Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard automated clinical chemistry analyzer and its associated reagents, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) device used for the quantitative measurement of analytes like HDL cholesterol. It is not used for treating or providing therapy to patients.

Diagnostic

Yes

The document explicitly states multiple times that the device is "For in vitro diagnostic use only" and describes its function as "in vitro quantitative measurement of a variety of analytes of clinical interest" using "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." This clearly indicates its role in diagnosing conditions by analyzing biological samples.

SaMD (Software as a Medical Device)

No

The device description explicitly lists major hardware components including a command center/operator interface, a sampling center, a disposable tip processing center, and two chemistry processing centers. It is described as a "fully automated, computer controlled, clinical chemistry analyzer," indicating significant hardware.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is a clear declaration of its intended purpose.
Nature of the Device: The device is a clinical chemistry analyzer designed to measure analytes in biological fluids (serum, plasma, etc.) in vitro (outside the living body). This is the core function of an IVD.
Reagents and Calibrators: The description mentions the use of "reagents, calibrators and controls designed for use with the system." These are essential components of an IVD system used for testing biological samples.
Clinical Interest: The analytes measured are of "clinical interest," indicating their relevance to diagnosing or monitoring health conditions.
High Volume Clinical Use: The system is designed for "high volume clinical in-vitro diagnostics applications," further reinforcing its IVD nature.
Specific Assay: The description details the use of the system for the "VITROS dHDL assay for HDL cholesterol," which is a common diagnostic test.

All these points strongly indicate that the VITROS 5,1 FS Chemistry System and its associated components are intended for and function as In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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 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.

Product codes (comma separated list FDA assigned to the subject device)

JIT, JJE, LBR

Device Description

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.

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

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Correlation study performed using a panel of 107 patient samples.
Precision, expected values, linearity, and specificity of the VITROS dHDL assay were determined through studies or literature resources.
Key results from method comparison studies, linearity, and precision for various analytes, including dHDL, were provided.

Precision:

dHDL (HDL Cholesterol):
- Mean Conc.: 49.6 mg/dL, Within Day SD: 0.92, Within Lab SD: 1.58, Within Lab CV%: 3.37, No. Observ.: 88, No. Days: 22
- Mean Conc.: 67.1 mg/dL, Within Day SD: 1.38, Within Lab SD: 2.02, Within Lab CV%: 3.01, No. Observ.: 88, No. Days: 22

Method Comparison Study Results:

dHDL (HDL Cholesterol): Slope: 0.974, Intercept: -0.0682, R: 0.984, Versus Predicate: Bayer ADVIA 1650 System with Bayer Direct HDL Cholesterol II

Linearity: Reportable (Dynamic) Range

dHDL (HDL Cholesterol): 3.00-100.0 mg/dL (VITROS 5,1 FS Chemistry System), Predicate: 17-90 mg/dL (Bayer ADVIA 1650 System with Bayer Direct HDL Cholesterol I)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K946090, K990346, K982341

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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

1

Predicate Device(s) 1.5

New devices	Predicate devices
1. VITROS Chemistry Products 5,1
FS Chemistry System	1. VITROS 950 Chemistry System FDA
510(k) Number K946090
2. VITROS Chemistry Products
dHDL assay	2. Bayer ADVIA 1650 Chemistry System
FDA 510(k) Number K990346
	3. Bayer Direct HDL Cholesterol II
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.

2

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 and
Homogeneous immunoassay.	Chemistry Slides - Colorimetric,
Potentiometric, Rate, Immunorate.
MicroTip reagents - Endpoint colorimetric
and rate, Enzyme-coupled Immunoassay,
Homogeneous Turbidimetric
Immunoassay, Enhanced Latex
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
Interface	Yes	Yes	Yes
Primary Container Sampling	Yes	Yes	Yes
Multiple Lots of Reagents On-	Yes	Not stated	Yes
Board at One Time
Reagent Barcode Readers	Yes	Yes	Yes

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

3

г

| Comparison Table continued
Attribute VITROS® 950 Chemistry System Bayer ADVIA 1650 Chemistry VITROS® 5,1 FS Chemistry System |------------------------------ | Incubator Positions Colorimetric = 27 positions, 15 positions, and Immunorate/Colorimetric 26 positions. | 221 cuvettes MicroTip incubator = 48 positions | Load Master Curve Information | Load Assay Protocol Information | Calibration | Display Calibration Curve | Display Calibration Data | Multiple Lots of Calibrator
Supported? | Multiple Calibrations on Each
Lot of Calibrator or Reagent? | Yes | On-Analyzer Storage of
Reagents MicroTip reagents duration assay |
| Reagent Packs On-Board positions for MicroTip diluents. |
| Electrolyte Reference Fluid
Reservoir Capacity | Specimen Type (lyzed off system for HbA1c) | Predicate device #1
| Predicate device #2
System | New device #1
|
----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Rate/Colorimetric = 24 positions,
Potentiometric =
=
| Chemistry slide incubator = 106 positions
|
| 3.5" Diskette | User configurable | CD-ROM |
| Software | User configurable | CD-ROM |
| Programmable | Programmable | Programmable |
| No | Yes | No |
| Yes | Yes | Yes |
| Yes | Not stated | Yes |
| Not stated | Yes |
| Yes - up to 5 weeks | Yes- average 28 days | Yes - up to 5 weeks for Chemistry slides
dependent on
| 75 | 46 | 89 positions for Chemistry Slides, 36
reagents and
| 800 10 µL drops (disposable) | Not applicable | 800 10 µL drops (disposable) |
| Serum, plasma, urine, CSF | Serum, plasma and urine | Serum, plasma, urine, CSF, whole blood
|

