K Number

Device Name

DIMENSION VISTA FLEX REAGENT CARTRIDGES

Manufacturer

DADE BEHRING, INC.

Date Cleared

2006-07-10

(27 days)

Product Code

LDP CDT CEO CFR CHH DIH DKJ JFJ JGJ JHS JQB KLI KLR KNK LAR LBS LCR LEG LEH MRR

Regulation Number

862.3030

Intended Use

The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose. The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy. The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma. The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy. The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning). The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy. The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy. The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy. The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy. The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Device Description

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system. The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

More Information

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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

K963244, K942640, K941584, K861700, K861700, K031135, K053157, K020724, K033809, K861700, K950180, K861700, K032573, K904301, K862359, K962818, K010871, K862359, K982880, K963267

Reference Devices

K 051087

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a packaging modification for in-vitro diagnostic reagent cartridges used on an automated system. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical assays and their performance equivalence to predicate devices.

Therapeutic

No
Explanation: The device is described as an "in-vitro diagnostic test method" intended to measure various substances in bodily fluids for diagnosis and treatment monitoring, not to directly treat a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the measurements obtained by this device (reagent cartridges for various analytes) are "used in the diagnosis and treatment" of various conditions, such as acetaminophen overdose, pancreatitis, myocardial infarction, liver diseases, diabetes mellitus, lipid disorders, and many others. This directly indicates its role in the diagnostic process. The "Device Description" also refers to the devices as "in-vitro diagnostic test methods (assays)".

SaMD (Software as a Medical Device)

The device is described as reagent cartridges for an in-vitro diagnostic system, which are physical components containing chemical reagents. The submission is for a packaging modification to these physical cartridges.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the devices are "intended to measure" various substances (acetaminophen, amylase, creatine kinase, etc.) in human biological samples (serum, plasma, urine, cerebrospinal fluid). It also clearly states that these measurements are "used in the diagnosis and treatment" of various diseases and conditions. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
Device Description: The "Device Description" section refers to the devices as "prepackaged in-vitro diagnostic test methods (assays)". This is a direct declaration that the devices are IVDs.
Predicate Devices: The listed predicate devices are all described as "Dimension® [Substance] Flex® reagent cartridge", and the submission is for a packaging modification to these "in-vitro diagnostic devices". This further confirms their IVD status.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACTM method is an in vitro diagnostic test for the quantitative measurement of acetaminophen, an analgesic and antipyretic, in human serum and plasma on the Dimension Vista™ System. Acetaminophen measurements may be used in the diagnosis and treatment of acetaminophen overdose.

The AMY method is an in vitro diagnostic test for the quantitative measurement of amylase in human serum, plasma, and urine on the Dimension Vista™ System.

The CK method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista™ System.

The CHOL method is an in vitro diagnostic test for the quantitative measurement of cholesterol in human serum and plasma on the Dimension Vista™ System.

The GGT method is an in vitro diagnostic test for the quantitative measurement of gamma-glutamyl transferase in human serum and plasma on the Dimension Vista™ System.

The GLU method is an in vitro diagnostic test for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on the Dimension Vista™ System.

The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol in human serum and plasma on the Dimension Vista™ System. Measurements of high-density lipoprotein cholesterol are used as an aid to diagnose lipid disorders.

The LDLC method is an in vitro diagnostic test for the quantitative measurement of low-density lipoprotein cholesterol in human serum and plasma on the Dimension Vista™ System. Measurements of low-density lipoprotein cholesterol are used in the diagnosis and treatment of lipid disorders such as diabetes mellitus, atherosclerosis and various liver and renal diseases.

The LIDO method is an in vitro diagnostic test for the quantitative measurement of lidocaine in human serum and plasma on the Dimension Vista™ System. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose, and in therapeutic drug monitoring.

The MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista™ System.

