(26 days)
No
The document describes in-vitro diagnostic assays and reagent cartridges for use 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 analysis of biological samples.
No
This device is described as an "in-vitro diagnostic assay" and its intended use is for "measurement," "quantitative determination," or "qualitative and semiquantitative determination" of various substances in biological samples. It provides analytical test results for diagnosis and monitoring, but it does not treat or cure medical conditions, which is the function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for measurements used in "diagnosis and treatment" of various conditions, and also refers to several components as "in-vitro diagnostic assay" or "in-vitro diagnostic test".
No
The device description explicitly states it is a "floor model, fully automated, microprocessor-controlled, integrated instrument system" and refers to "reagent cartridges" and a "HA1C kit," indicating it is a hardware-based in-vitro diagnostic system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The intended use sections for multiple components (HAIC assay, AMPH Flex®, BARB Flex®, BENZ Flex®, COC Flex®, EXTC Flex®, METH Flex®, OPI Flex®, PCP Flex®, THC Flex®) explicitly state that they are "in-vitro diagnostic assays" or "in-vitro diagnostic tests."
- Measurement of Analytes in Human Samples: The device is intended to measure various substances (CKMB, hemoglobin A1c, amphetamines, barbiturates, benzodiazepines, benzoylecgonine, methylenedioxymethamine, methadone, opiates, phencyclidine, cannabinoids) in human biological samples (plasma, serum, whole blood, urine). This is a core characteristic of IVDs.
- Used for Diagnosis and Treatment: The intended uses clearly state that the measurements obtained are used in the "diagnosis and treatment" of various conditions (myocardial infarction, muscle diseases, diabetes mellitus, drug use or overdose). This is the purpose of an IVD.
- Device Description: The device description refers to the components as "in-vitro diagnostic devices."
The fact that this is a Special 510(k) for a packaging modification to existing cleared IVDs further confirms its classification as an IVD.
N/A
Intended Use / Indications for Use
The Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a r no Difficial of Your - See the activity of the creatine kinase MB isoenzyme in plasma and de vice intendou to measurement with isoenzyme are used in the diagnosis and treatment Scrum: "Infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The HAIC assay used on the Dimension Vista™ integrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c(HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
The AMPH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The BARB Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of barbiturates in human urine. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The BARB method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The BENZ Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzodiazepines in human urine. Measurements obtained . with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The BENZ method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The COC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose. The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The EXTC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamine (MDMA), and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The METH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methadone in human urine. Measurements obtained with the METH method are used to detect methadone use or overdose and to determine compliance with methadone maintenance treatment. The METH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The OPI Flex® reagent cartridge (300 ng/mL cutoff) used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of opiates in human urine. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose. The OPI method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The PCP Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The PCP method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The THC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of cannabinoids in human urine. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose. The THC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
JHS, LCP, DKZ, DIS, JXM, DIO, DJR, DJG, LCM, LDJ
Device Description
Dade Behring Dimension Vista™ Flex® reagent cartridges and the HA1C kit are prepackaged Dude Delining Sincers on that are specifically designed to be used on the Dade m-viro diagnosio took model (asted system, a floor model, fully automated, microprocessor-Dontrolled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K051087). 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 calibrator included in the Dimension Vista™ HAIC kit is the same product (unchanged) as that used in the Dimension® HA1C Kit. 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
human serum and plasma, anticoagulated whole blood, human urine
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.
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.
K943024, K011852, K040133, K000459, K000458, K033713, K053337, K000466, K003209, K000462, K000461
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.
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
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a series of handwritten alphanumeric characters. The characters appear to be "K062128". The characters are written in a dark ink, and the background is white. The handwriting is somewhat stylized, with some characters having loops or curves.
