(79 days)
No
The document describes a standard immunoassay technology and mentions data analysis by a microprocessor, but there is no indication of AI or ML being used.
No
The device is an in vitro diagnostic test used for measurement and diagnosis, not for treating or providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the methods and products are "an in vitro diagnostic test" or "an in vitro diagnostic assay" for the measurement of specific biomarkers (CKMB, Troponin I, Myoglobin) that "can be used in the diagnosis" of various conditions like myocardial infarction and muscular dystrophy.
No
The device description clearly outlines a hardware-based immunoassay system (Stratus® CS analyzer) that utilizes physical reagents (TestPaks, CalPaks, DilPaks) and an optical system to measure reaction rates. While a microprocessor performs data analysis, the core functionality relies on physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states for each component (CKMB method, CKMB Calibrator, CKMB Dilution Pak, Troponin I method, Troponin I Calibrator, Troponin I Dilution Pak, Myoglobin method, Myoglobin Calibrator, Myoglobin Dilution Pak) that it is an "in vitro diagnostic test" or "in vitro diagnostic product".
Furthermore, the intended use involves the measurement of analytes (CKMB, cardiac troponin I, myoglobin) in human samples (heparinized plasma) to aid in the diagnosis and treatment of medical conditions (myocardial infarction, muscular dystrophy, acute coronary syndromes, renal or heart disease). This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
CKMB
Method
The Stratus® CS Acute Care™ CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E. C. No. 2.7.3.2) in heparinized plasma. CKMB measurements can be used as an aid in diagnosing acute myocardial infarction. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
Calibrator
The Stratus® CS Acute Care™ CKMB Calibrator (CKMB CalPak), Cat. No. CCKMB-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ CKMB method.
Diluent
The Stratus® CS Acute Care™ CKMB Dilution Pak (CKMB DilPak), Cat. No. CCKMB-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CKMB TestPak, CAT. NO. CCKMB, for the measurement of samples with elevated levels of CKMB.
cTnI
Method
The Stratus® CS Acute Care™ Troponin I (cTnI) method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac troponin I can also be used as aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
Calibrator
The Stratus® CS Acute Care™ Troponin I Calibrator (cTnI CalPak), CAT. NO. CCTNI-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ cardiac troponin I method.
Diluent
The Stratus® CS Acute Care™ Troponin I Dilution Pak (cTnI DilPak), CAT. NO. CCTNI-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTnI TestPak, CAT. NO. CCTNI, for the measurement of samples with elevated levels of cardiac troponin I.
MYO
Method
The Stratus® CS Acute Care™ myoglobin (MYO) method is an in vitro diagnostic test for the measurement of the myoglobin in heparized plasma. Myoglobin measurements can be used as an aid in diagnosing myocardial infarction. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
Calibrator
The Stratus® CS Acute Care™ Myoglobin Calibrator (MYO CalPak), CAT. NO. CMYO-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ Myoglobin method.
Diluent
The Stratus® CS Acute Care™ Myoglobin Dilution Pak (MYO DilPak), CAT. NO. CMYO-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ MYO TestPak, CAT. NO. CMYO, for the measurement of samples with elevated levels of myoglobin.
Product codes
JHX, MMI, DDR, JIT
Device Description
CKMB
Method
The Stratus® CS Acute Care™ CKMB method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is immobilized in the center portion of a square piece of glass fiber paper in the CKMB TestPak. Sample is then added onto the paper where it reacts with the immobilized CKMB antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the B subunit of the CKMB molecule is pipetted onto the reaction zone of the paper. During this second incubation period, more enzyme-labeled antibody reacts with the bound CKMB, forming an antibody-antigen-labeled enzyme sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of CKMB in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Calibrator
The Stratus® CS Acute Care CKMB calibrator (CKMB CalPak) is a refrigerated liquid product containing human heart CKMB in a buffered bovine protein matrix with stabilizers and preservative. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent
The Stratus® CS Acute Care CKMB Diluent (CKMB DilPak) is a refrigerated liquid product containing buffered human protein matrix with stabilizers and 0.2% sodium azide. The kit consists of 5 DilPaks with diluent in one well.