The PCHE method is an in vitro diagnostic test for the quantitative measurement of pseudocholinesterase activity in human serum and plasma on the Dimension Vista™ System. PCHE measurements may be used in the diagnosis and treatment of cholinesterase inhibition disorders.

The PHOS method is an in vitro diagnostic test for the quantitative measurement of phosphorus in human serum, plasma, and urine on the Dimension Vista™ System.

The PROC method is an in vitro diagnostic test for the quantitative measurement of procainamide in human serum and plasma on the Dimension Vista™ System. Procainamide measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring.

The SAL method is an in vitro diagnostic test for the quantitative measurement of salicylate in human serum on the Dimension Vista™ System. Salicylate test results may be used in the diagnosis and treatment of salicylate overdose and for monitoring salicylate levels during therapy.

The T4 method is an in vitro diagnostic test for the quantitative measurement of total thyroxine in human serum and plasma on the Dimension Vista™ System.

The TOBR method is an in vitro diagnostic test for the quantitative measurement of tobramycin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Tobramycin measurements may be used in the diagnosis an treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The TRIG method is an in vitro diagnostic test for the quantitative measurement of triglycerides in human serum and plasma on the Dimension Vista™ System. Measurements obtained are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.

The URCA method is an in vitro diagnostic test for the quantitative measurement of uric acid in human serum, plasma, and urine on the Dimension Vista™ System.

The VALP method is an in vitro diagnostic test for the quantitative measurement of valproic acid in human serum and plasma on the Dimension Vista™ System. Valproic acid measurements may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The VANC method is an in vitro diagnostic test for the quantitative measurement of vancomycin, a glycopeptide antibiotic, in human serum and plasma on the Dimension Vista™ System. Vancomycin measurements may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

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

LDP, JFJ, JHS, CHH, JQB, CFR, LBS, MRR, KLR, JGJ, DIH, CEO, LAR, DKJ, KLI, LCR, CDT, KNK, LEG, LEH

Device Description

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

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)

Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance. The Flex® reagent cartridges are substantially equivalent in design, principle, and performance to the Dimension® system Flex® reagent cartridges. They have the same intended use and indications for use.

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.

K963244, K942640, K941584, K861700, K861700, K031135, K053157, K020724, K033809, K861700, K950180, K861700, K032573, K904301, K862359, K962818, K010871, K862359, K982880, K963267

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.

K 051087

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

§ 862.3030 Acetaminophen test system.

(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.

Summary

K061655

JUL 1 0 2006

510(k) Summary of Safety and Effectiveness 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.

Submitter's Name:	Lorraine H Piestrak
	Dade Behring Inc.
	P.O. Box 6101
	Newark, DE 19714-610

June 12, 2005 Date of Preparation:

Name of Products:

Dimension VistaTM Acetaminophen (ACTM) Flex® reagent cartridge Dimension Vista™ Amylase (AMY) Flex® reagent cartridge Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge Dimension Vista™ Glucose (GLU) Flex® reagent cartridge Dimension Vista™ High Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge Dimension Vista™ Low Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge Dimension Vista™ Magnesium (MG) Flex® reagent cartridge Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge Dimension VistaTM Phosphorus (PHOS) Flex® reagent cartridge Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge

FDA Classification Name:

Classification Name:	Common/Usual Name:
862.3030 Acetaminophen test system	Acetaminophen test system
862.1070 Amylase test system	Amylase test system
862.1215 Creatine kinase test system	Creatine kinase test system
862.1175 Cholesterol (total) test system	Cholesterol test system
862.1360 Gamma-glutamyl transpeptidase test system	GGT test system
862.1345 Glucose test system	Glucose test system
862.1475 Lipoprotein test system (HDL)	HDL Cholesterol test system

