(74 days)
Not Found
No
The description focuses on automated laboratory procedures and standard analytical technologies (photometric, turbidimetric, chemiluminescence, nephelometric, ion selective multisensor). There is no mention of AI, ML, or any learning algorithms.
No.
This device is an in vitro diagnostic device used for measuring various analytes in human body fluids for diagnostic purposes, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Dade Behring Dimension Vista™ Integrated system is an "in vitro diagnostic device." It also mentions that measurements obtained by the various components are "used in the diagnosis and treatment" of various conditions like renal and metabolic diseases, abnormal protein metabolism, phenobarbital use or overdose, myocardial infarction, aldosteronism, diabetes insipidus, and other electrolyte imbalances.
No
The device description clearly states it is a "floor model, fully automated, microprocessor-controlled, integrated instrument system" that uses "prepackaged Dade Behring Flex® reagent test cartridges" and utilizes various detection technologies. This indicates significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Dade Behring Dimension Vista™ Integrated system is an in vitro diagnostic device..."
- Purpose of the Device: The intended use describes the device's function as determining a variety of analytes in human body fluids to aid in the diagnosis and treatment of various diseases and conditions. This is the core purpose of an in vitro diagnostic device.
- Components are IVDs: The descriptions of the individual reagent cartridges, calibrators, and controls also indicate their use in a test system to measure analytes in human specimens for medical purposes, which aligns with the definition of IVD components.
N/A
Intended Use / Indications for Use
The Dade Behring Dimension Vista™ Integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Vista™ system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
The Urea Nitrogen Flex® reagent cartridge (BUN) is intended for the quantitative measurement of urea nitrogen (an end product of urea nitrogen metabolism) in human serum, plasma, and urine on the Dimension VistaTM system.
The Immunoglobulin G Flex® reagent cartridge (IGG) is intended for the quantitative measurement of immuoglobulin G (IgG) in human serum and plasma on the Dimension Vista™ system.
The Phenobarbital Flex® reagent cartridge (PHNO) is intended for the quantitative measurement of phenobarbital in human serum and plasma on the Dimension Vista™ system.
The Mass creatine kinase MB isoenzyme Flex® reagent cartridge (MMB) is intended for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista™ system for the confirmation of acute myocardial infarction.
The V-L YTE™ Integrated Multisensor is intended for the quantitative measurement of sodium, potassium, and chloride in human serum, plasma, and urine on the Dimension Vista™ system.
The Chemistry I calibrator is intended for the calibration of the Urea Nitrogen (BUN) method on the Dimension Vista™ system.
The Protein 1 calibrator is intended for the calibration of the Immunoglobulin G (IGG) method on the Dimension Vista™ system.
The Protein 1 controls, H, M. & L are intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin G (IGG) results on the Dimension Vista™ system.
The Drug 1 calibrator is intended for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ system.
The Mass CKMB Isoenzyme calibrator is intended for the calibration of the creatine kinase MB isoenzyme (MMB) method on the Dimension Vista™ system.
The V-LYTE™ Standard A & B are intended for the calibration of the Na'/K /Cl methods on the Dimension Vista™ system.
Product codes (comma separated list FDA assigned to the subject device)
CDQ, CEM, CFQ, CGZ, DLZ, JGS, JHY, JIT, JIX, JJY, CKA, JJE
Device Description
The Dade Bchring Dimension Vista™ Integrated system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Dade Behring Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multifunctional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminesence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Vista™ system includes a communications and connectivity workstation (Easy Link™) for interaction with laboratory information system (L1S) networks, monitoring the usage of the system to suggest preventive maintenance, and QC result management.
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)
Split processed onlined banka demonstrates equivalent performance in evaluations of the representative methods.