cTnI (TROP on original submission)
Method
The Stratus® CS Acute Care™ Troponin I method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the c TnI TestPak. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the cardiac troponin I molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Calibrator
The Stratus® CS Acute Care Troponin I calibrator (cTnI CalPak) is a frozen liquid product containing native, human troponin complex, in a human serum base with less than 0.1% sodium azide. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent
The Stratus® CS Acute Care Troponin I Diluent (cTnI DilPak) is a refrigerated liquid product containing a buffered human protein matrix with stabilizers and less than 0.1% sodium azide. The kit consists of 5 DilPaks with diluent in one well.
MYO
Method
The Stratus® CS Acute Care™ MYO method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal myoglobin antibody is added to the center portion of a square piece of glass fiber paper in the MYO TestPak. This antibody recognizes a distinct antigenic site on the myoglobin molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the myoglobin molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound myoglobin, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Calibrator
The Stratus® CS Acute Care MYO calibrator (MYO CalPak) is a refrigerated liquid product containing human heart myoglobin in a bovine albumin matrix with stabilizers and less than 0.1 % sodium azide. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent
The Stratus® CS Acute Care MYO Diluent (MYO DilPak) is a refrigerated liquid product containing a buffered bovine protein matrix with stabilizers and 0.2 % sodium azide. The kit consists of 5 DilPaks with diluent in one well.
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
trained health care professionals in the clinical laboratory and point of care (POC) settings
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)
Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.
Method comparison and precision analysis were performed at three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within each of two hospital systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dade Behring Stratus® STAT Fluorometric Analyzer CKMB TestPak including in . Dade Denring Sudatas 3999) and Stratus® CS CKMB CalPak (K981097) Dirrak (K984007/K981077), Dade Behring Stratus® CS Freate Care Stratus® CS cTnl CalPak (K012233/K983722/K012233), Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including . Dade Deliring Stratus® GS) and Stratus® CS MYO CalPak (K981101)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
C 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: | Pamela A. Jurga
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101
302-631-8891 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | June 6, 2005 |
| Name of Product(s): | Stratus® CS Acute Care™ MB isoenzyme of creatine kinase (CKMB)
TestPak
Stratus® CS Acute Care™ CKMB CalPak (the assay calibrator)
Stratus® CS Acute Care™ CKMB DilPak (the assay diluent)
Stratus® CS Acute Care™ Troponin I (cTnI) TestPak
Stratus® CS Acute Care™ cTnI CalPak (the assay calibrator)
Stratus® CS Acute Care™ cTnI DilPak (the assay diluent)
Stratus® CS Acute Care™ Myoglobin (MYO) TestPak
Stratus® CS Acute Care™ MYO CalPak (the assay calibrator)
Stratus® CS Acute Care™ MYO DilPak (the assay diluent) |
FDA Classification Name(s):
- · Fluorometric method, cpk or isoenzymes and associated calibrator and diluent
- · Immunoassay method, troponin subunit and associated calibrator and diluent
- · Myoglobin, Antigen, Antiserum Control and associated calibrator and diluent (all Class II)
FDA Guidance Document(s): "Bundling Multiple Devices or Multiple Indications in a Single Submission" - 11/26/2003
Predicate Device(s):
- Dade Behring Stratus® STAT Fluorometric Analyzer CKMB TestPak including in . Dade Denring Sudatas 3999) and Stratus® CS CKMB CalPak (K981097) Dirrak (K984007/K981077) and Stratus® CS STAT Fluorometric Analyzer in addition to the CKMB TestPak and DilPak)
- adultion to the CremB® CS Acute Care™ Troponin I (cTnI) TestPak including . Dade Benting Stratus® CS Freate Care Stratus® CS cTnl CalPak (K012233/K983722/K012233)
- (KVI ZZSJKY037ZZNN12237)
Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including
Pade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including . Dade Deliring Stratus® GS) and Stratus® CS MYO CalPak (K981101)
1
Device Description(s):
CKMB
Method