862.1475 Lipoprotein test system (LDL)	LDL Cholesterol test system
862.3555 Lidocaine test system	Lidocaine test system
862.1495 Magnesium test system	Magnesium test system
862.3240 Cholinesterase test system	Pseudocholinesterase test system
862.1580 Phosphorus (inorganic) test system	Phosphorus test system
862.3320 Digoxin test system ( Procainamide)	Procainamide test system
862.3830 Salicylate test system	Salicylate test system
862.1700 Total thyroxine test system	Total T4 test system
862.3900 Tobramycin test system	Tobramycin test system
862.1705 Triglyceride test system	Triglyceride test system
862.1775 Uric acid test system	Uric acid test system
862.3645 Neuroleptic drugs radioreceptor assay test system	Valproic Acid test system
862.3950 Vancomycin test system	Vancomycin test system

Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

| New Product | Predicate | Predicate
510(k) # | Device
Class | Regulation | Product
Code |
|-----------------------------------------------------|------------------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™
ACTM Flex®
reagent cartridge | Dimension® ACTM
Flex® reagent
cartridge | K963244 | II | 862.3030 | LDP |
| Dimension Vista™
AMY Flex®
reagent cartridge | Dimension® AMY
Flex® reagent
cartridge | K942640 | II | 862.1070 | JFJ |
| Dimension Vista™
CK Flex® reagent
cartridge | Dimension® CK
Flex® reagent
cartridge | K941584 | II | 862.1215 | JHS |
| Dimension Vista™
CHOL Flex®
reagent cartridge | Dimension® CHOL
Flex® reagent
cartridge | K861700 | I* | 862.1175 | CHH |
| Dimension Vista™
GGT Flex®
reagent cartridge | Dimension® GGT
Flex® reagent
cartridge | K861700 | I* | 862.1360 | JQB |
| Dimension Vista™
GLU Flex®
reagent cartridge | Dimension® GLUC
Flex® reagent
cartridge | K031135 | II | 862.1345 | CFR |
| Dimension Vista™
HDLC Flex®
reagent cartridge | Dimension® AHDL
Flex® reagent
cartridge | K053157 | I* | 862.1475 | LBS |
| Dimension Vista™
LDLC Flex®
reagent cartridge | Dimension® ALDL
Flex® reagent
cartridge | K020724 | I* | 862.1475 | MRR |
| New Product | Predicate | Predicate
510(k) | Device
class | Regulation | Product
Code |
| Dimension Vista™
LIDO Flex®
reagent cartridge | Dimension® LIDO
Flex® reagent
cartridge | K033809 | II | 862.3555 | KLR |
| Dimension Vista™
MG Flex® reagent
cartridge | Dimension® MG
Flex® reagent
cartridge | K861700 | I* | 862.1495 | JGJ |
| Dimension Vista™
PCHE Flex®
reagent cartridge | Dimension® PCHE
Flex® reagent
cartridge | K950180 | I* | 862.3240 | DIH |
| Dimension Vista™
PHOS Flex®
reagent cartridge | Dimension® PHOS
Flex® reagent
cartridge | K861700 | I* | 862.1580 | CEO |
| Dimension Vista™
PROC Flex®
reagent cartridge | Dimension® PROC
Flex® reagent
cartridge | K032573 | II | 862.3320 | LAR |
| Dimension Vista™
SAL Flex® reagent
cartridge | Dimension® SAL
Flex® reagent
cartridge | K904301 | II | 862.3830 | DKJ |
| Dimension Vista™
T4 Flex® reagent
cartridge | Dimension® T4
Flex® reagent
cartridge | K862359 | II | 862.1700 | KLI |
| Dimension Vista™
TOBR Flex®
reagent cartridge | Dimension® TOBRA
Flex® reagent
cartridge | K962818 | II | 862.3900 | LCR |
| Dimension Vista™
TRIG Flex®
reagent cartridge | Dimension® TGL
Flex® reagent
cartridge | K010871 | I* | 862.1705 | CDT |
| Dimension Vista™
URCA Flex®
reagent cartridge | Dimension® URCA
Flex® reagent
cartridge | K862359 | I* | 862.1775 | KNK |
| Dimension Vista™
VALP Flex®
reagent cartridge | Dimension® VALP
Flex® reagent
cartridge | K982880 | II | 862.3645 | LEG |
| Dimension Vista™
VANC Flex®
reagent cartridge | Dimension® VANC
Flex® reagent
cartridge | K963267 | II | 862.3950 | LEH |

