K Number

Device Name

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides

Manufacturer

Ortho-Clinical Diagnostics, Inc.

Date Cleared

2018-10-30

(90 days)

Product Code

CGZ CGA KHS

Regulation Number

862.1170

Intended Use

1. VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. 2. VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. 3. VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Description

The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products Cl- Slides, VITROS Chemistry Products ECO2 Slides, and VITROS Chemistry Products GLU Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K162020, K120765, K163433

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard in vitro diagnostic chemistry assays and systems. There is no mention of AI, ML, or any computational methods beyond typical data analysis for performance studies.

Therapeutic

No
Explanation: This device is for in vitro diagnostic use, meaning it measures substances in biological samples to aid in diagnosis and treatment monitoring. It does not directly provide therapy or interact with the patient's body to treat a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" for all listed products (Cl- Slides, ECO2 Slides, GLU Slides). Furthermore, it details how measurements from these products are "used in the diagnosis and treatment of..." various medical conditions, such as "electrolyte and metabolic disorders," "disorders associated with changes in body acid-base balance," and "carbohydrate metabolism disorders."

SaMD (Software as a Medical Device)

The device description explicitly states that the VITROS Chemistry MicroSlide range of products are combined with the VITROS XT 7600 Integrated System to perform the assays. This indicates the device includes physical components (slides and the integrated system) in addition to any potential software.

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 for each product explicitly states: "For in vitro diagnostic use only."
Intended Use: The intended use is to "quantitatively measure" specific analytes (chloride, total carbon dioxide, glucose) in human biological samples (serum, plasma, urine, cerebrospinal fluid). This is a core function of in vitro diagnostics.
Clinical Purpose: The measurements are stated to be "used in the diagnosis and treatment of" various medical conditions (electrolyte and metabolic disorders, acid-base balance disorders, carbohydrate metabolism disorders). This clearly indicates a clinical purpose for the testing performed by the device.
Device Description: The device description confirms that these products are "combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays," which are the diagnostic tests.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of tissues, organs or blood, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only.
VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

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

CGZ, KHS, CGA

Device Description

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)

Method comparison studies were conducted by testing a minimum of 125 human serum samples with analyte concentrations within the measuring ranges (MR) of chloride, carbon dioxide and glucose assays on the VITROS XT 7600 Integrated System and the VITROS 5600 Integrated System (predicate device).
In addition, 125human urine samples were tested for chloride and 125 human urine samples and 125 human CSF samples were tested for glucose on the candidate and predicate test systems.
Key results are summarized in the Method Comparison Regression Analysis Data Table.

Precision studies were conducted following EP05-A3, Evaluation of Quantitative Measurement Procedures, Approved Guidelines – Third Edition (2014). The study was performed by testing a minimum of two Quality control fluids and three human based precision fluids using the chloride (Cl-), carbon dioxide (ECO2), and glucose (GLU) assays. Samples were analyzed using one VITROS XT 7600 Integrated System over 20 days, with 2 runs per day and 2 replicates per specimen (n=80).

Linearity studies were performed according to CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline (2003). VITROS CI- Slides, VITROS ECO2 Slides, and VITROS GLU Slides were tested on the VITROS XT 7600 Integrated System. A series of eleven proportionally related admixtures of low and high test fluids were tested to verify linearity; each sample was tested in triplicate, a minimum of two replicates was acceptable for analysis. The linearity studies support the claimed measuring ranges for the VITROS CI-, VITROS ECO2, and VITROS GLU assays.

Detection capability studies for each analyte were evaluated based upon CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurements Procedures: Approved Guidelines – Second Edition (2012).
Limit of blank (LoB) studies were performed by testing 4 blank samples. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 216 observations (72 results per reagent lot).
Limit of detection (LoD) studies were performed by testing 4 pools of human samples with analyte concentrations close to the expected detection limit for each analyte. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, with the 4 human sample pools every day. for a total of 216 observations (72 results per reagent lot).
Limit of Quantitation studies were performed using 4 pools of low level samples with analyte concentrations close to the expected LoQ of the corresponding assay. Samples were tested in replicates of 4 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 144 observations (48 results per reagent lot).