The Stratus® CS Acute Care™ CKMB method is a two-site sandwich assay based upon solid I inc Stratus® Co Houte Care - CPIA) technology. In this procedure, dendrimer linked phase Raular Farmon minutioussaly (12 the center portion of a square piece of glass fiber paper in the CKMB TestPak. Sample is then added onto the paper where it reacts with the immobilized in the CKMB antibody. After a short incubation, a conjugate consisting of enzyme-labeled ann Olevil antibody directed against a distinct antigenic site on the B subunit of the CKMB moleoule is pipetted onto the reaction zone of the paper. During this second incubation period, more is procted ontibody reacts with the bound CKMB, forming an antibody-antigen-labeled enzyme labored antibody reasons 1 labeled antibody is later eluted from the field of view of the annood) Barawien Triv applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs mouding substrate for the enzymatic rate of the bound fraction increases directly with shirananeously with the wash the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Calibrator
The Stratus® CS Acute Care CKMB calibrator (CKMB CalPak) is a refrigerated liquid product containing human heart CKMB in a buffered bovine protein matrix with stabilizers and preservative. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent
The Stratus® CS Acute Care CKMB Diluent (CKMB DilPak) is a refrigerated liquid product containing buffered human protein matrix with stabilizers and 0.2% sodium azide. The kit consists of 5 DilPaks with diluent in one well.
cTnI (TROP on original submission)
Method
The Stratus® CS Acute Care™ Troponin I method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the c TnI TestPak. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the cardiac troponin I molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
2
Calibrator
Callbrator
The Stratus® CS Acute Care Troponin I calibrator (cTnI CalPak) is a frozen liquid product The Stratus® CS Acute Care Troponia Feature base with less than 0.1% sodium
containing native, human troponin complex, in a human colors! - Caling containing native, human toponiii complex, in a haman sorain case ware.
azide. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrato reagent in three wells.
Diluent
Diluent
The Stratus® CS Acute Care Troponin I Diluent (cTnI DilPak) is a refrigerated inquide - The stra The Status® CS Acute Care Tropolian I Dirach. (Secure dess than 0.1% sodium azide. The kit consists of 5 DilPaks with diluent in one well.
MYO
Method
Methou
The Stratus® CS Acute Care™ MYO method is a two-site sandwich assay based upon solid The Straus® CS Acate Care - M I O mealse is a vince is a comments of this procedure, dencified in monoclonal myoglobin antibody is added to the center portion of a square piece of glass fiber monocional myoglobal antibody is added o cecognizes a distinct antigenic site on the myoglobin paper in the MTO Festians. This interests with the paper where it reacts with the immobilized antimorecute. Sample is then added ento une pare a conjugate consisting of enzyme-labeled illyogioun antibody. Atter a short measurence site on the myoglobin molecule is monocional antibody unrected against as a paper. During this second incubation period, enzymelabeled antibody reacts with the bound myoglobin, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS Sandwich. The unoound noorbounds solution to the center of the reaction zone. By including allary201 by upprying a caosaate "he wash solution, initiation of enzyme activity occurs Substrator the vith the wash. The enzymatic rate of the bound fraction increases directly with simultaneously with the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Calibrator
The Stratus® CS Acute Care MYO calibrator (MYO CalPak) is a refrigerated liquid product The buttuale OL Heart myoglobin in a bovine albumin matrix with stabilizers and less than 0.1 % Containing numan nour myogloom in a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent
The Stratus® CS Acute Care MYO Diluent (MYO DilPak) is a refrigerated liquid product containing a buffered bovine protein matrix with stabilizers and 0.2 % sodium azide. The kit consists of 5 DilPaks with diluent in one well.
Intended Use:
СКМВ
Method
The Stratus® CS Acute Care™ CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E. C. No. 2.7.3.2) in heparinized plasma. CKMB measurements can be used as an aid in diagnosing acute myocardial
3
infarction. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
Calibrator
The Stratus® CS Acute Care™ CKMB Calibrator (CKMB CalPak), Cat. No. CCKMB-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ CKMB method.