| Dimension Vista™ | Predicate | Sample Type | Slope | Intercept | Correlation Coefficient (r) | n |
|---|---|---|---|---|---|---|
| BUN | Dimension® BUN | Serum/Plasma | 1.03 | 0.92 | 0.998 | 111 |
| Urine | 0.92 | 18.6 | 0.988 | 75 | ||
| IGG | Dimension ® IGG | Serum/Plasma | 0.92 | 1.89 | 0.985 | 98 |
| PHNO | Dimension ® PHNO | Serum/Plasma | 1.04 | 1.7 | 0.995 | 75 |
| MMB | Dimension ® MMB | Serum/Plasma | 1.05 | 1.4 | 0.997 | 136 |
| V-LYTE™ Na+ | Dimension ® QuikLYTE™ Na+ | Serum/Plasma | 1.02 | -1.3 | 0.997 | 103 |
| Urine | 0.98 | 2.5 | 0.998 | 52 | ||
| V-LYTE™ K+ | Dimension ® QuikLYTE™ K+ | Serum/Plasma | 1.01 | -0.06 | 0.999 | 103 |
| Urine | 1.00 | 0.12 | 0.999 | 52 | ||
| V-LYTE™ Cl- | Dimension ® QuikLYTE™ Cl- | Serum/Plasma | 1.02 | -0.3 | 0.998 | 104 |
| Urine | 1.02 | -3.3 | 0.998 | 51 |
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.
K944093, K860021, K990551, K012470, K012468, K944932, K011035, K970343, K970336, K970330
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
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
K05-1087]
JUL 1 ] 2005
DADE BEHRING
and the comments of
:
DADE BEHRING INC P.O. Box 6101 Newark, DE 19714
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 19714-6101 |
April 27, 2005 Date of Preparation:
Name of Product:
Dimension Vista™ Integrated system Dimension Vista™ Urea Nitrogen Flex® reagent cartridge (BUN) Dimension Vista™ Chemistry 1 Calibrator Dimension Vista™ Immunoglobulin G Flex® reagent cartridge (IGG) Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Controls, H, M, L Dimension Vista™ Phenobarbital Flex® reagent cartridge (PHNO) Dimension Vista™ Drug 1 Calibrator Dimension Vista™ Mass creatine kinase MB isoenzyme Flex® reagent cartridge (MMB) Dimension Vista™ MMB Calibrator Dimension Vista™ V-LYTE™ Integrated Multisensor (Na'/K'/CT) Dimension Vista™ V-LYTE™ Standard A and Standard B
FDA Classification Name:
Discrete photometric chemistry analyzer for clinical use (Class I)
Urea Nitrogen, immunoglobulin G, phenobarbital, mass creatine kinase MB isochzyme, sodium, potassium and chloride test systems, their associated calibrators, and controls (Class II).
008026
1
Predicate Device:
The following table describes the predicate device classification, regulation and product code associated with this pre-market notification:
| New
Product | Predicate
Device | Predicate
510(k) | Device
Class | Regulation | Product
Code |
|------------------------------------------------------------------|------------------------------------------------------------|---------------------|-----------------|------------------------------------------|-------------------|
| Dimension Vista ™ 1500
Integrated chemistry system | Dimension® XL/RxL
clinical chemistry analyzer | K944093 | I | 862.2160 | JJE |
| Dimension Vista™ BUN
Flex® reagent cartridge | Dimension® BUN
Flex® reagent cartridge | K860021 | II | 862.1770 | CDQ |
| Dimension Vista™
Chemistry 1 Calibrator | Dimension® Chem 1
Calibrator | K860021 | II | 862.1150 | JIX |
| Dimension Vista™ IGG
Flex® reagent cartridge | Dimension ® IGG
Flex® reagent cartridge | K990551 | II | 866.5510 | CFQ |
| Dimension Vista™ Protein I
Calibrator | N Protein Standard SL | K012470 | II | 862.1150 | JIX |
| Dimension Vista™ Protein 1
Controls H, M. L | N/T Protein Controls SL | K012468 | II | 862.1660 | JJY |
| Dimension Vista™ PHNO
Flex® reagent cartridge | Dimension ® PHNO
Flex® reagent cartridge | K944932 | II | 862.3660 | DLZ |
| Dimension Vista™ Drug 1
Calibrator | Dimension® Drug
Calibrator | K011035 | II | 862.1150 | JIX |
| Dimension Vista™ MMB
Flex® reagent cartridge | Dimension® MMB
Flex® reagent cartridge | K970343 | II | 862.1215 | JHY |
| Dimension Vista™ MMB
Calibrator | Dimension® MMB
Calibrator | K970336 | II | 862.1150 | JIT |
| Dimension Vista™ V-LYTETM
Integrated Multisensor
Na+/K+/Cl | Dimension® Indirect IMT
system (QuikLYTE®)
Na+/K+/Cl | K970330 | II | K-862.1600
Na-862.1665
Cl-862.1170 | CEM
JGS
CGZ |
| Dimension Vista™ V-LYTETM
Standard A & Standard B | Dimension® QuikLYTE®
Standard A & Standard B | K860021 | II | 852.1150 | JIT |
Device Description:
The Dade Bchring Dimension Vista™ Integrated system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Dade Behring Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multifunctional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminesence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Vista™ system includes a communications and connectivity workstation (Easy Link™) for interaction with laboratory information system (L1S) networks, monitoring the usage of the system to suggest preventive maintenance, and QC result management.
