(45 days)
The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
For in vitro diagnostic use only. The VITROS dHDL Reagent Pack quantitatively measures HDL cholesterol (HDLC) concentration in serum and plasma. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
For in vitro diagnostic use only. VITROS Chemistry 2. Products Calibrator Kit 19 is used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate dHDL.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is a saline solution used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Calibrator Kit 19 to calibrate dHDL.
The VITROS 5,1 FS Chemistry System is a fully automated, computer controlled, clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins and other chemistries of clinical interest in biological fluids such as serum, plasma, urine and cerebral spinal fluid (sample type is chemistry dependent). The system has been designed for high volume clinical in-vitro diagnostics applications. The analyzer operates in conjunction with reagents, calibrators and controls designed for use with the system. The instrument provides automatic dilution capability for all assays on board the system. The system analyzes up to 845 tests per hour with up to 40 analytes per sample. Major hardware components include a command center/operator interface, a sampling center, a disposable tip processing center, the VITROS Chemistry Slide General Chemistry center, and the VITROS MicroTip Special Chemistry processing center.
The VITROS Chemistry MicroTip range of products (in this case VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1), are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dHDL assay for HDL cholesterol.
The provided text describes the VITROS 5,1 FS Chemistry System and the VITROS Chemistry Products dHDL assay, including their intended use, device descriptions, and comparison to predicate devices, but it does not explicitly state acceptance criteria or provide a detailed study plan with methodologies typically used to "prove" a device meets acceptance criteria in the way a clinical study would for efficacy.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through performance characteristics such as precision, correlation, and linearity, which are common for in vitro diagnostic (IVD) devices.
However, I can extract the relevant performance data presented that implicitly serves as evidence for the device's acceptable performance in comparison to its predicates.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The submission demonstrates the performance of the VITROS 5,1 FS Chemistry System and the VITROS Chemistry Products dHDL assay by comparing their characteristics to legally marketed predicate devices. For IVD devices like this, the "acceptance criteria" are generally met by demonstrating that the new device performs equivalently or comparably to existing, approved devices for the intended use. This is primarily shown through method comparison studies, precision assessments, and linearity studies.
1. Table of Acceptance Criteria and the Reported Device Performance
Implicit Acceptance Criteria: The performance (slope, intercept, correlation coefficient, precision, and linearity) of the new device should be comparable to or within acceptable limits relative to the predicate devices. The study aims to show substantial equivalence.
| Performance Characteristic | Implicit Acceptance Criteria (Comparable to Predicate) | Reported Device Performance (VITROS 5,1 FS Chemistry System / dHDL assay) | Predicate Device Comparison |
|---|---|---|---|
| Method Correlation (dHDL) | Slope close to 1, intercept close to 0, R-value close to 1 | Slope: 0.9742Intercept: -0.0682 mg/dLCorrelation Coefficient (R): 0.9836 | Bayer Direct HDL Cholesterol II assay |
| Precision (dHDL) | Low Within Day SD, Low Within Lab SD, Low Within Lab CV% | Mean Conc. 49.6 mg/dL: WD SD=0.92, WL SD=1.58, WL CV=3.37%Mean Conc. 67.1 mg/dL: WD SD=1.38, WL SD=2.02, WL CV=3.01% | Not explicitly compared to predicate's precision values in this document fragment, but results indicate good precision. |
| Linearity (dHDL) | Reportable range comparable to predicate. | Reportable Range: 3.00-100.0 mg/dL | Bayer ADVIA 1650 System with Bayer Direct HDL Cholesterol I (Predicate range: 17-90 mg/dL) - Note: The predicate HDL assay is referred to as "HDL Cholesterol II" in the correlation section and "HDL Cholesterol I" in the linearity section. Assuming similar performance. |
| Other Assays (e.g., AST, CREA, PHYT, Na+, URIC) - Method Correlation (Slope, Intercept, R) | Slope close to 1, intercept close to 0, R-value close to 1 | AST: S=1.00, I=-5.92, R=0.996CREA: S=0.98, I=0.04, R=1.000PHYT: S=1.02, I=-0.09, R=0.997Na+: S=1.00, I=-0.82, R=0.999URIC: S=1.00, I=0.02, R=1.000 | VITROS 950 System with respective VITROS Chemistry Products Slides |
| Other Assays - Precision (e.g., AST, CREA, PHYT, Na+, URIC) | Low Within Day SD, Low Within Lab SD, Low Within Lab CV% | AST (38 U/L): WD SD=0.5, WL SD=0.7, WL CV=1.8%CREA (1.1 mg/dL): WD SD=0.03, WL SD=0.03, WL CV=2.5%Na+ (119 mmol/L): WD SD=0.6, WL SD=1.0, WL CV=0.8%PHYT (8.3 µg/mL): WD SD=0.18, WL SD=0.32, WL CV=3.8%URIC (4.5 mg/dL): WD SD=0.04, WL SD=0.07, WL CV=1.7% | Not explicitly compared to predicate's precision values in this document fragment. |
| Other Assays - Linearity | Reportable range comparable to predicate. | AST: 3-750 U/LCREA: 0.05-14.00 mg/dLPHYT: 3.00-40.00 µmol/LNa+: 75.0-250.0 mmol/LURIC: 0.50-17.00 mg/dL | VITROS 950 System with respective VITROS Chemistry Products Slides (Comparable ranges specified) |
2. Sample size used for the test set and the data provenance
- dHDL Correlation Study Test Set Sample Size: 107 patient samples.
