Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The fluorometric analyzer is intended to duplicate manual analytical procedures by performing automatically various steps, such as pipetting, incubation and measuring fluorescence.

Device Description

The Stratus® CS STAT fluorometric analyzer is a benchtop instrument capable of processing up to four in vitro diagnostic tests per sample. An operator of the analyzer introduces a specimen collection tube filled with whole blood into the instrument, along with the appropriate TestPaks for processing. The instrument transfers and spins an aliquot of the sample, delivers the spun plasma and other self-contained reagents to the reaction area of the TestPak, reads the reaction rate via front surface fluorescence and prints out quantitative test results.

The CKMB TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase in heparinized plasma.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Stratus® CS CKMB TestPak vs. Predicate)	Unit/Context
Slope	0.97	N/A
Intercept	0.65	N/A
Correlation Coefficient	0.988	N/A
Range of Samples	0.0 - 123.9	ng/mL

Limitations on Acceptance Criteria: The document does not explicitly state defined acceptance criteria with pre-specified thresholds (e.g., "Slope must be between 0.95 and 1.05"). Instead, it presents the results of a comparison study and implies that these results demonstrate substantial equivalence to the predicate device. The FDA's letter confirms substantial equivalence based on these results.

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

Sample Size: n = 215
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but the description of a "split sample comparison study" suggests a prospective collection where samples were run on both devices concurrently.

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

This information is not provided in the document. The study is a comparison between two in-vitro diagnostic devices, not a study evaluating human interpretation or a device's ability to diagnose conditions where ground truth would be established by experts. The "ground truth" in this context is the measurement provided by the legally marketed predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The study compares the quantitative output of two diagnostic devices. There is no mention of adjudication of interpretations or diagnoses by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. This device is an in-vitro diagnostic analyzer for measuring a biomarker (CKMB) and is not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The "split sample comparison study" directly compares the performance of the new Stratus® CS STAT fluorometric analyzer and its CKMB TestPak against the predicate Dade Stratus® fluorometric analyzer. This comparison is of the device's performance itself, without human intervention in the result generation process beyond operating the instrument.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the predicate device, the Dade Stratus® fluorometric analyzer. The study design aims to demonstrate that the new device's measurements are substantially equivalent to those of the legally marketed predicate.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable. This device is a fluorometric analyzer and a test kit, not a machine learning or AI-based system that would typically require a distinct "training set" in the computational sense. The device's performance is based on its established analytical methodology and engineering, not on learning from data in a training phase.

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

This information is not provided and not applicable for the reasons stated in point 8.

Summary

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K981099

MAY 26 1998

SECTION A

Summary of Safety and Effectiveness

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DADE BEHRING

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

Stratus® CS STAT fluorometric analyzer Stratus® CS CKMB TestPak

Summary of Safety and Effectiveness

The CKMB TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase in heparinized plasma.

The Stratus® CS STAT fluorometric analyzer is substantially equivalent to the Dade Stratus® fluorometric analyzer, which was cleared by the FDA through the 510(k) process. The CKMB assay performed by the CKMB TestPak is substantially equivalent to the CKMB assay performed on the Dade Stratus® analyzer, which was also cleared by the FDA through the 510(k) process. Both methodologies have the same intended uses and are processed on automated systems using similar detection systems for the determination of CKMB.

A split sample comparison study was conducted between the two systems with the following results:

n	Slope	Intercept	CorrelationCoefficient	Range ofSamples
215	0.97	0.65	0.988	0.0 - 123.9

0.0 - 123.9 ng/mL

Carolyn K. George

Carolyn K. George Regulatory Affairs and Compliance Manager

March 24, 1998
Date

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MAY 2 6 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

Re : K981099 Stratus® CS STAT Fluorometric Analyzer and Stratus® CS CKMB TestPak Requlatory Class: II Product Code: JHX, KHO March 24, 1998 Dated: Received: March 26, 1998

Dear Ms. George:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Bitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Indications Statement

Device Name: Stratus® CS CKMB TestPak

Indications for Use: Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Name: Stratus® CS STAT fluorometric analyzer

Indications for Use: The fluorometric analyzer is intended to duplicate manual analytical procedures by performing automatically various steps, such as pipetting, incubation and measuring fluorescence.

Evelyn K. Yenge

Carolyn K. George Regulatory Affairs and Compliance Manager

March 24, 1998
Date

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical 510(k) Number

K98/099

510(k) Number

Division Sign-Off Office of Device Evaluation

prescription use

0000000

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.