Interference Testing was performed in accordance with CLSI EP07-A2. Interference Testing in Clinical Chemistry, Approved Guidance-Second Edition. Clinical and Laboratory Standards Institute. November 2005, using VITROS CI , VITROS ECO2 and VITROS GLU assays. Assays were tested on one VITROS XT 7600 Integrated System ('VITROS XT 7600, Test System) and one VITROS 5600 Integrated System (VITROS 5600. Predicate/Control System). Testing on the representative assays included known chemical interferents, common chemical substances identified with potential to interfere based upon risk assessment, as well as several claimed non-interferents. Results demonstrate acceptable bias on the VITROS XT 7600 versus the VITROS 5600 for currently claimed interferents.

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.

K162020, K120765, K163433

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

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 30, 2018

Ortho-Clinical Diagnostics, Inc. Marlene Hanna Director, Regulatory Affairs 100 Indigo Creek Drive Rochester, NY 14626

Re: K182072

Trade/Device Name: VITROS Chemistry Products Cl-Slides VITROS Chemistry Products ECO2 Slides VITROS Chemistry Products GLU Slides Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ, KHS, CGA Dated: July 30, 2018 Received: August 1, 2018

Dear Marlene Hanna:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K182072

Device Name VITROS Chemistry Products Cl- Slides VITROS Chemistry Products ECO2 Slides VITROS Chemistry Products GLU Slides

Indications for Use (Describe)

VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only.

VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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5 510(k) Summary Information

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: K182072

Submitter's Information

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4041 Fax: (585) 453-3368

Contact Person:

Marlene Hanna, RAC Director, Regulatory Affairs

Date of Preparation: July 30, 2018

Device Proprietary Name(s):

VITROS Chemistry Products Cl- Slides VITROS Chemistry Products ECO2 Slides VITROS Chemistry Products GLU Slides

Common Names:

Chloride assay Carbon dioxide assay Glucose assay

Classification Names

| VITROS | Product
Code | Class | Regulation Section | Panel |
|--------|-----------------|----------|---------------------------------------------|-----------|
| Cl- | CGZ | Class II | 21 CFR 862. 1170 chloride test system | |
| ECO2 | KHS | Class II | 21 CFR 862. 1160 carbon dioxide test system | Clinical |
| GLU | CGA | Class II | 21 CFR 862. 1345 glucose test system | Chemistry |

Predicate Device(s)

| No. | New Devices | Predicate Devices | Predicate Device
FDA 510(k)
Number |
|-----|------------------------------------------|------------------------------------------|------------------------------------------|
| 1 | VITROS Chemistry
Products Cl- Slides | VITROS Chemistry
Products Cl- Slides | K162020 |
| 2 | VITROS Chemistry
Products ECO2 Slides | VITROS Chemistry
Products ECO2 Slides | K120765 |
| 3 | VITROS Chemistry
Products GLU Slides | VITROS Chemistry
Products GLU Slides | K163433 |

Intended Use Statement(s)

1. VITROS Chemistry Products Cl- Slides

Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

2. VITROS Chemistry Products ECO2 Slides

Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5.1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

3. VITROS Chemistry Products GLU Slides

Rx Only. For in vitro diagnostic use only.

VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Description

The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products Cl- Slides, VITROS Chemistry Products ECO2 Slides, and VITROS Chemistry Products GLU

Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays.

Comparison to Predicate Devices

The following tables show similarities and differences between the new and predicate devices.

Similarities
Device
Characteristic	Candidate
VITROS Cl- Slides	Predicate Device
VITROS Cl- Slides
K162020
Intended Use	Rx Only. For in vitro diagnostic
use only. VITROS Chemistry
Products Cl- Slides quantitatively
measure chloride (Cl-)
concentration in serum, plasma and
urine.	Same
Method
Principle	Potentiometric; Electrode (ISE),
Direct (undiluted)	Same
Reactive
Ingredients
per cm2	Silver 0.4 mg and silver chloride
0.2 mg	Same
Sample type	Serum and plasma, urine	Same
Sample volume	10 µL	Same
Measuring
Range	Serum: 50.0 -175.0 mmo/L
Urine: 15-300 mmol/L	Same
Differences
Device
Characteristic	Candidate
VITROS Cl- Slides	Predicate Device
VITROS Cl- Slides
K162020
Instrumentation	VITROS 250/350/950/5,1 FS and
4600 Chemistry Systems and the
VITROS 5600/ XT 7600 Integrated
System	VITROS
250/350/950/5,1 FS and
4600 Chemistry
Systems and the
VITROS 5600/
XT 7600 Integrated System

