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. Measurements of CKMB can be used in the diagnosis and treatment of myocardial infarction and progressive, 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 intended to be used in conjunction with the Acute Care™ CKMB TestPak for the measurement of samples with elevated levels of CKMB.

The Stratus® CS Acute Care™ Troponin I method (cTnl) is an in vitro diagnostic assay 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.

The Stratus® CS Acute Care™ Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ Troponin I method.

The Stratus® CS Acute Care™ Troponin I Dilution Pak (cTnI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTnI TestPak for the measurement of samples with elevated levels of cardiac Troponin I.

The Stratus® CS Acute Care™ Myoglobin method (MYO) is an in vitro diagnostic assay for the measurement of myoglobin in heparinized plasma. 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 care professionals in the clinical laboratory and point of care (POC) settings.

The Stratus® CS Acute Care™ Myoglobin Calibrator (MYO CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ myoglobin method.

The Stratus® CS Acute Care™ Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ MYO TestPak for the measurement of samples with elevated Myoglobin levels.

Device Description

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 added to 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 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, enzyme-labeled antibody reacts with the bound CKMB, 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 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.

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.

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.

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.

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.

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.

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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Dade Behring's Stratus® CS Acute Care™ assays (CKMB, Troponin I, and Myoglobin), along with their associated calibrators and diluents. The core of this submission is to achieve substantial equivalence for these products to allow their use in Point-of-Care (POC) settings in addition to the clinical laboratory.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for precision or accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices and showing that performance in "non-laboratory" (POC) settings is comparable to that in "laboratory" settings.

The key performance metric reported, implicitly serving as the acceptance criterion, is the comparability of precision and accuracy data generated by "non-laboratory" personnel (POC) to that generated by "laboratory" personnel.

Metric/Criteria	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Precision	Precision data generated by "non-laboratory" personnel should be comparable to precision data generated by "laboratory" personnel.	Precision data generated by "non-laboratory" personnel is comparable to precision data generated by "laboratory" personnel, supporting the addition of point of care to the intended use for CKMB, cTnI, and Myoglobin assays.
Accuracy	Accuracy data generated by "non-laboratory" personnel should be comparable to accuracy data generated by "laboratory" personnel.	Accuracy data generated by "non-laboratory" personnel is comparable to accuracy data generated by "laboratory" personnel, supporting the addition of point of care to the intended use for CKMB, cTnI, and Myoglobin assays.
Substantial Equivalence	The Stratus® CS Acute Care™ products (TestPaks, CalPaks, DilPaks for CKMB, cTnI, and MYO) are substantially equivalent in principle of operation and performance to their respective predicate devices. No formulation or design changes were made.	The Stratus® CS Acute Care™ products were determined to be substantially equivalent to their predicate devices. The products are identical, use the same manufacturing processes, and labeling changes only reflect new intended use and minor format changes.

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: The document explicitly states: "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 hospitals (2))."
- It does not provide a specific number of samples or patients included in these method comparison and precision analyses. It only mentions where the testing was conducted.
Data Provenance: The locations are described as "three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within each of two hospitals (2))". This suggests a prospective study design as data was generated at these sites for the purpose of the submission. The country of origin is not explicitly stated, but given the submitter's address (Newark, DE, USA), it's highly likely the study was conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth in the context of diagnostic interpretation for the test set. This type of submission is for in vitro diagnostic (IVD) assays, where the "ground truth" for evaluating performance is typically established by reference methods or clinical diagnosis (e.g., confirmed myocardial infarction) against which the assay results are compared.
The text focuses on the performance of the assay itself (precision, accuracy) when operated by different personnel. It states: "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 implies the operators were "trained health care professionals" (as per the intended use), but not necessarily "experts" establishing ground truth in a diagnostic sense for the comparative study.

