VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1

K031924 · Ortho-Clinical Diagnostics · JIT · Aug 7, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031924
• Device Name: VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
• Applicant: Ortho-Clinical Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurements 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.) The VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 10 is for in vitro diagnostic use only. The dHDL quantitatively measures HDL Cholesterol in plasma and serum. HDL cholesterol is used to evaluate the risk of developing coronary artery disease. The risk of CHD increases with lower HDL cholesterol concentrations.

Device Story

VITROS 5,1 FS Chemistry System is a fully automated, random-access clinical chemistry analyzer for high-volume diagnostic labs. It processes serum, plasma, urine, and CSF samples. The system utilizes two primary processing centers: Chemistry Slides (colorimetric, potentiometric, rate, immunorate) and MicroTip liquid reagents (spectrophotometric, immunoassay). For dHDL assays, the system performs multi-point rate measurements on patient samples. Operators interface via touchscreen/keyboard to manage worklists, calibration, and QC. The system performs automated sample identification, aspiration, incubation, and photometric analysis. Results are reported to the clinician to assess CHD risk based on HDL concentrations. The system features automated clot detection, level sensing, and bi-directional LIS connectivity.

Clinical Evidence

Bench testing only. Performance evaluated through method comparison studies using 107 patient samples, demonstrating a correlation of 0.9836 with the predicate. Precision studies (within-day and within-lab CV%) were conducted for multiple analytes (AST, CREA, Na+, PHYT, URIC, dHDL) over 10-22 days. Linearity and reportable ranges were established for all tested analytes.

Technological Characteristics

Random-access clinical chemistry analyzer. Technologies: colorimetric, potentiometric, rate, immunorate (slides); endpoint colorimetric, rate, enzyme-coupled/homogenous turbidometric/enhanced latex immunoassays (MicroTip). Connectivity: Ethernet/LIS. Operating system: QNX Neutrino v6.1x. Calibration: automated on-line math. Sample handling: barcode/rack positioning. Throughput: 845 tests/hour.

Indications for Use

Indicated for in vitro quantitative measurement of HDL cholesterol in human serum or plasma to evaluate coronary heart disease (CHD) risk. Used for clinical chemistry analysis in high-volume laboratory settings.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• VITROS 950 Chemistry System (K946090)
• Bayer ADVIA 1650 Chemistry System (K990346)
• Bayer Direct HDL Cholesterol II (K982341)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 5,1<br>FS Chemistry System | 1. VITROS 950 Chemistry System FDA<br>510(k) Number K946090 |
| 2. VITROS Chemistry Products<br>dHDL assay | 2. Bayer ADVIA 1650 Chemistry System<br>FDA 510(k) Number K990346 |
| | 3. Bayer Direct HDL Cholesterol II<br>FDA 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,<br>Immunorate | Colorimetric, Potentiometric, Rate and<br>Homogeneous immunoassay. | Chemistry Slides - Colorimetric,<br>Potentiometric, Rate, Immunorate.<br>MicroTip reagents - Endpoint colorimetric<br>and rate, Enzyme-coupled Immunoassay,<br>Homogeneous Turbidimetric<br>Immunoassay, Enhanced Latex<br>Turbidimetric 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 Computer<br>Interface | Yes | Yes | Yes |
| Primary Container Sampling | Yes | Yes | Yes |
| Multiple Lots of Reagents On- | Yes | Not stated | Yes |
| Board at One Time<br>Reagent Barcode Readers | Yes | Yes | Yes |

| 1.8.1 Table 1 | New device #1 versus Predicate devices #1 and #2 | | |
|---------------|--------------------------------------------------|--|--|
| | | | |