- Other Assays Method Comparison (AST, CREA, PHYT, Na+, URIC): Sample size for these individual method correlations is not explicitly stated, but the 'R' values are provided, implying a comparison was done.
- Data Provenance: The document does not specify the country of origin for the patient samples. It mentions "patient samples," which typically implies prospective collection for such studies, but it is not explicitly stated if they were prospective or retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of device submission. For IVD devices, the "ground truth" is typically established by comparing the new device's measurements against a predicate device or a reference method, rather than expert interpretation of images or clinical findings.
4. Adjudication method for the test set
- This information is not applicable to this type of device submission. Adjudication methods (like 2+1) are typically used for subjective assessments (e.g., image interpretation), not for quantitative measurements by a chemistry analyzer. The "adjudication" here is the mathematical comparison to the predicate device's quantitative results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable to this type of device submission. MRMC studies are relevant for imaging devices that involve human interpretation, often with AI assistance. This device is a chemistry analyzer for quantitative measurements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance data presented (precision, linearity, method correlation) are inherently standalone performance of the analyzer and its assay reagents. As an automated IVD device, its primary function is to provide quantitative results without real-time human intervention in the measurement process itself, beyond loading samples and reagents.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the new device's performance was established by comparing its quantitative measurements against the results obtained from legally marketed predicate devices. Specifically for dHDL, the predicate was the Bayer Direct HDL Cholesterol II assay. For other assays, the VITROS 950 Chemistry System with its corresponding assays served as the predicate.
8. The sample size for the training set
- The document does not specify a separate "training set" sample size. For IVD devices, method development usually involves internal studies, but the submission focuses on verification and validation studies using patient samples and controls, which are analogous to a test set. There isn't typically an "AI training set" in the context of this type of analyzer.
9. How the ground truth for the training set was established
- As a training set is not explicitly mentioned in the context of AI model development, this question is not applicable. For the development and validation of an IVD assay, ground truth is established through rigorous chemical and biological validation methods, often comparing results against established reference methods or highly characterized control materials, before performance against a predicate is assessed. This is an analytical validation, not an AI model training and ground truth establishment.
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Section I Summary Information
510(k) Summary 1
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ K03/924
K03/924
1.1 Submitter's Information
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-3768 Fax: (585) 453-3368
Contact Person: Neil Greenberg, PhD Manager, Regulatory Affairs
1.2 Date of Preparation: June 20, 2003
1.3 Device Proprietary Name(s)
VITROS 5,1 FS Chemistry System VITROS Chemistry Products dHDL Reagent Pack VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1
Common Names:
Clinical chemistry analyzer HDL Cholesterol assay
1.4 Classification Names
Discrete photometric chemistry analyzer for clinical use: 21 CFR 862.2160 Lipoprotein test system: 21 CFR 862.1475 Calibrator: 21 CFR 862.1150
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Predicate Device(s) 1.5
| New devices | Predicate devices |
|---|---|
| 1. VITROS Chemistry Products 5,1FS Chemistry System | 1. VITROS 950 Chemistry System FDA510(k) Number K946090 |
| 2. VITROS Chemistry ProductsdHDL assay | 2. Bayer ADVIA 1650 Chemistry SystemFDA 510(k) Number K990346 |
| 3. Bayer Direct HDL Cholesterol IIFDA Docket Number K982341 |
Intended Use Statement(s) 1.6
The VITROS 5.1 FS Chemistry System is a random access, fully automated clinical chemistry analyzer, intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma.