VITROS Chemistry Products Cl- Slides Table 1

Similarities
Device
Characteristic	Candidate
VITROS ECO2 Slides	Predicate Device
VITROS ECO2 Slides
K120765
Intended Use	Rx Only. For in vitro diagnostic
use only. VITROS Chemistry
Products ECO2 Slides
quantitatively measure total carbon
dioxide (CO2) concentration in
serum and plasma.	Same
Basic principle	Enzymatic Endpoint	Same
Reactive
Ingredients
per cm2	Phosphoenolpyruvate carboxylase
(bacteria) 0.20 U; malate
dehydrogenase (porcine heart) 0.26
U; phosphoenolpyruvate
0.39 mg and nicotinamide adenine
dinucleotide, reduced 0.44 mg	Same
Wavelength	340 nm	Same
Sample type	Serum, plasma	Same
Sample volume	6 µL	Same
Measuring
Range	5-40 mmol/L	Same
Differences
Device
Characteristic	Candidate
VITROS ECO2 Slides	Predicate Device
VITROS ECO2 Slides
K120765
Instrumentation	VITROS 250/350/950/5,1 FS and
4600 Chemistry Systems and the
VITROS 5600/ XT 7600 Integrated
System	VITROS
250/350/950/5,1 FS and
4600 Chemistry
Systems and the
VITROS 5600
Integrated System

Table 2 VITROS Chemistry Products ECO2 Slides

Similarities
Device
Characteristic	Candidate
VITROS GLU Slides	Predicate Device
VITROS GLU
Slides
(K163433)
Intended Use	Rx Only. For in vitro diagnostic use
only. VITROS Chemistry Products
GLU Slides quantitatively measure
glucose (GLU) concentration in
serum, plasma, urine, and
cerebrospinal fluid	Same
Basic principle
Reactive
Ingredients
per cm²	Colorimetric	Same
	Glucose oxidase ( Aspergillus sp. ) 0.77 U;
peroxidase (horseradish root) 3.6 U;
1,7-dihydroxynaphthalene (dye
precursor) 67 µg and 4-
aminoantipyrine hydrochloride (dye
precursor) 0.11 mg.	Same
Wavelength	540 nm	Same
Sample type	Serum, plasma, urine, CSF	Same
Sample volume	6 µL	Same
Measuring
Range	Serum: 20.0-625.0 mg/dL
Urine and CSF: 20.0-650.0 mg/dL	Same
Differences
Device
Characteristic	Candidate
VITROS GLU Slides	Predicate Device
VITROS GLU
Slides
(K163433)
Instrumentation	VITROS 250/350/950/5,1 FS and
4600 Chemistry Systems and the
VITROS 5600/ XT 7600 Integrated
System	VITROS
250/350/950/5,1 FS
and 4600 Chemistry
Systems and the
VITROS 5600
Integrated System

VITROS Chemistry Products GLU Slides Table 3

Method Comparison

In addition, 125human urine samples were tested for chloride and 125 human urine samples and 125 human CSF samples were tested for glucose on the candidate and predicate test systems. The results are summarized below:

| VITROS
assay | #
Sample
S
Tested | # Samples
MR | N | Regression
Analysis | Slope | Intercept | Test
range | Claimed
Measuring
Range |
|--------------------------|----------------------------|---------------------------|-----|------------------------|-------|-----------|---------------|-------------------------------|
| CL-
Serum
(mmol/L) | 125 | 0 | 125 | Passing
Bablok | 1.00 | -0.11 | 51.2-167.5 | 50.0-175.0 |
| CI-
Urine
(mmol/L) | 125 | 2 | 123 | Weighted
Deming | 1.00 | -0.11 | 15-290 | 15-300 |
| ECO2
Serum
(mg/dL) | 125 | 1 | 124 | Deming | 0.99 | 0.19 | 7.1-38.4 | 5.0-40.0 |
| GLU
serum
(mg/dL) | 125 | 1 | 124 | Weighted
Deming | 1.00 | 0.49 | 22.1-593.8 | 20.0-625.0 |
| GLU
Urine
(mg/dL) | 125 | 0 | 125 | Weighted
Deming | 1.00 | 0.28 | 25.3-600.4 | 20.0-650.0 |
| GLU
csf
(mg/dL) | 125 | 0 | 125 | Weighted
Deming | 1.00 | 0.22 | 22.9-649.5 | 20.0-650.0 |

Summary of VITROS XT 7600 Method Comparison Regression Analysis Data

MR=measuring range

In addition to the above mentioned method comparison studies, testing was performed to determine the precision, linearity, limit of detection, and Interfering substances of the representative VITROS assays on the VITROS XT 7600 System.

