The Stratus® CS Acute Care™ BhCG method is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free B subunt, of the human chorionic gonadotropin hormone in heparimized plasma. BhCG is used for the carly detection of pregnancy. 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™ (fhCG Calibrator (fhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus@ ('S Acute Care™ fshCG method.

The Stratus® CS Acute Care™ (ShCG Dilution Pak (BhCG DilPak) is an in wirro diagnostic product intended to be used in conjunction with the Acute Care™ [ShCG TestPak for the measurement of samples with clevated levels of (BhCG).

The Stratus® CS Acute Care™ NT-proBNP method is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. This method is for use by trained health care professionals in the clinical laboratory and point of eare (POC) settings.

The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in virro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ NT-proBNP (pBNP) method.

The Stratus® CS Acute Carc™ NT-proBNP Dilution Pak (pBNP DilPak) is an in virro diagnostic product intended to be used in conjunction with the Acute Care™ (pBNP TestPak for the measurement of samples with elevated levels of NT-proBNP .

Device Description

The Stratus® CS Acute Care™ BhCG method is a solid phase, two-site sandwich fluorometric immunoassay based upon Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal filt G antibody is added to the center portion of a square piece of glass fiber paper in the BhCG TestPak. The dendrimer binds clectrostatically to the glass fibers and immobilizes the capture antibody to the paper. Sample is then added, whereupon fillCG reacts with the immobilized antibody. After a short incubation, a conjugate, consisting of enzyme-laheled (alkaline phosphatase) monoclonal antibody directed against a distinct antigenic site on the ßhCG molecule, is pipetted onto the reaction zone of the paper. During this scoond incubation period, the unbound, labeled antibody is radially eluted with a wash solution. By including substrate (4methylumbeliferyl phosphate) for the enzyme within the wash solution, initiation of enzyme activity occurs simultancously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of BhCG in the sample.

Utilization of two monoclonal antibodies which are specific for distinct antigenie sites on the B subunit of hCG allows the assay to measure the total fihCG in the sample, vis, both the intact hCG dimer and the free B subunit. Concentration 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™ NT-proBNP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked polyclonal antibody is added to the center portion of a square piece of glass fiber paper in the pBNP TestPak. This antibody recognizes a distinct antigenic site on the NT-proBNP 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 polyclonal antibody directed against a second distinct antigenic site on the NT-proBNP molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound NT-proBNP, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later cluted 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 NT-proBNP 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.

AI/ML Overview

This summary describes the acceptance criteria and performance of the Dade Behring Stratus® CS Acute Care™ BhCG and NT-proBNP assays, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of specific thresholds for precision and accuracy. Instead, the acceptance criterion for both the BhCG and NT-proBNP assays is based on demonstrating substantial equivalence to their respective legally marketed predicate devices, especially regarding:

Principle of operation and performance.
Comparability of precision and accuracy data generated by "non-laboratory" (point-of-care, POC) personnel to "laboratory" personnel, supporting the addition of POC to the intended use.

Reported Device Performance:

Feature/Metric	BhCG TestPak, CalPak, DilPak Performance (vs. K003696 Predicate)	NT-proBNP TestPak, CalPak, DilPak Performance (vs. K043476 Predicate)
Substantial Equivalence	Demonstrated in principle of operation and performance.	Demonstrated in principle of operation and performance.
Formulation/Design Changes	None reported; identical to predicate.	None reported; identical to predicate.
Manufacturing Processes	Same as predicate.	Same as predicate.
Labeling Changes	Reflects new intended use (POC), supporting data, and new name.	Reflects new intended use (POC), supporting data, and new name.
Precision & Accuracy	Data generated by "non-laboratory" personnel is comparable to "laboratory" personnel.	Data generated by "non-laboratory" personnel is comparable to "laboratory" personnel.
Intended Use Expansion	Inclusion of Point-of-Care (POC) settings.	Inclusion of Point-of-Care (POC) settings.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact number of samples used in the "method comparison and precision analyses." It only states that these analyses were performed at three different locations.
Data Provenance: The studies were conducted at three different locations:
- One clinical laboratory (LAB)
- One Emergency Department (ED)
- One Cardiac Care Unit (CCU)
  The document indicates the data was generated through "method comparison and precision analyses," which are typically considered prospective data collection. The countries of origin are not specified but implied to be within the scope of the manufacturer's (Dade Behring Inc., Newark, DE, USA) operations.