Device Description 1.7
1.7.1 The VITROS 5,1 FS Chemistry System is a fully automated, computer controlled, clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins and other chemistries of clinical interest in biological fluids such as serum, plasma, urine and cerebral spinal fluid (sample type is chemistry dependent). The system has been designed for high volume clinical in-vitro diagnostics applications. The analyzer operates in conjunction with reagents, calibrators and controls designed for use with the system. The instrument provides automatic dilution capability for all assays on board the system. The system analyzes up to 845 tests per hour with up to 40 analytes per sample. Major hardware components include a command center/operator interface, a sampling center, a disposable tip processing center, the VITROS Chemistry Slide General Chemistry center, and the VITROS MicroTip Special Chemistry processing center.
1.7.2 The VITROS Chemistry MicroTip range of products (in this case VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1), are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dHDL assay for HDL cholesterol.
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Comparison to Predicate Devices 1.8
The following tables show similarities and differences between the new and predicate devices identified in Section 1.5 of this summary.
| Predicate device #1 | Predicate device #2 | New device #1 | |
|---|---|---|---|
| Attribute | VITROS® 950 Chemistry System | Bayer ADVIA 1650 Chemistry System | VITROS® 5,1 FS Chemistry System |
| Maximum Throughput | 752 tests per hour | 1650 tests per hour | 845 tests per hour |
| Maximum Throughput | 300 samples per hour | 1200 samples per hour | 370 samples per hour |
| Technology/Methodologies | Colorimetric, Rate, Potentiometric,Immunorate | Colorimetric, Potentiometric, Rate andHomogeneous immunoassay. | Chemistry Slides - Colorimetric,Potentiometric, Rate, Immunorate.MicroTip reagents - Endpoint colorimetricand rate, Enzyme-coupled Immunoassay,Homogeneous TurbidimetricImmunoassay, Enhanced LatexTurbidimetric Immunoassay. |
| Sample Containers Supported | Cups, primary sample collection tubes | Cups, primary sample collection tubes | Cups, primary sample collection tubes |
| Selective/Discrete Testing | Yes | Yes | Yes |
| STAT Capability | Yes | Yes | Yes |
| Sample ID Input | Manual or Bar code | Manual or Bar Code | Manual or Bar Code |
| On-line Quality Control | Yes | Yes | Yes |
| Test Panels Available | Yes | Yes | Yes |
| Bi-directional ComputerInterface | Yes | Yes | Yes |
| Primary Container Sampling | Yes | Yes | Yes |
| Multiple Lots of Reagents On- | Yes | Not stated | Yes |
| Board at One TimeReagent Barcode Readers | Yes | Yes | Yes |
| 1.8.1 Table 1 | New device #1 versus Predicate devices #1 and #2 | ||
|---|---|---|---|
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г
| Comparison Table continuedAttribute | Predicate device #1VITROS® 950 Chemistry System | Predicate device #2Bayer ADVIA 1650 Chemistry System | New device #1VITROS® 5,1 FS Chemistry System |
|---|---|---|---|
| Incubator Positions | Rate/Colorimetric = 24 positions,Colorimetric = 27 positions, Potentiometric =15 positions, and Immunorate/Colorimetric =26 positions. | 221 cuvettes | Chemistry slide incubator = 106 positionsMicroTip incubator = 48 positions |
| Load Master Curve Information | 3.5" Diskette | User configurable | CD-ROM |
| Load Assay Protocol Information | Software | User configurable | CD-ROM |
| Calibration | Programmable | Programmable | Programmable |
| Display Calibration Curve | No | Yes | No |
| Display Calibration Data | Yes | Yes | Yes |
| Multiple Lots of CalibratorSupported? | Yes | Not stated | Yes |
| Multiple Calibrations on EachLot of Calibrator or Reagent? | Yes | Not stated | Yes |
| On-Analyzer Storage ofReagents | Yes - up to 5 weeks | Yes- average 28 days | Yes - up to 5 weeks for Chemistry slidesMicroTip reagents duration dependent onassay |
| Reagent Packs On-Board | 75 | 46 | 89 positions for Chemistry Slides, 36positions for MicroTip reagents anddiluents. |
| Electrolyte Reference FluidReservoir Capacity | 800 10 µL drops (disposable) | Not applicable | 800 10 µL drops (disposable) |