2
Intended Use:
The Dade Behring Dimension Vista™ Integrated system is an in vitro diagnostic device intended to t he Dade Benting & monel orocedures such as pipetting, mixing, heating, and measuring spectral duptions marrati mary noan ete of analytes in human body fluids. Vista™ system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
Representative Methods Intended Use:
The Urea Nitrogen Flex® reagent cartridge (BUN) is intended for the quantitative measurement of urea nitrogen (an end product of urea nitrogen metabolism) in human serum, plasma, and urine on the Dimension VistaTM system.
The Immunoglobulin G Flex® reagent cartridge (IGG) is intended for the quantitative measurement of immuoglobulin G (IgG) in human serum and plasma on the Dimension Vista™ system.
The Phenobarbital Flex® reagent cartridge (PHNO) is intended for the quantitative measurement of phenobarbital in human serum and plasma on the Dimension Vista™ system.
The Mass creatine kinase MB isoenzyme Flex® reagent cartridge (MMB) is intended for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista™ system for the confirmation of acute myocardial infarction.
The V-L YTE™ Integrated Multisensor is intended for the quantitative measurement of sodium, potassium, and chloride in human serum, plasma, and urine on the Dimension Vista™ system.
The Chemistry I calibrator is intended for the calibration of the Urea Nitrogen (BUN) method on the Dimension Vista™ system.
The Protein 1 calibrator is intended for the calibration of the Immunoglobulin G (IGG) method on the Dimension Vista™ system.
The Protein 1 controls, H, M. & L are intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin G (IGG) results on the Dimension Vista™ system.
The Drug 1 calibrator is intended for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ system.
The Mass CKMB Isoenzyme calibrator is intended for the calibration of the creatine kinase MB isoenzyme (MMB) method on the Dimension Vista™ system.
The V-LYTE™ Standard A & B are intended for the calibration of the Na'/K /Cl methods on the Dimension Vista™ system.
3
Comparison to Predicate Device:
Both the Dimension Vista™ Integrated system and the predicate Dimension® RxL clinical chemistry Bom the Dimension Visia - meegrated of exible plastic, Dade Behring Flex® reagent system employ prepackaged reagents in nextore places, but itsal samples using a variety of in vitro diagnostic test methods. Both systems utilize integrated, ion selective multisense of the villed diagnosite test methods. "Don't systems and chloride electrolytes. A comparison of the technology for analysis of socially, polassialin and only as the may are systems is provided in the following table:
| Feature | Dimension Vista™ System | Dimension® RxL Analyzer |
|---|---|---|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| System Control | Fully automatic, | |
| microprocessor controlled | Fully automatic, | |
| microprocessor controlled | ||
| User Interface | Keyboard control | |
| Hand held barcode reader | ||
| Stationary barcode scanners | ||
| Graphical user interface | ||
| On line help | Keyboard control | |
| Stationary barcode scanners | ||
| Graphical user interface | ||
| On line help | ||
| Detection | ||
| Technologies | photometric | |
| turbidimetric | ||
| chemiluminescence | ||
| nephelometric | ||
| multisensor electrodes, ion | ||
| selective | photometric | |
| turbidimetric | ||
| multisensor electrodes, ion selective | ||
| Reagents | Prepackaged, 12-well plastic, Dade | |
| Behring Flex® reagent cartridges, | ||
| stored on board | Prepackaged, 6 & 8 well plastic, Dade | |
| Behring Flex® reagent cartridges | ||
| stored on board | ||