Not exempt from premarket notification per 862.9 or per Reserved Medical Devices list

Device Description:

was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

Intended Use:

Acetaminophen

Amylase

The AMY method is an in vitro diagnostic test for the quantitative measurement of amylase in human serum, plasma, and urine on the Dimension Vista™ System.

Creatine Kinase

The CK method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista™ System.

Cholesterol

The CHOL method is an in vitro diagnostic test for the quantitative measurement of cholesterol in human serum and plasma on the Dimension Vista™ System.

Gamma-glutamyl transferase

The GGT method is an in vitro diagnostic test for the quantitative measurement of gamma-glutamyl transferase in human serum and plasma on the Dimension Vista™ System.

Glucose

The GLU method is an in vitro diagnostic test for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on the Dimension Vista™ System.

High-Density Lipoprotein Cholesterol

The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol in human serum and plasma on the Dimension

Vista™ System. Measurements of high-density lipoprotein cholesterol are used as an aid to diagnose lipid disorders.

Low-Density Lipoprotein Cholesterol

The LDLC method is an in vitro diagnostic test for the quantitative measurement of lowdensity lipoprotein cholesterol in human serum and plasma on the Dimension Vista™ System. Measurements of low-density lipoprotein cholesterol are used in the diagnosis and treatment of lipid disorders such as diabetes mellitus, atherosclerosis and various liver and renal diseases.

Lidocaine

Magnesium

The MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista™ System.

Pseuodcholinesterase

Phosphorus

The PHOS method is an in vitro diagnostic test for the quantitative measurement of phosphorus in human serum, plasma, and urine on the Dimension Vista™ System.

Procainamide

Salicylate

Thyroxine

The T4 method is an in vitro diagnostic test for the quantitative measurement of total thyroxine in human serum and plasma on the Dimension Vista™ System.

Tobramycin

Triglyceride

Uric Acid

The URCA method is an in vitro diagnostic test for the quantitative measurement of uric acid in human serum, plasma, and urine on the Dimension Vista™ System.

Valproic Acid

Vancomycin

Comparison to Predicate Device:

Both the Dimension Vista™ Flex® reagent cartridges and the predicate Dimension® Flex® reagent cartridges contain prepackaged reagents in flexible plastic, cartridges. A comparison of the important similarities and differences between the two Flex® cartridges is provided in the following table:

| Feature | Dimension Vista™
Flex® reagent cartridge | Dimension® Analyzer
Flex® reagent cartridge |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Reagents | Prepackaged, 12-well plastic, Dade
Behring Flex® reagent cartridges | Prepackaged, 6 & 8 well plastic, Dade
Behrlng Flex® reagent cartridges |
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Indications for Use | Same as Dimension® analyzer | As described in 510(k)s for each
previously cleared method. |
| Final concentration
of sample/reagent
ratio in test milieu | Same as Dimension® analyzer | As described in 510(k)s for each
previously cleared method |
| Tablet Sizes | 7/32" | 7/32" & 9/32" |
| Total tests contained
in each Flex®
cartridge | Approximately three times more
than contained in Dimension®
Flex® reagent cartridges | As described in 510(k)s for each
previously cleared method. |
| Calibration | 30 to 90 days
(determined for each method) | 30 to 90 days
As described in 510(k)s for each
previously cleared method. |

Comments on Substantial Equivalence:

The Dade Behring Dimension Vista™ Flex® reagent cartridges and the Dimension® Flex® reagent cartridges are designed similarly for the same purpose. Both contain prepackaged reagents for in-vitro diagnostic tests that are processed on microprocessorcontrolled, integrated instrument systems to analyze a variety of analytes in human specimens.