| Specimen Type | Serum, plasma, urine, CSF | Serum, plasma and urine | Serum, plasma, urine, CSF, whole blood(lyzed off system for HbA1c) |
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| Comparison Table continued | Predicate device #1 | Predicate device #2 | New device #1 |
|---|---|---|---|
| Attribute | VITROS® 950 Chemistry System | Bayer ADVIA 1650 Chemistry System | VITROS® 5,1 FS Chemistry System |
| Operator Interface | Touchscreen, Keyboard, Floppy Diskettes | Touchscreen and Keyboard | Touchscreen, Keyboard, CD |
| Test Modes | Continuous, Random, STAT | Continuous, Random, STAT | Continuous, Random, STAT |
| On-Analyzer Sample Capacity | 40 | 200 | 150 routine samples plus 10 STATsamples |
| Maximum reagent test capacity | 4500 chemistry slides | 32,200 tests maximum | Chemistry Slides = 5340MicroTip reagents = 3600 |
| Periodic Maintenance checks inS/W | Yes | Yes | Yes |
| Subsystem Performance Tests inS/W | Yes | Yes | Yes |
| Diagnostics Package in S/W | Yes | Yes | Yes |
| Sample Status Screen | No | Yes | Yes |
| Environmental Monitoring | Yes | Yes | Yes |
| Sample Programming | Yes (Via keyboard and LIS - broadcastdownload) | Yes (Via keyboard and host computer) | Yes (Via keyboard and LIS - eitherbroadcast download or host query) |
| Stored sample programs | 10,000 | Not stated | 10,000 |
| Maximum Test per Sample | 40 | Not stated | 40 |
| Result Reporting | Yes | Yes | Yes |
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ﻟﺴ
| Comparison Table continuedAttribute | Predicate device #1VITROS® 950 Chemistry System | Predicate device #2Bayer ADVIA 1650 Chemistry System | New device #1VITROS® 5,1 FS Chemistry System |
|---|---|---|---|
| Patient Results On-board | 5,000 records | 70,000 patient sample records | 25,000 records |
| S/W Quality Control Package | Yes | Yes | Yes |
| QC Results On-board | 12 control fluid files with 160 analyte/controlfluid combinations | Not stated | 100 control fluid files with 2,190 resultsper analyte/control fluid combination |
| Sample Usage per Assay | 5 - 11 µL, depending on assay selected | 2 - 30 µL, depending on assay selected | 2 - 12 µL, depending on assay selected |
| Sample meteringDisposable Tip Loading | Disposable TipManual Tip Loading | ProbeNone | Disposable TipOn-board supply of 2000 tips,automatically fed. |
| Minimum Sample Volume(including dead volume) | For a VITROS Microsample cup - 30 µL +11 µL per assay (worst case) for 1-6 assays,100 µL + 11 µL per assay (worst case) for 7or more assays. | From sample cup 30 µL + 50 µL per assay(worst case);collection tube 30 µL + 200 µL per assay | For a VITROS Microsample cup - 30 µL +11 µL per assay (worst case) for 1-6assays, 100 µL + 11 µL per assay (worstcase) for 7 or more assays. |
| Addition / Removal of Samples | While running | While running | While running |
| Clot Detection | Yes | Yes | Yes |
| Level Sense (sample) | Yes | Yes | Yes |
| Level Sense (waste) | No | Not applicable | Yes |
| Waste Capacity | None stated | Requires drain with minimum capacity 6.8gallons per hour; probes and cuvettes arewashed and reused. | Slide waste = 3,780 Chemistry Slides.Other Disposables waste = approximately1,145 VITROS® VersaTips, 140VITROS® FS MicroTips, 3 MicroTiptrays, and 100 VITROS® FS Cuvettes (ora total of approximately 5.5 pounds). |
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| DeviceCharacteristic | New Device #2:VITROS dHDL assay | Predicate Device #3:Bayer HDL Cholesterol IIassay |
|---|---|---|
| Basic principle | Homogeneous enzymaticcolorimetric test | Homogeneous enzymaticcolorimetric test |
| Reagents | Liquid ready to use | Liquid ready to use |
| Test Type | Multi-point rate | 2-point rate |
| Instrumentation | VITROS 5,1 FS ChemistrySystem | Bayer ADVIA 1650Chemistry System |
| Sample type | Serum and plasma (Liheparin). | Serum and plasma (Liheparin). |
| Sample volume | 3 µL | 5 µL |
| Incubation timeand temperature | Incubation 1: 5 minutesIncubation 2: 3.2 minutes | 10 minutes |
| IncubationTemperature | 37°C | 37°C |
New device #2 versus Predicate device # 3 1.8.2 Table 2
Substantial equivalence of the VITROS 5,1 FS Chemistry System to commercially available predicates, the VITROS 950 Chemistry System and the Bayer ADVIA 1650 Chemistry System, is demonstrated by the feature and functions comparison Table 1.
