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SIEMENSJUL 092014510(k) SummaryIntroduction: According to the requirements of 21 CER 807.92, the following information providessufficient details to understand the basis for determination of substantial equivalence.The assigned 510(k) Number:1. SubmitterMailing Address:Contact Person:Phone Number:Fax Number:E-mail Address:Date Prepared:2. Device NameProprietary Name:Measurand:Type of Test:Regulation Section:Classification:Products Code:Panel:3. Predicate Device NamePredicate 510(k) No:4. Device Description:5. Intended Use:Indication for Use:Special Conditions forUse Statement(s):Special InstrumentRequirements:k141444Siemens Healthcare Diagnostics Inc.52 10 Pacific Concourse DriveLos Angeles, CA 90045Donna VelasquezRegulatory Technical Specialist(31 0)-645-8200 x7403(310)-645-9999donna.velasquez siemens.comMay 30, 2014IMMULITE 2000 Cortisol Calibration Verification MaterialQuality Control materials for IMMULITE 2000 Cortisol assayCalibration Verification Material (CVM) for IMMULITE 2000Cortisol assay21 CER 862.1660, Quality Control MaterialClass I ReservedJJX - Single (Specified) Analyte Controls (Assayed andUnassayed)Clinical Chemistry (75)IMMULITE R 2000 Total T3 Calibration Verification Material(CVM)K133 124The IMMULITE 2000 Cortisol Calibration Verification Material(CVM) contains one set of four vials each 3mL. CVM1 containshuman serum with preservatives and CVM2, CVM3, and CVM4contain various levels of cortisol in human serum withpreservatives.See Indications for Use Statement belowThe IMMULITE Cortisol Calibration Verification Material(CVM) is for in vitro diagnostic use in the verification ofcalibration of the IMMULITE Cortisol assay on the IMMULITE2000 systemsFor prescription use onlyIMMULITEO 2000 SystemsPages 1 of 12

SIEMENS6. Technological Characteristicsand Substantial Equivalence A comparison of the device features, intended use, and otherComparison with Predicate:information demonstrates that the IMMULITE 2000 CortisolCalibration Verification Material (CVM) is substantially equivalentto the predicate device as summarized in Table 1.Table 1: Substantial Equivalence ComparisonSIMILARITIESCandidate DeviceIMMULITE 2000 Cortisol CVM[Th IMUIT9Cortisol lsMatrixUsePredicate DeviceIMMULITE 2000 Total T3 CVMThe IMMULITE Total T3CairtoVefctonMeilVerification Material (CVM) is for invitro diagnostic use in the verification of (CVM) is for in vitro diagnostic use inthe verification of calibration of theotslcairto fteIM LTIMMULITE Total T3 assay on thealiaion the IMULITE Corsytis.assaMMUITEonthe 000systms.IMMULITE 2000 systems-20 0 CLiquidStable unopened until theexpiration date4Human Serum with preservativesSingle Use idate DeviceIMMULITE 2000 Cortisol CVMCortisolPredicate DeviceIMMULITE 2000 Total T4 CVMTotal T37. Non-Clinical Performance TestinsPerformance testing has been carried out to demonstrate that this device meets the performancespecifications for its intend use. The following tests were performed on the candidate device.Stability Summary:IThe stability study was conducted to validate real-time shelf life and open component (in-use or openvial) claim for the IMMULITE 2000 Cortisol Calibration Verification Material (CVM) to ensure thatit maintains optimal product performance on IMMULITE 2000 platforms throughout the establishedshelf life of the CVM. The Calibration Verification Materials are stable up to 14 months when storedat -20 0 C prior to opening and stable for 8 hours at ambient or room temperature (15-25 0 C) afteropening.Pages 2 of 12

SIEMENSStability Protocol SummaryThe CVM study protocols are run as part of the calibrator stability testing.The stabilitycalibrators/C VMs are run in duplicate (as a minimum) at the time points shown in Table 2, and thedose value is determined from the reference calibrator curve.Table 2: Stability Protocol SummaryCVM 1111182182182182365365365365425425425425For Open Component testing, the results were determined from a 2-point adjustment. UsingIMMULITE 2000 Cortisol (L2KCO) kit lot 362, lot 090 CVMs were tested at 2-hourly intervals forup to 9 hours at ambient or room temperature (15-250 C) conditions.Stability Acceptance Criteria SumnmaryThe Acceptance Criteria for the Cortisol Calibration Verification Material (CVM) are in 2 parts.Part I consists of guideline acceptance criteria which require dose value of stabilitycalibrators/CVM to fall between 20% of assigned dose for CVM level 2, 15% of assigned dosefor level 3 and 19% of assigned dose for level 4. Padt 2 review limits criteria which require dosevalue of the controls to be within 2 Standard Deviations (SD) of the control target value whengenerated from the stability calibrator curve. If the result is not within acceptable dose range of 20%for level 2, 15% of assigned dose for level 3 and within 19% of assigned dose for level 4, thenadditional data review is conducted using part 2 criteria.Traceabilit:The IMMULITE Cortisol CVMs are traceable to an internal material which has been gravimetricallyprepared. The CVMs are manufactured using qualified materials and measurement procedures.Value Assignment:The IMMULITE Cortisol CVMs are 4 level materials which are a subset of 8 level Cortisolcalibrators. Calibrators are not commercialized but are used internally during manufacture and releasetesting of Cortisol reagents and two point adjustors.The IMMULITE calibrators and thereforeCVMs are value assigned using assigned reference calibrators. The CVMs are manufactured usingqualified materials and measurement procedures. The CVMs dose values are generated using curvegenerated by assigned reference calibrators. The CVM values are calculated based on the recoveredvalues for each run on each instrument independently. CVM values are then averaged across allsystems. Quality control is performed by calculating the recovery of patient samples, spiked patientsamples and controls using the assigned CVM values. Six levels of commercially available controlsand 25 patient serum samples, 3 spiked normal serum samples and 5 normal serum samples were usedto validate calibrator/CVM value assignments.Pages 3 of 12

