety

K 110 510K

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Regulation Number and Section

§ 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).