Precision

Samples were analyzed using one VITROS XT 7600 Integrated System over 20 days, with 2 runs per day and 2 replicates per specimen (n=80).

System	Fluid ID	Mean	N	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Repeatability (Within Run)						Within Day		Between Day		Between Cal		Within Lab (Total)
7600	CLS-5903-1	86	80	0.4	0.5	0.5	0.6	0.6	0.7	0.6	0.7	1.0	1.2
7600	CLS-5905-2	108	80	0.4	0.4	0.6	0.5	0.7	0.7	0.7	0.6	1.2	1.1
7600	CLS-PP1	66	80	0.3	0.4	0.4	0.5	0.2	0.3	0.5	0.7	0.6	0.9
7600	CLS-PP4	127	80	0.4	0.4	0.6	0.4	0.4	0.3	1.2	0.9	1.4	1.1
7600	CLS-PP5	160	80	0.6	0.4	0.6	0.4	0.4	0.2	1.6	1.0	1.8	1.1
7600	CLS-SRM	106	80	0.4	0.3	0.5	0.5	0.3	0.3	1.0	0.9	1.2	1.1

Cl- Serum (mmol/L) Precision Table

Cl- Urine (mmol/L) Precision Table

System	Fluid ID	Mean	N	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
				Repeatability
(Within Run)		Within
Day		Between
Day		Between
Cal		Within Lab
(Total)
7600	CLU-66791-1	101	80	0.4	0.3	0.6	0.6	0.2	0.2	0.7	0.7	0.9	0.9
7600	CLU-66792-2	189	80	0.5	0.3	0.9	0.5	0.4	0.2	2.1	1.1	2.3	1.2
7600	CLU-PP1	22	80	0.3	1.3	0.5	2.2	0.2	1.0	0.2	0.9	0.6	2.6
7600	CLU-PP3	151	80	0.4	0.3	0.5	0.4	0.5	0.3	0.6	0.4	0.9	0.6
7600	CLU-PP5	249	80	0.7	0.3	1.0	0.4	1.2	0.5	3.6	1.4	3.9	1.6
7600	CLU-URN	67	80	0.3	0.4	0.3	0.5	0.2	0.4	0.5	0.7	0.6	0.9

ECO2 (mmol/L) Precision Table

System	Fluid ID	Mean	N	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Repeatability (Within Run)														Within Day	Between Day	Between Cal	Within Lab (Total)
7600	ECO2-5903-1	26	80	0.3	1.0	0.4	1.4	0.5	1.9	0.0	0.0	0.6	2.4
7600	ECO2-5905-2	16	80	0.3	21.7	0.4	2.5	0.1	0.6	0.3	1.8	0.5	3.1
7600	ECO2-PP1	8	80	0.3	3.2	0.4	4.5	0.1	1.5	0.4	5.6	0.6	7.4
7600	ECO2-PP3	17	80	0.3	1.5	0.3	2.0	0.1	0.6	0.2	1.4	0.4	2.5
7600	ECO2-PP5	33	80	0.3	0.8	0.4	1.3	0.4	1.2	0.3	0.8	0.6	1.9
7600	ECO2-SRM	26	80	0.2	0.8	1.1	4.2	0.4	1.5	0.0	0.0	1.2	4.4

GLU (mg/dL) Serum Precision Table

System	Fluid ID	Mean	N	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Repeatability (Within Run)
Within Day
Between Day
Between Cal
Within Lab (Total)
7600	GLUS32-5903-1	89	80	0.4	0.4	0.6	0.7	0.5	0.6	0.0	0.0	0.8	0.9
7600	GLUS32-5905-2	282	80	1.1	0.4	1.4	0.5	1.9	0.7	1.0	0.4	2.6	0.9
7600	GLUS32-PP1	27	80	0.2	0.7	0.3	1.2	0.3	1.1	0.2	0.9	0.5	1.8
7600	GLUS32-PP3	116	80	0.5	0.4	0.6	0.5	0.5	0.4	0.2	0.2	0.8	0.7
7600	GLUS32-PP5	566	80	1.7	0.3	2.5	0.4	2.4	0.4	5.0	0.9	6.1	1.1
7600	GLUS32-SRM	99	80	0.3	0.3	0.5	0.5	0.5	0.5	0.3	0.3	0.8	0.8

