The IMMULITE® 2000 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE® 2500 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

Device Description

The IMMULITE 2000, IMMULITE 2500 Vancomycin assay is a solid phase competitive chemiluminescent enzyme immunoassay. The solid phase (bead) is coated with ligandlabeled vancomycin. The reagent contains alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine antivancomycin in the patient sample competes with the ligand-labeled solid phase for vancomycin binding sites on the monoclonal murine anti-vancomycin enzyme conjugate. The excess sample and reagent are removed by a centrifugal wash. Finally, chemiluminescent substrate is added to the bead and signal is generated in proportion to the bound enzyme. The assay includes an automatic on-board predilution of 1/20 prior to immunoreaction. Immunoreaction incubation time is 30 minutes. The sample volume required is 10 µL for the test and 250 uL dead volume. The sample types are serum and plasma (heparin or EDTA).

AI/ML Overview

{
  "acceptance_criteria_study": {
    "1_acceptance_criteria_table": [
      {
        "Criterion": "Reportable Range",
        "Acceptance Criteria": "Not explicitly stated as a separate acceptance criterion, but the reported range is 3.0 µg/mL – 50 µg/mL.",
        "Reported Device Performance": "3.0 µg/mL – 50 µg/mL for both IMMULITE 2000 and IMMULITE 2500 Vancomycin assays."
      },
      {
        "Criterion": "Limit of Blank (LoB)",
        "Acceptance Criteria": "The highest value expected to be seen in a series of results for samples that contain no analyte, based on CLSI guideline EP17-A. Computed as mean CPS - 1.65 * total SDcps, then converted to vancomycin dose.",
        "Reported Device Performance": "0.4 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Limit of Detection (LoD)",
        "Acceptance Criteria": "The actual concentration at which an observed test result is likely to exceed the Limit of Blank (LoB) and may therefore be declared as detected, based on CLSI guideline EP17-A. Formula: LoD = LoB + 1.65 * SD.",
        "Reported Device Performance": "0.9 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Precision (IMMULITE 2000)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 47 µg/mL should not be greater than 10.2% and 6.8%, respectively.",
        "Reported Device Performance": "Max statistics across 3 lots show intra-assay CV% not greater than 10.2% and inter-assay CV% not greater than 6.8% over the range of approximately 5 to 47 µg/mL."
      },
      {
        "Criterion": "Precision (IMMULITE 2500)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 45 µg/mL should not be greater than 6.1% and 6.0%, respectively.",
        "Reported Device Performance": "Max statistics for one kit lot show intra-assay CV% not greater than 6.1% and inter-assay CV% not greater than 6.0% over the range of approximately 5 to 45 µg/mL."
      },
      {
        "Criterion": "Linearity (Average Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable for patient samples. The reported value is 96.0%.",
        "Reported Device Performance": "Average recovery for patient samples tested in the IMMULITE 2000/IMMULITE 2500 Vancomycin assay was 96.0%."
      },
      {
        "Criterion": "Spiked Recovery (Average % Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable. The reported value is 101%.",
        "Reported Device Performance": "Average % recovery for spiked patient samples was 101%."
      },
      {
        "Criterion": "Interfering Substances (Bilirubin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Bilirubin up to 20 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Hemoglobin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Hemoglobin up to 600 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Triglycerides)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Triglycerides up to 3000 mg/dL."
      },
      {
        "Criterion": "Cross-Reactivity",
        "Acceptance Criteria": "No detectable cross-reactivity to various potential cross-reactants when vancomycin-spiked human serum sample is tested.",
        "Reported Device Performance": "No detectable cross-reactivity to a long list of substances (e.g., Acetaminophen, Amikacin, etc.) at high concentrations (typically 500 µg/mL), or Teicoplanin/CDP-1 at relevant concentrations."
      },
      {
        "Criterion": "Interference (HAMA/RF)",
        "Acceptance Criteria": "No detectable interference from HAMA or Rheumatoid Factor (RF) in tested samples.",
        "Reported Device Performance": "No detectable interference from HAMA (up to 1880 ng/mL) and RF (up to 2330 IU/mL)."
      },
      {
        "Criterion": "Sample Type Correlation (SST Serum vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For SST vs Serum: slope 1.00 (95% CI: 0.96 to 1.05), intercept -0.07 (95% CI: -1.43 to 1.28), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X - 0.07; slope = 1.00 (95% CI: 0.96 to 1.05); intercept = -0.07 (95% CI: -1.43 to 1.28); r = 0.99. Deming Regression: Y= 1.01 X - 0.28; slope = 1.01 (95% CI: 0.97 to 1.06); intercept = - 0.28 (95% CI: - 1.64 to 1.09)."
      },
      {
        "Criterion": "Sample Type Correlation (Lithium Heparin vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For Lithium Heparin vs Serum: slope 1.02 (95% CI: 0.97 to 1.06), intercept 0.03 (95% CI: -1.25 to 1.30), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y=1.02 X + 0.03; slope = 1.02 (95% CI: 0.97 to 1.06); intercept = 0.03 (95% CI: -1.25 to 1.30); r = 0.99. Deming Regression: Y= 1.02 X - 0.15; slope = 1.02 (95% CI: 0.98 to 1.06); intercept = - 0.15 (95% CI: -1.43 to 1.14)."
      },
      {
        "Criterion": "Sample Type Correlation (EDTA vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For EDTA vs Serum: slope 1.00 (95% CI: 0.96 to 1.04), intercept 0.001 (95% CI: -1.19 to 1.19), r= 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X + 0.001; slope = 1.00 (95% CI: 0.96 to 1.04); intercept = 0.001 (95% CI: -1.19 to 1.19); r= 0.99. Deming Regression: Y=1.01 X - 0.15; slope =1.01 (95% CI: 0.97 to 1.05); intercept = - 0.15 (95% CI: - 1.35 to 1.05)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2000 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.971. Slope = 1.022 (95% CI: 0.983 to 1.061), Intercept = 0.727 (95% CI: 0.060 to 1.394)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.966. Slope = 1.028 (95% CI: 0.985 to 1.071), Intercept = 0.495 (95% CI: -0.236 to 1.226)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs IMMULITE 2000)",
        "Acceptance Criteria": "High correlation (r=0.970) between methods, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.970. Slope = 0.981 (95% CI: 0.943 to 1.019), Intercept = 0.170 (95% CI: -0.526 to 0.866)."
      },
      {
