(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use.

(2) Elecsys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias.

(3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.

(4) Elecsys Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

(5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Device Description

(1) The Elecsys Folate III assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

(2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.

(3) The Elecsys Folate III CalSet is a lyophilized product consisting of human serum with folic acid in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate III assay.

(4) Elecsys Folate III CalCheck is a lyophilized product consisting of human serum with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate III CalSet.

(5) The Elecsys PreciControl Anemia is a lyophilized control serum based on human serum matrix in three concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys Ferritin, Folate III, and Vitamin B12 immunoassays.

AI/ML Overview

The Elecsys Folate III Test System, including Elecsys Folate III, Elecsys RBC Folate Hemolyzing Reagent, Elecsys Folate III CalSet, Elecsys Folate III CalCheck, and Elecsys PreciControl Anemia, is designed for the in vitro quantitative determination of folate in human serum, plasma, and erythrocytes. This system is intended for use in the diagnosis and treatment of anemias on Elecsys and cobas e immunoassay analyzers.

The acceptance criteria for the Elecsys Folate III and Elecsys RBC Folate Hemolyzing Reagent assays were established through comparison studies against their respective predicate devices (Elecsys Folate II Assay and Elecsys RBC Folate Hemolyzing Reagent (K051292)). The primary method for proving the device meets these criteria is through Method Comparison studies using Passing-Bablok and Linear Regression analysis.

Here's the breakdown of the acceptance criteria and performance:

Acceptance Criteria Category	Acceptance Criteria (Predicate Device)	Reported Device Performance (Elecsys Folate III)
Elecsys Folate III Assay
Measuring Range	0.600 - 20.00 ng/mL	1.5 - 20.0 ng/mL
Precision (Total CV for Human Samples < 10 ng/mL)	6.1-13.8%	7.0-13.3%
Precision (Total CV for Human Samples > 10 ng/mL)	7.0%	5.0%
Analytical Sensitivity (Lower Detection Limit)	0.6 ng/mL	Limit of Detection = ≤1.5 ng/mL
Interferences (Icterus)	recovery within ± 10% of initial value for bilirubin < 684 µmol/L	recovery within ± 10% of initial value for bilirubin < 564 µmol/L
Interferences (Lipemia)	recovery within ± 10% of initial value for Intralipid < 1500 mg/dL	recovery within ± 10% of initial value for Intralipid < 1500 mg/dL
Interferences (Biotin)	recovery within ± 10% of initial value for biotin < 123 nmol/L	recovery within ± 10% of initial value for biotin < 86.1 nmol/L
Interferences (IgG)	recovery within ± 10% of initial value for IgG < 16 g/L	recovery within ± 10% of initial value for IgG < 16 g/L
Interferences (IgA)	recovery within ± 10% of initial value for IgA < 4.0 g/L	recovery within ± 10% of initial value for IgA < 4.0 g/L
Elecsys RBC Folate Hemolyzing Reagent
Measuring Range (without hematocrit consideration)	up to 620 ng/mL	46.5 – 572 ng/mL
Precision (Total CV for sample 1)	6.8% CV @ 478 ng/mL	7.0% CV @ 229 ng/mL
Precision (Total CV for sample 2)	6.6% CV @ 573 ng/mL	7.2% CV @ 350 ng/mL
Precision (Total CV for sample 3)	5.5% CV @ 623 ng/mL	7.2% CV @ 481 ng/mL
Method Comparison (Folate III Assay)		Passing/Bablock: Slope = 1.13, Y intercept = -0.10, tau = 0.833; Linear Regression: Slope = 1.13, Y intercept = -0.06, r=0.962
Method Comparison (RBC Folate Hemolyzing Reagent)		Passing/Bablock: Slope = 1.096, tau = 0.700; Linear Regression: Slope = 1.019, r = 0.921

Study Details:

Sample sizes used for the test set and data provenance:
- Elecsys Folate III Assay (Method Comparison): N=98 samples. Sample concentrations were between approximately 1.76 and 15.9 ng/mL. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned.
- Elecsys RBC Folate Hemolyzing Reagent (Method Comparison): N=98 samples. Sample concentrations were between approximately 123 and 566 ng/mL. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned.
- Elecsys RBC Folate Hemolyzing Reagent (Expected Values): N=262 samples from a study in the USA. This suggests a prospective study for establishing typical ranges.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic assay that measures a biochemical marker (folate concentration). Ground truth for measured analytes is typically established by reference methods or validated assays, not by expert consensus. The comparison is made against the predicate devices' measurements.
Adjudication method for the test set: Not applicable. The studies are method comparisons against a predicate device, not diagnostic performance studies requiring adjudication of disagreements among experts.
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: Not applicable. This is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human reader interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a standalone immunoassay system (Elecsys Folate III assay run on Elecsys and cobas e immunoassay analyzers). The performance data presented (measuring range, precision, sensitivity, interferences, method comparison) reflects the standalone performance of the assay and the instrument system, without human intervention in the measurement process itself, beyond standard laboratory procedures for sample handling and instrument operation.
The type of ground truth used: For the method comparison studies, the "ground truth" was the measurements obtained by the predicate devices: Elecsys Folate II assay for serum folate and Elecsys RBC Folate Hemolyzing Reagent + Elecsys Folate II assay for RBC folate. This is a form of comparative reference standard.
The sample size for the training set: Not applicable. As an in vitro diagnostic assay, there is no "training set" in the context of machine learning or AI models. The assay performance is developed and validated through a series of analytical studies.
How the ground truth for the training set was established: Not applicable. See point 7.

Summary

{0}------------------------------------------------

K082340

510(k) Summary

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, address, contact

Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 (317) 521 - 3723

JUN 19 2009

Contact Person: Kathie J. Goodwin

Date Prepared: July 25, 2008

	Device Name

Proprietary names: (1) Elecsys Folate III

(2) Elecsys RBC Folate Hemolyzing Reagent

(3) Elecsys Folate III CalSet

(4) Elecsys Folate III CalCheck

(5) Elecsys PreciControl Anemia

Common names:

(1) Folate III

(2) RBC Folate

(3) Folate III CalSet

(4) Folate III CalCheck

(5) PreciControl Anemia

Classification names: (1) Folic Acid Test System

(2) Folic Acid Test System

(3) Calibrator

(4) Quality Control Material (Assayed and Unassayed)

(5) Quality Control Material (Assayed and Unassayed)

Product codes: (1) CGN

(2)	CGN
	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(3) JIT

(4) JJX
(5) JJY

{1}------------------------------------------------

(1) The Elecsys Folate III assay employs a competitive test principle using Description natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

(2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.

Device

{2}------------------------------------------------

Intended use Folate III:

Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.

RBC Folate Hemolyzing Reagent:

Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erythrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.

Folate III CalSet:

Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.

Folate III CalCheck:

Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

PreciControl Anemia:

Elecsys PreciControl Anemia is used for the quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Folate III and RBC Folate Hemolyzing Reagent: Measurements obtained Indications for Use by these devices are used in the diagnosis and treatment of anemias.

Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.

Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

{3}------------------------------------------------

Substantial The Elecsys Folate III Test System is substantially equivalent to the Elecsys equivalence Folate II Test System. This test system includes the following 5 components which have been cleared under the following K numbers:

1. Elecsys Folate II (K043318)
1. Elecsys RBC Hemolyzing Reagent (K051292)
1. Elecsys Folate II CalSet II (K042490)
1. Elecsys Folate II CalCheck II (K043320)
1. Elecsys PreciControl Anemia (K051517)

(The original Elecsys Folate Assay was cleared under K973674.)