3. Number of Experts and their Qualifications for Ground Truth:

The document mentions "non-laboratory" personnel (ED or CCU operators) and "laboratory" personnel who generated the precision and accuracy data.
It does not specify the number of individual "experts" used to establish ground truth or their specific qualifications (e.g., years of experience, specific medical board certifications). The ground truth for these assays would typically be the reference method results from a clinical laboratory or another established method.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1 consensus. The evaluation focuses on the device's performance (precision, accuracy, method comparison) against established laboratory methods, rather than expert consensus on diagnostic images or clinical assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done in the context of this 510(k) submission. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This submission is for an in-vitro diagnostic assay for quantitative measurement, which doesn't involve human 'readers' interpreting 'cases' in the same way. The evaluation focused on the comparability of results generated by different types of operators (lab vs. non-lab) using the device, not on human cognitive performance with and without AI.

6. Standalone (Algorithm Only) Performance:

This is an in-vitro diagnostic (IVD) device, specifically an immunoassay for quantitative measurement of biomarkers. The "device" itself (Stratus® CS analyzer and TestPaks) performs the measurement and analysis. Therefore, the performance described is already the standalone performance of the algorithm/device system without human-in-the-loop decision-making in the same manner as an AI imaging algorithm might require. Human operators perform the test and interpret the numerical result, but the measurement is device-driven.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance would have been established by reference laboratory methods for the BhCG and NT-proBNP analytes. The "method comparison" arm of the study indicates that results from the new device were compared against results from other established methods, typically the predicate device or a gold standard laboratory method.
For the purpose of comparing "non-laboratory" personnel results to "laboratory" personnel results, the ground truth for performance metrics (precision and accuracy) would be derived from the known concentrations of control materials or the established values from the predicate device/reference method when run by trained laboratory professionals.

8. Sample Size for the Training Set:

The document does not mention a separate "training set" or its sample size. This is consistent with the nature of the device. This 510(k) submission is for modifications to existing (predicate) IVD assays to expand their intended use to point-of-care settings. These are immunoassay-based systems, not machine learning algorithms that require a distinct training phase. The "development" of the assay itself would have involved extensive analytical validation, but this specific submission focuses on demonstrating equivalency for the expanded use.

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

As there is no distinct "training set" in the context of this 510(k) submission for an immunoassay, the establishment of ground truth for a training set is not applicable. The device's performance is validated against established analytical methods and clinical correlations, where "ground truth" refers to the accurate measurement of the analyte by a highly reliable method or the clinical outcome/diagnosis being correlated.

Summary

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6 2006 APR

Dade Behring Inc.

510(k) Premarket Notification Stratus@ CS [3hCG TestPak, Stratus® CS [9hCG CalPak, Stratus® CS [3hCG DilPak and Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak, Stratus® (S Acute Care™ NT-proBNP (pBNP) CalPak, Stratus B CS Acute CareTM NT-proBNP (pBNP) DilPak

510(k) Sunımary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.

The assigned 510(k) number is:

K060548

1 . Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

Manufacturer:

Contact Information:

Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Pamela A. Jurga Tel: 302-631-8891

Date of Preparation:

February 28, 2006

2. Device Name / Classification

Stratus® CS Acute Care™ ßhCG TestPak / Class II .
Stratus® CS Acute Care™ BhCG Call'ak (the assay calibrator) / Class II .
Stratus® CS Acute Care™ BhCG DilPak (the assay diluent) / Class II .
Stratus® CS Acute Carc™ NT-proBNP (pBNP) TestPak / Class II .
Stratus® CS Acute Care™ NT-proBNP (pBNP) CalPak (the assay calibrator) / . Class II
Stratus@ CS Acute Care™ NT-proBNP (pBNP) DilPak (the assay difuent) / . Class II

3. Identification of the Predicate Device

Dade Behring Stratus® CS BhCG TestPak, CalPak and DilPak . K003696
Dade Behring Stratus@ CS pBNP Acute Care™ TestPak, CalPak and DillPak . K043476

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Dade Deliring me.
Stratus® CS BhCG TestPak, Stratus® CS fJhCG CalPak, Stratus® CS BhCG DilPak and Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak, Stratus® CS Acute Care™ NT-proBNP) (pBNP) CalPak, Stratus® CS Acute Care™ NT-proBNP (pBNP) DilPak

FDA Guidance Document(s):

"Bundling Multiple Devices or Multiple Indications in a Single . Submission" - 11/26/2003
"Class II Special Control Guidance Document for B-Type Natriuretic . Peptide Premarket Notifications: Final Guidance for Industry and FDA Reviewers" - 11/30/2000

Device Description(s): 4.

BhCG

Method

Calibrator

The Stratus® CS Acute Care BhCG calibrator (BhCG CalPak) contains human hCG in a bovine serum matrix with preservatives. The BhCG CallPak is a single-use liquid product which contains one calibrator level at an approximate concentration of 950 mlU/m1.* [1U/L] in each of three wells. The kit consists of five CalPaks at a single calibrator level.

Diluent

The Stratus® CS Acute Care (ShCG Diluent (BhCG DilPak) contains a liquid buffered bovine protein protein matrix with stabilizers and 0.09% sodium azide. The kit consists of 5 DilPaks with diluent in one well.