        "Criterion": "Assay Kit Stability",
        "Acceptance Criteria": "Support a claim of 360 days shelf life when stored at 2-8°C, based on real-time and accelerated stress studies.",
        "Reported Device Performance": "Results of real-time and accelerated stress studies support the claim of 360 days shelf life for the assay kits when stored at 2-8°C."
      }
    ],
    "2_sample_size_and_data_provenance_test_set": {
      "Limit of Blank": {
        "Sample Size": "60 replicates of a zero analyte heparin plasma and serum sample, and the assay zero calibrator. Assayed across 3 IMMULITE 2000 kit lots (with 3 instruments per lot) and 1 IMMULITE 2500 kit lot (with 3 instruments per lot).",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Limit of Detection": {
        "Sample Size": "Five different samples with low concentrations of vancomycin (>0.4 ug/mL to 1.6 ug/mL). Assayed using 3 IMMULITE 2000 kit lots (2 instruments per lot) and 1 IMMULITE 2500 kit lot (2 instruments per lot). Eight runs of 2 replicates per sample over 8 separate days.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Precision": {
        "Sample Size": "Two aliquots of each test sample in two runs per day over 20 different days, for a total of 80 replicates per test sample per lot. Three different kit lots on IMMULITE 2000 platform and one lot on IMMULITE 2500, with two instruments used per lot. Precision pools targeted 5, 10, 20, 30, and 45 µg/mL.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Linearity": {
        "Sample Size": "10 patient samples (neat, 4 in 8, 2 in 8 and 1 in 8 dilutions) across the therapeutic range (9 to 46 ug/mL). Each assayed in triplicate.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Spiked Recovery": {
        "Sample Size": "6 patient sample pools spiked with various concentrations of 3 different spiking solutions.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Interfering Substances/Cross-Reactivity/HAMA/RF": {
        "Sample Size": "Varies by substance. Typically, neat normal human serum and human serum spiked with 25 ug/mL vancomycin, spiked with the potential interfering substance. Assayed in 2 replicates. For HAMA/RF, 6 normal human samples for HAMA, 5 RF-positive human samples and 1 normal for RF.",
        "Data Provenance": "Human serum samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Alternate Sample Types (Correlation Study)": {
        "Sample Size": "SST vs Serum: N=33. Lithium Heparin vs Serum: N=32. EDTA vs Serum: N=31. Matched sets of human serum, SST, lithium heparin and EDTA samples spiked with various concentrations of vancomycin. Each run in duplicate.",
        "Data Provenance": "Human samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Clinical Sample Population (Method Comparison)": {
        "Sample Size": "IMMULITE 2000 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs IMMULITE 2000: N=164 endogenous serum patient samples.",
        "Data Provenance": "Endogenous serum from patients being treated with vancomycin. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      }
    },
    "3_number_and_qualifications_of_experts_ground_truth": "N/A. This document describes the validation of an in vitro diagnostic assay (a laboratory test) for quantitative measurement of vancomycin. The 'ground truth' for this type of device is typically established through analytical methods and comparisons to a predicate device, rather than expert consensus on image interpretation or clinical diagnosis. The predicate device (AxSYM® Vancomycin II) serves as the reference for method comparison.",
    "4_adjudication_method_test_set": "N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology diagnosis) to establish ground truth from multiple readers. This document describes analytical performance studies of a quantitative assay, where objective measurements are compared against reference methods or established analytical criteria. No human adjudication is mentioned or implied.",
    "5_mrmc_comparative_effectiveness_study": "No. This document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers. The studies focus on the analytical performance of the device and its comparison to a predicate device, not on human-in-the-loop performance or the effect size of AI assistance for human readers.",
    "6_standalone_performance_study": "Yes. The entire document describes standalone performance studies of the IMMULITE 2000/2500 Vancomycin assays. The reported metrics (e.g., Limit of Blank, Limit of Detection, Precision, Linearity, Spiked Recovery, Interference, Cross-Reactivity, Sample Type Correlation, Method Comparison) represent the algorithm's (assay's) performance without human intervention in the measurement process, beyond initiating the automated assay and interpreting the quantitative result.",
    "7_type_of_ground_truth_used": "The ground truth for the analytical and method comparison studies relies on several approaches:\n\n*   **CLSI Guidelines:** For LoB and LoD, the 'ground truth' calculation methodology is defined by CLSI guidelines (EP17-A). Precision is guided by CLSI EP5-A2.\n*   **Analytical Standards/Spiking:** For linearity, spiked recovery, interfering substances, and cross-reactivity, ground truth is established by preparing samples with known, precise concentrations of vancomycin or potential interferents.\n*   **Predicate Device:** For method comparison and sample type correlation, the predicate device (Abbott AxSYM Vancomycin II) or the serum sample type (for correlation studies) serves as the reference or 'ground truth' method against which the new device's measurements are compared. This demonstrates substantial equivalence.",
    "8_sample_size_training_set": "N/A. For these in vitro diagnostic assays, the concept of a 'training set' in the machine learning sense is not directly applicable. The assay 'learns' and establishes its Master Curve at the site of manufacture using calibrators, which are not provided to customers. The document states that calibrators are used at the site of manufacture to establish the Master Curve. The specific sample size for this manufacturing calibration process is not provided in the document.",
    "9_how_ground_truth_for_training_set_was_established": "N/A. Similar to the training set concept, the 'ground truth' for the manufacturing calibration is established internally by DPC based on their proprietary calibration process using reference materials (Vancomycin adjustors and calibrators). The document states: \"In all IMMULITE platform instruments, calibrators are used at the site of manufacture to establish the Master Curve, which is encoded in the kit barcode label.\" The calibrators themselves are likely traceable to recognized reference standards for vancomycin concentration, establishing their 'ground truth'."
  }
}