| Calibrators | Stored on board | User places on system as needed |
| System fluids and | ||
| Supplies | Stored on board | Stored on board |
| Reaction Vessels | hard plastic cuvettes & | |
| plastic reaction vessels | soft, plastic cuvettes & | |
| plastic reaction vessels | ||
| Temperature control | Reactions are controlled at 37°C | |
| Reagents are stored at 2 to 8 °C | Reactions are controlled at 37°C | |
| Reagents are stored at 2 to 8 °C | ||
| Spectral Selection | Interference filters - | |
| xenon flash lamp source | Interference filters - | |
| quartz/halogen lamp source | ||
| Test Throughput | ||
| (typical) | Up to 1500 tests/hr | Up to 500 tests/hr |
| LIS external | ||
| connectivity | ||
| capability | Yes | Yes |
4
| Feature | Dimension Vista™ System | Dimension® RxL Analyzer |
|---|---|---|
| System | ||
| Performance | ||
| Monitoring | Automatic preventive maintenance | |
| (usage - based) | Traditional preventative maintenance | |
| (time-based) | ||
| Sample Level | ||
| Detection Capability | Automatic | Automatic |
| Calibration/QC | Automatic and Manual | |
| calibration/QC | Manual calibration/QC | |
| Sample Integrity | ||
| (hemolysis, icterus, | ||
| lipemia) Monitoring | Yes - spectral interference | |
| monitoring (optional) | Yes- spectral interference | |
| monitoring (optional) |
Comments on Substantial Equivalence:
Comments on Substantial Equivaneared.
The automated Dade Behring Dimension® RxL and Dimension Vista™ Integrated The automated Dade Bearing Dimenstrone worpose. Both are floor model units that are Systems are designed sinmary 10. and bases prepackaged, Dade microprocessor-controned, integrated ion selective multisensor technology to analyze a variety of analytes in human body fluids. Both systems spectrally analyze andryze a variety of andrytos in nemanochemical methodologies. Split processod onlined banka demonstrates equivalent performance in evaluations of the representative methods.
| Dimension
Vista™ | Predicate | Sample
Type | Slope | Intercept | Correlation
Coefficient (r) | n |
|---------------------|---------------|----------------|-------|-----------|--------------------------------|-----|
| BUN | Dimension® | Serum/Plasma | 1.03 | 0.92 | 0.998 | 111 |
| | BUN | Urine | 0.92 | 18.6 | 0.988 | 75 |
| IGG | Dimension ® | Serum/Plasma | 0.92 | 1.89 | 0.985 | 98 |
| | IGG | | | | | |
| PHNO | Dimension ® | Serum/Plasma | 1.04 | 1.7 | 0.995 | 75 |
| | PHNO | | | | | |
| MMB | Dimension ® | Serum/Plasma | 1.05 | 1.4 | 0.997 | 136 |
| | MMB | | | | | |
| V-LYTE™ | Dimension ® | Serum/Plasma | 1.02 | -1.3 | 0.997 | 103 |
| Na+ | QuikLYTE™ Na+ | Urine | 0.98 | 2.5 | 0.998 | 52 |
| V-LYTE™ | Dimension ® | Serum/Plasma | 1.01 | -0.06 | 0.999 | 103 |
| K+ | QuikLYTE™ K+ | Urine | 1.00 | 0.12 | 0.999 | 52 |
| V-LYTE™ | Dimension ® | Serum/Plasma | 1.02 | -0.3 | 0.998 | 104 |
| Cl- | QuikLYTE™ Cl- | Urine | 1.02 | -3.3 | 0.998 | 51 |
Representative Method Comparison Data Dimension Vista™ vs. Predicate Method
5
Conclusion:
Conclusion:
The automated Dimension® RxL and Dimension Vista™ Integrated systems are I he anomated Dimensione TRA and performance based on the similarity of system substantially equivalent in principons using methods representative of each of the Vista™ system detection technologies. In addition, the representative test methods Vista - System detoon on occassium and chloride) when compared to their predicates are equivalent in performance and design.
Lorraine A. Reskiak
Lorraine H Piestrak Regulatory Affairs & Compliance Manager April 27, 2005
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/6/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The seal is simple and monochromatic.