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 19714-6101 | AUG 2 1 2006 |
|----------------------|------------------------------------------------------------------------------------|--------------|
| Date of Preparation: | July 25, 2006 | |
Name of Products:
Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge Dimension Vista™ Hemoglobin A1c Kit (HA1C) Dimension Vista™ Urine Amphetamine Screen (AMPH) Flex® reagent cartridge Dimension Vista™ Urine Barbiturates Screen (BARB) Flex® reagent cartridge Dimension Vista™ Urine Benzodiazepines Screen (BENZ) Flex® reagent cartridge Dimension Vista™ Urine Cocaine metabolite Screen (COC) Flex® reagent cartridge Dimension Vista™ Urine Ecstasy Screen (EXTC) Flex® reagent cartridge Dimension Vista™ Urine Methadone Screen (METH) Flex® reagent cartridge Dimension Vista™ Urine Opiates Screen (OPI) Flex® reagent cartridge Dimension Vista™ Urine Phencyclidine Screen (PCP) Flex® reagent cartridge Dimension Vista™ Urine Cannabinoids Screen (THC) Flex® reagent cartridge
FDA Classification Name:
| Classification Name: | Common/Usual Name: |
|---|---|
| 862.1215 Differential Rate Kinetic Method, Cpk or Isoenzymes | Creatine kinase isoenzyme test system |
| 864.7470 Assay, Glycosylated Hemoglobin | Glycosylated hemoglobin test system |
| 862.3100 Enzyme Immunoassay, Amphetamine | Amphetamine test system |
| 862.3150 Enzyme Immunoassay, Barbiturate | Barbiturate test system |
| 862.3170 Enzyme Immunoassay, Benzodiazepine | Benzodiazepine test system |
| 862.3250 Enzyme Immunoassay, Cocaine and Metabolites | Cocaine and metabolite test system |
| 862.3100 Enzyme Immunoassay, Amphetamine | Ecstasy test system |
| 862.3620 Enzyme Immunoassay, Methadone | Methadone test system |
| 862.3650 Enzyme Immunoassay, Opiates | Opiate test system |
| 862.3100 Enzyme Immunoassay, Phencyclidine | Phencyclidine test system |
| 862.3870 Enzyme Immunoassay, Cannabinoids | Cannabinoid test system |
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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™
CKMB Flex®
reagent cartridge | Dimension® Flex®
CKMB reagent cartridge | K943024 | II | 862.1215 | JHS |
| Dimension Vista™
HA1C Kit | Dimension®
HA1C Kit | K011852 | II | 864.7470 | LCP |
| Dimension Vista™
AMPH Flex®
reagent cartridge | Dimension® Flex®
AMPH reagent cartridge | K040133 | II | 862.3100 | DKZ |
| Dimension Vista™
BARB Flex® reagent
cartridge | Dimension® Flex®
BARB reagent cartridge | K000459 | II | 862.3150 | DIS |
| Dimension Vista™
BENZ Flex® reagent
cartridge | Dimension® Flex®
BENZ reagent cartridge | K000458 | II | 862.3170 | JXM |
| Dimension Vista™
COC Flex® reagent
cartridge | Dimension® Flex®
COC reagent cartridge | K033713 | II | 862.3250 | DIO |
| Dimension Vista™
EXTC Flex® reagent
cartridge | Dimension® Flex®
EXTC reagent cartridge | K053337 | II | 862.3100 | DKZ |
| Dimension Vista™
METH Flex®
reagent cartridge | Dimension® Flex®
METH reagent cartridge | K000466 | II | 862.3620 | DJR |
| Dimension Vista™
OPI Flex® reagent
cartridge | Dimension® Flex®
OPI reagent cartridge | K003209 | II | 862.3650 | DJG |
| Dimension Vista™
PCP Flex® reagent
cartridge | Dimension® Flex®
PCP reagent cartridge | K000462 | II | 862.3100 | LCM |
| Dimension Vista™
THC Flex® reagent
cartridge | Dimension® Flex®
THC reagent cartridge | K000461 | II | 862.3870 | LDJ |
Device Description:
Dade Behring Dimension Vista™ Flex® reagent cartridges and the HA1C kit are prepackaged Dude Delining Sincers on that are specifically designed to be used on the Dade m-viro diagnosio took model (asted system, a floor model, fully automated, microprocessor-Dontrolled, integrated instrument system. The Dimension Vista™ system was previously cleared
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with seven associated test methods (K051087). 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 calibrator included in the Dimension Vista™ HAIC kit is the same product (unchanged) as that used in the Dimension® HA1C Kit. The packaging modification, does not affect the intended use of the devices. nor does it alter the fundamental scientific technology of the devices.
Intended Use:
Creatine Kinase MB Isoenzyme
The CKMB method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB Isoenzyme in human serum and plasma on the Dimension Vista™ System.
Hemoglobin A1c Kit
The HA1C assay used on the Dimension Vista™ System is an in vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c (HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Urine Amphetamine/Methamphetamine Screen
The AMPH method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300. 500. or 1000 ne/mL on the Dimension Vista™ System. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.
Urine Barbiturates Screen
The BARB method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of barbiturates in human urine on the Dimension Vista™ System. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose.
Urine Benzodiazepines Screen
The BENZ method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of benzodiazepines in human urine on the Dimension Vista™ System. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
3
Urine Cocaine metabolite Screen
The Cocaine method is an in vitro diagnostic test for the qualitative and semi-quantitative I he COC Methou is an in Thiro Chaghostic construction in human urine using a cutoff of 150 or delemmation of belizeyneegommo (60cm) System. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose.
Urine Ecstasy Screen
The EXTC method is an in vitro diagnostic test for the qualitative and semi-quantitative I IIE EATC Inchiou is all in vir o diaglies betamine (MDMA) and closely related drugs in human urine using a cutoff of 300 or 500 ng/mL on the Dimension Vista™ System. Measurements urine using a cutorn of 500 or over in the diagnosis and treatment of ecstasy use or overdose.