Summary

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Rec'd 11/16/06

Revised

SUMMARY OF SAFETY AND EFFECTIVENESS

Assigned 510(k) Number

The assigned 510(k) number is

Sponsor Name and Address

Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles. CA 90045-6900 (310) 645-8200

Contact

Deborah L. Morris Director, Clinical Affairs and Regulatory Submissions (310) 645-8200 extension 7426 dmorris@dpconline.com

Device Name

Trade Name:	IMMULITE® 2000 Vancomycin, IMMULITE 2500Vancomycin
Classification:	Class II device, LEH 21 CFR 862.3950
DPC Catalog Number:	L2KVN2 (200 tests); L2KVN6 (600 tests), L5KVN2 (200 tests); L5KVN6 (600 tests)

Description of Device

Vancomycin Adjustors for the IMMULITE 2000/IMMULITE 2500: Adjustors are used to correlate the signal counts per second (CPS) of the IMMULITE platform instrument in

DEL - 5 2006

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the user's lab to those of the Master Curve and to account for the changes in reagent enzyme activity and/or operating conditions. The Vancomycin Adjustors, included in the reagent kit, are two levels (Low and High) of lyophilized vancomycin in a human serum/buffer matrix.

Function of Calibrators and Adjustors in the IMMULITE Family of Instruments: In all IMMULITE platform instruments, calibrators are used at the site of manufacture to establish the Master Curve, which is encoded in the kit barcode label. The calibrators are not provided to the customers because the calibration of a specific kit lot is completed at the DPC manufacturing site. Adjustors are used to correlate the signal counts per second (CPS) of the particular IMMULITE instrument in the user's lab to those of the Master Curve and to account for the changes in reagent enzyme activity and/or operating conditions. The quality of the adjustment is monitored by reviewing the slope and the intercept of the adjustment process, not the target values of the adjustors. The acceptance criteria of the slope and the intercept are specified in the Acceptability Criteria section in the specific IMMULITE platform instrument Operator's Manual. Therefore, concentrations of the adjustors are not provided to customers.

Indications for Use

IMMULITE® 2000 Vancomycin assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

Manufacturing Site

The IMMULITE 2000, IMMULITE 2500 Vancomycin assay is manufactured by Diagnostic Products Corporation at the following locations:

Diagnostic Products Corporation Reagent Manufacturing Division 5700 West 96th Street Los Angeles, CA 90045-5597 FDA Establishment #: 2017183

Diagnostic Products Corporation

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Corporate Offices 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 FDA Establishment #: 3005250747

Comparison to the Predicate

A summary of the features of the IMMULITE 2000/IMMULITE 2500 Vancomycin ssay and the predicate device (AxSYM® Vancomycin II) (K955851) is presented below.

Item	IMMULITE 2000/2500	AxSYM Vancomycin II
Assay Type	Immunoassay	Immunoassay
Antiserum	Monoclonal (mouse)	Monoclonal (mouse)
Cut-Off	N/A	N/A
Intended Use	For in vitro diagnostic usewith the IMMULITE 2000or IMMULITE 2500Analyzer – for thequantitative measurement ofvancomycin in serum andplasma (EDTA orheparinized), as an aid inmonitoring the therapeuticadministration of thisantibiotic.	The AxSYM Vancomycin II assayis a reagent system for thequantitative measurement ofvancomycin, an antibiotic drug, inserum or plasma. Themeasurements obtained are usedin the diagnosis and treatment ofvancomycin overdose and inmonitoring levels of vancomycinto ensure appropriate therapy.
Reportable Range	3.0 µg/mL – 50 µg/mL	3.00 µg/mL – 100 µg/mL
Analytical Sensitivity(limit of blank,detection)	0.4 µg/mL Limit of Blank0.9 µg/mL Limit ofDetection	2.00 µg/mL (analyticalsensitivity)
Sample Volume	10 µL IMM 200010 µL IMM 2500	Varies depending on the type ofsample container. For samplecups, 150 µL (STAT: 94 µL).Minimum volumes calculated byAxSYM System.
Sample Type	Serum and plasma (heparin,EDTA)	Serum and plasma (sodiumheparin, citrate, EDTA, oxalate)
Interferences	No significant interferencefrom:Bilirubin up to 200 mg/LHemoglobin up to 600mg/dLTriglycerides up to 3000mg/dL	Less than 10% interference from:Bilirubin up to 20 mg/dLHemoglobin up to 1.0 g/dLTriglycerides up to 2300 mg/dLTotal Protein from 3 - 10 g/dL
Adjustment Interval	2 weeks	Per AxSYM System Operator'sManual
Item	IMMULITE 2000/2500	AxSYM Vancomycin II
Calibration Range(Standardization)	0.0 µg/mL - 100 µg/mL(VANCOMYCINHYDROCHLORIDE CRSbatch 2).	0.00 µg/mL - 100 µg/mL(AxSYM Vancomycin II StandardCalibrators)

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

Standards/Guidance Documents Referenced

1. Clinical and Laboratory Standards Institute (CLSI). Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Second Edition, CLSI document EPS-A2 (ISBN 1-56238-000-0). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
1. Clinical Laboratory Standard Institute (CLSI). Protocols for the Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. CLSI document EP17-A Vol 24 No 34. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

Reportable Range

The reportable range for the IMMULITE 2000/IMMULITE 2500 Vancomycin assay 3-50 µg/mL.