{4}------------------------------------------------

510(k) Summary, Continued

Substantial
equivalence comparison

Elecsys Folate III Reagent
Feature	Elecsys Folate III Assay	Predicate Device: Elecsys Folate IIAssay (K043318)
Intended Use	Binding assay for the in vitroquantitative determination offolate in human serum. Thebinding assay is intended for useon Elecsys and cobas eimmunoassay analyzers.	Binding assay for the in vitroquantitative determination of folate inhuman serum. The binding assay isintended for use on Elecsys and cobas eimmunoassay analyzers.
Indication forUse	This assay may be used as an aidin the diagnosis and treatment ofanemias.	This assay may be used as an aid in thediagnosis and treatment of anemias.
Assay Protocol	ElectrochemiluminescentImmunoassay	Electrochemiluminescent Immunoassay
Sample Type	Serum (tubes containingseparating gel can be used)	Serum (tubes containing separating gelcan be used)
LabeledInstrumentPlatform	Roche Elecsys 2010/ cobas e 411and MODULAR ANALYTICSE170 (Elecsys module)/ cobas e601 analyzers.	Roche Elecsys 2010/ cobas e 411 andMODULAR ANALYTICS E170(Elecsys module)/ cobas e 601analyzers.
Calibrator	Elecsys Folate III CalSet	Elecsys Folate II CalSet II
Calibrationfrequency	Once per reagent lot andAfter 1 month when usingsame reagent lotAfter 7 days when using samereagent kitAs required per QC findings orpertinent regulations	Once per reagent lot andAfter 1 month when using samereagent lotAfter 7 days when using samereagent kitAs required per QC findings orpertinent regulations
Controls	PreciControl Anemia	PreciControl Anemia
Traceability	This method has beenstandardized against the ElecsysFolate II assay	This method has been standardizedagainst the Elecsys Folate assay

. . . . . . .

{5}------------------------------------------------

Reagent Stability	Unopened 2-8°C - up toexpirationOpened 2-8°C - 8 weeksOn Elecsys 2010 and cobas e411-2 weeks	Unopened 2-8°C - up to expirationOpened 2-8°C -12 weeksOn Elecsys 2010 and cobas e411- 2weeks
MeasuringRange	1.5 - 20.0 ng/mL	0.600 - 20.00 ng/mL
Precision	Elecsys 2010 and cobas e411 TotalPrecision(range of values)PreciControl Anemia 2: SD 0.467 ng/mL; CV 6.4% PreciControl Anemia 3: SD 0.986 ng/mL; CV 6.3% Human Samples < 10 ng/mL, CV 7.0-13.3% Human Samples > 10 ng/mL, CV 5.0%	Elecsys 2010 and cobas e411 Total Precision(range of values)PreciControl Universal 1: SD 0.82 ng/ml; CV 6.8% PreciControl Universal 2: SD 0.50 ng/ml; CV 7.9% Human Samples < 10 ng/mL, CV 6.1-13.8% Human Samples > 10 ng/mL, CV 7.0%
AnalyticalSensitivity	Limit of Blank = ≤0.640 ng/mLLimit of Detection = ≤1.5 ng/mLLimit of Quantitation = ≤2.0 ng/mL	Lower Detection Limit = 0.6 ng/mL
AnalyticalSpecificity	The following cross-reactivitieswere found:Aminopterin 2.7%Folinic acid 2.3%Amethopterin 2.3%	Same

Interferences	• The assay is unaffected by icterus(bilirubin < 564 µmol/L or < 33mg/dL), lipemia (Intralipid <1500 mg/dL), and biotin < 86.1nmol/L or < 21 ng/mL, IgG < 16g/L and IgA < 4.0 g/L.Criterion: Recovery within ± 10% ofinitial value with samples >5 ng/mL and<+/- 0.5 ng/mL with samples ≤ 5 ng/mL.• In patients receiving therapy withhigh biotin doses (i.e. >5mg/day), no sample should betaken until at least 8 hours afterthe last biotin administration.• No interference was observedfrom rheumatoid factors up to aconcentration of 1000 IU/mL.• In vitro tests were performed on18 commonly usedpharmaceuticals and in additionon human erythropoietin. Nointerference with the assay wasfound.	• The assay is unaffected by icterus(bilirubin < 684 µmol/L or < 40 mg/dL),lipemia (Intralipid < 1500 mg/dL), andbiotin < 123 nmol/L or < 30 ng/mL, IgG< 16 g/L and IgA < 4.0 g/L.Criterion: Recovery within ± 10% of initial value.• In patients receiving therapy with highbiotin doses (i.e. >5 mg/day), no sampleshould be taken until at least 8 hoursafter the last biotin administration.• No interference was observed fromrheumatoid factors up to a concentrationof 1000 IU/mL.• In vitro tests were performed on 56commonly used pharmaceuticals and inaddition on human erythropoietin. Nointerference with the assay was found.
	• It is contraindicated to measuresamples of patients receivingtherapy with certainpharmaceuticals, e.g.methotrexate or leucovorin,because of the cross-reactivity offolate binding protein with thesecompounds.	• Folate assays of samples from patientsreceiving therapy with certainpharmaceuticals, e.g. methotrexate orleucovorin, are contraindicated becauseof the cross-reactivity of folate bindingprotein with these compounds.
	• In rare cases, interference due toextremely high titers of	• In rare cases, interference due toextremely high titers of antibodies to
	antibodies to streptavidin andruthenium can occur.	streptavidin and ruthenium can occur.
Dilution	Sample measuring >20ng/mL canbe manually diluted and a dilutionfactor of 2 applied	Sample measuring >20ng/mL can bemanually diluted and a dilution factor of2 applied
Expected Values	American Journal of ClinicalNutritionExpected = 4.6 - 34.8 ng/mL(all ages & male/female)	New England Journal Of MedicineExpected = 3.1 – 17.5 ng/mL