Diluent
The Stratus® CS Acute Care™ CKMB Dilution Pak (CKMB DilPak), Cat. No. CCKMB-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CKMB TestPak, CAT. NO. CCKMB, for the measurement of samples with elevated levels of CKMB.
cTnI
Method
The Stratus® CS Acute Care™ Troponin I (cTnI) method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac troponin I can also be used as aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
Calibrator
The Stratus® CS Acute Care™ Troponin I Calibrator (cTnI CalPak), CAT. NO. CCTNI-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ cardiac troponin I method.
Diluent
The Stratus® CS Acute Care™ Troponin I Dilution Pak (cTnI DilPak), CAT. NO. CCTNI-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTnI TestPak, CAT. NO. CCTNI, for the measurement of samples with elevated levels of cardiac troponin I.
MYO
Method
The Stratus® CS Acute Care™ myoglobin (MYO) method is an in vitro diagnostic test for the measurement of the myoglobin in heparized plasma. Myoglobin measurements can be used as an aid in diagnosing myocardial infarction. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
Calibrator
The Stratus® CS Acute Care™ Myoglobin Calibrator (MYO CalPak), CAT. NO. CMYO-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ Myoglobin method.
Diluent
The Stratus® CS Acute Care™ Myoglobin Dilution Pak (MYO DilPak), CAT. NO. CMYO-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ MYO TestPak, CAT. NO. CMYO, for the measurement of samples with elevated levels of myoglobin.
4
Substantial Equivalence:
CKMB
Method
The Stratus® CS Acute Care™ CKMB Test Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS CKMB TestPak (K984067/K981099). Both assays are in vitro immunoassays with an intended use as an aid in diagnosing acute myocardial infarction.
There are no formulation or design changes associated with the Stratus® CS CKMB TestPak intended use change. The two products are identical and use the same manufacturing processes. Labeling changes reflect the new intended use, supporting data and new name in addition to minor format changes.
Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.
Calibrator
The Stratus® CS Acute Care™ CKMB calibrator (CKMB CalPak) is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS CKMB CalPak (K981097). Both calibrators are intended to be used to calibrate the Stratus® CS Acute Care™ CKMB assay.
There are no formulation or design changes associated with the Stratus® CS CKMB TestPak intended use change. The two calibrator products are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.
Diluent
The Stratus® CS Acute Care™ CKMB Dil Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS CKMB DilPak (K984067/K981099). Both diluents are intended to be used in conjunction with the Stratus® CS Acute Care™ CKMB TestPaks for the measurement of samples with elevated levels of CKMB.
There are no formulation or design changes associated with the Stratus® CS CKMB TestPak intended use change. The two diluent products are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.
cTnI
Method
The Stratus® CS Acute Care™ Troponin I Test Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus CS Acute Care™ Troponin I TestPak (K033487/K984093/K981098). Both assays are in vitro immunoassays with an intended use as an aid in the diagnosis of acute myocardial infarction and risk stratification of patients with acute coronary syndrome.
There are no formulation or design changes associated with the Stratus® CS cTnI TestPak intended use change. The two products are identical and use the same manufacturing processes. Labeling changes reflect the new intended use and supporting data in addition to minor format changes.
5
Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and I recuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.
Calibrator
The Stratus® CS Acute Care™ Troponin I Calibrator (cTnI CalPak) is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus CS Acute Care™ Troponin I CalPak (K012233/K983722/K981100). Both calibrators are intended to be used to calibrate the Troponin I (cTnI) assay on the Stratus® CS analyzer.
There are no formulation or design changes associated with the Stratus® CS Acute Care™ cTnI TestPak intended use change. The two calibrator products are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.
There are no formulation or design changes associated with the Stratus® CS CKMB TestPak intended use change. The two calibrator products are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes
Diluent
The Stratus® CS Acute Care™ Troponin I Dil Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS cTnI DilPak (K981098). Both diluents are intended to be used in conjunction with the cTnI TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of cardiac troponin I.