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modifications, do not affect the intended use of the devices, nor do they alter the fundamental scientific technology of the devices.

Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance.

Conclusion:

The Flex® reagent cartridges, containing reagents for testing ACTM, AMY, CK, CHOL, GGT, GLU, HDLC, LDLC, LIDO, MG, PCHE, PHOS, PROC, SAL, T4, TOBR, TRIG, URCA, VALP, and VANC on the Dimension® Vista™ Integrated system are substantially equivalent in design, principle, and performance to the Dimension® system Flex® reagent cartridges. They have the same intended use and indications for use. Comparative testing also demonstrates substantially equivalent performance.

Kairaine H. Priestner

braine H Piestrak Regulatory Affairs & Compliance Manager June 12, 2006

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like emblem with three overlapping shapes resembling human figures. The emblem is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in capital letters.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manager Dade Behring, Inc. 500 GBC Drive PO Box 6101, M/S 514 Newark, DE 19714-6101

JUL 1 0 2006

Re: K061655

Trade/Device Name: See attached list of device trade names Regulation Number: 21 CFR§862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP, JFJ, JHS, CHH, JQB, CFR, LBS, MRR, KLR, JGJ, DIH, CEO, LAR, DKJ, KLI, LCR, CDT, KNK, LEG, LEH Dated: June 12, 2006 Received: June 13, 2006

Dear Ms. Piestrak;

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, Orug, 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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CIFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Device/Trade Names:

Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge Dimension Vista™ Amylase (AMY) Flex® reagent cartridge Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge Dimension VistaTM Glucose (GLU) Flex® reagent cartridge Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge Dimension Vista™ High Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge Dimension Vista™ Low- Density Lipoprotein Cholesterol Flex(LDLC)® reagent cartridge Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge Dimension Vista™ Magnesium (MG) Flex® reagent cartridge Dimension Vista™ Pseudocholinsterase (PCHE) Flex® reagent cartridge Dimension VistaTM Phosphorus (PHOS) Flex® reagent cartridge Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge

510(k) Number (if known):

Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge Device Name:

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of Jo

Carol Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

1139(k) K061655

510(k) Number (if known):

Dimension Vista™ Amylase (AMY) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page Lof 20

Carol C Benson
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K061655

510(k) Number (if known):

Device Name: Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page of of 20

Carol C. Beum
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K061655

510(k) Number (if known):

Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page of of 20

510(k) Number (if known):

Device Name: Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ______________ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson

vision Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

K061655

Page of of H)

510(k) Number (if known):

Device Name: Dimension Vista™ Glucose (GLU) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use --------(21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page of 20

Carol C Benson
Revision Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

KO61655

510(k) Number (if known):

Dimension Vista™ High Density Lipoprotein Cholesterol Device Name: (HDLC) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benam

Office of In Vitro Diagnostic Device Evaluation and Safety

061655

Page of of 20

510(k) Number (if known):

Dimension Vista™ Low-Density Lipoprotein Cholesterol Device Name: (LDLC) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 8 of 20

Carol C. Benson

31011 Sign-Oll

Office of In Vitro Diagnostic Device Evaluation and Safety

KO61655

510(k) Number (if known):

Device Name: Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 9 of 20

Carol C. Benson

1 31213-61

Cice of In Vitro Diagnostic Device Evaluation and Safety

Image /page/19/Picture/14 description: The image contains handwritten text that appears to be an identifier or code. The text reads 'K-0616 SS', with a hyphen separating the 'K' from the numbers. The handwriting is somewhat stylized, giving the text a unique and personal touch.

510(k) Number (if known):

Dimension Vista™ Magnesium (MG) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 10f 20

Carol C. Benson

O Hoe of In Vitro Diagnostic Device E. raluation and Safety

K061655

510(k) Number (if known):

Device Name: Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page of of 20

Cauof C. Benson

Tipe of In Vitro Diagnostic Device ultration and Safety