JUL 1 1 2005
Food and Drug Administrat 2098 Gaither Road Rockville MD 20850
Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manager Dade Behring, Inc. Chemistry/ Immunochemistry P.O. Box 6101 Bldg 500; M.S. 514 Newark, DE 19714
K051087 Re:
Trade/Device Name: Dimension Vista™ Integrated System Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Regulatory Class: Class H
Product Code: CDQ, CEM, CFQ, CGZ, DLZ, JGS, JHY, JIT, JIX, JJY, CKA, JJE Dated: July 1, 2005 Received: July 5, 2005
Dear Ms. Piestrak:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beceeer on the device is substantially equivalent (for the indications ferenced above und have very to legally marketed predicate devices marketed in interstate for use sured in the encrease of 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, de rices mat have occh require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rou may, dierelere, mains of the Act include requirements for annual registration, listing of general controls proving 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to bach adderal 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 r lease be devilode that i Dr runation that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith 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 (QS) regulation (21 CFR Part 820).
7
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification: "The PDS 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, IT you desire specific information accuration of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the villo Diagnostic Dovice Dranding by reference to premarket notification" (21CFR Part 807.97). Tegulation chitica, TMISORananing of Trion on your responsibilities under the Act from the Tou thay other of Scheral meethanenenal 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,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
510(k) Number (if known):
Dimension Vista™ Integrated System Device Name:
Indications For Use:
The Dade Behring Dimension Vista™ Integrated system is an in viiro diamostic device intended to The Dade Behring Dimension Vista --------------------------------------------------------------------------------------------------------------------------------------------duplicate manual analytical procedures such as pipetang, wisting system chemical and intensities to determine a variety of analytes in hamar - relation of the - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 immunochemical appreations disensor technology for clinical use.
Lorraine H Pestiak
Lorraine H Piestrak Regulatory Affairs & Compliance Manager April 27, 2005
Use
Prescription Use (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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
210(k)_051087
9
1051087
510(k) Number (if known):
Device Name:
Dimension Vista™ Urea Nitrogen Flex® reagent cartridge (BUN) Dimension Vista™ Chem I Calibrator
Indications For Use:
The Dimension Vista™ Urea Nitrogen Flex® reagent cartridge (BDN) is a device intended to
r and uring The Dimension Vistal™ Orea Nitrogen netaboliege (a serum, plasma, and urine.
measure urea nitrogen (an end-product of nitrogen metabolism) in seriain rena measure urea nitrogen (an end-product of mitrogen metalonism) in order (1)
Measurements obtained by this device are used in the diagnosis and treatment of eertain renal and metabolic diseases.
The Dimension Vista™ Chem I Calibrator is intended for medical purposes for use in a test The Dimension Vista™ Chem I Canolator is intended for measur provincies in the system to estaonerea nitrogen in human specimens.
Lorraine H Piestrak
Lorraine H Piestrak Regulatory Affairs & Compliance Manager April 27, 2005
Prescription Use (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 (O(VD)
Division Sign-Off
Page of 6
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 051087
10
510(k) Number (if known): KU
510(k) Number (if known): K05 1087
Device Name:
Dimension Vista™ Immunoglobulin G Flex® reagent cartridge (IGG) Dimension Vista™ Protein I Calibrator Dimension Vista™ Protein 1 Controls, H, M, L
Indications For Use:
The Dimension Vista™ Immunoglobulin G Flex® reagent cartridge (IGG) is a device that The Dimension Vista™ Immunochemical techniques the immunoclobulin G
consists of the reagents used to measure by immunodoulin G alle immunostralia consists of the reagents used to measure by intimional of inimaly with in the diagnosis
(serum antibody) in serum and plasma. Measurement of immersions agents, (serum antibody) in serum and plastia. "Weasurement of thinking of ability to resist infectious agents.
The abnormal protein metabolism and the body's lack of ability to resi
The Dimension Vista™ Protein 1 Calibrator is intended for medical purposes for use in a test The Dimension Vista™ Profess I Canorator is mendou for more of values in the measurement of IgG in human specimens.
The Dimension Vista™ Protein 1 Controls, H. M, L, are intended for medical purposes for use in The Dimension Vista™ Procein I Colifors, IT. M, E, are monorous and a test system to est or analytical instrument variation.