Limit of Blank

The determination of Limit of Blank was guided by Clinical Laboratory Standard Institute (CLSI). Protocols for the Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. CLSI document EP17-A Vol 24 No 34. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

This guideline defines Limit of Blank (LoB) as the mean or (more conservatively) the highest value expected to be seen in a series of results for samples that contain no analyte.

Sixty replicates of a zero analyte heparin plasma and serum sample as well as the assay zero calibrator were assayed in 3 IMMULITE 2000 kit lots using 3 IMMULITE 2000 instruments per lot and in one IMMULITE 2500 kit lot using 3 instruments per lot in one run per sample type/lot/instrument. IMMULITE 2000/IMMULITE 2500 Vancomycin has a competitive assay format with decreasing chemiluminescent output associated with increasing vancomycin concentration. Limit of Blank (LoB) was computed parametrically as the mean chemiluminescent output measured in counts per second (CPS) minus 1.65 * total SDcps for each instrument, kit lot, and sample type. The computed LoBcps were then transformed into vancomycin doses. The aggregate results were assessed for the most conservative package insert claim.

The LoB claim for the IMMULITE 2000 and IMMULITE 2500 is 0.4 ug/mL.

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Limit of Detection

The determination of Limit of Detection was guided by Clinical Laboratory Standard Institute (CLSI). Protocols for the Determination of Limits of Detection and Limits of Ouantitation: Approved Guideline. CLSI document EP17-A Vol 24 No 34. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004. This guideline defines the Limit of Detection (LoD) as the actual concentration at which an observed test result is likely to exceed the Limit of Blank (LoB) and may therefore be declared as detected. The general formula for LoD = LoB + 1.65 * SD.

Five different samples with relevant low concentrations of vancomycin at the range greater than LoB to 4 * LoB (>0.4 ug/mL to 1.6 ug/mL) werc assayed using 3 IMMULITE 2000 kit lots on 2 IMMULITE 2000 instruments per lot and using one IMMULITE 2500 kit lot using 2 instruments. Eight runs of 2 replicates per sample were completed on 8 separate days. The sample-specific LoD was calculated as LoB + 1.65 * SD somble for each sample on each instrument used for each kit lot. The aggregate results were assessed for the most conservative package insert claim.

The LoD claim for the IMMULITE 2000 and IMMULITE 2500 is 0.9 ug/mL.

Precision

Precision performance studies were guided by CLSI document EP5-A2 Clinical and Laboratory Standards Institute (CLSI). Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Second Edition. CLS1 document EP5-A2 (ISBN 1-56238-000-0). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

The study was conducted using three different kit lots on the IMMULITE 2000 platform and one lot on the IMMULITE 2500, assaying two aliquots of each test sample in two runs per day over 20 different days (not necessarily consecutive) for a total of 80 replicates per test sample per lot. Two instruments were used per lot.

Precision pools targeted clinically important cut-off values. Since the peak therapeutic range of vancomycin is from 25-40 µg/mL, the therapeutic trough levels range from 5-10 ug/mL, and trough toxicity may be of concern at levels above 10 ug/mL, precision pools targeted 5, 10, 20, 30, and 45 ug/mL.

For the IMMULITE 2000, maximum statistics across 3 lots using 2 instruments per lot indicate that intra- and inter-assay CV% over the range of approximately 5 to 47 ug/mL are not greater than 10.2% and 6.8%, respectively,

For the IMMULITE 2500, maximum statistics for one kit lot using 2 instruments indicate that intra- and inter-assay CV% over the range of approximately 5 to 45 µg/mL are not greater than 6.1% and 6.0%, respectively.

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Linearity

Dilutions of 10 patient samples (neat, 4 in 8, 2 in 8 and 1 in 8) across the therapeutic range of the assay (9 to 46 ug/mL) were assayed in the IMMULITE 2000/IMMULITE 2500 Vancomycin assay in triplicate with the mean taken as the final result. Average recovery (% observed/expected) for patient samples tested in the IMMULITE 2000/IMMULITE 2500 Vancomycin assay was 96.0%.

Spiked Recovery

Spiked recovery experiments test the ability of an assay to quantitatively recover added analyte. Average % recovery for 6 patient sample pools spiked with various concentrations of 3 different spiking solutions were tested in the IMMULITE 2000/IMMULITE 2500 Vancomycin assay. The average % recovery for these spiked patient samples was 101%.

Interfering Substances

The IMMULITE 2000/IMMULITE 2500 Vancomycin assay was tested for interference by bilirubin, hemoglobin and triglycerides.

Presence of conjugated or unconjugated bilirubin in concentrations up to 20 mg/dL has no effect on results within the precision of the assay.

Presence of hemoglobin in concentrations up to 600 mg/dL has no effect on results within the precision of the assay.

Presence of triglycerides in concentrations up to 3,000 mg/dL has no effect on results within the precision of the assay.