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| Comparison Table continued<br>Attribute | Predicate device #1<br>VITROS® 950 Chemistry System | Predicate device #2<br>Bayer ADVIA 1650 Chemistry System | New device #1<br>VITROS® 5,1 FS Chemistry System |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Incubator Positions | Rate/Colorimetric = 24 positions,<br>Colorimetric = 27 positions, Potentiometric =<br>15 positions, and Immunorate/Colorimetric =<br>26 positions. | 221 cuvettes | Chemistry slide incubator = 106 positions<br>MicroTip 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 Calibrator<br>Supported? | Yes | Not stated | Yes |
| Multiple Calibrations on Each<br>Lot of Calibrator or Reagent? | Yes | Not stated | Yes |
| On-Analyzer Storage of<br>Reagents | Yes - up to 5 weeks | Yes- average 28 days | Yes - up to 5 weeks for Chemistry slides<br>MicroTip reagents duration dependent on<br>assay |
| Reagent Packs On-Board | 75 | 46 | 89 positions for Chemistry Slides, 36<br>positions for MicroTip reagents and<br>diluents. |
| Electrolyte Reference Fluid<br>Reservoir 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<br>(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 STAT<br>samples |
| Maximum reagent test capacity | 4500 chemistry slides | 32,200 tests maximum | Chemistry Slides = 5340<br>MicroTip reagents = 3600 |
| Periodic Maintenance checks in<br>S/W | Yes | Yes | Yes |
| Subsystem Performance Tests in<br>S/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 - broadcast<br>download) | Yes (Via keyboard and host computer) | Yes (Via keyboard and LIS - either<br>broadcast 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 continued<br>Attribute | Predicate device #1<br>VITROS® 950 Chemistry System | Predicate device #2<br>Bayer ADVIA 1650 Chemistry System | New device #1<br>VITROS® 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/control<br>fluid combinations | Not stated | 100 control fluid files with 2,190 results<br>per 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 metering<br>Disposable Tip Loading | Disposable Tip<br>Manual Tip Loading | Probe<br>None | Disposable Tip<br>On-board supply of 2000 tips,<br>automatically fed. |
| Minimum Sample Volume<br>(including dead volume) | For a VITROS Microsample cup - 30 µL +<br>11 µL per assay (worst case) for 1-6 assays,<br>100 µL + 11 µL per assay (worst case) for 7<br>or more assays. | From sample cup 30 µL + 50 µL per assay<br>(worst case);<br>collection tube 30 µL + 200 µL per assay | For a VITROS Microsample cup - 30 µL +<br>11 µL per assay (worst case) for 1-6<br>assays, 100 µL + 11 µL per assay (worst<br>case) 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 6.8<br>gallons per hour; probes and cuvettes are<br>washed and reused. | Slide waste = 3,780 Chemistry Slides.<br>Other Disposables waste = approximately<br>1,145 VITROS® VersaTips, 140<br>VITROS® FS MicroTips, 3 MicroTip<br>trays, and 100 VITROS® FS Cuvettes (or<br>a total of approximately 5.5 pounds). |

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| Device<br>Characteristic | New Device #2:<br>VITROS dHDL assay | Predicate Device #3:<br>Bayer HDL Cholesterol II<br>assay |
|------------------------------------|------------------------------------------------------|-----------------------------------------------------------|
| Basic principle | Homogeneous enzymatic<br>colorimetric test | Homogeneous enzymatic<br>colorimetric test |
| Reagents | Liquid ready to use | Liquid ready to use |
| Test Type | Multi-point rate | 2-point rate |
| Instrumentation | VITROS 5,1 FS Chemistry<br>System | Bayer ADVIA 1650<br>Chemistry System |
| Sample type | Serum and plasma (Li<br>heparin). | Serum and plasma (Li<br>heparin). |
| Sample volume | 3 µL | 5 µL |
| Incubation time<br>and temperature | Incubation 1: 5 minutes<br>Incubation 2: 3.2 minutes | 10 minutes |
| Incubation<br>Temperature | 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).

| VITROS<br>Chemistry<br>Products assay | Units | Mean<br>Conc. | Within<br>Day SD | Within<br>Lab SD | Within<br>Lab<br>CV% | No.<br>Observ. | No.<br>Days |
|---------------------------------------|--------|---------------|------------------|------------------|----------------------|----------------|-------------|
| AST (Aspartate<br>aminotransferase) | 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 (HDL<br>Cholesterol) | 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 (Aspartate<br>aminotransferase) | 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 FS<br>Chemistry System | | Predicate |
|-------------------------------------|-----------------------------------|-------------------|-----------------------------------------------------------------|
| AST (Aspartate<br>aminotransferase) | 3-750 U/L | 3-750 U/L | VITROS 950 System<br>with VITROS Chemistry Products AST Slides |
| CREA (Creatinine) | 0.05-14.00 mg/dL | 0.05-14.00 mg/dL | VITROS 950 System<br>with VITROS Chemistry Products CREA Slides |
| PHYT (Phenytoin) | 3.00-40.00 µmol/L | 3.00-40.00 µmol/L | VITROS 950 System<br>with VITROS Chemistry Products PHYT Slides |
| Na+ (Sodium) | 75.0-250.0 mmol/L | 75.0-250.0 mmol/L | VITROS 950 System<br>with VITROS Chemistry Products Na+ Slides |
| URIC (Uric acid) | 0.50-17.00 mg/dL | 0.50-17.00 mg/dL | VITROS 950 System<br>with VITROS Chemistry Products URIC Slides |
| dHDL (HDL Cholesterol) | 3.00-100.0 mg/dL | 17-90 mg/dL | Bayer ADVIA 1650 System<br>with 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 [phone]. 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 [phone] or [phone] 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:

- 1. VITROS Chemistry Products dHDL Reagent Pack
- 2. VITROS Chemistry Products Calibrator Kit 19
- 3. 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.
- 3. 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