Tourcene H Pestiak
Lorraine II Piestrak Regulatory Affairs & Compliance Manager April 27, 2005
Prescription Use (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 CDR Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 3 of 6
Office of In Vitro Diagnostic Device Evaluation and Safety
051087 510(k)_
11
K051087 510(k) Number (if known):
Device Name:
Dimension Vista™ Phenobarbital Flex® reagent cartridge (PHNO) Dimension Vista™ Drug 1 Calibrator
Indications For Use:
The Dimension Vista™ Phenobarbital Flex® reagent cartridge (PFFNO) is a device intended to The Dimension Vista™ Phenobarbian Flex® reagon controlice (12 homan serum and plasma.
measure phenobarbital, an antiepileptic and sedative-hypnotic of phenobarbital measure phenobarbital, an antieplied and sedant-six and treatment of phenobarbital
Measurements obtained by this device are used in the diamonrate therapy. Measurements obtained by this device are used in the diegreem.
use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
Dimension Vista™ Drug I Calibrator is intended for medical purposes for use in a test system to Dimension Vistal™ Drug I Canbrator is intended for medical parports of the measurement of phenobarbital in human specimens.
Louvie A Restiak
Srraine II Piestrak Regulatory Affairs & Compliance Manager April 27, 2005
Prescription Use
(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)
K.L. Graf
Division Sign-Off
Page 4 of 6
Office of In Vitro Diagnostic Device Evaluation and Safety
051087 510(k)_
12
510(k) Number (if known): K051087
Device Name:
Name:
Dimension Vista™ Mass creatine kinase MB isoenzyme Flex® reagent cartridge (MMB)
Contraction Carea CACR Collector Dimension Vista™ MMB Calibrator
Indications For Use:
Increating Vista™ Mass creatine kinase MB isoenzyme Flex® reagent cartidge (MMB)
The Dimension of the sticity of the MB isoenzyme of creatine phosphokinase in The Dimension Vista™ Mass creatine kinse MB isoenzyme of creatine phosphosinase in
is a device intended to measure the activity of the MB isoenzyme of creatine phosphosinase It is a device intended to measure the MB isoenzyme of creating phophones are used in the
plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used plasma and serum. Theatment of myocardial infarction.
The Dimension Vista™ MMB Calibrator is intended for medical purposes for use in a test The Dimension Vista™ MIB Calibrator is meeted in the determination of values in the
system to establish points of reference that are used in the determination of values in th system to establish points of reference that are assure in his .
measurement of mass creatine kinase MB isoenzyme in human specimens.
Theasurement of mass creatine kinase MB
Lorraine H Pastiak
Lorraine H Piestrak Lorranic 11 1 resular.
Regulatory Affairs & Compliance Manager April 27, 2005
Prescription Use (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) NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_051087
13
510(k) Number:
051087 Device Name: Dimension Vistar™ V-L YTE™ Integrated Multisensor Na'/K4/4Cl T
Device Name: Dimension Vistar™ V-L VTE™ Standard A Dimension Vista™ V-LYTE™ Standard A Dimension Vista
Indications For Use:
The Dimension Vista™ V-LYTE ™ Sodium test system is intended to measure sodium in serim, plasma The Dimension Visia" ( v Societ is intended to the diagnosis and treation of aldosteronism
and urine. Measured by this device are used in the diagnosis and treation of large Inc Dillector (excessive secretion of the hormore aldosterone), addetes many and one of the secured by
dilute urine, accompanies delevident, inancroprinte antidivetic hormons seccetion, or (olses were destraction of the actrolyte imbalance.
alsoass in as a g The Dimension V-LYTE Th Potassum test system is unchece to monitor electrolyte balance in the Alama and urine. Measurements obtained by this device the moments of the most of the levels.
diagnosis and treatment of diseases conditions, characterized by low or high blo
The Dimension Vista™ V-LYTE ™ Chloride test system is intended to measure chloride in sense, and treatment of The Dimension Vista™ V-LYTE ™ Chloride test system is mended to measure in the diagnosis and treatment of prasma and metabolic disorders.
The Dimension Vista™ V-LYTE ™ Standard A and Standard B are intended for medical purposes for use The Dimension Vista™ V-LYTE I™ Standard & and Standard B aro mommation of values in the in a test system to establion in human speciment.
Lorraine H. Pastorek
orraine H Piestrak Eorraine ry Affairs & Compliance Manager April 27, 2005
AND/OR
NEEDED)
Over-The-Counter Use_ (21 CFR 801)
Prescription Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEWS (PLEASE DO NOT WEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 6 of 6
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________