Cross-Reactivity

Potential serum cross-reactants were spiked at concentrations listed in the following table into a neat normal human serum sample and a human serum sample spiked with 25 ug/mL vancomycin. The IMMULITE 2000/IMMULITE 2500 Vancomycin assay is highly specific for vancomycin. Results are presented below for potential cross-reactants tested in the vancomycin-spiked human serum sample. There was no detectable crossreactivity to the materials tested.

Potential Cross Reactant	Concentration ofpotential cross-reactant (µg/mL)	# ofReplicates	Sample Tested1	SD (CV%)	Cross-Reactivity2
Acetaminophen	500	2	23.47	0.30 (1.3)	ND
Amikacin	500	2	22.89	0.13 (0.6)	ND
Ampicillin	500	2	22.56	0.18 (0.8)	ND
Amphotericin B	500	2	23.85	0.36 (1.5)	ND
Potential Cross Reactant	Concentration ofpotential cross-reactant (µg/mL)	# ofReplicates	Sample Tested1Obs. MeanResultAfter Spike	SD (CV%)	Cross-Reactivity2
Bendroflumethiazide	500	2	22.99	0.31 (1.3)	ND
Caffeine	500	2	22.73	0.41 (1.8)	ND
Carbenicillin	500	2	22.12	1.03 (4.7)	ND
Cefamandole Nafate	500	2	23.91	0.72 (3.0)	ND
Cefazolin	500	2	23.01	0.35 (1.5)	ND
Cephalexin	500	2	23.35	0.20 (0.9)	ND
Cephalosporin C'	500	2	22.69	1.27 (5.6)	ND
Cephalothin	500	2	23.49	0.71 (3.0)	ND
Chloramphenicol	500	2	23.13	0.80 (3.5)	ND
Chlorothiazide	500	2	22.28	0.64 (2.9)	ND
Ciprofloxacin	500	2	23.32	0.78 (3.3)	ND
Clindamycin	500	2	22.30	0.34 (1.5)	ND
Crystalline DegradationProduct-1 (CDP-1)	10	2	24.36	1.10 (4.5)	ND
Crystalline DegradationProduct-1 (CDP-1)	20	2	23.33	0.57 (2.4)	ND
Crystalline DegradationProduct-1 (CDP-1)	25	2	24.01	1.03 (4.3)	ND
Crystalline DegradationProduct-1 (CDP-1)	50	2	22.96	0.74 (3.2)	ND
Crystalline DegradationProduct-1 (CDP-1)	100	2	23.05	0.52 (2.3)	ND
Erythromycin	500	2	23.41	0.82 (3.5)	ND
Ethacrynic Acid	500	2	22.89	0.76 (3.3)	ND
Ethambutol	500	2	23.31	0.83 (3.6)	ND
5-Fluorocytosine	500	2	23.15	0.88 (3.8)	ND
Furosemide	500	2	23.30	0.49 (2.1)	ND
Fusidic Acid	500	2	23.43	0.32 (1.4)	ND
Gentamycin	500	2	23.54	0.36 (1.5)	ND
Sodium heparin	500	2	23.53	0.25 (1.1)	ND
Hydrochlorothiazide	500	2	24.32	1.45 (6.0)	ND
Ibuprofen	500	2	24.17	0.59 (2.4)	ND
Isoniazid	500	2	23.97	0.26 (1.1)	ND
Kanamycin A	500	2	23.70	0.57 (2.4)	ND
Kanamycin B	500	2	22.54	0.33 (1.5)	ND
Lincomycin	500	2	22.15	0.91 (4.1)	ND
Methylprednisolone	500	2	23.60	0.31 (1.3)	ND
Methotrexate	500	2	22.06	0.00 (0.0)	ND
Nalidixic Acid	500	2	23.66	2.02 (8.5)	ND
Naproxen	500	2	22.10	0.25 (1.1)	ND
Neomycin	500	2	22.02	0.13 (0.6)	ND
Netilmicin	500	2	22.75	0.04 (0.2)	ND
Niacin (Nicotinic Acid)	500	2	22.29	0.15 (0.7)	ND
Nitrofurantoin	500	2	22.94	0.57 (2.5)	ND
Oxaprozin	500	2	23.49	0.04 (0.2)	ND
Oxytetracycline	500	2	23.20	0.49 (2.1)	ND
Penicillin G Potassium Salt	500	2	22.51	0.11 (0.5)	ND
Penicillin V Potassium Salt	500	2	22.56	0.65 (2.9)	ND
Phenacetin	500	2	23.00	1.19 (5.2)	ND
Prednisolone	500	2	22.97	1.17 (5.1)	ND
Prednisone	500	2	22.32	0.06 (0.3)	ND
Potential Cross Reactant	Concentration ofpotential cross-reactant (µg/mL)	Sample Tested1			Cross-Reactivity2
		# ofReplicates	Obs. MeanResultAfter Spike	SD (CV%)
Rifampin	500	2	22.92	0.70 (3.1)	ND
Salicylic Acid	500	2	23.90	0.14 (0.6)	ND
Sisomicin	500	2	23.13	0.78 (3.4)	ND
Spectinomycin	500	2	23.52	0.79 (3.4)	ND
Streptomycin	500	2	23.47	0.28 (1.2)	ND
Sulfadiazine	500	2	22.34	0.54 (2.4)	ND
Sulfamethoxazole	500	2	24.11	1.69 (7.0)	ND
Sulfisoxazole	500	2	23.75	0.92 (3.9)	ND
Teicoplanin	10	2	24.80	1.10 (4.4)	ND
Teicoplanin	25	2	23.62	0.74 (3.1)	ND
Teicoplanin	50	2	24.65	1.08 (4.4)	ND
Teicoplanin	100	2	23.41	0.11 (0.5)	ND
Tetracycline	500	2	22.11	0.25 (1.1)	ND
Ticarcillin	500	2	23.93	0.01 (0.0)	ND
Tobramycin	500	2	23.65	0.39 (1.6)	ND
Trimethoprim	500	2	23.18	0.06 (0.3)	ND

