(62 days)
No
The description details a standard immunoassay technology and does not mention any AI or ML components in the device description, performance studies, or key metrics.
No
The device measures vancomycin levels in patient samples, which assists in monitoring therapeutic administration, but it does not directly administer a therapeutic agent or perform a therapeutic function on the patient. It is an in vitro diagnostic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." The assay measures vancomycin levels in patient samples, which serves as an aid in monitoring therapeutic drug administration, a clear diagnostic application.
No
The device description clearly outlines a solid phase competitive chemiluminescent enzyme immunoassay involving physical reagents (bead, enzyme conjugate, substrate) and an analyzer (IMMULITE 2000/2500) for quantitative measurement, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma...". This directly indicates that the device is intended for diagnostic use outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
LEH
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).
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
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. 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.
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:
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%.
Interferences:
The IMMULITE 2000/IMMULITE 2500 Vancomycin assay was tested for interference by bilirubin, hemoglobin and triglycerides.
No significant interference was observed from:
- Bilirubin up to 20 mg/dL
- Hemoglobin up to 600 mg/dL
- Triglycerides up to 3,000 mg/dL
Cross-Reactivity:
The IMMULITE 2000/IMMULITE 2500 Vancomycin assay is highly specific for vancomycin. No detectable cross-reactivity was observed with a wide range of potential cross-reactants including common antibiotics, other drugs, and various biological substances (e.g., Acetaminophen, Amikacin, Ampicillin, Amphotericin B, Bendroflumethiazide, Caffeine, Carbenicillin, Cefamandole Nafate, Cefazolin, Cephalexin, Cephalosporin C', Cephalothin, Chloramphenicol, Chlorothiazide, Ciprofloxacin, Clindamycin, Crystalline Degradation Product-1 (CDP-1), Erythromycin, Ethacrynic Acid, Ethambutol, 5-Fluorocytosine, Furosemide, Fusidic Acid, Gentamycin, Sodium heparin, Hydrochlorothiazide, Ibuprofen, Isoniazid, Kanamycin A, Kanamycin B, Lincomycin, Methylprednisolone, Methotrexate, Nalidixic Acid, Naproxen, Neomycin, Netilmicin, Niacin (Nicotinic Acid), Nitrofurantoin, Oxaprozin, Oxytetracycline, Penicillin G Potassium Salt, Penicillin V Potassium Salt, Phenacetin, Prednisolone, Prednisone, Rifampin, Salicylic Acid, Sisomicin, Spectinomycin, Streptomycin, Sulfadiazine, Sulfamethoxazole, Sulfisoxazole, Teicoplanin, Tetracycline, Ticarcillin, Tobramycin, Trimethoprim, Albumin, Cholesterol, IgG, and Heparin).
No detectable interference was observed from Human Anti-Mouse Antibodies (HAMA) and rheumatoid factor (RF).
Alternate Sample Types:
Correlation study assessed the degree of equivalence between serum and heparinized plasma, EDTA plasma, and SST serum. Matched sets of samples spiked with various concentrations of vancomycin were assayed.
- SST Serum Separator Tube (Y) vs Serum (X): N=33. Linear Least Squares Regression: 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.
- Lithium heparin (Y) vs Serum (X): N=32. Linear Least Squares Regression: 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.
- EDTA (Y) vs Serum (X): N=31. Linear Least Squares Regression: 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, Mean EDTA = 26.9 µg/mL.
Clinical Sample Population:
Comparison of IMMULITE 2000 and IMMULITE 2500 with the predicate device AxSYM Vancomycin II. Serum samples from patients treated with vancomycin were used.
- IMMULITE 2000 (Y) vs AxSYM Vancomycin II (X): N=162. Reference Method Sampling Range: 3.70 - 38.6 ug/mL. Linear Least Squares Regression: 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 Abbott AxSYM = 15.57 µg/mL, Mean IMMULITE 2000 = 16.63 µg/mL. High correlation (r=0.971).
- 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: 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 Abbott AxSYM = 15.57 µg/mL, Mean IMMULITE 2500 Lot 111A = 16.50 µg/mL. High correlation (r=0.966).
- IMMULITE 2500 (Y) vs IMMULITE 2000 (X): N=164. Reference Method Sampling Range: 4.11 - 39.8 µg/mL. Linear Least Squares Regression: 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). Mean IMMULITE 2000 = 16.65 µg/mL, Mean IMMULITE 2500 = 16.50 µg/mL. High correlation (r=0.970).