In order to demonstrate the safe and effective performance of the VITROS 5,1 FS Chemistry System with VITROS Chemistry Products Slides, a representative sample of marker assays was selected to demonstrate key performance characteristics of the system. This performance demonstration provides information for each of the general methodology classes for commercially available VITROS Chemistry Products Slides that can be used to measure various analytes with the VITROS 5.1 FS Chemistry System, including colorimetric endpoint, potentiometric, multipoint rate, multipoint immunorate, and two-point rate methods.
The VITROS Chemistry Products dHDL Reagent Pack and VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 are substantially equivalent to the Bayer Direct HDL Cholesterol Method that was cleared by the FDA (K982341) for IVD use.
The relationship between the VITROS dHDL assay and the Bayer Direct HDL Cholesterol II assay, determined by Least Squares linear regression, is:
VITROS dHDL assay = 0.9742 x X - 0.0682 (mg/dL), with a correlation coefficient of 0.9836. where X is Bayer Direct HDL Cholesterol II assay.
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This relationship was determined from a panel of 107 patient samples.
In addition to the above mentioned correlation study, studies were performed or literature resources were used to determine the precision, expected values, linearity, and specificity of the VITROS dHDL assay, (refer to the VITROS Chemistry Products Reagent Pack Instructions for Use for summaries of the results of these studies).
| VITROSChemistryProducts assay | Units | MeanConc. | WithinDay SD | WithinLab SD | WithinLabCV% | No.Observ. | No.Days |
|---|---|---|---|---|---|---|---|
| AST (Aspartateaminotransferase) | U/L | 38 | 0.5 | 0.7 | 1.8 | 60 | 10 |
| 200 | 1.2 | 2.4 | 1.2 | 60 | 10 | ||
| CREA (Creatinine) | mg/dL | 1.1 | 0.03 | 0.03 | 2.5 | 60 | 10 |
| 5.8 | 0.08 | 0.10 | 1.8 | 60 | 10 | ||
| Na+ (Sodium) | mmol/L | 119 | 0.6 | 1.0 | 0.8 | 60 | 10 |
| 142 | 0.8 | 1.2 | 0.9 | 60 | 10 | ||
| PHYT (Phenytoin) | µg/mL | 8.3 | 0.18 | 0.32 | 3.8 | 60 | 10 |
| 14.5 | 0.33 | 0.46 | 3.2 | 60 | 10 | ||
| 26.0 | 0.94 | 1.20 | 4.6 | 60 | 10 | ||
| URIC (Uric acid) | mg/dL | 4.5 | 0.04 | 0.07 | 1.7 | 60 | 10 |
| 10.2 | 0.08 | 0.11 | 1.1 | 60 | 10 | ||
| dHDL (HDLCholesterol) | mg/dL | 49.6 | 0.92 | 1.58 | 3.37 | 88 | 22 |
| 67.1 | 1.38 | 2.02 | 3.01 | 88 | 22 |
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្រ
| Analyte | Slope | Intercept | R | Versus Predicate |
|---|---|---|---|---|
| AST (Aspartateaminotransferase) | 1.00 | -5.92 | 0.996 | VITROS 950 System with VITROS Chemistry Products AST Slides |
| CREA (Creatinine) | 0.98 | 0.04 | 1.000 | VITROS 950 System with VITROS Chemistry Products CREA Slides |
| PHYT (Phenytoin) | 1.02 | -0.09 | 0.997 | VITROS 950 System with VITROS Chemistry Products PHYT Slides |
| Na+ (Sodium) | 1.00 | -0.82 | 0.999 | VITROS 950 System with VITROS Chemistry Products Na+ Slides |
| URIC (Uric acid) | 1.00 | 0.02 | 1.000 | VITROS 950 System with VITROS Chemistry Products URIC Slides |
| dHDL (HDL Cholesterol) | 0.974 | -0.0682 | 0.984 | Bayer ADVIA 1650 System with Bayer Direct HDL Cholesterol II |
Method Comparison Study Results with VITROS 5,1 FS Chemistry System Table 3
Linearity: Reportable (Dynamic) Range Table 4
| VITROS 5,1 FSChemistry System | Predicate | ||
|---|---|---|---|
| AST (Aspartateaminotransferase) | 3-750 U/L | 3-750 U/L | VITROS 950 Systemwith VITROS Chemistry Products AST Slides |