・

Elecsys Folate III Test System (including RBC Folate Hemolyzing Reagent)

{6}------------------------------------------------

' :

{7}------------------------------------------------

: : : : : :

ﺴﺮ

MethodComparison	A comparison of the Elecsys Folate III assay (Elecsys 2010 Immunoassayanalyzer) and the Elecsys Folate II assay (Elecsys 2010 Immunoassayanalyzer) where N=98Sample concentrations were between approx. 1.76 and 15.9 ng/mLPassing/Bablock:Slope = 1.13Y intercept = -0.10tau = 0.833Linear RegressionSlope = 1.13Y intercept = -0.06r=0.962
----------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

. :

11 - 11 - 11

{8}------------------------------------------------

(2) Elecsys RBC Folate Hemolyzing Reagent
Feature	Elecsys RBC FolateHemolyzing Reagent	PredicateElecsys RBC Folate HemolyzingReagent(K051292)
Intended Use/Indications for Use	Elecsys RBC FolateHemolyzing Reagent is usedtogether with the Elecsys FolateIII assay for the quantitativedetermination of folate inerythrocytes (RBC folate) onthe Elecsys 2010/cobas e 411analyzers.	Elecsys RBC Folate HemolyzingReagent is used together with theElecsys Folate II assay for thequantitative determination offolate in erythrocytes (RBCfolate).
Expected Values	Study in the USA using theElecsys Folate III assay thecobas e411 Immunoassayanalyzer, N=262:(Values corrected for hematocrit)Median - 902 ng/mL$2.5^{th}97.5^{th}$ percentile – 499-1504 ng/mL	Study in the USA using theElecsys Folate III assay on theElecsys 2010 and cobas e411Immunoassay analyzers, N=121:(values corrected for hematocrit)Median – 790 ng/mL$2.5^{th}97.5^{th}$ percentile – 496-1477ng/mL
Precision	Total Precision (n=84)(values not corrected for hematocrit)2010/cobas e411 Analyzer7.0% CV @ 229 ng/mL7.2% CV @ 350 ng/mL7.2% CV @ 481 ng/mL	Total Precision (n=63)(values corrected for hematocrit)2010/cobas e411 Analyzer6.8% CV @ 478 ng/mL6.6% CV @ 573 ng/mL5.5% CV @ 623 ng/mL
MeasuringRange	46.5 – 572 ng/mLThe lower end of the measuringrange is derived from the lowerend of the serum folate test.Values are not corrected forhematocrit	Without consideration forhematocrit, up to 620 ng/mL(derived from the upper limit ofthe serum folate test)

{9}------------------------------------------------

MethodComparison	A comparison of the Elecsys RBC Folate together with the ElecsysFolate III assay (Elecsys 2010/cobas e411 analyzer; calibrated withElecsys Folate III CalSet: y) and the Elecsys RBC Folate with theElecsys Folate II assay (Elecsys 2010/cobas e411 analyzer: calibratedwith Elecsys Folate II CalSet II; x) where N=98(Values were not corrected for Hematocrit)Sample concentrations were between approx. 123 and 566 ng/mLPassing/Bablock:Slope = 1.096tau = 0.700Linear RegressionSlope = 1.019r = 0.921
Dilution	Sample measuring >20ng/mL canbe manually diluted and adilution factor of 2 applied	Sample measuring >20ng/mL canbe manually diluted and a dilutionfactor of 2 applied