There are no formulation or design changes associated with the Stratus® CS Acute Care™ Troponin I TestPak intended use change. The two diluent products are identical and use the same manufacturing processes. Labeling changes reflect the new intended use, supporting data and new name in addition to minor format changes.
MYO
Method
The Stratus® CS Acute Care™ MYO Test Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS MYO TestPak (K981102/K984065). Both assays are in vitro immunoassays with an intended use as an aid in diagnosing acute myocardial infarction.
There are no formulation or design changes associated with the Stratus® CS MYO TestPak intended use change. The two products are identical and use the same manufacturing processes. Labeling changes reflect the new intended use, supporting data and new name in addition to minor format changes.
Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.
Calibrator
The Stratus® CS Acute Care™ Myoglobin Calibrator (MYO CalPak) is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS MYO CalPak
6
(K981101). Both calibrators are intended to be used for calibration of the Stratus® CS Acute Care™ MYO method.
There are no formulation or design changes associated with the Stratus® CS MYO TestPak intended There are no formulation of abones are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.
Diluent
The Stratus® CS Acute Care™ MYO DilPak is substantially equivalent in the principle of operation The Stratus® CD Avato Care - 1110 DilPak (K984065/K981102). Both allu performance to the ourrom Daco Don'the MYO TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of myoglobin.
There are no formulation or design changes associated with the Stratus® CS MYO TestPak intended There are no formation of abonducts are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.
Comparison to Predicate Device:
The modification of these three methods by adding point of care to the intended use is supported by data submitted in their original method 510(k)'s included in Attachment D.
Method comparison and precision analysis were performed at three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within each of two lavoratory (2) This data and a summary of information on the operators and their training, from either the ED or CCU, i.e. "non-lab" operators, is also included in the original 510(k)'s.
This data supports use of these products by trained health care professionals in the clinical laboratory and point of care (POC) settings
Conclusion:
The products listed in the following table are substantially equivalent based on their indications for use and performance characteristics. Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.
| Predicate Device | New Device |
|---|---|
| Dade Behring Stratus® STAT Fluorometric | |
| Analyzer CKMB TestPak (K984067/K981099) | The Stratus® CS Acute Care™ MB isoenzyme |
| of creatine kinase (CKMB) TestPak | |
| Stratus® CS CKMB CalPak (K981097) | Stratus® CS Acute Care™ CKMB CalPak |
| Stratus® CS CKMB DilPak | |
| (K984067/K981099) | Stratus® CS Acute Care™ CKMB DilPak |
| Dade Behring Stratus® CS Acute Care™ | |
| Troponin I (cTnI) TestPak | |
| (K033487/K984093/K981098) | Stratus® CS Acute Care™ Troponin I (cTnI) |
| TestPak |
7
| Stratus® CS cTnI CalPak
| (K012233/K983722/K012233), | Stratus® CS Acute Care™ cTnI CalPak |
|---|---|
| Stratus® CS cTnI DilPak | |
| (K033487/K984093/K981098) | Stratus® CS Acute Care™ cTnI DilPak |
| Dade Behring Stratus® CS STAT Fluorometric | |
| Analyzer MYO TestPak (K981102/K984065) | Stratus® CS Acute Care™ Myoglobin (MYO) |
| TestPak | |
| Stratus® CS MYO CalPak (K981101) | Stratus® CS Acute Care™ MYO CalPak |
| Stratus® CS MYO DilPak (K981102/K984065) | Stratus® CS Acute Care™ MYO DilPak |
Pamela A. Jurga Regulatory Affairs and Compliance Manager
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
SEP = 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Pamela A. Jurga Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101
K051650 Re:
Trade/Device Name: Stratus® CS Acute Care™ MB isoenzyme of creatine kinase (CKMB) TestPak
Stratus® CS Acute Care™ CKMB CalPak Stratus® CS Acute Care™ CKMB DilPak Stratus® CS Acute Care™ Troponin I (cTnI) TestPak Stratus® CS Acute Care™ cTnl CalPak Stratus® CS Acute Care™ cTnI DilPak Stratus® CS Acute Care™ Myoglobin (MYO) TestPak Stratus® CS Acute Care™ MYO CalPak Stratus® CS Acute Care™ MYO DilPak Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system
Regulatory Class: Class II Product Code: JHX, MMI, DDR, JIT Dated: June 16, 2005
Received: June 21, 2005
Dear Ms. Jurga:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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.