| CREA (Creatinine) | 0.05-14.00 mg/dL | 0.05-14.00 mg/dL | VITROS 950 Systemwith VITROS Chemistry Products CREA Slides |
| PHYT (Phenytoin) | 3.00-40.00 µmol/L | 3.00-40.00 µmol/L | VITROS 950 Systemwith VITROS Chemistry Products PHYT Slides |
| Na+ (Sodium) | 75.0-250.0 mmol/L | 75.0-250.0 mmol/L | VITROS 950 Systemwith VITROS Chemistry Products Na+ Slides |
| URIC (Uric acid) | 0.50-17.00 mg/dL | 0.50-17.00 mg/dL | VITROS 950 Systemwith VITROS Chemistry Products URIC Slides |
| dHDL (HDL Cholesterol) | 3.00-100.0 mg/dL | 17-90 mg/dL | Bayer ADVIA 1650 Systemwith Bayer Direct HDL Cholesterol I |
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1.9 Conclusions
The data presented in this pre-market notification demonstrate that the performance of the VITROS 5,1 FS Chemistry System and the VITROS Chemistry Products dHDL assay are substantially equivalent to the cleared predicate devices.
Equivalence to predicates was demonstrated using commercially available reagents along with patient samples.
The data presented in the premarket notification provide a reasonable assurance that the VITROS 5,1 FS Chemistry System and the VITROS dHDL assay are safe and effective for the stated intended uses.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/10/Picture/2 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. The lines are thick and bold, creating a sense of dynamism. The bird is encircled by a ring of text, though the text is too blurry to read. The logo is simple, yet distinctive, and likely represents an organization or company related to aviation, nature, or environmental conservation.
AUG - 7 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Neil Greenberg, Ph.D. Manager, Regulatory Affairs Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K031924
Trade/Device Name: VITROS 5,1 FS Chemistry System VITROS Chemistry Products dHDL, Reagent Pack VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1 Regulation Number: 21 CFR 862.1150
Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT; JJE; LBR Dated: June 20, 2003 Received: June 23, 2003
Dear Dr. Greenberg:
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 (OS) 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K031924 |
|---|---|
| Device Names: | VITROS 5,1 FS Chemistry System |
| Intended Use: | The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benson/r Jean Cooper, DVM
Division Sign-Off
OR
Office of In Vitro Diagnostic Device Evaluation and Safety
KO31924 510(k)________________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use __
(Optional Format 1-2-96)
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Statement of Intended Use
Page 2 of 2
510(k) Number (if known): K031924
Device Names:
-
- VITROS Chemistry Products dHDL Reagent Pack
-
- VITROS Chemistry Products Calibrator Kit 19
-
- VITROS Chemistry Products FS Calibrator 1
Intended Uses:
- I. For in vitro diagnostic use only. The VITROS dHDL Reagent Pack quantitatively measures HDL cholesterol (HDLC) concentration in serum and plasma. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
- For in vitro diagnostic use only. VITROS Chemistry 2. Products Calibrator Kit 19 is used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate dHDL.
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- For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is a saline solution used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Calibrator Kit 19 to calibrate dHDL.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Carol C Benam for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031924
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.