1 25 ug/mL vancomycin added to human scrum sample

2 ND = Not Detectable

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1 25 µg/mL vancomycin added to human serum sample

11 ND = Not Detectable

Albumin, cholesterol, IgG, and heparin were spiked at concentrations listed in the following table into a neat normal human serum sample and a human serum sample spiked with 25 µg/mL vancomycin. The IMMULITE 2000/IMMULITE 2500 Vancomycin assay is highly specific for vancomycin. Results are presented below for potential cross-reactants tested in the vancomycin-spiked human serum sample. There was no detectable cross-reactivity to the materials tested.

Potential Cross Reactant	Concentration ofpotential cross-reactant	Sample Tested'			Cross-reactivity"
		# ofReplicates	Obs. Mean	SD
Albumin	10 g/dL	2	23.96	0.53 (2.2)	ND
Cholesterol	500 mg/dL	2	26.06	0.81 (3.1)	ND
IgG	6g/dL	2	24.60	0.47 (1.9)	ND
Heparin	500 USP units/mL	2	23.98	0.58 (2.4)	ND

1 25 ug/mL vancomycin added to each human serum sample

11 ND = Not Detectable

Human Anti-Mouse Antibodies (HAMA) and rheumatoid factor (RF) were also analyzed for potential interference/cross-reactivity. Six normal human samples were spiked with 6 different concentrations of HAMA. These HAMA-spiked samples were assayed neat and also spiked with 25 µg/mL of vancomycin. Five RF-positive human samples and one normal (no RF) human sample were assayed neat and also spiked with 25 µg/mL of vancomycin.

The IMMULITE 2000/IMMULITE 2500 Vancomycin assay is highly specific for vancomycin. Results are presented below for potential cross-reactants tested in the vancomycin-spiked human serum sample. There was no detectable interference in the samples tested.

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Potential Cross-reactant	Concentrationof potentialinterferent	Sample Tested'			% Cross-
sample		# ofReplicates	Obs. Mean	SD(CV%)	reactivity"
HAMA sample 1	100 ng/mL	2	25.98	0.54 (2.1)	ND
HAMA sample 2	188 ng/mL	2	26.02	1.63 (6.3)	ND
HAMA sample 3	250 ng/mL	2	25.38	1.22 (4.8)	ND
HAMA sample 4	500 ng/mL	2	25.31	1.65 (6.5)	ND
HAMA sample 5	1000 ng/mL	2	25.83	1.71 (6.6)	ND
HAMA sample 6	1880 ng/mL	2	26.11	0.87 (3.3)	ND
RF sample 1	1007 IU/mL	2	24.22	1.34 (5.5)	ND
RF sample 2	1045 IU/mL	2	26.83	0.47 (1.8)	ND
RF sample 3	2330 IU/mL	2	25.41	1.08 (4.3)	ND
RF sample 4	2025 IU/mL	2	26.53	0.91 (3.4)	ND
RF sample 5	833 IU/mL	2	24.49	0.93 (3.8)	ND

1 25 µg/mL vancomycin added to each human serum sample

" ND = Not Detectable

Alternate Sample Types

The IMMULITE 2000/IMMULITE 2500 Vancomycin assay is indicated for use in serum and plasma. A sample type correlation study assessed the degree of equivalence between serum and heparinized plasma, EDTA plasma, and SST scrum.

Matched sets of human serum, SST, lithium heparin and EDTA samples spiked with various concentrations of vancomycin to obtain values from <3 µg/mL to 50 µg/mL were assayed. Each individual sample was run in duplicate and the mean taken as the final result. Regression analyses are presented below.

SST Serum Separator Tube (Y) vs Serum (X): N=33

Lincar Least Squares Regression (illustrated below): Y= 1.00 X - 0.07; slope = 1.00 (95% CI: 0.96 to 1.05); intercept = -0.07 (95% CI: -1.43 to 1.28); r = 0.99

Deming Regression: Y= 1.01 X - 0.28 slope = 1.01 (95% CI: 0.97 to 1.06); intercept = - 0.28 (95% CI: - 1.64 to 1.09)

Mean serum = 26.7 µg/mL Mean SST = 26.7 µg/mL

Linear Least Squares Plot

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Image /page/9/Figure/0 description: This image is a scatter plot that compares serum and SST concentrations, both measured in micrograms per milliliter. The x-axis represents serum concentration, while the y-axis represents SST concentration. The data points are clustered around a line of best fit, which is described by the equation y = 1.00x - 0.07. The concentrations range from approximately 0 to 50 micrograms per milliliter.

Bland-Altman difference plot (the differences between the results of two assays are plotted against the averages of the two assays)

Image /page/9/Figure/2 description: This image is a scatter plot that compares two methods of measurement. The x-axis represents the mean of both methods in micrograms per milliliter, ranging from 0 to 40. The y-axis represents the difference between the methods, also in micrograms per milliliter, ranging from -5 to 5. There are dashed lines at approximately 3.5 and -3.5, and a dotted line at 0 labeled as 'Zero bias'.