4

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
samples
Maximum reagent test capacity	4500 chemistry slides	32,200 tests maximum	Chemistry Slides = 5340
MicroTip reagents = 3600
Periodic Maintenance checks in
S/W	Yes	Yes	Yes
Subsystem Performance Tests in
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
download)	Yes (Via keyboard and host computer)	Yes (Via keyboard and LIS - either
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

5

ﻟﺴ

| Comparison Table continued
Attribute | Predicate device #1
VITROS® 950 Chemistry System | Predicate device #2
Bayer ADVIA 1650 Chemistry System | New device #1
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
fluid combinations | Not stated | 100 control fluid files with 2,190 results
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
Disposable Tip Loading | Disposable Tip
Manual Tip Loading | Probe
None | Disposable Tip
On-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 7
or 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 1-6
assays, 100 µL + 11 µL per assay (worst
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
gallons per hour; probes and cuvettes are
washed and reused. | Slide waste = 3,780 Chemistry Slides.
Other Disposables waste = approximately
1,145 VITROS® VersaTips, 140
VITROS® FS MicroTips, 3 MicroTip
trays, and 100 VITROS® FS Cuvettes (or
a total of approximately 5.5 pounds). |

6

| Device
Characteristic | New Device #2:
VITROS dHDL assay | Predicate Device #3:
Bayer HDL Cholesterol II
assay |
|------------------------------------|------------------------------------------------------|-----------------------------------------------------------|
| Basic principle | Homogeneous enzymatic
colorimetric test | Homogeneous enzymatic
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
System | Bayer ADVIA 1650
Chemistry System |
| Sample type | Serum and plasma (Li
heparin). | Serum and plasma (Li
heparin). |
| Sample volume | 3 µL | 5 µL |
| Incubation time
and temperature | Incubation 1: 5 minutes
Incubation 2: 3.2 minutes | 10 minutes |
| Incubation
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.

7

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
Chemistry
Products assay | Units | Mean
Conc. | Within
Day SD | Within
Lab SD | Within
Lab
CV% | No.
Observ. | No.
Days |
|---------------------------------------|--------|---------------|------------------|------------------|----------------------|----------------|-------------|
| AST (Aspartate
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
Cholesterol) | mg/dL | 49.6 | 0.92 | 1.58 | 3.37 | 88 | 22 |
| | | 67.1 | 1.38 | 2.02 | 3.01 | 88 | 22 |

8

្រ

Analyte	Slope	Intercept	R	Versus Predicate
AST (Aspartate
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
Chemistry System | | Predicate |
|-------------------------------------|-----------------------------------|-------------------|-----------------------------------------------------------------|
| AST (Aspartate
aminotransferase) | 3-750 U/L | 3-750 U/L | VITROS 950 System
with VITROS Chemistry Products AST Slides |
| CREA (Creatinine) | 0.05-14.00 mg/dL | 0.05-14.00 mg/dL | VITROS 950 System
with VITROS Chemistry Products CREA Slides |
| PHYT (Phenytoin) | 3.00-40.00 µmol/L | 3.00-40.00 µmol/L | VITROS 950 System
with VITROS Chemistry Products PHYT Slides |
| Na+ (Sodium) | 75.0-250.0 mmol/L | 75.0-250.0 mmol/L | VITROS 950 System
with VITROS Chemistry Products Na+ Slides |
| URIC (Uric acid) | 0.50-17.00 mg/dL | 0.50-17.00 mg/dL | VITROS 950 System
with VITROS Chemistry Products URIC Slides |
| dHDL (HDL Cholesterol) | 3.00-100.0 mg/dL | 17-90 mg/dL | Bayer ADVIA 1650 System
with Bayer Direct HDL Cholesterol I |

9

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.

10

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).

11

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

12

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)

13

Statement of Intended Use

Page 2 of 2

510(k) Number (if known): K031924

Device Names:

1. VITROS Chemistry Products dHDL Reagent Pack
1. VITROS Chemistry Products Calibrator Kit 19
1. 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.
1. 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