Urine Methadone Screen
The METH method is an in vitro diagnostic test for the qualitative and semi-quantitative I he MILTTT method is all in Viro diagnoine on the Dimension Vista™ System. Measurements determination of method are used to detect methadone use or overdose, and to determine compliance with methadone maintenance treatment.
Urine Opiates Screen
The OPI method is an in vitro diagnostic test for the qualitative and semi-quantitative I he Oi i niculou is an in 'nive alagarine on the Dimension Vista™ System. Measurements decemmation of oplates in maintained in the diagnosis and treatment of opiates use or overdose.
Urine Phencyclidine Screen
The PCP method is an in vitro diagnostic test for the qualitative and semi-quantitative I IC I CT nichlod is an in viro canghouse worke on the Dimension Vista™ System. Measurements determination of phenoyondation in names and treatment of phencyclidine use or overdose.
Urine Cannabinoids Screen
The THC method is an in vitro diagnostic test for the qualitative and semi-quantitative I he 111c mediod is an in 71/7 o' diagnosurine on the Dimension Vista™ System. Measurements determination or cannaction the diagnosis and treatment of cannabinoids use or overdose.
4
Comparison to Predicate Device:
Compullion to 1 realert of Flex® reagent cartridges/kit and the predicate Dimension® Flex® Dour the Difficilision Visia - Pieres reagents in flexible plastic cartridges. A comparison of the reagult cartruges in contain propactials as reagues as as a 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
Behring 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. |
| HA1C calibrator | Same product as Dimension®
HA1C calibrator | As described in K011852 |
Comments on Substantial Equivalence:
The Dade Behring Dimension Vista™ Flex® reagent cartridges and the Dimension® Flex® The Dado Bolling Dimensioned similarly for the same purpose. Both contain prepackaged reagents for in-vitro diagnostic tests that are processed on microprocessor-controlled, integrated instrument systems to analyze a variety of analytes in human specimens.
5
The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those The reagents connamed in the Damelible manufactured for the Dimension® clinical chemistry comained in the Frex® reagone cartring analyzers. The calibrator included in the Dimension Vista™ Systems, another railing of the same product (unchanged) as that used in the Dimension® HA1C Kit. 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:
Conclusion:
The Flex® reagent cartridges/kit, containing reagents for testing CKMB, HA1C, AMPH, BARB, THE FIEA® FEAGERE Canning Concenting Concension® Vista™ Integrated system are DENZ, COC, LATC, METTI, OF I, I OF , Les , Lean performance to the Dimension® system Flex® Substantially equivalent in abongs, for same intended use and indications for use. Comparative testing also demonstrates substantially equivalent performance.
Louise H. Prestvik
Lorraine H Piestrak Regulatory Affairs & Compliance Manager July 25, 2006
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract representation of a human figure.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Lorraine Piestrak Regulatory Affairs & Compliance Manager Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101
AUG 2 1 2006
Re: K062128
Trade/Device Name: Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge Dimension Vista™ Hemoglobin A1c Kit (HA1C) Dimension Vista™ Urine Amphetamine/Methamphetamine Screen (AMPH)Flex® reagent cartridge Dimension Vista™ Urine Barbiturates Screen (BARB) Flex® reagent cartridge Dimension Vista™ Urine Benzodiazepines Screen (BENZ) Flex® reagent cartridge Dimension Vista™ Urine Cocaine metabolite Screen (COC) Flex® reagent cartridge Dimension Vista™ Urine Ecstasy Screen (EXTC) Flex® reagent cartridge Dimension Vista™ Urine Methadone Screen (METH) Flex® reagent cartridge Dimension Vista™ Urine Opiates Screen (OPI) Flex® reagent cartridge Dimension Vista™ Urine Phencyclidine Screen (PCP) Flex® reagent cartridge Dimension Vista™ Urine Cannabinoids Screen (THC) Flex® reagent cartridge Regulation Number: 21 CFR$862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHS, LCP, DKZ, DIS, JXM, DIO, DJR, DJG, LCM, LDJ Dated: July 25, 2006 Received: July 26, 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. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
7
Page 2 - Ms. Lorraine Piestrak
,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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) 276-0450. 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/cdrl/industry/support/
Sincerely yours,
Alberto
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
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510(k) Number (if known): K06212
Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® Device Name: reagent cartridge
Indications For Use:
The Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a r no Difficial of Your - See the activity of the creatine kinase MB isoenzyme in plasma and de vice intendou to measurement with isoenzyme are used in the diagnosis and treatment Scrum: "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)
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Division Sign-Off
Division Sign-Off
510(k) K062128
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