NT-proBNP

Method

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510(k) Premarket Notification Stratus@CS []hCG] TestPak, Stratus® CS []hCG CalPak, Stratus® CS []hCG ]DiPak and Stratusik CS Acute Care™ NT-proBNP (pBNP) TestPak, Stratus R CS Acute Care™ NT-proBNP (pBNP) CalPak, Stratus R CS Acute Care™ NT-proBNP (pBNP) DilPak

against a second distinct antigenic site on the NT-proBNP molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound NT-proBNP, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later cluted 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 NT-proBNP 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 Carc pBNP Calibrator is a frozen liquid product containing synthetic human NT-proBNP in a bovine albumin 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 pBNP Diluent is a refrigerated product containing a buffered bovine protein matrix with stabilizers and preservative. The kit consists of 5 DilPaks with diluent in one well

5. Device Intended Use:

BhCG

Method

The Stratus® CS Acute Care™ BhCG method is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free B subunit, of the human chorionic gonadotropin hormone in heparinized plasma. BhCG is used for the carly detection of pregnancy. 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™ (ShCG Calibrator (ShCG CalPak), Cat. No. CBHCG-C is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ ßhCG method.

IDiluent

The Stratus® CS Acute Care™ BhCG Dilution Pak (BhCG DilPak), Cat. No. CBHCG-D is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ fihCG TestPak CAT. NO. CBHCG, for the measurement of samples with elevated levels of [}hCG .

NT-proBNP

Method

The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic perside (NT-proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NTproBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) scttings,

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Dade Delining ine.
Stratus® CS [3hCG TestPak, Stratus® CS [3hCG CalPak, Stratus® CS [8hCG DilPak and Stratus® CS pic C Test an, caratoo Espares (S Acute Carc™ NT-proBNP) (pBNP) CalPak, Stratus® CS Acute Care™ NT-proBNP (pBNP) Dill'ak

Calibrator

The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) ), CAT. NO. CPBNP-C is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ NTproBNP (pBNP) method.

Diluent

The Stratus® CS Acute Care™ NT-proBNP Dilution Pak (pBNP DilPak), CAT. NO. CPBNP-D is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ pBNP TestPak, REF CPBNP, for the measurement of samples with clevated levels of NT-proBNP .

Medical device to which equivalence is claimed: (1.

Substantial Equivalence:

The products are substantially equivalent to the commercial Dade Behring Stratus® CS (JhCG and NT-proBNP TestPaks, CalPaks and DilPaks.

βhCG TestPak, CalPak and DilPak	K003696
pBNP Acute Care ™ TestPak, CalPak and DilPak	K043476

BHCG

Method

The Stratus@CS Acute Care™ ßhCG Test Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS BhCG TestPak (K003696). Both assays are in vitro diagnostic tests for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma and are used for the early detection of pregnancy.

There are no formulation or design changes associated with the Stratus® CS BhCG 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™ {}hCG calibrator ({}hCG CallPak) is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS BhCG CalPak (K003696). Both calibrators are intended to be used to callbrate the Stratus® CS Acute Care™ BhCG assay.

There are no formulation or design changes associated with the Stratus® CS flhCG CalPak name 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.

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Stratus® CS BhCG TestPak, Stratus® CS BhCG CalPak, Stratus® CS (BhCG DilPak and Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak, Stratus® CS Acute Care™ NT-proBNP) (pBNP) CalPak, Stratus® CS Acute Care™ NT-proBNP (pBNP) DilPak

Diluent

The Stratus® CS Acute Care™ ßhCG Dil Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus@CS BhCG DilPak (K003696). Both diluents are intended to be used in conjunction with the Stratus® CS Acute Care™ BhCG TestPaks for the measurement of samples with elevated levels of ßhCG.

There are no formulation or design changes associated with the Stratus® CS BhCG DilPak name change. The two dilucnt products are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.

pBNP

Mcthod

The Stratus® CS Acute Care™ pBNP Test Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus CS Acute Care™ pBNP TestPak (K043476). Both assays are in viro diagnostics test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The tests are further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.

There are no formulation or design changes associated with the Stratus® CS pBNP Textl'ak intended use change. The two products are identical and use the same manufacturing processes. I abeling changes reflect the new intended use and supporting data in addition to minor format changes.

Calibrator

The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is substantially equivalent in the principle of operation and performance to the current Dade Bchring Stratus CS® Acute Care™ pBNP CalPak (K043476). Both calibrators are intended to calibrate the NI-proBNP (pBNP) assay on the Stratus® CS analyzer.

There are no formulation or design changes associated with the Stratus® CS Acute Care™ nBNP CallPak name 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.

Dilucnt

The Stratus® CS Acute Care™ pBNP Dil Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS pBNP DillPak (K043476). Both dilucnts are intended to be used in conjunction with the pRNP TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of NT-proBNP.