GLU (mg/dL) Urine Precision Table

| System | Fluid ID | Mean | N | Repeatability
(Within Run) | | Within
Day | | Between
Day | | Between
Cal | | Within Lab
(Total) | |
|--------|---------------|------|----|-------------------------------|-----|---------------|-----|----------------|-----|----------------|-----|-----------------------|-----|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 7600 | GLU32-66791-1 | 29 | 80 | 0.2 | 0.6 | 0.4 | 1.3 | 0.3 | 1.2 | 0.4 | 1.4 | 0.7 | 2.2 |
| 7600 | GLU32-66792-2 | 285 | 80 | 1.4 | 0.5 | 2.3 | 0.8 | 0.9 | 0.3 | 0.8 | 0.3 | 2.6 | 0.9 |
| 7600 | GLU32-PP2 | 102 | 80 | 0.4 | 0.4 | 0.7 | 0.7 | 0.6 | 0.6 | 1.2 | 1.2 | 1.5 | 1.5 |
| 7600 | GLU32-PP3 | 232 | 80 | 1.1 | 0.5 | 2.4 | 1.0 | 3.5 | 1.5 | 0.9 | 0.4 | 4.3 | 1.9 |
| 7600 | GLU32-PP5 | 593 | 80 | 1.9 | 0.3 | 2.7 | 0.5 | 6.5 | 1.1 | 7.2 | 1.2 | 10.0 | 1.7 |

GLU (mg/dL) CSF Precision Table

GLU (mg/dL) CSF Precision Table
			Repeatability
(Within Run)		Within Day		Between
Day		Between
Cal		Within Lab
(Total)
System	Fluid ID	Mean	N	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
7600	GLUC32-5706-1	36	80	0.2	0.6	0.3	0.9	0.4	1.0	0.2	0.5	0.5	1.4
7600	GLUC32-5707-2	84	80	0.4	0.5	0.5	0.6	0.3	0.4	0.2	0.2	0.6	0.8
7600	GLUC32-CSF	41	80	0.2	0.5	0.3	0.6	0.3	0.9	0.2	0.4	0.5	1.2
7600	GLUC32-PP1	28	80	0.1	0.5	0.3	1.1	0.3	1.2	0.3	0.9	0.5	1.9
7600	GLUC32-PP4	289	80	1.3	0.5	1.7	0.6	1.4	0.5	2.2	0.7	3.1	1.1
7600	GLUC32-PP5	563	80	2.6	0.5	3.7	0.7	3.6	0.6	2.8	0.5	5.8	1.0

Linearity

The linearity studies support the claimed measuring ranges for the VITROS CI-, VITROS ECO2, and VITROS GLU assays.

Detection Limits

Limit of blank (LoB) studies were performed by testing 4 blank samples. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 216 observations (72 results per reagent lot). The LoB value for each assay was defined as the highest value achieved using blank samples with the stated probability (i.e. α.= 5%). Since the data for all assays were non-gaussian, a non-parametric approach was applied that estimates the LoB using the calculated rank position corresponding to the 95th percentile of the distribution of blank values observed."

Limit of detection (LoD) studies were performed by testing 4 pools of human samples with analyte concentrations close to the expected detection limit for each analyte. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, with the 4 human sample pools every day. for a total of 216 observations (72 results per reagent lot). The data were analyzed according to CLSI EP17-A2, using CLSI-approved statistical software Analyse-it version 4.95.4, Method Validation Edition (Analyse-it Software Limited, Leeds UK). The software calculated LoD using a pooled SD from the low level fluid results and the input LoB value for the assay. determined as described above. The LoD value for the highest resultant value achieved among the combinations of reagent lots and human pools evaluated, with the stated probability (i.e. ß= 5%).

Limit of Quantitation studies were performed using 4 pools of low level samples with analyte concentrations close to the expected LoQ of the corresponding assay. Samples were tested in replicates of 4 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 144 observations (48 results per reagent lot). Ortho defines LoQ as the lowest concentration with an imprecision of ≤20% and percent total allowable error