Lithium heparin (Y) vs Serum (X): N=32

Linear Least Squares Regression (illustrated below): Y=1.02 X + 0.03; slope = 1.02 (95% C1: 0.97 to 1.06); intercept = 0.03 (95% CI: -1.25 to 1.30); r = 0.99

Deming Regression: Y= 1.02 X -- 0.15; slope = 1.02 (95% C1: 0.98 to 1.06); intercept = - 0.15 (95% CI: -1.43 to 1.14)

Mean serum = 27.5 µg/mL Mean lithium heparin = 27.9 µg/mL

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Linear Least Squares Plot

Image /page/10/Figure/1 description: This image is a scatter plot that shows the relationship between Li Heparin and Serum. The x-axis represents Serum in (µg/mL), ranging from 0 to 50, while the y-axis represents Li Heparin in (µg/mL), ranging from 0 to 60. The plot includes a regression line with the equation y = 1.02x + 0.03, indicating a positive linear correlation between the two variables.

Bland-Altman difference plot (the differences between the results of two assays are plotted against the averages of the two assays)

Image /page/10/Figure/3 description: This image is a scatter plot that compares the difference between methods in micrograms per milliliter (µg/mL) on the y-axis and the mean of both methods in micrograms per milliliter (µg/mL) on the x-axis. The plot includes a horizontal dotted line labeled "Zero bias", as well as two dashed lines above and below the zero bias line. The data points are scattered around the zero bias line, with some points above and some below, indicating the variability in the difference between the two methods. The x-axis ranges from 0 to 50 µg/mL, while the y-axis ranges from -4 to 4 µg/mL.

EDTA (Y) vs Serum (X): N=31

Linear Least Squares Regression (illustrated below): Y= 1.00 X + 0.001; slope = 1.00 (95% CI: 0.96 to 1.04); intercept = 0.001 (95% CI: -1.19 to 1.19); r= 0.99

Deming Regression: Y=1.01 X - 0.15; slope =1.01 (95% CI: 0.97 to 1.05); intercept = - 0.15 (95% CI: - 1.35 to 1.05)

Mean serum = 26.8 µg/mL

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Mean EDTA = 26.9 µg/mL

Image /page/11/Figure/1 description: The image shows the title of a plot. The title of the plot is "Linear Least Squares Plot". The title is written in a bold font.

Image /page/11/Figure/2 description: This image is a scatter plot that shows the relationship between EDTA and serum concentrations. The x-axis represents serum concentration in micrograms per milliliter, and the y-axis represents EDTA concentration in micrograms per milliliter. The data points appear to follow a linear trend, and a regression line is plotted through the data with the equation y = 1.00x + 0.001. There are also lines above and below the regression line.

Bland-Altman difference plot (the differences between the results of two assays are plotted against the averages of the two assays)

Image /page/11/Figure/4 description: This image is a scatter plot that compares the mean of two methods in ug/mL on the x-axis and the difference between the methods in ug/mL on the y-axis. The plot shows a series of circular data points scattered across the graph. There are three horizontal dashed lines, one at zero labeled "Zero bias", one at approximately 2.7, and one at approximately -2.7.

Assay Kit Stability

Kit stability testing was conducted on multiple lots of the IMMULITE 2000/IMMULITE 2500 Vancomycin assay and included the following assessments:

Real-time stability at long term package insert storage conditions .

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Stress (accelerated) conditions to simulate storage/stress conditions . that might occur during shipment to and storage at customer facilities. Stress studies also support real-time stability.
- o 3-Day storage at 37°C
- o 7-Day storage at room temperature (15-30 °C)
- o 3 Freeze/thaw cycles (freeze -30°C to -5°C, thaw at 2-8°C)

To date, results of real-time and accelerated stress studies support the claim of 360 days shelf life for the IMMULITE 2000/IMMULITE 2500 Vancomycin assay kits when stored at 2-8°C.

Clinical Sample Population

The following assay methods were compared using endogenous serum from patients being treated with vancomycin. Multiple IMMULITE 2000 and IMMULITE 2500 instruments were used. Results are presented below comparing 162 endogenous serum patient Vancomycin levels in the IMMULITE 2000 versus the predicate AxSYM Vancomycin II and IMMULITE 2500 versus the predicate AxSYM Vancomycin II. Results show high correlation (r=0.97) between both platforms and the AxSYM. Results are also presented below comparing 164 endogenous serum patient Vancomycin levels in the IMMULITE 2500 versus the IMMULITE 2000. Results show high correlation (r=0.970) between methods. High correlation indicates equivalence of assays.

IMMULITE 2000 (Y) vs AxSYM Vancomycin II (X): N=162

Reference Method Sampling Range: 3.70 - 38.6 ug/mL

Linear Least Squares Regression (illustrated below): Y=1.022 X + 0.727; slope = 1.022 (95% CI: 0.983 to 1.061); intercept = 0.727 (95% CI: 0.060 to 1.394); r = .971

Deming Regression: Y=1.054X + 0.235; slope = 1.054 (95% CI: 1.013 to 1.094); intercept = 0.235 (95% CI: -0.452 to 0.923)

Mean, Median, SD Abbott AxSYM = 15.57 µg/mL, 14.42 µg/mL, 7.14 ug/mL

Mean, Median, SD IMMULITE 2000 = 16.63 µg/mL, 15.58 µg/mL, 7.51 μg/mL

Linear Least Squares Plot:

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Image /page/13/Figure/0 description: This image is a scatter plot comparing IMMULITE 2000 and Abbot AxSYM measurements in micrograms per milliliter. The x-axis represents Abbot AxSYM, and the y-axis represents IMMULITE 2000. A regression line is plotted through the data, with the equation y = 1.022x + 0.727 displayed on the graph, along with lines indicating the confidence interval.