There are no formulation or design changes associated with the Stratus@ CS Acute Care™ Troponin 1 TestPak intended use change. The two diluent products are identical and use the sume manufacturing processes. Labeling changes reflect the new intended use, supporting data and new name in addition to minor formal changes.

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Dade Behring Inc. 510(k) Premarket Notification Stratus® CS (JhCG TestPak, Stratus® CS (BhCG CalPak, Stratus® CS (BhCG DilPak and Stratus R. CS Acute Care™ NT-proBNP (pBNP) TestPak, Stratus* CS Acute Care™ NT-proBNP (pBNP) CallPak, Stratus® CS Acute CareTM NT-proBNP (pBNP) DilPak

Comparison to Predicate Device:

The modification of these two methods by adding point of care to the intended use is supported by data included in Section 18 (BhCG) and Section 19 (NT-proBNP).

Method comparison and precision analyses were performed at three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Carc Unit (CCU) within either one (BhCG) or two (NT-proBNP) external evaluation sites. This data and a summary of information on the operators and their training, from either the ED or CCU, i.c. "non-lab" operators, is also included in Sections 18 and 19.

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® CS βHCG TestPak(K003696)	The Stratus® CS Acute Care™ βHCG TestPak
Stratus® CS βHCG CalPak (K003696)	Stratus® CS Acute Care™ βHCG CalPak
Stratus® CS βHCG DilPak (K003696)	Stratus® CS Acute Care™ βHCG DilPak
Dade Behring Stratus® Acute Care™ pBNPTestPak (K043476)	Stratus® CS Acute Care™ pBNP TestPak
Stratus® CS pBNP CalPak (K043476)	Stratus® CS Acute Care™ pBNP CalPak
Stratus® CS pBNP DilPak (K043476)	Stratus® CS Acute Care™ pBNP DilPak

Paula L

Pamela A. Jurga Regulatory Affairs and Compliance Manager February 28, 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 features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.

Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Pamela A. Jurga Regulatory Affairs and Compliance Manager Dade Behring, Inc. PO Box 6101, Bldg. 500; M.S. 514 Newark, DE 19714-6101

K060548 Trade/Device Name: Stratus® CS Acute Care™ BhCG TestPak Stratus® CS Acute Care™ BhCG CalPak Stratus® CS Acute Care™ βhCG DilPak Stratus® CS Acute Care™ NT- proBNP (pBNP) TestPak assay Stratus® CS Acute Care™ NT- proBNP (pBNP) CalPak Stratus® CS Acute Care™ NT- proBNP (pBNP) DilPak Regulation Number: 21 CFR§862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA, NBC, JIT Dated: February 28, 2006 Received: March 1, 2006

6 2006

APR

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 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).

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Page 2 -

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

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

Sincerely yours,

Alberto G

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

Enclosure

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Stratus® CS (BhCG) TestPak, Stratus® CS {BhCG CalPak, Stratus® CS (BhCG DilPak and Stratus & CS Acute Care™ NT-proBNP (pBNP) TestPak, Suratus & CS Acute Care™ NT-proBNP) CalPak, Stratus B CS Acute CareTM NT-proBNP (pBNP) DilPak

Indications for Use

510(k) Number (if known): K0610548

Device Name:

Stratus® CS Acute Care™ BhCG TestPak .
Stratus@ CS Acute Care™ BhCG CalPak .
Stratus@ CS Acute Care™ BhCG DillPak

Indications For Use:

The Stratus® CS Acute Care™ BhCG method is an in viro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free B subunt, of the human chorionic gonadotropin hormone in heparimized plasma. BhCG is used for the carly detection of pregnancy. 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™ (fhCG Calibrator (fhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus@ ('S Acute Care™ fshCG method.

Prescription Use ___ x________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Carol Benson
Division Sign-Off

Page 1 org

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K060548

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510(k) Premarket Notification

Stratus® CS (BhCG) TestPak, Stratus® CS (BhCG CalPak, Stratus® CS (BhCG T)iPak and Stratus » CS Acule Care™ NT-proBNP (pBNP) TestPak, Stratus® CS Acute Care™ NT-proBNP (pBNP) CalPak, Stratus® CS Acute Care™ NT-proBNH (pBNP) DilPak

Indications for Use

K40548

510(k) Number (if known):

Device Name:

Stratus@ CS Acute Care™ NT-proBNP (pBNP) TestPak assay ●
Stratus@ CS Acute Carc™ NT-proBNP (pBNP) CalPak ●
Stratus@ CS Acute Care™ NT-proBNP (pBNP) Dill'ak .

Indications For Use:

The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in virro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ NT-proBNP (pBNP) method.

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

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

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

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

Carol Benson
Division Sign-Off

Page 1 of 2

51041 K060548

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.