4. Adjudication Method for the Test Set

No adjudication method is described in the provided text. The study focuses on comparing quantitative assay results between different operational settings (lab vs. POC) rather than on diagnostic interpretations that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more common for imaging devices or algorithms that directly assist human interpretation in making a diagnosis where multiple readers evaluate cases.
This submission is for an in vitro diagnostic (IVD) assay that measures biomarkers. The comparison is between the assay's performance (precision and accuracy) when operated by "laboratory" personnel versus "non-laboratory" personnel, not improving human readers' diagnostic accuracy with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable as the device is an in vitro diagnostic assay (a chemical test), not an AI algorithm. Its performance is inherent to the assay and analyzer, regardless of the operator, though operator technique can influence results.
The study did evaluate the assay's performance in a standalone manner, meaning the assay itself produced results, and these results were then assessed for precision and accuracy when executed by different types of operators (laboratory vs. "non-lab" or POC). There isn't an "algorithm-only" concept here in the sense of AI.

7. The Type of Ground Truth Used

For precision, the ground truth is the reproducibility of the assay itself, ideally measured against itself or reference materials.
For accuracy, the ground truth would typically be established by reference methods for CKMB, Troponin I, and Myoglobin, or clinical diagnosis of the conditions they aid in diagnosing (e.g., acute myocardial infarction).
However, the text strongly emphasizes substantial equivalence to existing predicate devices. This means the "ground truth" for the new intended use (POC) largely hinges on demonstrating that the results produced by the new method (in POC settings) are comparable to those produced by the predicate devices (which are already accepted) and the same device in traditional lab settings.

8. The Sample Size for the Training Set

The text does not mention a training set sample size. This is expected because the submission is for an IVD assay, not an AI or machine learning model that typically requires a distinct training phase. The assays' underlying chemistry and calibration are established through development, not a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI model, this question is not applicable. The development and initial validation of these assays would have followed standard IVD development procedures, establishing analytical performance characteristics (like linearity, limits of detection, interference, etc.) using reference materials and clinical samples. The current submission is primarily about demonstrating equivalent performance for an extended intended use (POC).

Summary

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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. JurgaDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101302-631-8891
Date of Preparation:	June 6, 2005
Name of Product(s):	Stratus® CS Acute Care™ MB isoenzyme of creatine kinase (CKMB)TestPakStratus® CS Acute Care™ CKMB CalPak (the assay calibrator)Stratus® CS Acute Care™ CKMB DilPak (the assay diluent)Stratus® CS Acute Care™ Troponin I (cTnI) TestPakStratus® CS Acute Care™ cTnI CalPak (the assay calibrator)Stratus® CS Acute Care™ cTnI DilPak (the assay diluent)Stratus® CS Acute Care™ Myoglobin (MYO) TestPakStratus® CS Acute Care™ MYO CalPak (the assay calibrator)Stratus® CS Acute Care™ MYO DilPak (the assay diluent)

Submitter's Name:

Pamela A. JurgaDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101302-631-8891

Date of Preparation:

June 6, 2005

Name of Product(s):

Stratus® CS Acute Care™ MB isoenzyme of creatine kinase (CKMB)TestPakStratus® CS Acute Care™ CKMB CalPak (the assay calibrator)Stratus® CS Acute Care™ CKMB DilPak (the assay diluent)Stratus® CS Acute Care™ Troponin I (cTnI) TestPakStratus® CS Acute Care™ cTnI CalPak (the assay calibrator)Stratus® CS Acute Care™ cTnI DilPak (the assay diluent)Stratus® CS Acute Care™ Myoglobin (MYO) TestPakStratus® 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)

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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

Diluent

cTnI (TROP on original submission)

Method

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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

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

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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.

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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.

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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.

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.

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

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(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 FluorometricAnalyzer CKMB TestPak (K984067/K981099)	The Stratus® CS Acute Care™ MB isoenzymeof 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

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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 FluorometricAnalyzer 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

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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

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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

Regulation Number and Section

§ 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.