Bland-Altman difference plot (the differences between the results of two assays are plotted against the averages of the two assays)

Image /page/13/Figure/2 description: This image is a scatter plot that compares the difference between methods (µg/mL) on the y-axis and the mean of all methods (µg/mL) on the x-axis. The x-axis ranges from 0 to 40, while the y-axis ranges from -6 to 10. There are two dashed lines at approximately y=4 and y=-2, and a 'Zero bias' label is present near the y=0 line. The data points are scattered around the y=0 line, with some outliers.

IMMULITE 2500 Lot 111A (Y) vs AxSYM Vancomycin 11 (X): N=162 Reference Method Sampling Range: 3.70 - 38.6 µg/mL

Linear Least Squares Regression (illustrated below): Y=1.028 X + 0.495; slope = 1.028 (95% CI: 0.985 to 1.071); intercept = 0.495 (95% CI: -0.236 to 1.226); r = 0.966

Deming Regression: Y=1.066X – 0.097; slope = 1.066 (95% Cl: 1.022 to 1.110); intercept = - 0.097 (95% CI: - 0.854 to 0.661) Mean, Median, SD Abbott AxSYM = 15.57 µg/mL, 14.42 µg/mL, 7.14 ug/mL

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

Mean, Median, SD IMMULITE 2500 Lot 111A = 16.50 µg/mL, 15.64 μg/mL, 7.60 µg/mL

Linear Least Squares Plot

Image /page/14/Figure/2 description: This image is a scatter plot comparing IMMULITE 2500 and Abbott AxSYM, both measured in micrograms per milliliter. The x-axis represents Abbott AxSYM, while the y-axis represents IMMULITE 2500. The plot shows a strong positive correlation between the two methods, with data points clustered around a regression line. The regression equation is given as y = 1.0281x + 0.495.

Bland-Altman difference plot (the differences between the results of two assays are plotted against the averages of the two assays)

Image /page/14/Figure/4 description: This image is a scatter plot that compares the difference between methods versus the mean of all methods. The x-axis is labeled "Mean of all methods (µg/mL)" and ranges from 0 to 40. The y-axis is labeled "Difference between methods (µg/mL)" and ranges from -6 to 8. There is a dashed line at y=0 labeled "Zero bias", and two other dashed lines at approximately y=4.5 and y=-3.

IMMULITE 2500 (Y) vs IMMULITE 2000 (X): N=164 Reference Method Sampling Range: 4.11 - 39.8 µg/mL

Linear Least Squares Regression (illustrated below): Y=0.981X + 0.170; slope = 0.981 (95% C1: 0.943 to 1.019); intercept = 0.170 (95% C1: -0.526 to 0.866); r = 0.970

Deming Regression: Y=1.011X - 0.342; slope =1.011 (95% CI: 0.972 to 1.051); intercept =- 0.342 (95% CI: - 1.060 to 0.376)

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Mean, Median, SD IMMULITE 2000 = 16.65 µg/mL, 15.66 µg/mL, 7.47 μg/mL

Mean, Median, SD IMMULITE 2500 = 16.50 µg/mL, 15.73 µg/mL, 7.55 μg/mL

Linear Least Squares Plot:

Image /page/15/Figure/3 description: This image is a scatter plot with a regression line. The x-axis is labeled "IMMULITE 2000 (µg/mL)" and ranges from 0 to 40. The y-axis ranges from 0 to 45. The regression equation is given as y = 0.981x + 0.170.

Image /page/15/Figure/4 description: The image shows the title of a Bland-Altman difference plot. The plot shows the differences between the results of two assays. These differences are plotted against the averages of the two assays. The Bland-Altman plot is used to compare two measurement techniques.

Image /page/15/Figure/5 description: This image is a scatter plot that shows the difference between methods in micrograms per milliliter on the y-axis and the mean of all methods in micrograms per milliliter on the x-axis. The y-axis ranges from -10 to 8, while the x-axis ranges from 0 to 40. There are three horizontal lines on the plot, one at 0 labeled "Zero bias", and the other two at approximately 3.5 and -3.5.

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Conclusions

The IMMULITE 2000/IMMULITE 2500 Vancomycin assay demonstrates acceptable analytical performance including analytical sensitivity and specificity, precision, linearity, and method comparison to the FDA cleared predicate device, Abbott AxSYM Vancomycin II.

The IMMULITE 2000/IMMULITE 2500 Vancomycin assay is therefore substantially equivalent to the FDA cleared predicate Abbott AxSYM Vancomycin II and thereby safe and effective for the following intended use:

IMMULITE® 2000 Vancomycin assay is intended for use as follows:

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Image /page/17/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is depicted with three curved lines forming its body and wings. Encircling the bird is text that reads 'UPRAVNI ODBOR MATICE HRVATSKE OSIJEK'. The text is arranged in a circular fashion around the bird, completing the logo.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Deborah Morris Diagnostic Products Corp. 5210 Pacific Concource Dr. Los Angeles, CA 90045-6900

DEC - 5 2006

Re: K063045

Trade/Device Name: Immulite 2000 Vancomycin and Immulite 2500 Vancomycin Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: October 2, 2006 Received: October 4, 2006

Dear Ms. Morris:

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 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).

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Page 2 -

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology 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): K063045

IMMULITE® 2000 Vancomycin Device Name: IMMULITE® 2500 Vancomycin

Indications For Use:

IMMULITE® 2000 Vancomycin assay is intended for use as follows:

The IMMULITE® 2500 Vancomycin assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2500 Analyzer -- for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

Prescription Use X (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 IF NEEDED)

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

Division Sign-Off

Office of In Vite Diagnostic Device Evaluation and Safety

K063045

Page 1 of 1

1000013

Regulation Number and Section

§ 862.3950 Vancomycin test system.

(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.