(3) Elecsys Folate III CalSet
Feature	Elecsys Folate III CalSet	PredicateElecsys Folate II CalSet II(K042490)
Intended Use	Elecsys Folate III CalSet is usedfor calibrating the quantitativeElecsys Folate III assay on theElecsys and cobas eimmunoassay analyzers.	Elecsys Folate II CalSet II is usedfor calibrating the quantitativeElecsys Folate II assay on theElecsys and cobas e immunoassayanalyzers.
Levels	Two	Two
Matrix	Human serum preserved with0.5% Bronidox L and bufferedwith 50mM HEPES	Human serum
Format	Lyophilized	Lyophilized
Stability	Unopened: up to the statedexpiration dateAfter reconstituting:At 2-8C – 3 daysAt -20C – 3 months (freeze onlyonce)Onboard: use only once	Unopened: up to the statedexpiration dateAfter reconstituting:At 2-8C – 3 daysAt -20C – 3 months (freeze onlyonce)Onboard: use only once

{10}------------------------------------------------

Composition
	Buffer: HEPES 50mM	No buffer or preverative in
	Preservative: Bronidox L 0.5%	composition

(4) Elecsys Folate III CalCheck
Feature	Elecsys Folate III CalCheck	PredicateElecsys Folate II CalCheck II(K043320)
Intended Use	For use in the verification of thecalibration established by theElecsys Folate III reagent on theindicated Elecsys and cobas eimmunoassay analyzers.	For use in the verification of thecalibration established by theElecsys Folate II reagent on theindicated Elecsys and cobas eimmunoassay analyzers.
Levels	Three	Three
Matrix	Human serum preserved with0.5% Bronidox L and bufferedwith 50mM HEPES	Human serum
Format	Lyophilized	Lyophilized
Stability	Unopened and stored at 2-8C:up to the stated expiration dateAfter reconstituting: 4 hours at20-25C	Unopened and stored at 2-8C: upto the stated expiration dateAfter reconstituting: 4 hours at 20-25C
Composition	Buffer: HEPES 50mMPreservative: Bronidox L 0.5%	No buffer or preverative incomposition

(5) Elecsys PreciControl Anemia
Feature	Elecsys PreciControl Anemia	PredicateElecsys PreciControl Anemia(K051517)
Intended Use	Elecsys PreciControl Anemia isused for quality control ofElecsys immunoassays on theElecsys and cobas eimmunoassay analyzers.	Elecsys PreciControl Anemia isused for quality control of theElecsys Ferritin, Folate II, andVitamin B12 immunoassays.
Levels	Three	Three
Matrix	Human serum	Human serum
Format	Lyophilized	Lyophilized

{11}------------------------------------------------

Stability
	Unopened: up to the statedexpiration date	Unopened: up to the statedexpiration date
	After reconstituting:	After reconstituting:
	At 20-25C: up to 8 hours	At 20-25C: up to 8 hours
	On board at 20-25C: up to 5hours	On board at 20-25C: up to 5 hours
	At 2-8C: 3 days	At 2-8C: 3 days
	At -20C: 1 month (freeze onlyonce)	At -20C: 1 month (freeze only once)
	After thawing: use only once	After thawing: use only once

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

Elecsys Folate III Test System (including RBC Folate Hemolyzing Reagent)

Page 12 of 12 .

{12}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and health.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 9 2009

Ms. Kathie Goodwin Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IA 46250

Re: K082340

Trade/Device Name: Roche Elecsys Folate III, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate III CalSet, Roche Elecsys Folate III CalCheck, Roche Elecsys PreciControl Anemia Regulation Number: 21 CFR 862.1295 Regulation Name: Folic Acid Test System Regulatory Class: Class II Product Code: CGN, JIT, JJY, JJX Dated: June 11, 2009 Received: June 16, 2009

Dear Ms. Goodwin:

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 either class II (Special Controls) or class III (PMA), 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 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

{13}------------------------------------------------

Page 2 -

CFR Part 807); labeling (21 CFR Parts 801 and 809); 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{14}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K082340

Device Name:

(1) Elecsys Folate III
(2) Elecsys RBC Folate Hemolyzing Reagent
(3) Elecsys Folate III CalSet
(4) Elecsys Folate III CalCheck

(5) Elecsys PreciControl Anemia

Indications for Use:

(3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.

(5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082340

Page 1 of 1

Regulation Number and Section

§ 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.