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Page 2 - Ms. Jurga
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advisou that I Dri blocan that your device complies with other requirements of the Act that I Dri has intates 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).
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter will and in your he FDA finding of substantial equivalence of your device to a legally prechated 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,
Coryt C. Hayr for
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
10
INDICATIONS FOR USE STATEMENTS.
INDICATIONS FOR USE STATEMENT
510(k) Number (If Known):
Device(s) Name(s):
Stratus® CS Acute Care™ MB isoenzyme of creatine kinase (CKMB) TestPak Stratus® CS Acute Care™ CKMB CalPak Stratus® CS Acute Care™ CKMB DilPak
Indications for Use:
The Stratus® CS Acute Care™ CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E.C. No 2.7.3.2) in the MD isocizythe of Creatine innus (1177 . Over used in the diagnosis and treatment of myocardial nepartined plasma. Measuronio of Orentessive, Duchenne-type muscular dystrophy. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
The Stratus® CS Acute Care™ CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ CKMB method.
The Stratus® CS Acute Care™ CKMB Dilution Pak (CKMB DilPak) is an in vitro diagnostic product The Straus® CS Acute Care - CRMD Dhanch Care™ CKMB TestPak for the measurement of samples with elevated levels of CKMB .
Prescription Use X
and/or
Over-the-counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(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
510(k) 051650
11
INDICATIONS FOR USE STATEMENT
510(k) Number (If Known):
.051650
Device(s) Name(s):
Stratus® CS Acute Care™ Troponin I (cTnI) TestPak Stratus® CS Acute Care™ cTnI CalPak Stratus® CS Acute Care™ cTnI DilPak
Indications for Use:
The Stratus® CS Acute Care™ Troponin I method (cTnl) is an in vitro diagnostic assay for the The Suatus® CS Acute Cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac troponing and anyone used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
The Stratus® CS Acute Care™ Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product I he Stratus® CS Acute Care - Troponin I Santalia (CS Acute Care™ Troponin I method.
The Stratus® CS Acute Care™ Troponin I Dilution Pak (cTnI DilPak) is an in vitro diagnostic The Strains® CS Acule Care - Hoponin Fination Frances - and TestPak for the measurement of samples with elevated levels of cardiac Troponin I.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| and/or | |
| Over-the-counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| Division Sign-Off |
Office of In Vitro Diagnostic DeviceEvaluation and Safety
510(k) 051650
12
INDICATIONS FOR USE STATEMENT
K 051650
510(k) Number (If Known):
Device(s) Name(s):
Stratus® CS Acute Care™ Myoglobin (MYO) TestPak Stratus® CS Acute Care™ MYO CalPak Stratus® CS Acute Care™ MYO DilPak
Indications for Use:
The Stratus® CS Acute Care™ Myoglobin method (MYO) is an in vitro diagnostic assay for the spay for the The Suatus® CS Acate Care - 117 oglobal insma. Measurements of myoglobin aid in the rapid diagnosis of renal or heart disease, e.g. myocardial infarction. This method is for use by trained health diagnosis of renar or near inical laboratory and point of care (POC) settings.
The Stratus® CS Acute Care™ Myoglobin Calibrator (MYO CalPak) is an in vitro diagnostic product The Stratus® CS Acute Care - Myoghoom Caneland (123) - 100 - Care™ myoglobin method.
The Stratus® CS Acute Care™ Myoglobin Dilution Pak (MYO DilPak) is an in viro diagnostic The Straus® CS Acule Cale~ Myogloom Bration Further Futt (Care™ MYO TestPak for the measurement of samples with elevated Myoglobin levels.
Prescription Use X
(Part 21 CFR 801 Subpart D)
and/or
Over-the-counter Use
(21 CFR 801 Subpart C)
(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
510(k) K051650