SIEMENSExpected Values/Target Values/Reference Range:Each CVM level was tested for a total of 27 replicates; 9 runs and 3 replicates per run, Y differentreagent kit lots and 8 IMMULITE 2000 systems. The Guideline Range (95% confidence interval) foreach CVM level was established based on the Target Mean and 2 Standard Deviation (SD). Thetarget values are provided in the IMMULITE 2000 CVM Calibration verification Material lotspecific value card. The expected assay range is I to 50 g/dL. The target values in Table 3 can beconsidered as guidelines.Table 3: Analyte Target Range ValuesAnalyte targetlevelsCVM, Level*Target'StandardGluideline 5.2LCOCVM4Assay Range1Ito 50 g/dL*Note: when CVMs are run by the customer, an actual value below and above the assay range will result whenthe customer programs the GyMs as calibration verifiers in the instrument software. If programmed as a patientor control, then the software will give values as or the assay lower and upper range.Each laboratory should establish their limits for acceptability based on methodology, clinicalsignificance and medical decision levels of the test analyte. The representative, total precisiontabulated in the respective assay instructions for use may be considered as one factor whenestablishing local, acceptable ranges. The values provided above may be considered as guidelines.Value assignment is lot specific.Standard/Guidance Documents Referenced:CEN 13640 Stability Testing of In Vitro Diagnostic ReagentsGuidance for Industry - Abbreviated 5 10(k) Submissions for In Vitro Diagnostic CalibratorsGuidance for Industry and FDA Staff - Assayed and Unassayed Quality Control MaterialProposed Labeling:The labeling is sufficient and it satisfies the requirements of 2l CFR Part 809. 108.Conclusion:The IMMULITE 2000 Cortisol Calibration Verification Material is substantially equivalent to thepredicate device intended for similar use. The substantial equivalence of the device is supported by thenon-clinical testing and was found to be comparable and supports the claims of substantialequivalence, product safety and effectiveness. Based on the testing completed and the comparisonswith predicate device, the IMMULITE 9 2000 Cortisol Calibration Verification Material does not raiseany new questions on safety and effectiveness and the results support a determination of substantialequivalence.Pages 4 of 12

SIEMENS510(k) SummaryIntroduction: According to the requirements of 21 CER 807.92, the following information providessufficient details to understand the basis for determination of substantial equivalence.The assigned 510(k) Number:1. SubmitterMailing Address:Contact Person:Phone Number:Fax Number:E-mail Address:Date .Prepared:2. Device NameProprietary Name:Measurand:Type of Test:Regulation Section:Classification:Products Code:Panel:3. Predicate Device NamePredicate 510(k) No:4. Device Description:5. Intended Use:Indication for Use:Special Conditions forUse Statement(s):Special InstrumentRequirements:k141444Siemens Healthcare Diagnostics Inc.5210 Pacific Concourse DriveLos Angeles, CA 90045Donna VelasquezRegul atory Technical Specialist(3 10) 645-8200 x7403(310) 645-9999donna.velasquez siemens.comMay 30, 2014IMMULITE 2000 Folic Acid Calibration Verification MaterialQuality Control materials for IMMULITE 2000 Folic Acid assayCalibration Verification Material (CVM) for IMMULITE 2000Folic Acid assay21 CFR 862.1660, Quality Control MaterialClass I ReservedJJN - Single (Specified) Analyte Controls (Assayed andUnassayed)Clinical Chemistry (75)IMMULITE 2000 DHEA-S04 Calibration Verification Material(CVM)K140258The IMMULITEO 2000 Folic Acid Calibration VerificationMaterial (CVM) contains one set of four vials, 3mL (CVM I) each,when reconstituted. CVMI contains a lyophilized human albuminbased matrix with preservatives. CVM2, CVM3, and CVM4contain various levels of lyophilized folic acid in human albuminbased matrix with preservatives.See Indications for Use Statement belowThe IMMULITE Folic Acid Calibration Verification Material(CVM) is for in vitro diagnostic use in the verification ofcalibration of the IMMULITE Folic Acid assay on theIMMULITE 2000 systemsFor prescription use onlyIMMULITE 2000 SystemsPages 5Sof 12