Key Results Summary: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity (limit of blank, detection):
- Limit of Blank (LoB): 0.4 ug/mL
- Limit of Detection (LoD): 0.9 ug/mL
Precision (CV%):
- IMMULITE 2000: intra-assay CV% not greater than 10.2%, inter-assay CV% not greater than 6.8%.
- IMMULITE 2500: intra-assay CV% not greater than 6.1%, inter-assay CV% not greater than 6.0%.
Average Recovery: 96.0% (linearity), 101% (spiked recovery).
Predicate Device(s)
AxSYM Vancomycin II (K955851)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 2500
Vancomycin |
|---------------------|--------------------------------------------------------------------------------|
| 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
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).
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
1
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.
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.
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
2
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 use | |
| with the IMMULITE 2000 | ||
| or 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. | The AxSYM Vancomycin II assay | |
| is a reagent system for the | ||
| quantitative measurement of | ||
| vancomycin, an antibiotic drug, in | ||
| serum or plasma. The | ||
| measurements obtained are used | ||
| in the diagnosis and treatment of | ||
| vancomycin overdose and in | ||
| monitoring levels of vancomycin | ||
| to 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 Blank | |
| 0.9 µg/mL Limit of | ||
| Detection | 2.00 µg/mL (analytical | |
| sensitivity) | ||
| Sample Volume | 10 µL IMM 2000 | |
| 10 µL IMM 2500 | Varies depending on the type of | |
| sample container. For sample | ||
| cups, 150 µL (STAT: 94 µL). | ||
| Minimum volumes calculated by | ||
| AxSYM System. | ||
| Sample Type | Serum and plasma (heparin, | |
| EDTA) | Serum and plasma (sodium | |
| heparin, citrate, EDTA, oxalate) | ||
| Interferences | No significant interference | |
| from: | ||
| Bilirubin up to 200 mg/L | ||
| Hemoglobin up to 600 | ||
| mg/dL | ||
| Triglycerides up to 3000 | ||
| mg/dL | Less than 10% interference from: | |
| Bilirubin up to 20 mg/dL | ||
| Hemoglobin up to 1.0 g/dL | ||
| Triglycerides up to 2300 mg/dL | ||
| Total Protein from 3 - 10 g/dL | ||
| Adjustment Interval | 2 weeks | Per AxSYM System Operator's |
| Manual | ||
| Item | IMMULITE 2000/2500 | AxSYM Vancomycin II |
| Calibration Range | ||
| (Standardization) | 0.0 µg/mL - 100 µg/mL | |
| (VANCOMYCIN | ||
| HYDROCHLORIDE CRS | ||
| batch 2). | 0.00 µg/mL - 100 µg/mL | |
| (AxSYM Vancomycin II Standard | ||
| Calibrators) |
3
Standards/Guidance Documents Referenced
-
- 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.
-
- 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.
4
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.
5
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 of
potential cross-
reactant (µg/mL) | # of
Replicates | 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 of
potential cross-
reactant (µg/mL) | # of
Replicates | Sample Tested1
Obs. Mean
Result
After 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 Degradation
Product-1 (CDP-1) | 10 | 2 | 24.36 | 1.10 (4.5) | ND |
| Crystalline Degradation
Product-1 (CDP-1) | 20 | 2 | 23.33 | 0.57 (2.4) | ND |
| Crystalline Degradation
Product-1 (CDP-1) | 25 | 2 | 24.01 | 1.03 (4.3) | ND |
| Crystalline Degradation
Product-1 (CDP-1) | 50 | 2 | 22.96 | 0.74 (3.2) | ND |
| Crystalline Degradation
Product-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 of
potential cross-
reactant (µg/mL) | Sample Tested1 | | | Cross-
Reactivity2 |
| | | # of
Replicates | Obs. Mean
Result
After 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
6
.
7
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 of
potential cross-
reactant | Sample Tested' | | | Cross-
reactivity" |
|--------------------------|--------------------------------------------------|--------------------|-----------|------------|-----------------------|
| | | # of
Replicates | 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.
8
| Potential Cross-reactant | Concentration
of potential
interferent | Sample Tested' | | | % Cross- |
|--------------------------|----------------------------------------------|--------------------|-----------|-------------|-------------|
| sample | | # of
Replicates | 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 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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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:
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.
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
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